| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2867977 | GA | 10/23/2025 |
DTAP DTAPHEPBIP DTAPIPV HEP HEPA MENB MNQ RV1 TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Product storage error; Product storage error; Product storage error; Product sto...
Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error
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Vaccines administered to patients after above temperature excursion; This non-serious case was repor...
Vaccines administered to patients after above temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis. On an unknown date, the patient received Engerix B, Rotarix liquid formulation, Havrix, Boostrix, Bexsero, Menveo, Infanrix, Kinrix and Pediarix. On an unknown date, an unknown time after receiving Engerix B, Rotarix liquid formulation, Havrix, Boostrix, Bexsero, Menveo, Infanrix, Kinrix and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Vaccines administered to patients after above temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt date: 01-OCT-2025 Medical Assistant called to report an above temperature excursion for Pediarix, Kinrix, Infanrix, Menveo (1-vial), Bexsero, Boostrix, Havrix, Rotarix (liquid), Engerix-B, on 5th May 2025, but noticed until 29th September 2025. The highest temperature reached was 63 degrees fahrenheit, and duration was 1 hour, with no prior excursions reported. Reporter mentioned that the vaccines were administered to patients after the excursion happened. The batch number was not provided upon follow- up with the reporter.
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| 2867978 | M | MI | 10/23/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
4L454 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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received a dose of Kinrix supposed to receive Pediarix dose number 3; received a dose of Kinrix supp...
received a dose of Kinrix supposed to receive Pediarix dose number 3; received a dose of Kinrix supposed to receive Pediarix dose number 3; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Previously administered products included Pediarix (received first dose on an unknown date) and Pediarix (received second dose on an unknown date). On an unknown date, the patient received the 3rd dose of Kinrix. The patient did not receive Pediarix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: received a dose of Kinrix supposed to receive Pediarix dose number 3) and wrong vaccine administered (Verbatim: received a dose of Kinrix supposed to receive Pediarix dose number 3). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-OCT-2025 A medical assistant reported that a 15-month-old received a dose of Kinrix. He was supposed to receive Pediarix dose number 3.
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| 2867980 | F | VA | 10/23/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS PFIZER\WYETH |
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Interchange of vaccine products; Interchange of vaccine products
Interchange of vaccine products; Interchange of vaccine products
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vaccine interchange; This non-serious case was reported by a pharmacist via call center representati...
vaccine interchange; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis. In APR-2025, the patient received the 1st dose of Bexsero. On 06-OCT-2025, the patient received Trumenba. On 06-OCT-2025, an unknown time after receiving Bexsero and Trumenba, the patient experienced interchange of vaccine products (Verbatim: vaccine interchange). The outcome of the interchange of vaccine products was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: The pharmacist reported that a patient came in to receive a Meningococcal B vaccine yesterday and they only have Trumenba. Her first dose was Bexsero in April 2025 and Trumenba was given one day before reporting. The batch number was not provided upon follow up with the reporter.
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| 2867981 | 46 | M | AZ | 10/23/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
7NX57 |
Underdose
Underdose
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received a pediatric dose of Engerix B instead of the adult formulation; received a pediatric dose o...
received a pediatric dose of Engerix B instead of the adult formulation; received a pediatric dose of Engerix B instead of the adult formulation; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 46-year-old male patient who received HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. On 07-SEP-2025, the patient received Engerix B pediatric. On 07-SEP-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: received a pediatric dose of Engerix B instead of the adult formulation) and underdose (Verbatim: received a pediatric dose of Engerix B instead of the adult formulation). The outcome of the adult use of a child product and underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-OCT-2025 The Vaccine Administration Facility is the same as Primary Reporter A registered nurse reported that a patient received a pediatric dose of Engerix B instead of the adult formulation The nurse requested for medical information.
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| 2867982 | 45 | M | AZ | 10/23/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
7NX57 |
Underdose
Underdose
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received a pediatric dose of Engerix B instead of the adult formulation; received a pediatric dose o...
received a pediatric dose of Engerix B instead of the adult formulation; received a pediatric dose of Engerix B instead of the adult formulation; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 45-year-old male patient who received HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. On 07-SEP-2025, the patient received Engerix B pediatric. On 07-SEP-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: received a pediatric dose of Engerix B instead of the adult formulation) and underdose (Verbatim: received a pediatric dose of Engerix B instead of the adult formulation). The outcome of the adult use of a child product and underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-OCT-2025 The Vaccine Administration Facility is the same as Primary Reporter A registered nurse reported that a patient received a pediatric dose of Engerix B instead of the adult formulation The nurse requested for medical information. Upon internal review the case was updated on 07-OCT-2025 The Suspect product was updated from Engerix 10mcg to Engerix B pediatric.
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| 2867986 | F | 10/23/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA PFIZER\BIONTECH PFIZER\BIONTECH |
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Body temperature, Hot flush, Pain in extremity, Pyrexia, Vaccination site erythe...
Body temperature, Hot flush, Pain in extremity, Pyrexia, Vaccination site erythema; Vaccination site reaction; Body temperature, Hot flush, Pain in extremity, Pyrexia, Vaccination site erythema; Vaccination site reaction
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hot flash; slight soreness/soreness in the arm; site reaction/slight reaction; site redness; fever/ ...
hot flash; slight soreness/soreness in the arm; site reaction/slight reaction; site redness; fever/ my head feels hot after; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flash), PAIN IN EXTREMITY (slight soreness/soreness in the arm), VACCINATION SITE REACTION (site reaction/slight reaction), VACCINATION SITE ERYTHEMA (site redness) and PYREXIA (fever/ my head feels hot after) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Concurrent medical conditions included Asthma, Multiple allergies (unspecified allergies) and Immune disorder (NOS). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (hot flash), PAIN IN EXTREMITY (slight soreness/soreness in the arm), VACCINATION SITE REACTION (site reaction/slight reaction), VACCINATION SITE ERYTHEMA (site redness) and PYREXIA (fever/ my head feels hot after). At the time of the report, HOT FLUSH (hot flash), PAIN IN EXTREMITY (slight soreness/soreness in the arm), VACCINATION SITE REACTION (site reaction/slight reaction), VACCINATION SITE ERYTHEMA (site redness) and PYREXIA (fever/ my head feels hot after) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medications were not reported. Current age of patient was reported as 63-years. It was reported that every time patient had been vaccinated for Covid, the head felt hot after; like she was running a fever but then again maybe it was a hot flash. Patient was not sure so used a thermometer that checked the forehead and had the ear thermometer and so checked around and the inside of the head got warmer, but it was never like dangerously warm. Patient got up to like 102 on the head but my throat stayed normal temperature, the surface of the head was normal temperature, arm pits were of normal temperature. With previous vaccinations patient also had fever, slight soreness, site redness and site reaction. Patient had received Moderna and Pfizer mRNA Covid vaccine whatever was available at the pharmacy. Patient probably had been vaccinated more than 10 times, possibly 15-16 times, since the vaccine became available, since the immune system was damaged. Patient understood that how coronavirus immunity was only short term so need to stay vaccinated up, because patient was on high risk to die if she catches Covid. Patient attempted to get a Covid booster every 4 months, but not every time it was possible. Patient had got the first COVID vaccine in 2021, primary care physician arranged the covid test for patient to see if patient had covid, it showed that patient did not had covid, but she did had immunity from the vaccine. Treatment medication was not reported. This case was linked to MOD-2025-790304 (Patient Link).
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| 2867987 | F | 10/23/2025 |
COVID19 |
MODERNA |
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Illness
Illness
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get sick after it every time; This spontaneous case was reported by a consumer and describes the occ...
get sick after it every time; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (get sick after it every time) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (get sick after it every time). At the time of the report, ILLNESS (get sick after it every time) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. The patient had not taken any other vaccines in the past 4 weeks. No concomitant medications were reported. The patient was over 65 years old and got a COVID vaccine every 3 months, asked for it and got it every time she travels. She got numerous vaccines a year and got sick after it every time. The reporter was not sure if the vaccine the patient got was Moderna, and stated that, she usually gets that but not sure. The reporter did not know exactly what one she was taking. It was reported that she got it because she wanted to get it, was not recommended by anyone and was just continuing to take it. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-790351 (Patient Link).
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| 2867988 | F | PA | 10/23/2025 |
COVID19 |
MODERNA |
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Pyrexia, Rash
Pyrexia, Rash
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it was a rather large rash. It covered her arm in the upper and lower areas/got a rash that was fair...
it was a rather large rash. It covered her arm in the upper and lower areas/got a rash that was fairly expansive on my arm. It went above the vaccine; it went down my arm; slight fever sometimes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (it was a rather large rash. It covered her arm in the upper and lower areas/got a rash that was fairly expansive on my arm. It went above the vaccine; it went down my arm) and PYREXIA (slight fever sometimes) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced RASH (it was a rather large rash. It covered her arm in the upper and lower areas/got a rash that was fairly expansive on my arm. It went above the vaccine; it went down my arm) and PYREXIA (slight fever sometimes). At the time of the report, RASH (it was a rather large rash. It covered her arm in the upper and lower areas/got a rash that was fairly expansive on my arm. It went above the vaccine; it went down my arm) and PYREXIA (slight fever sometimes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. The patient's current age was reported as 80 years old. No concomitant medications were reported. The patient had no vaccines in the past 4 weeks. The first time the patient got the vaccine, the worst side effect was developing a rash, found out that the reaction was not uncommon, and it was a rather large rash. The only other reaction she had was a slight fever sometimes. She thought that what she got in the way of a rash and fever was not an uncommon side effect. She did not experience anything else. She was under the impression that it certainly would be as safe as things can be. She understood that things could always happen in life, but as safe as Moderna, she should be able to go ahead. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790324 (E2B Linked Report). This case was linked to MOD-2025-790325 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2025: Live follow-up received contains non-significant information included reporter details added, verbatim of the events updated, narrative updated, and reference numbers were added. On 16-Oct-2025: Live follow-up received contains non-significant information included reference numbers were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790324:Case created for "People"
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| 2867989 | 55 | F | FL | 10/23/2025 |
COVID19 |
MODERNA |
3052663 |
Lymphangitis
Lymphangitis
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Lymphangitis of the arm/within 12 hours the axillary lymph nodes began aching and then it's jus...
Lymphangitis of the arm/within 12 hours the axillary lymph nodes began aching and then it's just been progressing down the arm/swelling of axillary glands, lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHANGITIS (Lymphangitis of the arm/within 12 hours the axillary lymph nodes began aching and then it's just been progressing down the arm/swelling of axillary glands, lymph node) in a 55-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052663) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In October 2025, the patient experienced LYMPHANGITIS (Lymphangitis of the arm/within 12 hours the axillary lymph nodes began aching and then it's just been progressing down the arm/swelling of axillary glands, lymph node) (seriousness criterion medically significant). At the time of the report, LYMPHANGITIS (Lymphangitis of the arm/within 12 hours the axillary lymph nodes began aching and then it's just been progressing down the arm/swelling of axillary glands, lymph node) had not resolved. Concomitant medications were not reported. It was reported that patient had the lymphangitis of the arm where the vaccination was applied. The lymphatic tract of the whole left arm from the axilla all the way to the wrist. Symptoms were noticed within 12 hours of administration. It was reported that within 12 hours the axillary lymph nodes began aching and then it had just been progressing down the arm. Patient went to the doctor and got a diagnosis of lymphangitis, no testing nor medication was reported, no hospitalization was required. Currently, the symptoms were pain when patient stretched out the arm, and it was tender on touching. And there was swelling of the axillary glands, lymph nodes. When the one side was seen versus the other, actually, one was swollen. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790345 (E2B Linked Report).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790345:same reporter different Patient
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| 2867990 | 1.92 | F | 10/23/2025 |
COVID19 |
MODERNA |
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Fatigue, Lethargy, Wrong product administered
Fatigue, Lethargy, Wrong product administered
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Lethargic, and not doing anything/just sitting in one place; Extremely tired; They mistakenly gave a...
Lethargic, and not doing anything/just sitting in one place; Extremely tired; They mistakenly gave an adult Moderna vaccine instead of the Moderna child vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic, and not doing anything/just sitting in one place), FATIGUE (Extremely tired) and WRONG PRODUCT ADMINISTERED (They mistakenly gave an adult Moderna vaccine instead of the Moderna child vaccine) in a 23-month-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 16-Oct-2025, the patient experienced LETHARGY (Lethargic, and not doing anything/just sitting in one place), FATIGUE (Extremely tired) and WRONG PRODUCT ADMINISTERED (They mistakenly gave an adult Moderna vaccine instead of the Moderna child vaccine). At the time of the report, LETHARGY (Lethargic, and not doing anything/just sitting in one place), FATIGUE (Extremely tired) and WRONG PRODUCT ADMINISTERED (They mistakenly gave an adult Moderna vaccine instead of the Moderna child vaccine) outcome was unknown. No concomitant medication was provided. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided.
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| 2867991 | 69 | VA | 10/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Feeling abnormal, Flushing, Incorrect dose administered, Palpitations
Feeling abnormal, Flushing, Incorrect dose administered, Palpitations
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accidentally gave me 2 shots; a little flushed; I feel like heart palpitations; I feel like rapid li...
accidentally gave me 2 shots; a little flushed; I feel like heart palpitations; I feel like rapid like 'PVC'; This is a spontaneous report received from a Pharmacist from medical information team. A 69-year-old patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 17Oct2025 at 14:40 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 69 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; IRBESARTAN; PLAVIX; VINCET; IBANDRONATE; SOMATULINE [LANREOTIDE]. Vaccination history included: comirnaty 2025-2026 (Dose 1, 0.3 mL single; left arm deltoid), administration date: 17Oct2025, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset 17Oct2025, outcome "unknown", described as "I feel like heart palpitations"; FEELING ABNORMAL (non-serious) with onset 17Oct2025, outcome "unknown", described as "I feel like rapid like 'PVC'"; FLUSHING (non-serious) with onset 17Oct2025, outcome "unknown", described as "a little flushed"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 17Oct2025 at 14:40, outcome "unknown", described as "accidentally gave me 2 shots". Therapeutic measures were not taken as a result of flushing, palpitations, feeling abnormal. Additional information: patient accidently received two doses of the vaccine today instead of one. She is feeling a little flushed. Patient and her husband each was supposed to get one COVID shot, no flu shot today. They were in the same room and the pharmacist was talking and she gave the patient a COVID shot and then she thought that she was receiving a flu shot, so she gave the patient's husband COVID shot. Patient received two COVID shots. Patient felt flushed at time of report. Face was kind of flushed. Patient feels like heart palpitations, but doesn't know if it's anxiety or it's a heart problem because she doesn't have heart problem. Patient feels flush and feels like rapid like "PVC". Patient was reporting in regarding that to make sure if she is okay, just wants to check on that there. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2867992 | F | 10/23/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
my9548 407264 |
Chills, Frequent bowel movements, Nausea, Pain, Vomiting; Chills, Frequent bowel...
Chills, Frequent bowel movements, Nausea, Pain, Vomiting; Chills, Frequent bowel movements, Nausea, Pain, Vomiting
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Increased bowel movements; Nausea; Vomiting; Chills; Aches; This is a spontaneous report received fr...
Increased bowel movements; Nausea; Vomiting; Chills; Aches; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 17Oct2025 as dose 5 (booster), single (Lot number: my9548), in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 17Oct2025 as dose 4 (booster), single (Lot number: 407264), in right arm. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ABATACEPT. Past drug history included: Iodine, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE (BOOSTER)), for Immunisation. The following information was reported: PAIN (non-serious) with onset 17Oct2025 at 23:00, outcome "recovering", described as "Aches"; CHILLS (non-serious) with onset 17Oct2025 at 23:00, outcome "recovering"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset 17Oct2025 at 23:00, outcome "recovering", described as "Increased bowel movements"; NAUSEA (non-serious) with onset 17Oct2025 at 23:00, outcome "recovering"; VOMITING (non-serious) with onset 17Oct2025 at 23:00, outcome "recovering". Therapeutic measures were not taken as a result of frequent bowel movements, nausea, vomiting, chills, pain. Additional information: The patient was taking other medications within 2 weeks of the event. No follow-up attempts are possible.
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| 2867993 | M | 10/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Ventricular extrasystoles
Ventricular extrasystoles
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Patient developed premature ventricular contractions; This is a spontaneous report received from a C...
Patient developed premature ventricular contractions; This is a spontaneous report received from a Consumer or other non HCP. A 52-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 14Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "long covid" (ongoing), notes: no previous cardiac issues. The patient's concomitant medications were not reported. The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious) with onset 15Oct2025, outcome "unknown", described as "Patient developed premature ventricular contractions". It was unknown if therapeutic measures were taken as a result of ventricular extrasystoles. Additional information: Patient received his covid vaccine on Tuesday, October 14. Patient developed premature ventricular contractions on October 15. Patient has ongoing long covid symptoms from a previous covid infection but no prior cardiac issues. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2867994 | 76 | F | PA | 10/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
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Tested positive for covid; This is a spontaneous report received from a Nurse. A 76-year-old female...
Tested positive for covid; This is a spontaneous report received from a Nurse. A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Sep2025 as extra dose for immunisation. The patient's relevant medical history included: "Hypertension", start date: 2010 (ongoing); "Allergies to Penicillin" (unspecified if ongoing); "Allergy a lot of beta blockers" (unspecified if ongoing); "Strong allergy to mold" (unspecified if ongoing); "Strong allergy to wool" (unspecified if ongoing); "minor cardiac issues" (unspecified if ongoing); "extremely low vitamin d level" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN oral taken for hypertension (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin d deficiency, start date: 30May2025 (ongoing). The patient also took other concomitant therapy. Past drug history included: Droperidol, reaction(s): "Allergic Droperidole". Vaccination history included: Bnt162b2 (Primary Immunization series), for COVID-19 Immunization. The following information was reported: COVID-19 (non-serious) with onset 06Oct2025, outcome "unknown", described as "Tested positive for covid". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Additional information: concomitant medication included cloromethadone at 25 mg tablet daily as a diuretic. She had the Flu Shot on 27Sep2025. This was before she got sick. She felt this may relevant as this was 8 days before she got sick. She is concerned and wanted to know if the flu shot can lower the resistant level to getting covid. On 06Oct2025 was when she started to experience chest wall pain and burning. At first she thought she was doing too much with cleaning and spraying. Then, on 07Oct2025 she started coughing and had a stuffy nose. The test she took on 06Oct2025 was negative for covid at 10:00 PM. Then on 07Oct2025 at 7:00 AM she tested positive for covid. When she first got diagnosed with covid she reiterated she had cough and nasal congestion, but no elevated temperature or body aches. The covid she had was very light. She had a cough and later stated the Paxlovid took care of this. She reiterated she had no fever. This is the patient's first time having covid in 5 years. She never had it. As treatment, the patient took PAXLOVID from 07Oct2025 to 12Oct2025 at 3 tablets together twice a day, 12 hours apart, by mouth.
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| 2867995 | 10/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Malaise
Malaise
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still feeling sick; This is a spontaneous report received from a Consumer or other non HCP. A patie...
still feeling sick; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), 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: MALAISE (non-serious), outcome "unknown", described as "still feeling sick". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2867996 | 79 | F | FL | 10/23/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
NA4452 NA4452 |
Angiopathy, Arthralgia, Chest discomfort, Chills, Disease recurrence; Dizziness,...
Angiopathy, Arthralgia, Chest discomfort, Chills, Disease recurrence; Dizziness, Fatigue, Migraine, Nausea, Pain
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severe chest pressure; Chills; body aches; Joint pain; Nausea; Dizziness; Fatigue; vascular issues; ...
severe chest pressure; Chills; body aches; Joint pain; Nausea; Dizziness; Fatigue; vascular issues; Migraine; had migraines before; This is a spontaneous report received from a Consumer or other non HCP. A 79-year-old female patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 18Oct2025 as dose 1 (0.3 units unknown), single (Lot number: NA4452, Expiration Date: 09Jul2026) at the age of 79 years, in left arm for covid-19 immunisation, Device Lot Number: NA4452. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Arthritis, From: 20 years ago; "Severe allergies to antibiotics" (unspecified if ongoing), notes: As a child, so in distant past; "major surgeries" (unspecified if ongoing); "breast cancer", start date: 2024 (unspecified if ongoing); "mastectomy" (unspecified if ongoing); "chemo therapy" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE HIGH DOSE taken for immunisation, on 03Oct2025 as dose number unknown, single. Vaccination history included: Moderna covid-19 vaccine (prior doses, got Covid in 2022.), administration date: 2020, for COVID-19 immunisation, reaction(s): "Got Covid". The following information was reported: CHILLS (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025); DIZZINESS (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025); FATIGUE (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025); ARTHRALGIA (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025), described as "Joint pain"; MIGRAINE (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025); NAUSEA (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025); PAIN (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025), described as "body aches"; DISEASE RECURRENCE (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025), described as "had migraines before"; CHEST DISCOMFORT (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025), described as "severe chest pressure"; ANGIOPATHY (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025), described as "vascular issues". Therapeutic measures were taken as a result of chest discomfort, chills, pain, arthralgia, nausea, dizziness, fatigue, angiopathy, migraine, disease recurrence. Additional information: No other concomitants, patient was fairly healthy. The patient had bad reaction to it within 12 hours, woke up with severe chest pressure, chills, migraine, body aches, joint pain, nausea, dizziness, and fatigue. Fatigue continued. Only thing that hung on a little, doesn't know if call handler is familiar with migraines, but migraines hang on for a little bit, not as a migraine, but as a little headache. Caller has had migraines before. All resolved by next morning, 19Oct2025. Events were not required a visit to the Emergency Room or Physician's Office. Treatment included normally took Aspirin 325mg at night for vascular issues. Did get up and take two Tylenol extra strength and was able to go back to sleep with an ice pack.
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| 2867997 | 78 | F | CA | 10/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Vaccination site erythema, Vaccination site pain, Vaccination site swelling
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Her arm was sore initially from the injection; Injection site turn quite red; Swelling around the in...
Her arm was sore initially from the injection; Injection site turn quite red; Swelling around the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 78-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 14Oct2025 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 78 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 22Oct2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "Allergic to Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergic to Erythromycin"; Retinol, reaction(s): "Allergic to Retinol". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Oct2025, outcome "not recovered", described as "Her arm was sore initially from the injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset 21Oct2025, outcome "not recovered", described as "Injection site turn quite red"; VACCINATION SITE SWELLING (non-serious) with onset 21Oct2025, outcome "not recovered", described as "Swelling around the injection site". Additional information: Her arm was sore initially from the injection, but nothing out of the ordinary. Today, after the flu shot yesterday, thought it was why her arm was so sore, but when she looked at her arm below where the flu injection was, it was very red and swollen and believes that is where the covid vaccine was injected. Feeling it, it is pretty swollen and is a large part of her arm. She does not know if it could be from the flu vaccine. It is well below where she got injected from the flu shot. The information sheet said that she could develop symptoms up to 14 days after receiving the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. No adverse events (AEs) required a visit to the Emergency Room and Physician's Office. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2867999 | 57 | F | TN | 10/23/2025 |
COVID19 PNC21 |
PFIZER\BIONTECH MERCK & CO. INC. |
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Erythema, Pruritus, Swelling; Erythema, Pruritus, Swelling
Erythema, Pruritus, Swelling; Erythema, Pruritus, Swelling
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Extreme Golf Ball Sized Redness; Itching; Swelling (not much but hasn't gone down); This is a s...
Extreme Golf Ball Sized Redness; Itching; Swelling (not much but hasn't gone down); This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 19Oct2025 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in arm for covid-19 immunisation; pneumococcal vaccine conj 21v (CRM197) (CAPVAXIVE), on 19Oct2025 as dose number unknown, 0.5 ml single, in right arm for immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious) with onset 19Oct2025 at 10:30, outcome "recovering", described as "Extreme Golf Ball Sized Redness"; PRURITUS (non-serious) with onset 19Oct2025 at 10:30, outcome "recovering", described as "Itching"; SWELLING (non-serious) with onset 19Oct2025 at 10:30, outcome "recovering", described as "Swelling (not much but hasn't gone down)". Therapeutic measures were not taken as a result of erythema, pruritus, swelling. Additional information: The patient has no known allergy. The patient did not receive any other vaccines within 4 weeks prior to the reported vaccination and was not taking any other medications within 2 weeks of the event onset. The patient was not hospitalized for the events. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2868000 | M | 10/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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he has come down with COVID even though he has had every Pfizer Covid-19 vaccine and booster/he got ...
he has come down with COVID even though he has had every Pfizer Covid-19 vaccine and booster/he got covid twice; he has come down with COVID even though he has had every Pfizer Covid-19 vaccine and booster/he got covid twice; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he has come down with COVID even though he has had every Pfizer Covid-19 vaccine and booster/he got covid twice". Despite getting fully vaccinated and boosted he got covid twice while on cruises. The patient said he had always gotten the Pfizer Vaccine, but then said he does not know; maybe it was Moderna. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2868001 | F | NV | 10/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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When she took the original COVID shot, absolutely nothing; Symptoms for 2 months; This is a spontane...
When she took the original COVID shot, absolutely nothing; Symptoms for 2 months; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 70-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune" (unspecified if ongoing); "kidney damage" (unspecified if ongoing); "Disabled" (unspecified if ongoing), notes: She was 100% disabled with fifty-six diagnosed medical problems from agent orange exposure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "When she took the original COVID shot, absolutely nothing"; COVID-19 (medically significant), outcome "unknown", described as "Symptoms for 2 months". Therapeutic measures were taken as a result of covid-19. Clinical course: During an inbound call for financial assistance, the Patient, (withheld) stated, " she was 100% disabled with fifty-six diagnosed medical problems from agent orange exposure. And because of that she always had to have a box of Paxlovid in the closet, she probably wouldn't have survived COVID if she did not had taken it last Oct when she got ill. And then, she got another box, back then it was free, and now that box has expired Whatever it is they want over six hundred and fifty from her. Which she cannot do just to keep something in the closet for if she got COVID, she was very lucky that she had this box last Oct, her symptoms lasted for two months. Pfizer hasn't helped her at all when she took the original COVID shot, absolutely nothing. Cause she had freaking auto immune. Later they kept saying something about 'well why didn't the shots work', because she had autoimmune.
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| 2868002 | M | 10/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
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tested positive for COVID 19; tested positive for COVID 19; This is a spontaneous report received fr...
tested positive for COVID 19; tested positive for COVID 19; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2025) positive. Clinical course: Patient tested positive for COVID 19. Patient got a Pfizer vaccine for COVID earlier this autumn. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2868003 | F | 10/23/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Alopecia, Dry skin, Pain of skin, Rash, Skin disorder; Skin fissures
Alopecia, Dry skin, Pain of skin, Rash, Skin disorder; Skin fissures
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hair loss; skin on her hand was so dry and cracked that it hurts; skin on her hand was so dry and cr...
hair loss; skin on her hand was so dry and cracked that it hurts; skin on her hand was so dry and cracked that it hurts; bumpy skin; skin on her hand was so dry and cracked that it hurts; huge rash/rash is on her whole-body including face and head/rash got worse/ splotches went from pea sized to baseball size. They tend to be round in nature and look more like a bruise/ blotches; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA284609 (Sanofi), AE-021212 (BioNTech SE). A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), till Apr2025 at single-dose for dermatitis atopic, psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: RASH (medically significant) with onset 2022, outcome "not recovered", described as "huge rash/rash is on her whole-body including face and head/rash got worse/ splotches went from pea sized to baseball size. They tend to be round in nature and look more like a bruise/ blotches"; ALOPECIA (non-serious), outcome "unknown", described as "hair loss"; DRY SKIN (non-serious), SKIN FISSURES (non-serious), PAIN OF SKIN (non-serious), outcome "unknown" and all described as "skin on her hand was so dry and cracked that it hurts"; SKIN DISORDER (non-serious), outcome "unknown", described as "bumpy skin". The action taken for dupilumab was dosage permanently withdrawn in Apr2025. Therapeutic measures were taken as a result of rash, dry skin, skin fissures, pain of skin. Clinical course: Patient explained she had developed a huge rash after she had her Covid shot while she was taking Dupixent. Last Covid was 2022 and the Dupixent was on Apr2025. The rash was on her whole-body including face and head (rash) (onset: an unknown date in 2022) (seriousness criteria: medically significant), her hair loss (alopecia). She asked a simple question: what had you learned about the intersectional medical outcomes for patients who both were Dupixent and COVID-19 users. That was when the undiagnosed skin problem began and it was awful. It was ruining her ability to function - the skin on her hand was so dry (dry skin) and cracked (skin fissures) that it hurts (pain of skin) she use Neosporin daily to quiet the pain and the impact on her skin had aged her face and body, much to her chagrin. Doctors had tried typical eczema treatments but they did not work. Now the doctor wanted to experiment with using Dupixent like drugs for psoriasis. She was now skeptical after use of the Dupixent and the COVID shots. She must say that for the few months that she used Dupixent without COVID-19 shots, her skin was beautiful, perfect for the first time in her 64 years of life. Through an administrative error, she lost financial support and so she went about 6 months, she got back on it never cleared her skin the way it had in the 1st usage. At the same time, she had taken 1-2 Covid shots/booster by that time so it was not clear whether the Dupixent did not work as well because of the Covid-19 shot. She called and asked questions of medical team and the pharmacist who provided the medication. She was only told to allow 2-3 days between shots - Dupixent and Covid-19. And nurse told her that sometimes when there was a hiatus in medication use, the medication did not work as effectively. Until the rash got worse about 9 months - 12 months later - the splotches went from pea sized to baseball size. They tend to be round in nature and look more like a bruise. She was regularly asked by family and friends whether she was being abused at home- that was how horrible these blotches look. There was a breakout on her face regularly happening close to the hairline, when the bumpy (skin swelling) part of the rash recedes, She guess it closes the hair follicle and that hair falls out. Where there was no rash, there was no hair loss. This was what she could tell. She didn't think this problem results from any one box of medication. It was acute and pervasive. Corrective treatment: Unknown topical lotions for rash; Neosporin (unspecified) for dry skin, pain of skin, skin fissures and not reported for alopecia, swelling. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. BNT162b2 is under agreement with BIONTECH SE.
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| 2868005 | MA | 10/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Vaccination site pain
Vaccination site pain
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a slightly sore arm at the injection site; This is a spontaneous report received from a Consumer or ...
a slightly sore arm at the injection site; This is a spontaneous report received from a Consumer or other non HCP. An elderly patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Epstein-Barr virus (Mono)" (unspecified if ongoing), notes: was well over 10 years ago; "gout in the past" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "a slightly sore arm at the injection site". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200820768 same patient, different doses/events;US-PFIZER INC-202200820941 same patient, different doses/events;
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| 2868006 | F | TN | 10/23/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Missed The Dosing Window For Her 2nd Dose of HEPLISAV-B; Initial report received on 17-Oct-2025. A ...
Missed The Dosing Window For Her 2nd Dose of HEPLISAV-B; Initial report received on 17-Oct-2025. A pharmacist reported that a 23-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and missed the dosing window for her second dose of HEPLISAV-B. No medical history or concomitant medications were reported. On 21-Jun-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 17-Oct-2025, 119 days after receiving HEPLISAV-B, the patient had missed the dosing window for her second dose of HEPLISAV-B. Over three months have passed since she received the first dose. The reporter noted that the due date for the second dose was late July. No additional information was reported. The outcome was not reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2868007 | 0.42 | F | TX | 10/23/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Bexsero (MenB vaccine) was given to my daughter when she was 5 month old/ received Bexsero in error ...
Bexsero (MenB vaccine) was given to my daughter when she was 5 month old/ received Bexsero in error instead of the appropriately ordered vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 5-month-old female patient who received Men B NVS (Bexsero) for prophylaxis. On 16-JUL-2024, the patient received Bexsero. On 16-JUL-2024, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero (MenB vaccine) was given to my daughter when she was 5 month old/ received Bexsero in error instead of the appropriately ordered vaccine). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-OCT-2025 Bexsero (MenB vaccine) was given to patient when she was 5-month-old. As per guidelines it was supposed to give for a 10-year-old. The batch number was not provided and a request for this information has been made.
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| 2868008 | M | MA | 10/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Antibody test, Vasculitis
Antibody test, Vasculitis
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suffered similar side-effects/diagnosed it as "Vasculitis"; This is a spontaneous report r...
suffered similar side-effects/diagnosed it as "Vasculitis"; This is a spontaneous report received from a Consumer or other non HCP. An adult male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number 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: VASCULITIS (non-serious), outcome "recovering", described as "suffered similar side-effects/diagnosed it as "Vasculitis"". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional Information: The patient in his 40's suffered side-effects from the Pfizer vaccine and his doctor diagnosed it as "Vasculitis'. His recovery was swifter. The doctor discovered that his Anti-Body level was extremely high, which meant, receiving the Covid 19 vaccine created more unnecessary Anti-Bodies which the immune system saw as more of an attack, and the response was major inflammation.
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| 2868009 | 10/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19
COVID-19
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had a prescription for Paxlovid; This is a spontaneous report received from a Consumer or other non ...
had a prescription for Paxlovid; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 6 (booster), 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 shot (DOSE 1, SINGLE), for COVID-19 Immunization; Pfizer covid shot (DOSE 2, SINGLE), for COVID-19 Immunization; Pfizer covid shot (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization; Pfizer covid shot (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization; Pfizer covid shot (DOSE 5 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "had a prescription for Paxlovid". Additional information: During an inbound call for financial assistance, the patient stated, had a prescription for Paxlovid, but could not afford to get it filled. Later in the call, the patient asked if patient have to have another prescription from their doctor or what for them to qualify for it or what? The patient had a prescription at (withheld). The patient can't take the shot. The patient was not getting into it. Patient had their COVID shots, had like six of them but they took it 3 years ago, and took the Pfizer, but patient had a bad reaction from it, so their doctor told them just not to take it. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2868010 | F | 10/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Swelling
Swelling
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Swelling; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 1000041...
Swelling; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 10000416295 (Genentech). A 68-year-old female patient received BNT162b2 (BNT162B2), 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: SWELLING (non-serious) with onset 25May2022, outcome "unknown". Batch/lot number is not provided, and it cannot be obtained.
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| 2868011 | 4 | M | 10/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8827AA |
No adverse event, Product storage error
No adverse event, Product storage error
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temperature excursion: temperature reached: 25.7 f degrees duration: 4 hours and 17 minutes with no ...
temperature excursion: temperature reached: 25.7 f degrees duration: 4 hours and 17 minutes with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from other health professional. This case was linked to other case US-SA-2025SA304532 This case involves a 4 years old male patient (3.5 cm and 19.09 kg) who who was administered to Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which had temperature excursion: temperature reached: 25.7 F degrees duration: 4 hours and 17 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot U8827AA, expiry date 30-Jun-2026, frequency once and strength standard) via intradermal route in the right arm for Immunisation and temperature excursion: temperature reached: 25.7 f degrees duration: 4 hours and 17 minutes with no reported adverse event (product storage error). Reportedly, human error occurred as refrigerator temperature knob was accidentality turned down. There was no Previous Excursion and administered post-excursion. The extended stability data did not cover the excursion; The routine check at 07:30 showed temperature within normal limits. Action taken was not applicable. 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.; Sender's Comments: US-SA-2025SA304532:Master case
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| 2868012 | 72 | F | PA | 10/23/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Fatigue, Headache, Nausea, Vaccination site erythema, Vaccination site pain; Vac...
Fatigue, Headache, Nausea, Vaccination site erythema, Vaccination site pain; Vaccination site swelling
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swelling, redness and pain at injection site; swelling, redness and pain at injection site; swelling...
swelling, redness and pain at injection site; swelling, redness and pain at injection site; swelling, redness and pain at injection site; nausea, headache and fatigue; nausea, headache and fatigue; nausea, headache and fatigue; Initial information received on 18-Oct-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 72 years old female patient who experienced swelling, redness and pain at injection site, mild nausea, headache and fatigue after receiving NVX-COV2373 (Original) adjuvanted vaccine [Nuvaxovid PFS]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Oct-2025, the patient received unknown dose of suspect NVX-COV2373 (Original) adjuvanted vaccine, Suspension for injection in pre-filled syringe (strength, lot number and expiry date not reported) via intramuscular route in unknown administration site for Vaccination against covid (COVID-19 immunization). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On 17-Oct-2025 the patient developed swelling, redness and pain at injection site (vaccination site swelling)(vaccination site erythema) (vaccination site pain), nausea, headache and fatigue (nausea) (fatigue) (latency: 3 days). Action taken: Not applicable. No corrective treatment was received for the events. At time of reporting, the outcome was Recovering / Resolving for all the events.
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| 2868013 | 68 | F | KY | 10/23/2025 |
FLUX FLUX FLUX FLUX FLUX FLUX FLUX FLUX FLUX FLUX FLUX FLUX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
U8859CA U8859CA U8859CA U8859CA U8859CA U8859CA U8859CA U8859CA U8859CA U8859CA U8859CA U8859CA |
Arthralgia, Condition aggravated, Expired product administered, Fibromyalgia, He...
Arthralgia, Condition aggravated, Expired product administered, Fibromyalgia, Headache; Influenza virus test negative, Myalgia, Neck pain, Oral herpes, Respiratory syncytial virus test negative; SARS-CoV-2 test negative; Bedridden, Condition aggravated, Emotional distress, Fibromyalgia, Headache; Influenza like illness, Influenza virus test negative, Malaise, Oral herpes, Pain; Photophobia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Arthralgia, Condition aggravated, Expired product administered, Fibromyalgia, Headache; Influenza virus test negative, Myalgia, Neck pain, Oral herpes, Respiratory syncytial virus test negative; SARS-CoV-2 test negative; Bedridden, Condition aggravated, Emotional distress, Fibromyalgia, Headache; Influenza like illness, Influenza virus test negative, Malaise, Oral herpes, Pain; Photophobia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
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developing a cold sore on the lip; headache; pain in the joints, knees, hips; pain in the muscle; ex...
developing a cold sore on the lip; headache; pain in the joints, knees, hips; pain in the muscle; experience fibromyalgia flare-up; Neck ache; Initial information received on 13-Oct-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 68 years old female patient who had fibromyalgia flare-up, neck ache, developing a cold sore on the lip, headache, pain in the joints, knees, hips and pain in the muscle after receiving influenza USP TRIVAL A-B high dose subvirion vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Oct-2025, the patient received an unknown dose 1 of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- high dose, expiry date- unknown, lot U8859CA) via unknown route in unknown administration site for Immunization (Immunization). On an unknown date in Oct-2025 the patient had fibromyalgia flare-up (fibromyalgia), neck ache (neck pain), headache, pain in the joints, knees, hips (arthralgia), pain in the muscle (myalgia) (unknown latency). On 11-Oct-2025 the patient had a cold sore on the lip (oral herpes) (latency- 9 days). It was reported that, the patient stated that they could not get out of bed after receiving the dose and continued to experience fibromyalgia flare-up, headache, neck ache, and pain in the joints, muscle, knees, and hips at the time of the call. They also reported developing a cold sore on the lip on 11-Oct-2025. The patient sounded visibly upset upon reporting these symptoms. Patient mentioned that they had been receiving flu shots for over 35 years without any adverse reactions until the most recent vaccination on 02-Oct-2025. They suspected that the administering nurse may have given an expired dose and requested confirmation of the product's expiration date based on the lot number they provided. They stated that their doctor confirmed that the product was a higher dose of an influenza vaccine from Sanofi Pasteur since they were over 65. Ultimately, they were unable to confirm the trade name of the product. Relevant laboratory test results included: Influenza virus test - On 02-Oct-2025: Negative Respiratory syncytial virus test - On 02-Oct-2025: Negative SARS-CoV-2 antibody test - On 02-Oct-2025: Negative Action taken was not applicable. The patient was treated with Ibuprofen for all the events. At time of reporting, the outcome was Unknown for all the events.
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| 2868014 | 14 | F | NY | 10/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8863BA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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patient was given two doses of FLUZONE NP in the same season with no reported adverse event; Initial...
patient was given two doses of FLUZONE NP in the same season with no reported adverse event; Initial information received on 15-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 years old female patient who received two doses of influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] in the same season with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant: No other immunization On 06-Sep-2025, the patient received an unknown dose 1 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- standard, expiry date- 30-JUN-2026 and lot U8863BA) via intramuscular route in the left deltoid for influenza (Influenza immunization). On 15-Oct-2025 she also received an unknown dose 2 of same vaccine (strength- standard, expiry date- 30-JUN-2026 and U8863BA) via intramuscular route in the left deltoid for influenza (Influenza immunization) in the same season with no reported adverse event (extra dose administered) (latency- same day). Action taken was not applicable. 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.
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| 2868015 | IN | 10/23/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2546 |
Product storage error
Product storage error
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received the vaccine outside of the cold chain guideline and did dispense/administered two vaccinati...
received the vaccine outside of the cold chain guideline and did dispense/administered two vaccinations from the box with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Infant and unknown gender patient who received Influenza Trivalent Recombinant Vaccine [Flublok] which was outside of the cold chain guideline and did dispense/administered two vaccinations from the box 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 in Oct-2025, the patient received an unknow dose of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection (lot TFAA2546, expiry date and strength not reported) via unknown route in unknown administration site for Influenza and it was outside of the cold chain guideline and did dispense/administered two vaccinations from the box with no reported adverse event (poor quality product administered) (latency same day). Reportedly, vaccine that was received late and was no longer viable. Pharmacy was closed on Saturday morning so maybe the delivery service was trying to deliver the vaccine on the 11th according to her. They were informed by a representative that if they haven't received it by the end of the Sunday, it was no longer a viable product. They got it first thing on Monday. Timestamp was 9:14 and it wa sconfirmed that it was non-viable after 12-Oct-2025. Their technician states that there was nothing in the box as sometimes there was the cold chain markers that can tell that it was outside of the temperature. It was just one box of Flublok. Action taken was not applicable. 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.
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| 2868016 | 70 | M | NJ | 10/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8855AA |
No adverse event, Product storage error
No adverse event, Product storage error
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fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a ...
fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a patient when the vaccines were basically considered frozen with no adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to master case US-SA-2025SA311022 This case involves a 70 years old male patient and reporter reported fridge went below the storage limit that it got to negative 11f and ended up giving Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone HD] to a patient when the vaccines were basically considered frozen with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or no other immunizations: no other immunizations On 15-Oct-2025, the patient received a dose of 0.5 ml once of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (strength- high dose) (lot U8855AA) (unknown expiry date) via unknown route in unknown administration site for Influenza (Influenza immunization); for which fridge went below the storage limit that it got to negative 11f and ended up giving fluzone HD to a patient when the vaccines were basically considered frozen with no adverse event (poor quality product administered) (latency- same day). It was reported, "Office manager called because their fridge went below the storage limit that it got to negative 11F. They ended up giving FLUZONE HD to 8 patients when the vaccines were basically considered frozen. She asked if the patients will experience adverse reactions. No Treatment was received" Action taken: Not applicable. 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.; Sender's Comments: US-SA-2025SA311022:Master case US-SA-2025SA310596:patient 2
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| 2868017 | 72 | F | NJ | 10/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8855AA |
No adverse event, Product storage error
No adverse event, Product storage error
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fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a ...
fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a patient when the vaccines were basically considered frozen with no adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with US-SA-2025SA311022 (cluster case). This case involves a 72 years old female patient and reporter reported fridge went below the storage limit that it got to negative 11f and ended up giving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] to a patient when the vaccines were basically considered frozen with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or ''no other immunizations'': no other immunizations On 15-Oct-2025, the patient received 0.5 ml once of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- high dose) (lot U8855AA) (unknown expiry date) via unknown route in unknown administration site for Influenza (Influenza immunization); for which fridge went below the storage limit that it got to negative 11f and ended up giving fluzone HD to a patient when the vaccines were basically considered frozen with no adverse event (poor quality product administered) (latency- same day). It was reported, ''Office manager called because their fridge went below the storage limit that it got to negative 11F. They ended up giving FLUZONE HD to 8 patients when the vaccines were basically considered frozen. She asked if the patients will experience adverse reactions. No Treatment was received''. Action taken was not applicable. 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.; Sender's Comments: US-SA-2025SA311022:MASTER CASE
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| 2868018 | 94 | F | NJ | 10/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8855AA |
No adverse event, Product storage error
No adverse event, Product storage error
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fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a ...
fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a patient when the vaccines were basically considered frozen with no adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with US-SA-2025SA311022 (cluster case). This case involves a 94 years old female patient and reporter reported fridge went below the storage limit that it got to negative 11f and ended up giving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] to a patient when the vaccines were basically considered frozen with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or ''no other immunizations'': no other immunizations On 15-Oct-2025, the patient received 0.5 ml once of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- high dose) (lot U8855AA) (unknown expiry date) via unknown route in unknown administration site for Influenza (Influenza immunization); for which fridge went below the storage limit that it got to negative 11f and ended up giving fluzone HD to a patient when the vaccines were basically considered frozen with no adverse event (poor quality product administered) (latency- same day). It was reported, ''Office manager called because their fridge went below the storage limit that it got to negative 11F. They ended up giving FLUZONE HD to 8 patients when the vaccines were basically considered frozen. She asked if the patients will experience adverse reactions. No Treatment was received''. Action taken was not applicable. 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.; Sender's Comments: US-SA-2025SA311022:master case
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| 2868019 | 69 | F | NJ | 10/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8855AA |
No adverse event, Product storage error
No adverse event, Product storage error
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fridge went below the storage limit that it got to negative 11 Fahrenheit/ They ended up giving FLUZ...
fridge went below the storage limit that it got to negative 11 Fahrenheit/ They ended up giving FLUZONE HD to patient when the vaccines were basically considered frozen with no AE; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to this case US-SA-2025SA311022 [master case]. This case involves a 69 years old female patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] post excursion, when fridge went below the storage limit that it got to negative 11 Fahrenheit and the vaccines were basically considered frozen with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8855AA, expiry date not reported , strength: High Dose, Frequency: once, via unknown route in unknown administration site for Influenza [Influenza immunisation] post excursion, fridge went below the storage limit that it got to negative 11 Fahrenheit, when the vaccines were basically considered frozen with no adverse event (poor quality product administered) (latency: same day). Reportedly, They ended up giving Fluzone HD to 8 patients when the vaccines were basically considered frozen. She asked if the patients will experience adverse reactions. Action taken was not applicable. 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.; Sender's Comments: US-SA-2025SA311022:patient 1
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| 2868020 | WI | 10/23/2025 |
FLU3 |
SANOFI PASTEUR |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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received two doses of the HD Flu vaccine, with no reported adverse event; Initial information receiv...
received two doses of the HD Flu vaccine, with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient of unknown demographics who received two doses of the influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Sep-2025, the patient received an unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (strength, dose, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination and he/she also received another dose of vaccine On 15-OCT-2025 with no reported adverse event (extra dose administered) (latency: on same day of last dose). Information regarding batch number corresponding to the one at time of event occurrence is requested. It was reported, she is calling to see if there are any issues or concerns in regard to that happening. It was confirmed with the nurse that the patient received Fluzone HD. Action taken was not applicable. 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.
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| 2868021 | 8 | M | NC | 10/23/2025 |
UNK |
UNKNOWN MANUFACTURER |
No batch number |
Injection site pain, Joint swelling, Pain in extremity, Product administered at ...
Injection site pain, Joint swelling, Pain in extremity, Product administered at inappropriate site, Sleep disorder
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Knee is also swollen; The leg where he got the flu shot was hurting; Leg also hurt; This spontaneous...
Knee is also swollen; The leg where he got the flu shot was hurting; Leg also hurt; This spontaneous case, initially received on 08-Oct-2025, was reported by a health professional and concerns a child male patient. Administration of company suspect drug: On 06-Oct-2025, the patient received Flucelvax (TIV) for Unknown, dose: not reported, route of administration: not reported, Anatomical location: thigh, Lot number: No batch number available and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 06-Oct-2025, the patient experienced Leg also hurt (outcome: Unknown). On 07-Oct-2025, the patient experienced Knee is also swollen (outcome: Unknown), The leg where he got the flu shot was hurting (outcome: Unknown). Two of her sons, received their flu shots (flucelvax) on 06-Oct-2025. Both had the vaccine administered by their pediatrician in their thigh. For her younger son, he was saying his leg hurt for most of the night to the point where he had trouble sleeping. For older old son, his leg also hurt and the next day (07-Oct-25) the leg where he got the flu shot was hurting and the area just above his knee was also swollen. She was making him an appointment with his pediatrician on 08-Oct-25 to have his leg checked. Flucelvax (TIV) action taken: Not Applicable The reporter did not provide the seriousness and causality for Leg also hurt, Knee is also swollen, The leg where he got the flu shot was hurting.; Reporter's Comments: Due to the spontaneous nature of the case, events are considered related for reporting purposes.
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| 2868023 | 59 | F | OH | 10/23/2025 |
COVID19 |
MODERNA |
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Arthralgia, Fatigue, Headache, Myalgia
Arthralgia, Fatigue, Headache, Myalgia
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Bad headache exhaustion, muscle and hoint pain
Bad headache exhaustion, muscle and hoint pain
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| 2868024 | 87 | M | CA | 10/23/2025 |
FLU3 RSV |
SANOFI PASTEUR PFIZER\WYETH |
UT8794DA MF2195 |
Asthenia, CSF protein increased, Guillain-Barre syndrome, Magnetic resonance ima...
Asthenia, CSF protein increased, Guillain-Barre syndrome, Magnetic resonance imaging spinal abnormal; Asthenia, CSF protein increased, Guillain-Barre syndrome, Magnetic resonance imaging spinal abnormal
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Development of severe GBS with profound weakness
Development of severe GBS with profound weakness
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| 2868025 | 2 | F | IA | 10/23/2025 |
FLU3 |
SEQIRUS, INC. |
AX5811A |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Vaccine was given not realizing that she was under 3 years old, the recommended age to receive Aflur...
Vaccine was given not realizing that she was under 3 years old, the recommended age to receive Afluria
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| 2868026 | 73 | M | CA | 10/23/2025 |
FLU3 |
SEQIRUS, INC. |
407244 |
Blood test, Dizziness, Electrocardiogram, Vertigo
Blood test, Dizziness, Electrocardiogram, Vertigo
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Per patient's wife and patient, he experienced severe dizziness the morning after the vaccine. ...
Per patient's wife and patient, he experienced severe dizziness the morning after the vaccine. When reporting the incident, the wife disclosed that the patient had history of vertigo and may have gotten triggered. The patient went to the ER and got a CKG and bloodwork done. Patient was told he had vertigo.
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| 2868027 | 79 | F | FL | 10/23/2025 |
FLU3 |
SANOFI PASTEUR |
ut8781da |
Ageusia, Anosmia
Ageusia, Anosmia
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Patient stated that the day after she got the shot she lost her sense of smell and taste which still...
Patient stated that the day after she got the shot she lost her sense of smell and taste which still has not returned. She came in today to relay that information to us so we could pass it on to the reporting site.
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| 2868028 | 35 | F | MD | 10/23/2025 |
COVID19 FLU3 TDAP |
PFIZER\BIONTECH SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
MY9550 948415 4B47k |
Musculoskeletal stiffness, Sensory disturbance; Musculoskeletal stiffness, Senso...
Musculoskeletal stiffness, Sensory disturbance; Musculoskeletal stiffness, Sensory disturbance; Musculoskeletal stiffness, Sensory disturbance
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Odd but mild nervous sensation throughout body at onset, akin to floating in water. Whiplash-like st...
Odd but mild nervous sensation throughout body at onset, akin to floating in water. Whiplash-like stiffness in trapezius and deltoids within 2 hours, worsening the following day before improving on the third day.
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| 2868029 | 55 | F | MI | 10/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8883BA |
Injection site pain, Injection site paraesthesia, Muscular weakness, Paraesthesi...
Injection site pain, Injection site paraesthesia, Muscular weakness, Paraesthesia
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After receiving vaccination (within few minutes) patient at first had pain at injection site, but tu...
After receiving vaccination (within few minutes) patient at first had pain at injection site, but turned into tingling of her arm starting at shoulder where she received the vaccine down to her fingers. She also noted weakness where her tingling was being felt, all on outside of her arm going down to affect pinky, ring and middle finger only. Patient tried to relax for a bit to see if it would go away but it persisted so she came back to the pharmacy. She also spoke with her Dr who recommended she keep track of it, if it is still bothering her after a week or 2 to contact them again. Spoke to her around 6:30 the same day of vaccination and she said it hasn't gotten worse, weakness has gone away but still has tingling.
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| 2868030 | 60 | F | CA | 10/23/2025 |
FLU3 RSV |
SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
ES4H5 SF5XK |
Injection site bruising, Injection site haemorrhage; Injection site bruising, In...
Injection site bruising, Injection site haemorrhage; Injection site bruising, Injection site haemorrhage
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Patient sent message in the survey that she had "long bruise" from the immunization on the...
Patient sent message in the survey that she had "long bruise" from the immunization on the right arm. The bandaid was soaked with blood when she removed it. She also had a finger prints of the thumb, middle finger and index finger from the immunization. Claims submitted.
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| 2868037 | 81 | F | PA | 10/23/2025 |
FLU3 |
SEQIRUS, INC. |
407259 |
Rash, Urticaria
Rash, Urticaria
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pt states she got a rash/hives the next day under bra area and on legs, took antihistamine and it he...
pt states she got a rash/hives the next day under bra area and on legs, took antihistamine and it helped
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| 2868039 | 83 | F | AZ | 10/23/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8763FA UT8763FA |
Dry throat, Fatigue, Injection site erythema, Injection site mass, Injection sit...
Dry throat, Fatigue, Injection site erythema, Injection site mass, Injection site warmth; Tinnitus
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Patient described after receiving the flu shot this year her arm turned red and hot at injection sit...
Patient described after receiving the flu shot this year her arm turned red and hot at injection site, she had a knot in her arm. She then had later symptoms of dry throat, ringing in the ears, and fatigue that have not subsided since the shot was administered.
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| 2868040 | 75 | F | FL | 10/23/2025 |
FLU3 MMR |
SANOFI PASTEUR MERCK & CO. INC. |
UT8781DA y009430 |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
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Pt requested meningitis vaccine, received MMR. No reported side effects.
Pt requested meningitis vaccine, received MMR. No reported side effects.
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