Influenza A; Influenza A; This spontaneous case, initially received on 20-Jan-2025, was reported by a non health professional and concerns a female patient with unknown age. Medical history and concomitant medications were unknown. Administration of company suspect drug: On 10-Oct-2024, the patient received Flucelvax (TIV) for an indication not reported, dose regimen: 0.5 ml, route of administration and anatomical location: not reported, Lot number: 946618. No additional suspect drugs. Adverse reactions/events and outcomes: On 06-Jan-2025, the patient experienced Influenza A (Medically Significant, outcome: Unknown), Influenza A (outcome: Not reported). The patient reported that was administered Flucelvax 2024-2025 (Lot #946618) on 10-Oct-2024 at Pharmacy. On Monday 06-Jan-2025 the patient was diagnosed with Influenza A (by point-of-care testing Influenza A rapid) at Urgent Care. It was unknown if patient was hospitalized. Treatment measures associated with event: Unknown Flucelvax (TIV) action taken: Not Applicable Reporter assessment: The reporter considered the events as non serious and did not provide a causality assessment.; Reporter’s Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. A lack of effect/vaccination failure can generally be expected for any medicinal/drug product/vaccine as a 100% success rate cannot be reasonably assumed in every patient treated.

Patient experience fever; site reaction ( bump); site reaction (red ); site reaction ( hard); This spontaneous case, initially received on 12-Jan-2025, was reported by a non health professional and concerns a(n) Other child female patient. Past medical history included Immunization. Administration of company suspect drug(s): On an unknown date, the patient received INN Flu Vaccine Seasonal for Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 12-Jan-2025, the patient experienced Patient experience fever (outcome: Recovered / Resolved, stop date: Jan-2025), site reaction ( bump) (outcome: Recovered / Resolved), site reaction (red ) (outcome: Recovered / Resolved), site reaction ( hard) (outcome: Recovered / Resolved). Non-drug treatment/Other action taken: INN Flu Vaccine Seasonal action taken: Not Applicable; Reporter’s Comments: The events were considered related

After received second Pfizer Covid shot patient flareups with FMF stopped. Patient used to get at least four attacks per year.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient’s relevant medical history included: “Familia Mediterranean Fever (FMF)” (unspecified if ongoing). The patient’s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome “unknown”, described as “After received second Pfizer Covid shot patient flareups with FMF stopped. Patient used to get at least four attacks per year.”. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.

affected balance, eyes, hands; affected balance, eyes, hands; affected balance, eyes, hands; every bone in body hurts; triggered an attack on lupus; triggered an attack on lupus; This is a spontaneous report received from a Consumer or other non HCP. A 91-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 29Nov2024 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient’s relevant medical history included: “Lupus”, start date: 2023 (ongoing), notes: under the care of a dermatologist, doing fine; “Covid-19”, start date: 2023 (unspecified if ongoing). The patient’s concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (medically significant, disability) with onset 2024, outcome “not recovered”, SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant, disability), outcome “not recovered” and all described as “triggered an attack on lupus”; BALANCE DISORDER (disability), EYE DISORDER (disability), LIMB DISCOMFORT (disability), outcome “not recovered” and all described as “affected balance, eyes, hands”; BONE PAIN (disability), outcome “not recovered”, described as “every bone in body hurts”. Clinical course: The patient got lupus 2 years ago (2023) when got covid (2023), but she has been under the care of a dermatologist. The patient was doing fine and the day after thanksgiving she got RSV vaccination shot, and patient has been sick ever since. The RSV shot triggered an attack on lupus, the shot also affected her balance, eyes, hands and every bone in body hurts. Patient stated that Pfizer was going to say the age, 91, had a lot to do with it but that’s not true. Now patient was suffering from these debilitating side effects. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.

I had the covid shot the vaccination shot and i got really sick from the shot.; Caller had the covid virus and they gave her Paxlovid to take; Caller had the covid virus and they gave her Paxlovid to take; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 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 included: “My kidneys are a little bit low” (unspecified if ongoing); “I also has a heart problem” (unspecified if ongoing). The patient’s concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2025, outcome “unknown” and all described as “Caller had the covid virus and they gave her Paxlovid to take”; ILLNESS (non-serious), outcome “unknown”, described as “I had the covid shot the vaccination shot and i got really sick from the shot”. It was reported that the patient had the covid shot the vaccination shot and she got really sick from the shot. Caller had the covid virus. Patient had fever. They gave her Paxlovid to take. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2025) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.

heart fluttering; fatigue; fever; weakness; very shaky; had to concentrate to be able to breath; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 75-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 included: “Stage III Endometrial cancer” (not ongoing), notes: she beat it, she’s in health now. The patient’s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Comirnaty (2023-2024 formula) (DOSE 3 (BOOSTER), SINGLE), administration date: Oct2023, for Covid-19 Immunization, reaction(s): “severe reaction”. The following information was reported: CARDIAC FLUTTER (medically significant), 10 hrs after the suspect product(s) administration, outcome “not recovered”, described as “heart fluttering”; FATIGUE (non-serious), 10 hrs after the suspect product(s) administration, outcome “not recovered”; PYREXIA (non-serious), outcome “not recovered”, described as “fever”; ASTHENIA (non-serious), 10 hrs after the suspect product(s) administration, outcome “not recovered”, described as “weakness”; TREMOR (non-serious), 10 hrs after the suspect product(s) administration, outcome “unknown”, described as “very shaky”; DYSPNOEA (non-serious), 10 hrs after the suspect product(s) administration, outcome “unknown”, described as “had to concentrate to be able to breath”. Clinical course: Caller had all her Pfizer COVID-19 doses, first, second, third and the most recent one, but on the last one, she started experiencing fever, weakness, heart fluttering, fatigue, and she’s wondering what to do now. She wanted to know whether to get the new vaccine or not. She mentioned she’s afraid to get another vaccination, but she’s also afraid of getting covid and not surviving. She doesn’t know what to do. She added that she’s 75 years old, and not in an age to fight. She also had a cancer diagnosis few years ago, it was Stage III Endometrial, and she beat it, she’s in health now, but her body is been through a lot. She mentioned her reaction was so bad, she really thought she was going to die. She stated that the fatigue went through weeks and weeks, and she went to the ER several times, and nobody knew what to do. Caller mentioned her previous dose was about a year ago, Oct2023, she mentioned it might have been the “bi-variant”. Caller also wanted to know if having a previous history of side effects to the other Pfizer COVID-19 Vaccine formulations would cause her to get a reaction again. Caller then spoke about “preveset” or “prevesid”, which is a medication given by doctors to make a milder case of covid if you take this medication within the first days of getting COVID, but she added her doctor told her that their site is not using that medication as it has too many complications, too many reactions. Caller finally stated that she will either try to get lucky, or maybe switch to Moderna to avoid reaction with our vaccine again. Consumer stated, “So, I had a several of the Pfizer COVID shot (Later clarified as Pfizer COVID-19 Shot) the 1st, the 2nd, the 3rd and the last one I had, I had terrible reaction from it that lasted, the most severe reaction was, I had it 11 O’clock in the morning and at 09:30 that evening the reaction was extremely severe, I suddenly got very weak, very shaky, my heart was kind of fluttering, I had to concentrate to be able to breath and I had extreme fatigue for weeks and weeks afterwards. So, I am wondering, what do I do now to not die from COVID because I am worried about it.” No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.

the syringe broke during reconstitution; This is a spontaneous report received from a Pharmacist from product quality group, Program ID. A patient (age and gender not provided) received respiratory syncytial virus vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome “unknown”, described as “the syringe broke during reconstitution”. Additional information: Pharmacist reported that they were having issues with reconstitution of respiratory syncytial virus vaccine prot.subunit pref 2v, the syringe broke during reconstitution process. Pharmacist was the one reconstituting it, had done two or three hundred of these, and this was the only one that had go wrong. The little collar on syringe broke. Pharmacist confirmed no patients were involved or administered with this vaccine. No glass shards were found. The glass vial did not break at all, only the plastic piece. Causality for “the syringe broke during reconstitution” was determined associated to device constituent of respiratory syncytial virus vaccine prot.subunit pref 2v (malfunction).

the device broke and the solution fell everywhere/solution fell all over the ground; This is a spontaneous report received from a Pharmacist from product quality group, Program ID:. A patient should have received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: KC7884, Expiration Date: Oct2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome “unknown”, described as “the device broke and the solution fell everywhere/solution fell all over the ground”. NDC Number: 0069034401. UPC Number: 300690344010. The reporter considered “the device broke and the solution fell everywhere/solution fell all over the ground” not related to rsv vaccine prot.subunit pref 2v. Causality for “the device broke and the solution fell everywhere/solution fell all over the ground” was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).

I start shaking; Got a light case of Covid 19; I took a test and it was positive; I felt like little cold like symptoms and with a little sore throat; I felt like little cold like symptoms and with a little sore throat; I still have the fatigue and some brain symptoms; The next day I can do almost nothing; In the middle of exercising, I need to stop and sit down; I still have the fatigue and some brain symptoms; I start shaking; The next day I can do almost nothing; In the middle of exercising, I need to stop and sit down; I still have the fatigue and some brain symptoms; Feeling a little under the weather; Sore arm; I had minimal side effects; Brain fog; I still have long covid symptoms; This serious initial spontaneous safety report was received by Novavax on 09-Oct-2024 from a consumer via Novavax Medical Information (NOV24-00567 and NOV24-00609). A female of unspecified age was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula)(Intramuscular) (Lot number was not provided in the report) in 2023. The following medical history was reported: ALLERGIC ASTHMA. No concomitant medications were reported. On an unspecified date after vaccination the patient experienced Feeling a little under the weather (Malaise) and Sore arm (Pain in extremity). In Nov-2023 the patient experienced I felt like little cold like symptoms and with a little sore throat (Nasopharyngitis) (Oropharyngeal pain), I took a test and it was positive (Vaccination failure) (Serious: Other Medically Important Condition), Got a light case of Covid 19 (COVID-19), I still have long covid symptoms (Post-acute COVID-19 syndrome), I still have the fatigue and some brain symptoms (fatigue) (Nervous system disorder). Treatment for COVID-19 included Paxlovid. Relevant lab tests included: COVID-19 TEST(Result: Positive, Test Date: Nov-2023). At the time of reporting, the event outcome of Fatigue and Nervous system disorder was Recovering/Resolving; the event outcome of Malaise, Pain in extremity, COVID-19 was Unknown; the event outcome of Post-acute COVID-19 syndrome was Not Recovered/Not Resolved/Ongoing, the event outcome of Nasopharyngitis, Oropharyngeal pain and Vaccination failure was Recovered/Resolved. On 15-Oct-2024, significant information was received from PQC via a follow-up query – added 2 new reporters, updated therapy start and end date from –2023 to 29-Oct-2023, and lot number to 5683MF012, vaccination facility telephone, added 1 new event: I had minimal side effects (PT: Adverse event) with the outcome as Recovered/Resolved. Patient’s past therapy was added: Nuvaxovid COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) administered on 15-Oct-2024, with associated events Pain, Headache and Fever. On 14-Nov-2024, significant information was received from a consumer via a query response: Added reporter’s middle name Added 1 new patient past therapy (Moderna in 2021 with reported event: Severe reaction to my 2nd Moderna shot). Added 2 new events in the patient past therapy for Nuvaxovid received in 2024: Not nearly as bad as my severe reaction to my 2nd Moderna shot in 2021, but definitely uncomfortable (PT: Adverse event), Worse since my booster (PT: Condition aggravated) Added body temperature increased in patient medical history Updated COVID test date from -Nov-2023 to 23-Nov-2023 Updated event onset date of I took a test and it was positive (PT: Vaccination failure) to 23-Nov-2023, added Paxlovid as treatment started on 23-Nov-2023. Added 2 new events – On an unknown date, the patient experienced Brain fog (PT: Brain fog); On an unknown date in Nov-2023, the patient experienced I start shaking (Tremor). The outcome of the events Brain fog and Tremor were Not Recovered/Not Resolved/Ongoing. The reported term for the event PT: Fatigue was updated from “I still have the fatigue and some brain symptoms” to “I still have the fatigue and some brain symptoms; The next day I can do almost nothing; In the middle of exercising, I need to stop and sit down”. Updated event outcome of PT: Fatigue to Not recovered/Not resolved/Ongoing. On 21-Nov-2024, the product quality complaint (PQC) investigation results were received. Per the investigation summary, the vaccine was expected ti meet all critical quality attributes at the time of vaccine administration. PQC was added as Report classification. On 20-Dec-2024, non-significant information was received from a consumer – No new information was received. On 25-Jan-2025, significant information was received from a consumer via a query response: History of Allergic asthma estimated start was provided as 25 years ago, and classified as current condition as response to whether condition is ongoing was “unknown/sometimes”. Added Flu vaccine to past therapy. Other COVID-19 vaccines site of administration for Moderna and Johnson & Johnson received in 2022 was updated to left arm. Dose number in series of two moderna doses received in 2022 was confirmed as Doses 1 and 2 while dose of Johnson & Johnson was in 2022 was confirmed as booster dose. The following events were upgraded to serious: fatigue (serious: disability), Nervous system disorder (serious: disability), COVID-19 (serious: disability), Adverse event (serious: disability), brain fog (serious: disability), Onset date of the event of PT: COVID-19 was updated to 23-Nov-2023 and outcome was updated recovered/resolved with sequelae. Onset date of the event of PT: Nasopharyngitis was updated to 23-Nov-2023 and outcome was updated recovered/resolved. Onset date of the event of PT: Oropharyngeal pain was updated to 23-Nov-2023 and outcome was updated recovered/resolved. Onset date of the event of PT: Malaise was updated to 23-Nov-2023 and outcome was updated recovered/resolved. Onset date of the event of PT: Pain in extremity was updated to 23-Nov-2023 and outcome was updated to recovered/resolved. Onset date of the event of PT: Adverse event was updated to 23-Nov-2023, and outcome was updated to recovered/resolved with sequelae. Onset date of the event of PT: Brain fog was updated to 23-Nov-2023. Onset date of the event of PTs: Fatigue and Nervous system disorder was updated to 23-Nov-2023, and outcome of the events were updated to not recovered/not resolved. Start date of the event of PT: Tremor was updated to 15-Dec-2023. Discrepancies were identified in the source document – Flu vaccine was reported as concomitant medication, but it was also stated that it was received a few weeks – 45 days, thus not captured as concomitant medication as it was beyond 30 days in the structured field. This was instead captured as past therapy. Start dates captured as 23-Nov-2023 as no month corresponds to 23 if the format of DD/MMM/YYYY is followed. Patient’s age was reported as 70 years, however age at the time of the event was retained (69 years).; Sender’s Comments: This 69 years old female experienced Malaise, Pain in extremity, Adverse event, Brain fog, Tremor, COVID-19, Post-acute COVID-19 syndrome, Nasopharyngitis, Oropharyngeal pain, Nervous system disorder, Fatigue and Vaccination failure after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (4). The event Vaccination failure was assessed as serious. The events of Fatigue, Nervous system disorder, COVID-19, Adverse event, and brain fog were reported as serious. The event Malaise, Pain in extremity, Tremor, Post-acute COVID-19 syndrome, Nasopharyngitis, Oropharyngeal pain were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and COVID-19, Post-acute COVID-19 syndrome, Tremor, Nasopharyngitis, Oropharyngeal pain, Nervous system disorder, Fatigue, Malaise, Pain in extremity, Adverse event and Brain fog is considered Possible; and the event of Vaccination failure is considered Related.

Patient contracted COVID in April of 22; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient contracted COVID in April of 22) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D71F21A, 028A21A and D121A21A) for COVID-19 prophylaxis. No Medical History information was reported. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (Patient contracted COVID in April of 22). At the time of the report, COVID-19 (Patient contracted COVID in April of 22) had resolved. No concomitant medication was reported. On 13-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Patient received 5h dose of Spikevax vaccine on OCT-2024. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.