his body has been “hacked” by the vaccination/he now receives “visions” and commands as if he were being controlled by an IT; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-017568 (BioNTech). 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. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome “unknown”, described as “his body has been “hacked” by the vaccination/he now receives “visions” and commands as if he were being controlled by an IT”. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. Additional information: since the vaccination, the patient assumed that his body had been “hacked” by the vaccination and that he now receives “visions” and commands as if he were being controlled by an IT. He asked that BioNTech disable this function or asks what can be done about it.

did get COVID even after having a vaccine; did get COVID even after having a vaccine; allergic to Covid vaccine; sick; fever; chills; ached; Muscles aches all over my body; headache; The initial case was missing the following minimum criteria: unspecified suspect drug. Upon receipt of follow-up information on 15Jan2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 75-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient’s relevant medical history included: “cancer”, start date: 2019 (unspecified if ongoing); “fibromyalgia” (unspecified if ongoing); “arthritis” (unspecified if ongoing); “Surgery” (unspecified if ongoing); “radiation therapy” (unspecified if ongoing). Concomitant medication(s) included: XANAX; WELLBUTRIN. Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 1, SINGLE; left arm), administration date: Oct2022, for COVID-19 Immunization, reaction(s): “chills”, “bad headache”, “sick”, “muscles aches all over my body”, “ached”, “fever”. The following information was reported: MYALGIA (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome “recovered”, described as “Muscles aches all over my body”; PAIN (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome “recovered”, described as “ached”; CHILLS (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome “recovered”; PYREXIA (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome “recovered”, described as “fever”; HEADACHE (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome “recovered”; ILLNESS (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome “recovered”, described as “sick”; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome “recovered” and all described as “did get COVID even after having a vaccine”; ALLERGY TO VACCINE (non-serious), outcome “unknown”, described as “allergic to Covid vaccine”. The patient underwent the following laboratory tests and procedures: Radiotherapy: (Aug2024) Unknown results. Therapeutic measures were taken as a result of illness, pyrexia, chills, pain, myalgia, headache. Clinical course: The patient reported that she had a reaction to the Pfizer COVID-19 vaccine in Oct2022 and 2023. She said, she got those and got really sick, and she said that she ran a fever, chills and she ached, and this occurred 4 to 6 hours after the vaccine, and real bad headache. Both times and they were all Pfizer. Treated herself with Tylenol. The patient also mentioned that she had cancer in 2019 and then had surgery for it and then in 2024 she had radiation therapy in Aug. The patient would like to get another Covid vaccine, but now is afraid of them. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.

Lost taste; Lost smell; Lost a lot of weight/ it was worse now; Lost a lot of weight/ it was worse now; This is a spontaneous report received from a Consumer or other non HCP. An 88-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 88 years intramuscular, in right arm for covid-19 immunisation. The patient’s relevant medical history included: “Diabetes” (unspecified if ongoing), notes: Diabetes; “lost a lot of weight” (unspecified if ongoing), notes: beginning past 2, 3 years. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; JANUVIA [SITAGLIPTIN PHOSPHATE] taken for diabetes mellitus. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), administration date: Apr2021, when the patient was 85 years old, for covid-19 immunization. The following information was reported: AGEUSIA (non-serious), outcome “unknown”, described as “Lost taste”; ANOSMIA (non-serious), outcome “unknown”, described as “Lost smell”; WEIGHT DECREASED (non-serious), CONDITION AGGRAVATED (non-serious), outcome “unknown” and all described as “Lost a lot of weight/ it was worse now”. Additional Information: The patient thought she had adverse events from the Pfizer vaccine. The patient had had it from the beginning like past 2, 3 years, she had been going there with this, in updates and follow up. The first one was in Apr2021 and the last one was on 29Oct2024. The patient did not know the time of vaccination, she thought it was noon 11, 12 or 1 o’clock, she was not sure. The patient could not tell the specific day, it gradually happened over time, and it was worse now, she had lost a lot of weight. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.

the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; swelling at the injection site; This is a spontaneous report received from a Nurse from medical information team. A 27-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 16Jan2025 as dose 1, single (Batch/Lot number: unknown), in right arm for maternal immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 18Jan2025, outcome “not recovered”, described as “swelling at the injection site”; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 18Jan2025, outcome “not recovered” and all described as “the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy”. Therapeutic measures were taken as a result of vaccination site warmth, vaccination site erythema, vaccination site inflammation, vaccination site pain, vaccination site pruritus, vaccination site swelling. Additional information: Patient was treated with Benadryl but didn’t help. Patient was asking for advise. Patient was advised by the reporter to use cold compresses, continuous Benadryl as needed or she could switch to Zyrtec.

no adverse event; HCP reports that PROQUAD was inadvertently administered after suffering from a Temperaturre excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient’s concurrent conditions, historical conditions and concomitant or historical medications was not provided. On 18-DEC-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection, for prophylaxis, 0.5 milliliter per series, lot number Y013574 which has been verified t be valid, expiration date not reported but upon internal review established as 03-FEB-2026 (strength, route of administration and anatomical location not reported); and sterile diluent (MERCK STERILE DILUENT) solution for injection (strength, indication, dose, lot number, expiration date, route of administration and anatomical site not provided). On the same date, the reported stated that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection was inadvertently administered after suffering from a temperature excursion, the product reached -11.6 degree celcius but previous excursions could not be confirmed, the product was out of range for 3 hours 5 minutes and 0 seconds but previous excursions could not be confirmed (Improper storage of product in use). No symptomatic adverse events were reported.

One febrile seizure was reported 14 days after dose 4 of PCV20; the seizure was considered not related to PCV20, but possibly related to the measles, mumps, and rubella or varicella vaccine; Literature Report: This literature marketed report has been received from the authors of the published article and refers to an infant of unspecified gender and age. The patient’s medical history, concurrent conditions, and concomitant medications were not provided. On unspecified date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) formulation as default: injection, or varicella virus vaccine live (Oka/Merck) (VARIVAX) formulation as default: injection (strength, dose, frequency, route of administration, vaccination scheme, site of vaccination, lot #, and expiration date were not provided) as a prophylaxis. On unspecified date, the patient experienced a febrile seizure. At the reporting time, the outcome of the event was not provided. The causal relationship between suspect vaccine with the event was considered as related (possibly related). A copy of the published article is attached as further documentation of the patient’s experience. Lot # is being requested and will be submitted if received.

Adacel was mixed with 0.5 ml of sterile diluent and administered to a patient in error with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient to whom had administered Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] was mixed with 0.5 ml of sterile diluent and administered to a patient in error with no reported adverse event. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: unknown, expiry date: 01-Feb-2026, lot 3CA17C1) via unknown route in unknown administration site as immunization and was mixed with 0.5 ml of sterile diluent and administered to a patient in error with no reported adverse event (product preparation error) (same day latency). 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.

ActHib was administered with sterile water instead of saline with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age/gender patient to whom HIB (PRP/T) VACCINE [ACT-HIB] was administered with sterile water instead of saline with no reported adverse event. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (dose, strength, lot, expiry and route: unknown) with sterile water instead of saline with no reported adverse event (product preparation error) (latency same day) in unknown administration site for immunization. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. 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.

inappropriate use due to inadvertently administering pentacel rather than tenivac with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a Other health professional. This case involves, a 8 years old male patient who received inappropriate use due to inadvertently administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] rather than Tenivac with no reported adverse event. The patient’s past medical treatment included Pediarix on 11-May-2017 with at 10 months of age. The patient’s past medical history, vaccination(s) and family history were not provided. On 20-Nov-2024, the patient who received inappropriate use due to inadvertently administered 0.5 ml dose (once) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UK044AA, expiry date: 31-Aug-2025) (unknown strength) via intramuscular route in the right deltoid for immunization rather than Tenivac with no reported adverse event (wrong product administered) (latency-same day). Reportedly, Nurse practitioner stated that patient to receive Tenivac as part of his catch-up immunization schedule on 05-Nov-2024, but he was inadvertently administered Pentacel instead. His vaccine schedule was as follows:11-May-2017, at 10 months of age; 05-Sep-2024, at 8 years of age and 20-Nov-2024 – Pentacel (DTaPIPV-Hib) instead of Tenivac (Td). 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.

feeling so bad; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a Consumer/ Non-Healthcare Professional. This case involves an unknown age / gender patient who was feeling so bad after receiving influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone High Dose]. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization). Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date the patient feeling so bad (feeling abnormal) (unknown latency) following the administration of influenza USP TRIVAL A-B high dose subvirion vaccine. Reportedly, no additional information or specific symptoms were shared. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event.