Vaccinated Friday 1/10/25, starting Saturday morning 1/11/25 headache, temperature 103.0, pain in all joints, exhaustion (slept 16 hrs). L arm sore starting then with a lump but not red or hot. Continued headache, joint pain, fatigue but not fever thru 1/13/25, felt better 1/14/15, return of symptoms 1/15/25 which is when pt reported it.

The patient got a dose of RSV vaccine in 2023. Patient got 2nd dose on 01-21-25 when not indicated. No adverse event reported from the patient at this time.

Contractions (Preterm); Maternal Exposure During Pregnancy, third trimester; A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY This is a Pfizer sponsored study report for protocol. This is the maternal case. This is a case for a 41-year-old maternal participant, who received study vaccine (PF-06928316; PLACEBO), while pregnant via intramuscular route in left deltoid on 19Jul2021 at 11:23 as single dose, at age of 41-year-old for prevention of respiratory syncytial virus (RSV) in the infant. No adverse events/reactions were reported in the e-diary on 19Jul2021. Participant was not unblinded. Medical history included fibroid from 2019 and ongoing, ongoing uterine fibroids diagnosed from Apr2018 with myomectomy in Apr2018, ongoing uterine fibroids diagnosed from May2019 with myomectomy in 2019, ongoing obesity from Nov2010 with laproscopic band placement and lap band removal in 2010, ongoing allergies (seasonal allergies, birch tree and apples) from 1980, ongoing mild bilateral pedal edema from 2021; pregnancy (C-section) on 12Mar2020, shoulder pain from Dec2008 to Dec2009 with shoulder surgery from Dec2008 to Dec2009, spontaneous abortion (SAB) from 2017 and from 1995. The mother never smoked, used alcohol, or used illicit drugs. Ongoing concomitant medications included fluticasone propionate (FLONASE) for seasonal allergies since 02Apr2021, and minerals NOS/vitamins NOS (PRENATAL VITAMINS) as supplement since Dec2020. There were no concomitant vaccines, prior vaccinations within 4 weeks, or family medical history relevant to the event. Current pregnancy details were as follows: first day of last menstrual period (LMP) was in Nov2020. Gestation at time of initial vaccination was 35 weeks 4 days. The mother had 4 pregnancies with 1 live birth via C-section, 1 elective abortion, 2 spontaneous abortions. The maternal participant experienced contraction (preterm) on 20Jul2021 at 02:00 which was caused hospitalization for less than one day. The clinical course was reported as follows: On 20Jul2021 at 02:00, about 14 hours after IP receipt, the participant woke up with nausea and diarrhea. At 03:00, the participant had abdominal pains, which worsened around 06:00 and she called her obstetrician-gynecologist (OBGYN) who instructed her to go to the labor and delivery suite for further evaluation at 07:06. At 08:37, the participant was admitted to the labor and delivery ward of the hospital (inpatient) with contractions. She presented to triage with complaints of abdominal pain-tightening, coming and going that she found very uncomfortable and thought she was having contractions. No leakage of amniotic fluid was observed, and fetal movements were present. Following evaluations were completed, fetal heart rate assessment: baseline 150, variability moderate and acceleration present. Normal fetal heart rate (FHR) category was: 1. Abdominal assessment: gravid and presentation: vertex. Uterine contractions: tocodynamometer (TOCO)-uterine irritability noted initially, resolved after 1 liter ringer’s lactate (RL) and rest. Tests performed on 20Jul2021 included urine analysis which showed +1 protein, +1 ketones. The participant underwent the following laboratory tests and procedures: Basophil count (0.0-0.0): (20Jul2021) 0.0 x10 3/mm3, notes: at 11:14; Basophil percentage (0.0-4.0): (20Jul2021) 0.1 %, notes: at 11:14; Eosinophil count (0.0-1.0): (20Jul2021) 0.0 x10 3/mm3, notes: at 11:14; Eosinophil percentage (0.0-7.0): (20Jul2021) 0.3 %, notes: at 11:14; Foetal heart rate: (unspecified date) baseline 150, notes: variability moderate and acceleration present. Normal fetal heart rate (FHR) category was: 1; Haematocrit (37.0-52.0): (20Jul2021) 39.2 %, notes: at 11:14; Haemoglobin (12.0-18.0): (20Jul2021) 12.6 g/dl, notes: at 11:14; Immature granulocyte count (0.0-3.0): (20Jul2021) 0.4 %, notes: at 11:14; TOCO: (unspecified date) uterine irritability noted initially, notes: resolved after 1 liter ringers lactate (RL) and rest; Lymphocyte count (1.0-4.0): (20Jul2021) 0.7 x10 3/mm3, notes: low at 11:14; Lymphocyte percentage (8.0-49.0): (20Jul2021) 7.8 %, notes: low at 11:14; Mean cell haemoglobin (27.0-31.0): (20Jul2021) 28.4 pg, notes: at 11:14; Mean cell haemoglobin concentration (31.0-36.0): (20Jul2021) 32.1 g/dl, notes: at 11:14; Mean cell volume (78.0-94.0): (20Jul2021) 88.5, notes: fL, at 11:14; Mean platelet volume (6.0-11.0): (20Jul2021) 9.2, notes: fL, at 11:14; Monocyte count (0.0-2.0): (20Jul2021) 0.4 x10 3/mm3, notes: at 11:14; Monocyte percentage (4.0-15.0): (20Jul2021) 4.4 %, notes: at 11:14; Neutrophil count (1.0-11.0): (20Jul2021) 7.8 x10 3/mm3, notes: at 11:14; Neutrophil percentage (37.0-84.0): (20Jul2021) 87 %, notes: high at 11:14; Platelet count (140-440): (20Jul2021) 380 x10 3/mm3, notes: at 11:14; Promyelocyte count (0.0-0.3): (20Jul2021) 0.0 x10 3/mm3, notes: at 11:14; Red blood cell count (3.8-5.9): (20Jul2021) 4.4 x10 6/mm3, notes: M/uL, at 11:14; Red blood cell nucleated morphology present (0.0-1.0): (20Jul2021) 0.0 %, notes: at 11:14; Red blood cell nucleated morphology present (0.0-0.0): (20Jul2021) 0.0 x10 3/mm3, notes: at 11:14; Red cell distribution width (11.5-14.5): (20Jul2021) 13.1 %, notes: at 11:14; Urine analysis: (20Jul2021) +1 protein, +1 ketones; Weight: (unspecified date) 129 kg; White blood cell count (4.0-10.0): (20Jul2021) 9.0 x10 3/mm3, notes: at 11:14. Participant was discharged at 11:57 on 20Jul2021. The maternal participant delivered a normal female infant with live delivery, gestational age at birth was 39 weeks, clear amniotic fluid. Apgar scores 1 min and 5 mins were 9. Birthweight was 2.98 kgs, length at birth was 50 cm and head circumference at birth was 33 cm. The action taken in response to the event for blinded study vaccine (PF- 06928316; PLACEBO) was not applicable. The outcome of the event was recovered on 20Jul2021. The investigator considered there was a reasonable possibility that the event “contractions (preterm)” was related to blinded study vaccine, but unrelated to concomitant drugs or clinical trial procedure. The blind was broken by sponsor due to serious, related, unexpected event. Follow-up (30Aug2021): New information reported includes: medical history and pregnancy outcome details. Follow-up (08Sep2021 and 11Sep2021): New information reported includes: Updated relevant medical history, unblinding status, last action taken as not applicable, and reaction data (updated outcome and date of recovery). Follow-up (18Feb2022 and 22Feb2022): This is a Pfizer Sponsored Interventional Study follow-up report for Protocol. Updated information: medical history details (TAB updated to SAB from 1995, myomectomy date updated), reaction data (hospital stay days added), added lab data, additional clinical course (LMP, event details). Follow-up (04Mar2022): This is a Pfizer Sponsored Interventional Study follow-up report for Protocol. Updated information: reporter details and medical history (start date of obesity updated to Nov2010). Follow-up (18Mar2022): This is a Pfizer Sponsored Interventional Study follow-up report for Protocol. Updated information: updated first date of LMP. Follow-up (15Jan2025): This is a literature report for the following literature source:. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Updated information: Updated Reporter and Literature information. The participant was found to be treated with a single PF-06928316 120 ug dose. It was reported that “premature labor the day after vaccination, which resolved that day after fluids and rest, with uncomplicated delivery at 39 weeks”.; Sender’s Comments: The event Premature Uterine Contractions is unlisted in the Single Reference Safety Document of the Investigational Product and unrelated to the study drug per company assessment and related per investigator. Based on the current information available, in a maternal participant with a history of 3 abortions and uterine fibroids, it is the company position that there is not a reasonable possibility study vaccine could have contributed to the event Premature Uterine Contractions. There is not enough evidence available to attribute a causal association between the event Premature Uterine Contractions and the study vaccine. Causality will be further reevaluated based on any additional information during the follow-up The impact of this report on the benefit/risk profile of the Pfizer PF-06928316; PLACEBO on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate

lung infection; infections all the way from the bladder; ear exploding; mucus that was coming out of their ears; eye infection; ear exploding and bleeding; patient is still experiencing symptoms despite treatment with fluzone hd/ short period of efficacy of FLUZONE HD; Initial information received on 16-Jan-2025 regarding an unsolicited valid serious case received from a Patient. This case involves a 75 years old female patient who experienced lung infection, infections all the way from the bladder, ear exploding and bleeding, eye infection and patient is still experiencing symptoms despite treatment / short period of efficacy of Influenza usp trival a-b high dose subvirion vaccine [Fluzone HD]. The patient’s past medical history included Ear tube insertion. The patient’s past medical treatment(s), and family history were not provided. The patient has been getting flu shots since the age of 23 years (unspecified manufacturer) At the time of the event, the patient had ongoing Hypersensitivity and Otorrhoea. On an unknown date in 2024, the patient received a dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe lot number not reported via unknown route in unknown administration site (dose, route, strength, lot/batch number and expiration date: not provided) for Influenza immunization. Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested. On an unknown date; patient was still experiencing symptoms despite treatment with FLUZONE HD. Patient also complained about the short period of efficacy of FLUZONE HD (therapeutic response shortened) (latency: approximately 5 months). Patient said that they were calling about the flu shot that they had. They said this year, its effects only lasted for five months and that their doctor told them not to get another one. They shared that they have four infections all the way from the bladder, (cystitis) (unknown latency) to their ear exploding (otorrhoea) (unknown latency) and bleeding (ear haemorrhage) (unknown latency), to their eyes (eye infection) (unknown latency), and lungs (pneumonia) (unknown latency). They said that they were also taking antibiotics “and all that stuff” but they said that they also needed the protection of a flu shot. They said that if it is not going to work, they wanted to know if it will also be like this next year. They said that “whatever it was” that used to work was taken out. Patient said that everybody had flu and said that the flu shots are really bad this year. After five months, their doctor told them to not go get another one. They said that they do not know what they are supposed to do. They said that they are unprotected. They said that they are a PCA (personal care assistant) and that they take care of sick people. They said that they don’t know what to do multiple times. Patient said that they took another dose of FLUZONE HD after it “wore off” in eight months. They tried to get another one five months after this and was advised by their doctor to not get another one. They were frustrated that it took less time this year to not work. MIS inquired more about the blood and explosion in their ears. Patient clarified that it was actually mucus that was coming out of their ears and that the flu shots used to “take care of that.” They shared that they were born in city with smog which was why they had natural allergies “and stuff.” They said that mucus also got out of their ear twice when they were younger. They said that they “knew it didn’t work anymore when” their ears went bad. They said that they ended up with their doctor and had tubes in their ears. They said that this was when they realized that it was the flu shot all along which made them get another one. They said that this flu shot lasted for four years. Patient said that the flu shot started lasting only a year and then eight months for the next one. Now, they are frustrated this time it only lasted for five months. They clarified that when mucus gets out of their ears, their eardrums pop and that this only happens when they don’t take the flu shot. They said that the flu shots have saved their life for 40 years and now that it is not working, they are afraid because they are a PCA and that they feel like a “vat of germs.” They said that they do not know if they should even be taking care of clients. They reiterated that they were a personal care assistant. They said that if the flu shots continue to not work, they might have to move “or something.” Patient inquired about an RSV (respiratory syncytial virus) shot that has recently “come out” and wanted to know if it can help control their mucus. MIS inquired about the brand name of the aforementioned RSV vaccine, then referred them to their HCP (healthcare professional). Patient was not able to confirm the brand name of the RSV vaccine. Patient said that they have plans and that they needed information. They said that they have been taking flu shots since they were 23 years old, during which it lasted for 35 years. Patient made a brief observation about how it was also in the middle of winter in their area Action taken- not applicable for all the events An unknown antibiotic as an corrective treatment was received for the events (eye infection, lung infection; otorrhoea; ear haemorrhage and cystitis) At time of reporting, the outcome was not recovered/ not resolved for otorrhoea and Unknown for all the events. Seriousness criteria- Medically significant for Pneumonia.; Sender’s Comments: Sanofi Company Comment dated 21-Jan-2025: This case involves a 75 years old female patient who experienced lung infection, after receiving Influenza usp trival a-b high dose subvirion vaccine [Fluzone HD]. The causal role of the company suspect vaccine cannot be assessed in the absence of information regarding temporal relevance. Further information regarding concurrent condition during vaccination, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed. Additionally the role of patient’s allergies; occupational exposure to infections cannot be overlooked either.

data logger usually logs the temperature twice a day but for some reason, on 23dec2024, it did not pick up on the temperature excursion at 46.5 degrees f for 15 minutes with no reported ae; Initial information received on 14-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 years old female patient who received IPV (VERO) [IPOL] which was exposed to temperature excursion due to data logger usually logs the temperature twice a day but for some reason, it did not pick up on the temperature excursion at 46.5 degrees f for 15 minutes with no reported adverse event. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation; Varicella zoster vaccine (Varicella vaccine) for Immunisation; Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for Immunisation; Influenza vaccine (Influenza) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. On 09-Jan-2025, the patient received 0.5 ml of dose 2 of IPV (VERO) Suspension for injection (strength- standard, expiry date- 31-Oct-2026 and lot X1C891M) once via intramuscular route in the right deltoid as Immunization which was exposed to temperature excursion due to data logger usually logs the temperature twice a day but for some reason, it did not pick up on the temperature excursion at 46.5 degrees f for 15 minutes with no reported adverse event (Poor quality product administered) (latency- same day). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder’s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

an auto immune disease; pain is unreal some days; congestive heart failure; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 45-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE CONGESTIVE (medically significant) with onset 2024, outcome “unknown”, described as “congestive heart failure”; AUTOIMMUNE DISORDER (medically significant), 6 months after the suspect product(s) administration, outcome “unknown”, described as “an auto immune disease”; PAIN (non-serious), outcome “unknown”, described as “pain is unreal some days”. The event “an auto immune disease” required physician office visit. Clinical details: Fast forward to 10 months ago the patient was diagnosed with congestive heart failure. Not 1 case of any kind of heart disease anywhere in either side of her family. The patient is a married woman, with 4 kids, and just had her 1st grandbaby. Before she had the shot in 2020, she was healthy, played softball as adult, very on the go with kids and work, never slowed down. 6 months after Pfizer’s covid vaccine, she is finding that she has an auto immune disease that most likely would have laid dormant rest of her life if she wouldn’t have had. 7 different dermatology confirmed. Pain is unreal some days. Her girls have to brush her hair after. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.

he is trying to be a father again, after the vaccines it was not successful; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (Dose 1, lot number unknown), for COVID-19 immunisation; Pfizer covid vaccine (Dose 2, lot number unknown), for COVID-19 immunisation. The following information was reported: INFERTILITY MALE (non-serious), outcome “not recovered”, described as “he is trying to be a father again, after the vaccines it was not successful”. Additional information: Patient used Pfizer Covid vaccine. After they give him 3 applications, he is trying to be a father again, after the vaccines it was not successful. He is very worried about it and he need to know if he can count on Pfizer’s help to solve this problem that is serious. The patient is the father of 3 beautiful children and he has never had this problem, after the vaccine, there was no result until currently. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.

I had 4 Pfizer covid vaccinations I had Covid 4 times.; I had 4 Pfizer covid vaccinations I had Covid 4 times.; This is a spontaneous report received from an Other HCP. A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome “unknown” and all described as “I had 4 Pfizer covid vaccinations I had Covid 4 times.”. Therapeutic measures were taken as a result of drug ineffective, covid-19. Only treated with Paxlovid this last diagnosis-first time very sick with no Paxlovid Rx. The information on the batch/lot number for BNT162b2 omicron (kp.2) has been requested and will be submitted if and when received.; Sender’s Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 OMICRON (KP.2) cannot be fully excluded.

Patient ran a temperature; exhausted; felt really bad; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome “unknown”, described as “Patient ran a temperature”; FATIGUE (non-serious), outcome “unknown”, described as “exhausted”; FEELING ABNORMAL (non-serious), outcome “unknown”, described as “felt really bad”. Additional information: Caller calling in regards to the covid vaccine this year. The caller mentions that the callers daughter gotten sick with the vaccine and stated both of them, yes referring to the patients vaccines. Daughter had the vaccine at the same time as granddaughter and no reactions it just made her sick. Patient ran a temperature and felt really bad and had to stay in bed. Was exhausted and felt bad. This is the fist time had a reaction. Never had a reaction except this year. Stated we have never had a reaction to it except this year, Caller mentioned that everyone she talked thats received the Pfizer vaccine this year has gotten ill. Caller has no details to provide, No lot numbers to provide for any other patient. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.

Psoriasis; This is a spontaneous report received from a Nurse. A 45-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: comirnaty (Dose 1; lot: EL9262), administration date: 21Jan2021, when the patient was 45-year-old, for COVID-19 immunization; comirnaty (Dose 2; lot: EM9809), administration date: 11Feb2021, when the patient was 45-year-old, for COVID-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset Aug2021, outcome “unknown”. Additional information: The patient called because she developed psoriasis after she took Pfizer COVID-19 Vaccine. Patient confirmed that she does not have psoriasis before she took it and then after she took the Pfizer Covid vaccine, she developed it.