| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2803359 | 68 | M | FL | 10/29/2024 |
FLU3 FLU3 FLU3 HEPA HEPA HEPA IPV IPV IPV JEV1 JEV1 JEV1 TDAP TDAP TDAP TYP TYP TYP CHIK CHIK CHIK |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR INTERCELL AG INTERCELL AG INTERCELL AG GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. |
U8515DA U8515DA U8515DA 2345B 2345B 2345B W1C751M W1C751M W1C751M JEV22H64E JEV22H64E JEV22H64E 4799G 4799G 4799G W1A991M W1A991M W1A991M |
CSF mononuclear cell count increased, CSF test, CSF white blood cell count incre...
CSF mononuclear cell count increased, CSF test, CSF white blood cell count increased, Headache, Meningism; Multipathogen PCR test, Musculoskeletal stiffness, Photosensitivity reaction, Pleocytosis, Pyrexia; Respiratory pathogen panel, Tenderness; CSF mononuclear cell count increased, CSF test, CSF white blood cell count increased, Headache, Meningism; Multipathogen PCR test, Musculoskeletal stiffness, Photosensitivity reaction, Pleocytosis, Pyrexia; Respiratory pathogen panel, Tenderness; CSF mononuclear cell count increased, CSF test, CSF white blood cell count increased, Headache, Meningism; Multipathogen PCR test, Musculoskeletal stiffness, Photosensitivity reaction, Pleocytosis, Pyrexia; Respiratory pathogen panel, Tenderness; CSF mononuclear cell count increased, CSF test, CSF white blood cell count increased, Headache, Meningism; Multipathogen PCR test, Musculoskeletal stiffness, Photosensitivity reaction, Pleocytosis, Pyrexia; Respiratory pathogen panel, Tenderness; CSF mononuclear cell count increased, CSF test, CSF white blood cell count increased, Headache, Meningism; Multipathogen PCR test, Musculoskeletal stiffness, Photosensitivity reaction, Pleocytosis, Pyrexia; Respiratory pathogen panel, Tenderness; CSF mononuclear cell count increased, CSF test, CSF white blood cell count increased, Headache, Meningism; Multipathogen PCR test, Musculoskeletal stiffness, Photosensitivity reaction, Pleocytosis, Pyrexia; Respiratory pathogen panel, Tenderness; CSF immunoglobulin increased, CSF mononuclear cell count increased, Chikungunya test, Fatigue, Headache; Meningism, Meningitis aseptic, Musculoskeletal discomfort, Musculoskeletal stiffness, Myalgia; Photosensitivity reaction, Pleocytosis, Polymerase chain reaction negative, Pyrexia
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Patient is a 68-year-old man with past medical history of prostate cancer in April 2024 pending radi...
Patient is a 68-year-old man with past medical history of prostate cancer in April 2024 pending radiation therapy initiation, who was supposed to travel to another country and in anticipation to his travel he received the following vaccines, within the first 2 weeks of October, Hepatitis A vaccine, Japanese encephalitis virus vaccine, polio inactivated vaccine, Tdap vaccine, typhoid inactivated vaccine, COVID vaccine, influenza vaccine, and chikungunya vaccine (last vaccine on 10/16/2024), who started with headache on 10/21/2024, fever for a week that resolved, headache that persist concomitantly with photosensitivity and neck sensitivity, neck stiffness and no focal neurologic complaint. He denies any arthralgias, myalgias or skin rash. No seizure or loss of consciousness. He came to Hospital, on arrival he was afebrile, hemodynamically stable with meningismus. He had a lumbar puncture and CSF show pleocytosis with predominance of mononuclears. Meningoencephalitis panel and respiratory pan
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| 2799006 | 77 | M | KS | 10/15/2024 |
CHIK CHIK JEV1 JEV1 CHIK CHIK CHIK CHIK CHIK CHIK CHIK JEV1 JEV1 JEV1 JEV1 JEV1 JEV1 JEV1 |
VALNEVA USA, INC. VALNEVA USA, INC. INTERCELL AG INTERCELL AG VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. INTERCELL AG INTERCELL AG INTERCELL AG INTERCELL AG INTERCELL AG INTERCELL AG INTERCELL AG |
24B011 24B011 JEV23A79E JEV23A79E 24B011 24B011 24B011 24B011 24B011 24B011 24B011 JEV23A79E JEV23A79E JEV23A79E JEV23A79E JEV23A79E JEV23A79E JEV23A79E |
Confusional state, Encephalitis, Influenza virus test negative, Magnetic resonan...
Confusional state, Encephalitis, Influenza virus test negative, Magnetic resonance imaging normal, Malaise; Posture abnormal, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Viral infection; Confusional state, Encephalitis, Influenza virus test negative, Magnetic resonance imaging normal, Malaise; Posture abnormal, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Viral infection; Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Balance disorder, Blood bilirubin increased; Blood culture negative, Blood sodium decreased, Chest X-ray normal, Confusional state, Dehydration; Diarrhoea, Fatigue, Hypochloraemia, Hyponatraemia, Influenza virus test negative; Leukopenia, Magnetic resonance imaging head normal, Malaise, Metabolic encephalopathy, Micturition urgency; Myalgia, Platelet count decreased, Posture abnormal, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Thrombocytopenia, Urinary tract infection, Urine analysis normal, Viral infection; White blood cell count decreased; Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Balance disorder, Blood bilirubin increased; Blood culture negative, Blood sodium decreased, Chest X-ray normal, Confusional state, Dehydration; Diarrhoea, Fatigue, Hypochloraemia, Hyponatraemia, Influenza virus test negative; Leukopenia, Magnetic resonance imaging head normal, Malaise, Metabolic encephalopathy, Micturition urgency; Myalgia, Platelet count decreased, Posture abnormal, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Thrombocytopenia, Urinary tract infection, Urine analysis normal, Viral infection; White blood cell count decreased
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On 09/19/2024, patient received consult and vaccinations for upcoming international travel. On 10/03...
On 09/19/2024, patient received consult and vaccinations for upcoming international travel. On 10/03/2024, patient's spouse, called in to report status of client. Spouse stated that client began feeling ill on 09/27/24 and had fever of 103 degrees Fahrenheit. Spouse took client to an urgent care clinic and states they were informed client had most likely caught a virus and discharged home. Spouse states symptoms worsened and patient became confused and unable to sit upright. Spouse stated she took client to the emergency room on 09/27/24 and client was admitted. Spouse stated client had tests performed for Flu, Covid, RSV and an MRI all with negative results. Spouse stated the hospitalist informed her that he felt patient was having an "encephalitis like response most likely caused by the IXCHIQ vaccine". Spouse then stated client has an IgA deficiency they had "forgot about" since client has been asymptomatic since diagnosis. This was not listed on intake forms at time of consult. At time of call, spouse stated patient's symptoms had improved and was hopeful he would be discharged home within a few days. Follow up calls placed to client and spouse to check status and verify hospital information with no return calls received.
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| 2858208 | 16 | M | PA | 09/11/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVBO43A |
Expired product administered
Expired product administered
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Menveo 2 vial expired dose administration; This non-serious case was reported by a other health prof...
Menveo 2 vial expired dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVBO43A, expiry date 31-JUL-2025) for prophylaxis. On 14-AUG-2025, the patient received Menveo. On 14-AUG-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Menveo 2 vial expired dose administration). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 15-AUG-2025 The reporter reported that he or she wanted to know how to proceed after giving an expired dose of Menveo 2 vial.
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| 2858209 | 17 | F | MO | 09/11/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVB072A |
Product preparation issue
Product preparation issue
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Only diluent administered; Only diluent administered; This non-serious case was reported by a nurse ...
Only diluent administered; Only diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB072A, expiry date 30-APR-2026) for prophylaxis. On 15-AUG-2025, the patient received Menveo. On 15-AUG-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 15-AUG-2025 The reporter reported that patient came in for meningococcal vaccine today for school and most recently their facility have gotten 2 different kinds of Menveo (1 vial and 2 vial). The patient received 1 vial (diluent) of the 2 vial presentation of Menveo thinking it was the 1 vial presentation which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
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| 2858210 | 75 | F | 09/11/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Extensive swelling of vaccinated limb, Hypoaesthesia, Inappropriate schedule of ...
Extensive swelling of vaccinated limb, Hypoaesthesia, Inappropriate schedule of product administration, Swelling, Swelling face; Vaccine positive rechallenge
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my arm got swelled up the whole way down to my wrist; numb right arm/neck numbness/numb right side o...
my arm got swelled up the whole way down to my wrist; numb right arm/neck numbness/numb right side of the face/numb skull/numb front of the face; Swelling went up my neck and the back of my skull on the right side, right where my ears are; Swelling in the side of my face on the right side; got a first dose of shingles vaccine a few years ago/ restart the series, and she got recombinant zoster vaccine on July 21st, 2025; This non-serious case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingrix with an associated reaction of hypoaesthesia (received first dose few years ago on an unknown date, for tolerance refer linked case US2025AMR111862). On 21-JUL-2025, the patient received the 2nd dose of Shingles vaccine (right arm). On 21-JUL-2025, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too long (Verbatim: got a first dose of shingles vaccine a few years ago/ restart the series, and she got recombinant zoster vaccine on July 21st, 2025). On an unknown date, the patient experienced extensive swelling of vaccinated limb (Verbatim: my arm got swelled up the whole way down to my wrist), hypoesthesia (Verbatim: numb right arm/neck numbness/numb right side of the face/numb skull/numb front of the face), local swelling (Verbatim: Swelling went up my neck and the back of my skull on the right side, right where my ears are) and facial swelling (Verbatim: Swelling in the side of my face on the right side). Rechallenge with Shingles vaccine was positive. The outcome of the extensive swelling of vaccinated limb, local swelling and facial swelling were not reported and the outcome of the hypoesthesia was unknown and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the extensive swelling of vaccinated limb, hypoesthesia, local swelling and facial swelling to be related to Shingles vaccine. It was unknown if the company considered the extensive swelling of vaccinated limb, hypoesthesia, local swelling and facial swelling to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR111862 Additional Information: GSK Receipt Date: 19-AUG-2025 The patient self-reported this case for herself. Patient explained she got a first dose of Shingles vaccine (unknown brand name or lot number) a few years ago (unknown specific date) and she got a bad reaction. And now her physician recommended to restart the series, and she got recombinant zoster vaccine (unknown brand name or lot number), but she was having a bad reaction again, exactly the same reaction than the first time, numbing of the one side of her face, and the back of her skull and down her right arm were she got the shot. The patient did tell her physician the first Shingles shot she had, she had bad reactions from and she really did not want to take the shot again, but she just said that she thought it was a very good idea if she would, she said this one was different, it might have been different but it was still the same reaction, first dose and second dose was exactly the same, she got it and her arm got swelled up the whole way down to her wrist and then it went up her neck and the back of her skull on the right side, right where her ears were and the side of her face on the right side, it was like a numbing, both her skull and the front of her face were like numb and she did not like those reactions.; Sender's Comments: US-GSK-US2025AMR111862:same patient
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| 2858211 | M | NH | 09/11/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
NC3C7 |
Expired product administered
Expired product administered
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Arexvy was administered 11 days past its expiration date; This non-serious case was reported by a ot...
Arexvy was administered 11 days past its expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 81-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number NC3C7, expiry date 20-AUG-2025) for prophylaxis. On 31-AUG-2025, the patient received Arexvy (intramuscular). On 31-AUG-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Arexvy was administered 11 days past its expiration date). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 2-Sep-2025 On 31-Aug-2025 a dose of Arexvy was administered to patient 11 days past its expiration date.
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| 2858212 | 67 | M | 09/11/2025 |
COVID19 |
MODERNA |
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Mental disorder, Pyrexia
Mental disorder, Pyrexia
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mental illness; fever; This spontaneous case was reported by a consumer and describes the occurrence...
mental illness; fever; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL DISORDER (mental illness) and PYREXIA (fever) in a 67-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 28-Sep-2024, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced MENTAL DISORDER (mental illness). At the time of the report, MENTAL DISORDER (mental illness) and PYREXIA (fever) outcome was unknown. No concomitant medication was reported. The patient wanted to know about the best vaccine for the elderly. The patient had underlying condition. When he got the vaccine last year, ha had fever. The patient had mental illness. It was unknown if the patient experienced any additional symptoms/events. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. There were no lab data/results available. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2024-778544 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2024-778544:Patient 1 (Wife case)
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| 2858213 | F | 09/11/2025 |
COVID19 |
MODERNA |
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Nausea
Nausea
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bad as her first Moderna COVID vaccine that was the worst I was nauseous for a week; This spontaneou...
bad as her first Moderna COVID vaccine that was the worst I was nauseous for a week; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (bad as her first Moderna COVID vaccine that was the worst I was nauseous for a week) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (bad as her first Moderna COVID vaccine that was the worst I was nauseous for a week). At the time of the report, NAUSEA (bad as her first Moderna COVID vaccine that was the worst I was nauseous for a week) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. It was reported that none of the vaccines were as bad as her first Moderna COVID vaccine, that was the worst, patient was nauseous for a week. No other details were provided. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Reporter causality was not provided. This case was linked to MOD-2025-789232 (Patient Link). Reporter did not allow further contact
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| 2858214 | F | FL | 09/11/2025 |
COVID19 |
MODERNA |
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Vaccination site rash, Vaccination site swelling
Vaccination site rash, Vaccination site swelling
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a rash and swelling at the injection site/covid arm; a rash and swelling at the injection site/covid...
a rash and swelling at the injection site/covid arm; a rash and swelling at the injection site/covid arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (a rash and swelling at the injection site/covid arm) and VACCINATION SITE SWELLING (a rash and swelling at the injection site/covid arm) in a female patient of an unknown age 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) (Intramuscular use) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (a rash and swelling at the injection site/covid arm) and VACCINATION SITE SWELLING (a rash and swelling at the injection site/covid arm). At the time of the report, VACCINATION SITE RASH (a rash and swelling at the injection site/covid arm) and VACCINATION SITE SWELLING (a rash and swelling at the injection site/covid arm) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) and SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. It was reported that patient experienced rash and swelling at the injection site after receiving the Moderna Covid vaccine on two out of three occasions. It was subsided in 4-7 days. It has been called COVID arm. The reporter was inquiring if this reaction was common and whether it was advisable for their patient to receive the new booster. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.
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| 2858215 | M | 09/11/2025 |
COVID19 |
MODERNA |
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Lung disorder
Lung disorder
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Lung issues; This spontaneous case was reported by a consumer and describes the occurrence of LUNG D...
Lung issues; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (Lung issues) in a male patient of an unknown age 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced LUNG DISORDER (Lung issues). At the time of the report, LUNG DISORDER (Lung issues) outcome was unknown. Concomitant medication was not provided. It was reported that the patient had received all of the Moderna mRNA vaccinations until this year and was looking for the new one. The reporter mentioned that the patient had a lung issue and did not want to catch COVID. It was not clarified whether the lung issues were pre-existing prior to COVID vaccines. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.
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| 2858216 | F | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chills, Pyrexia
Chills, Pyrexia
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received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; ...
received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever", "received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever". The following information was reported: CHILLS (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever". Additional information: A consumer inquired whether the COMIRNATY (2025-2026 Formula) includes the new variant Stratus or the current variant. Another inquiry was made regarding the difference between the 2024-2025 and 2025-2026 formulations. Additionally, the consumer reported having received five prior COVID-19 vaccines with similar side effects, including chills and slight fever, and asked whether the current 2025-2026 formulation would cause the same side effects. In a separate inquiry, the consumer asked whether individuals aged 5 through 64 years who work as privacy are eligible to receive the vaccine or if a doctor's prescription is required. 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-202500176826 same patient, different doses;
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| 2858217 | F | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chills, Nausea, Vaccination site pain, Vaccination site pruritus, Vaccination si...
Chills, Nausea, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
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Swelling, itching, pain at injection site lasting for 3 days; Swelling, itching, pain at injection s...
Swelling, itching, pain at injection site lasting for 3 days; Swelling, itching, pain at injection site lasting for 3 days; Swelling, itching, pain at injection site lasting for 3 days; Nausea; Chills; This is a spontaneous report received from a Consumer or other non HCP. A 33-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Sep2025 at 19:00 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 05Sep2025, outcome "unknown"; NAUSEA (non-serious) with onset 05Sep2025, outcome "unknown"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 05Sep2025, outcome "recovered" (07Sep2025) and all described as "Swelling, itching, pain at injection site lasting for 3 days". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site pruritus, vaccination site pain, nausea, chills. Additional information: patient received Advil for the events. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2858218 | M | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arthralgia, Pain in extremity
Arthralgia, Pain in extremity
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shoulder started getting sore; felt sore/prior experience with previous administration; This is a sp...
shoulder started getting sore; felt sore/prior experience with previous administration; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 (BNT162B2), 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: ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder started getting sore"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "felt sore/prior experience with previous administration". Additional information: Patient's arm and shoulder started getting sore as it has on previous occasions. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2858219 | M | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arthralgia, Pain in extremity
Arthralgia, Pain in extremity
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shoulder started getting sore; felt sore/prior experience with previous administration; This is a sp...
shoulder started getting sore; felt sore/prior experience with previous administration; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 (BNT162B2), as dose 2, 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: ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder started getting sore"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "felt sore/prior experience with previous administration". Additional information: Patient's arm and shoulder started getting sore as it has on previous occasions. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2858220 | 80 | M | WY | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0587 |
Device leakage, Syringe issue, Underdose
Device leakage, Syringe issue, Underdose
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Hub of Comirnaty single dose syringe broke and vaccine leaked out as vaccine was provided; Hub of Co...
Hub of Comirnaty single dose syringe broke and vaccine leaked out as vaccine was provided; Hub of Comirnaty single dose syringe broke and vaccine leaked out as vaccine was provided; Hub of Comirnaty single dose syringe broke and vaccine leaked out as vaccine was provided; This is a spontaneous report received from a Pharmacist. An 80-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Sep2025 as dose 1, single (Lot number: NA0587) at the age of 80 years for covid-19 immunisation, Device Lot Number: NA0587. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: UNDERDOSE (non-serious), DEVICE LEAKAGE (non-serious), SYRINGE ISSUE (non-serious) all with onset 04Sep2025 and all described as "Hub of Comirnaty single dose syringe broke and vaccine leaked out as vaccine was provided". Therapeutic measures were not taken as a result of underdose, device leakage, syringe issue. Causality for "hub of comirnaty single dose syringe broke and vaccine leaked out as vaccine was provided" was determined associated to device constituent of BNT162b2 omi xbb.1.5 (malfunction). Additional information: the patient did not receive any other vaccine within 4 weeks prior to BNT162b2 omi xbb.1.
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| 2858221 | F | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dizziness
Dizziness
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dizzy; This is a spontaneous report received from a Consumer or other non HCP from medical informati...
dizzy; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 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: Comirnaty (2023-2024 formula) (DOSE NUMBER UNKNOWN, SINGLE), administration date: 2023, for COVID-19 immunization, reaction(s): "dizzy". The following information was reported: DIZZINESS (hospitalization), outcome "unknown", described as "dizzy". The event "dizzy" required emergency room visit. Clinical course: Patient got the Pfizer covid vaccine in 2023 and 2024 and got dizzy and had dizzy ever since. Patient had to the hospital, emergency rooms and her doctor and no one knows why patient was dizzy. Patient would like to see the recall letter. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2858222 | F | WA | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
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Bone pain, COVID-19, Drug ineffective, Eye pain, Influenza like illness
Bone pain, COVID-19, Drug ineffective, Eye pain, Influenza like illness
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COVID-19; COVID-19; her eyes hurt; bones hurt; feels like have the flu; This is a spontaneous report...
COVID-19; COVID-19; her eyes hurt; bones hurt; feels like have the flu; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; EYE PAIN (non-serious), outcome "not recovered", described as "her eyes hurt"; BONE PAIN (non-serious), outcome "not recovered", described as "bones hurt"; INFLUENZA LIKE ILLNESS (non-serious), outcome "not recovered", described as "feels like have the flu". The events "covid-19", "her eyes hurt", "bones hurt" and "feels like have the flu" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19, eye pain, bone pain, influenza like illness. Clinical course: She got the vaccine for the covid. Now, her eyes hurt and feels like have the flu, and bones hurt. Her siblings asked if she wanted the vaccine and they'll pay for it. She got the vaccine and is feeling worse than what she was. She was still feeling like this. She does not work. She stays at home. She went to a clinic and cannot get any better. She was told that she needed to go to the clinic, went there on 2nd day because feeling ill and gave three pills to take in the morning and three at night. She has been taking these pills and does not get any better. They are not doing anything. She takes these pills and then something else happens. Pills are clarified to be Paxlovid. Her husband and son are worse than her. No further details mentioned regarding husband and son. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2858223 | F | VA | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
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Asthenia, Pain in extremity
Asthenia, Pain in extremity
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sore arm; down with energy; This is a spontaneous report received from a Consumer or other non HCP f...
sore arm; down with energy; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 72-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; ASTHENIA (non-serious), outcome "unknown", described as "down with energy". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. Additional information: The caller reported that she had multiple sclerosis for 30 years and received the original Pfizer Covid-19 vaccine in 2020, followed by six booster doses from Pfizer. She stated that she did not experience any problems and tolerated them well, with only flu shottype responses. She then received her seventh booster dose with the Moderna Covid-19 vaccine, which activated her multiple sclerosis and required steroid treatment due to complications. Her neurologist advised her against receiving further Covid-19 vaccines, and this advice had been given two years earlier. She remained ambulant but did not want to risk reactivating her multiple sclerosis and had sought advice on whether she should receive the new vaccine. She verified the information provided by the transferring agent. She explained that her final booster, which was Moderna, had activated her multiple sclerosis, while the Pfizer vaccines had only caused mild effects such as a sore arm and mild fatigue for a day, which she did not consider negative. At the time of the Moderna vaccination, she had been on an immunosuppressant, though she later clarified that she was modulated rather than immunosuppressed. She added that she wanted to inquire about the new Comirnaty vaccine to determine whether it was suitable for someone over 65 and immunomodulated, as she did not want to experience the severe reaction she had with Moderna, which left her struggling to get out of bed for a couple of weeks.The caller explained that she had never contracted Covid-19 and became concerned after reading that the new Pfizer Covid-19 vaccine was described as producing a robust response. At the time of onset, she was 68 to 69 years old, overweight, and completely mobile. She stated that the Moderna Covid-19 vaccine had severely affected her, whereas she tolerated the Pfizer vaccines well. No healthcare professional contact details were available. She had received six doses of the Pfizer Covid-19 vaccine. The first dose was given on 03 February 2021, lot EM9810, injected in the arm. The second dose was given on 26 February 2021, lot EN6198, injected in the arm. The third dose was given on 22 October 2021, lot FH8027, expiry 28 February 2022, injected in the right arm. The fourth dose was given on 10 May 2022, lot FN2908, although the final digit on the vaccination card appeared unclear, injected in the arm. The fifth dose was given on 19 May 2023, with the lot recorded as either C1 or CJ3270, injected in the arm. The sixth dose was recorded as 13 September 2022, although she thought it might have been 13 September 2023 due to a miswritten date, with the lot number documented as either 6JZ524 or 6J2524, site not specified. She reported that nothing abnormal showed up on testing and that her MRIs remained stable with no active lesions. She required steroids only after the Moderna dose. She reiterated that she had no issues with the Pfizer Covid-19 vaccines, which caused only mild reactions, but she wanted to investigate further before considering the new vaccine after reading it could cause a stronger response. The report was filed based on information provided by both the transferring agent and the caller.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500177753 same patient/SD/AE, different dose;
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| 2858224 | 28 | F | PA | 09/11/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792LA |
Exposure during pregnancy, No adverse event
Exposure during pregnancy, No adverse event
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Received vaccine during pregnancy, with no reported adverse event; Initial information received on 0...
Received vaccine during pregnancy, with no reported adverse event; Initial information received on 04-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 28 years old pregnant female patient who was exposed to Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] during pregnancy, with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Received vaccine during pregnancy, with no reported adverse event occurred at 29 weeks of pregnancy and the patient was exposed to Influenza Usp Trival A-B Subvirion No Preservative Vaccine at 29 weeks of pregnancy, during third pregnancy trimester. The date of last menstrual period was reported as 17-Feb-2025. The estimated due date is 17-Nov-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 04-Sep-2025, the pregnant patient received 1DF(dosage form) (Dose 1) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot UT8792LA, expiry date and strength not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) and vaccine during pregnancy, with no reported adverse event (exposure during pregnancy) (latency same day). Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.
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| 2858226 | 0.5 | M | OH | 09/11/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK199AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
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administered PENTACEL that was reconstituted with a different diluent - a diluent produced by Merck....
administered PENTACEL that was reconstituted with a different diluent - a diluent produced by Merck.with no adverse event; inappropriate use due to the patient only receiving the HIb part of pentacel with no reported adverse event; Initial information received on 08-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who was administered only hib part of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] that was reconstituted with a different diluent - a diluent produced by merck with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Concomitant medications included hepatitis b vaccine, pneumococcal vaccine and polio vaccine (polio) for prophylactic vaccination (Immunisation). On 14-Aug-2025, the patient received only hib part of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, suspension for injection (dose 0.5 ml) (lot UK199AA and expiry date 30-Apr-2026) (strength: standard and frequency: once) via intramuscular route in the thigh NOS (not otherwise specified) for immunization and was reconstituted with a different diluent - a diluent produced by merck with no adverse event (product preparation error) (single component of a two-component product administered) (Latency: same day). Reportedly, HCP reported that the powder part of PENTACEL was administered with Merck Sharp '& Dohme Live Virus Sterile Diluent. No adverse reaction was reported at the time of call. 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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| 2858235 | VA | 09/11/2025 |
HPV9 |
MERCK & CO. INC. |
Y013565 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; GARDASIL-9 was administered after TE on 8/18/2025; 3 patients were administered GA...
No additional AE; GARDASIL-9 was administered after TE on 8/18/2025; 3 patients were administered GARDASIL-9.; This spontaneous report was received from an office manager, referring to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported. On 18-Aug-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL) SYRINGE 0.5 mL (involved lot # Y013565 has been verified to be valid, expiration date: 01-Feb-2027); administered for prophylaxis (route, and site of administration were not provided). Temperature excursions were (1.5 C) Celsius (C) and time frame was for 2 hours, 24 minutes, 0 seconds; (0.9 C) for 5 hours, 14 minutes, 0 seconds. There was a previous temperature excursion 7/8: (8.3 C) for 0 hours, 44 minutes, o seconds. No report of adverse effect nor product quality complaint involved. This is one of four reports from the same reporter.
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| 2858236 | OH | 09/11/2025 |
HEPA |
MERCK & CO. INC. |
X024966 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional AE; inadvertent administration of expired VAQTA to a patient; This spontaneous report ...
No additional AE; inadvertent administration of expired VAQTA to a patient; This spontaneous report was received from a medical student (also mentioned as health care professional discrepancy) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 18-Aug-2025, the patient was inadvertently vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (valid lot #X024966, expiration date reported and confirmed as 23-Mar-2025; dose, route of administration, and anatomical location were not provided) as prophylaxis. No additional adverse event reported.
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| 2858237 | F | 09/11/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Vaccination site pain; Fatigue, Insomnia, Vaccination site pain; Fatigue, Insomn...
Vaccination site pain; Fatigue, Insomnia, Vaccination site pain; Fatigue, Insomnia, Vaccination site pain; Vaccination site pain; Fatigue, Insomnia, Vaccination site pain; Fatigue, Insomnia, Vaccination site pain; Vaccination site pain; Fatigue, Insomnia, Vaccination site pain; Fatigue, Insomnia, Vaccination site pain
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mild pain in her shoulder for the first and second shots; This is a spontaneous report received from...
mild pain in her shoulder for the first and second shots; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 62-year-old female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "mild pain in her shoulder for the first and second shots". Additional information: The patient got the new covid vaccine yesterday and she had a lot of pain where the injection was given (9 out of 10 on a pain scale) . She never had side effects except for a mild pain in her shoulder for the first and second shots which would go away. She was not sleeping well because of the pain in her shoulder after the current vaccine and as a result, she was tired. How long will this last? She is 62 years old. 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-202500176839 same patient, different doses/events;US-PFIZER INC-202500177424 same patient, different doses/events;
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| 2858238 | F | VA | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
EN6198 |
Asthenia, Pain in extremity
Asthenia, Pain in extremity
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sore arm; down with energy a little bit; This is a spontaneous report received from a Consumer or ot...
sore arm; down with energy a little bit; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 69-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: EN6198), in arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: she had MS for 30 years. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EM9810, Site: Injection in the arm), administration date: 03Feb2021, for COVID-19 immunization, reaction(s): "sore arm", "down with energy a little bit". The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "down with energy a little bit"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". Additional information: Other Conditions: No; Investigations: No; Other Products: No; Caller on the line calling about the Comirnaty previous formulation/Covid-19 vaccines and reported that she had MS for 30 years and then she got the original covid vaccine in 2020. She had 6 booster doses from Pfizer. She reported not having any problems and was doing well. She also reported that she had a flu shot type response with the Pfizer covid vaccines. Her neurologist advised against getting another covid vaccine and that was 2 years ago. She is ambulant, but did not want to activate her MS and was wanting advice on whether or not to get the new vaccine. She did not have anything other than a response like she would have with a flu shot from the Pfizer covid vaccines and she was good with that. She clarified that she had a sore arm and down with energy a little bit for a day or so after receiving the Pfizer Covid-19 Vaccines. It was not a big deal and she does not see it as a negative at all. She has never had Covid anyway. Weight: Said it was too much. She was completely mobile. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500177753 same patient/SD/AE, different dose;
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| 2858239 | F | TX | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID After Pfizer Shots; COVID After Pfizer Shots; This is a spontaneous report received from a Con...
COVID After Pfizer Shots; COVID After Pfizer Shots; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID After Pfizer Shots". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: During an inbound call for financial assistance, the patient stated, "I have the COVID, and my doctor ordered that Paxlovid" Later on, patient stated, "Yeah and they usually give it to me, because I have asthma and then it goes into my lungs and then I get double pneumonia, so they try to get me this medicine right away. But last year when I bought it, the medicine didn't cost that much" After providing to 2 options for completing the enrollment, patient stated, "I don't even feel like looking at a computer right now." When obtaining the date of birth patient stated, "I'm going to be 69 next month." Later on, patient stated, "If I didn't have asthma, I wouldn't worry about it so much. But last time, I wound up getting double pneumonia, and I had to go to the hospital for 4 weeks when it first came out, for COVID" When confirming that she has taken Paxlovid for COVID previously, patient stated, "Yeah, so last year when I got the COVID, I think it was last believe it or not, I think it was last October that I got the COVID and took that medicine then, but it didn't cost this much" While gathering information to create the account patient stated, "I'm sorry I have to blow my nose." Later on, patient stated, "Okay, I took the Pfizer shots too, for the COVID." At the end of the call, patient stated, "Faster I get well, the better It'll be." The call was transferred to a DSU Pharmacist, reference number. However, the reportable safety information provided to the DSU Pharmacist was incomplete. Sending this source document to include: Patient currently has asthma, previously went to the hospital for double pneumonia, and previously caught COVID last October, and also took the Pfizer shots. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2858240 | 09/11/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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Lymphoedema; Lymphoedema
Lymphoedema; Lymphoedema
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Lymphoedema; This is a spontaneous report received from a Consumer or other non HCP. Other Case iden...
Lymphoedema; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789109 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHOEDEMA (non-serious), outcome "unknown". Additional information: It was reported that On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema). At the time of the report, lymphedema outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient had been recently diagnosed with lymphedema and needed to get covid vaccines within the next few weeks and wanted to know if it was safe to get the Spikevax vaccine since had both Moderna and Pfizer. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2858242 | 5 | M | PA | 09/11/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
3C423 z010383 |
Erythema, Feeling hot, Pain, Pyrexia, Swelling; Erythema, Feeling hot, Pain, Pyr...
Erythema, Feeling hot, Pain, Pyrexia, Swelling; Erythema, Feeling hot, Pain, Pyrexia, Swelling
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redness, swelling, pain, fever warmth started 24-48 hours after vaccines
redness, swelling, pain, fever warmth started 24-48 hours after vaccines
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| 2858244 | 63 | F | SC | 09/11/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Computerised tomogram, Diverticulitis, Full blood count, Lipase, Metabolic funct...
Computerised tomogram, Diverticulitis, Full blood count, Lipase, Metabolic function test; Urine analysis
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Diverticulitis (NEVER had before and was never told that I had diverticulosis despite my 3 colonosco...
Diverticulitis (NEVER had before and was never told that I had diverticulosis despite my 3 colonoscopies(polyps) Symptoms began about 4 days after the NEW MODERNA vaccine and worsened as the day and night went on.
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| 2858245 | 13 | M | AR | 09/11/2025 |
TDAP |
SANOFI PASTEUR |
u8353ba |
Blood glucose normal, Dizziness, Loss of consciousness
Blood glucose normal, Dizziness, Loss of consciousness
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patient felt faint, dropped to his knees and briefly passed out. Mom called for assistance. patie...
patient felt faint, dropped to his knees and briefly passed out. Mom called for assistance. patient was laid down on waiting bench, respiration normal, pulse weak. blood sugar 85 patient drank concentrated glucose and water and begin to revive. He asked him to sit for another 10 mins and then he felt well enough to leave. Mom was given benedryl and glucose in case patient felt pourly again. Patient was told to go to ER if any other reaction occurs
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| 2858246 | 71 | F | MI | 09/11/2025 |
FLU3 |
SANOFI PASTEUR |
U8764BB |
Arthralgia, Pain in extremity
Arthralgia, Pain in extremity
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Patient called on 09/11/2025 that she received flu vaccine on 08/24/2025 and is experiencing pain in...
Patient called on 09/11/2025 that she received flu vaccine on 08/24/2025 and is experiencing pain in arm and shoulder, no treatment yet
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| 2858247 | 73 | TX | 09/11/2025 |
FLU3 |
SANOFI PASTEUR |
UT8804AA |
Dyspnoea exertional, Headache, Pyrexia
Dyspnoea exertional, Headache, Pyrexia
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Patient reports that the vaccine caused Mild headache, 99.3 Fever (normal temperature 97), shortness...
Patient reports that the vaccine caused Mild headache, 99.3 Fever (normal temperature 97), shortness of breath while walking or climbing.
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| 2858248 | 73 | F | OH | 09/11/2025 |
COVID19 FLU3 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. SEQIRUS, INC. |
MY9550 407246 407246 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Patient came into pharmacy to receive 1 Flu and 1 Covid (Pfizer). Patient accidentally received 2 Fl...
Patient came into pharmacy to receive 1 Flu and 1 Covid (Pfizer). Patient accidentally received 2 Fluad shots (one in each deltoid) and 1 additional vaccine of Comirnaty in her left deltoid. Patient had no issues or side effects relating to the vaccine after receiving the vaccines and for an additional 15 minutes. Called patient at 6:44 pm to check on status and patient had no complaints or side effects. Counseled patient may have increased risk of aches and injection site soreness.
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| 2858249 | 79 | M | CO | 09/11/2025 |
FLU3 |
SANOFI PASTEUR |
u8764cb |
Arthralgia, Aspiration joint
Arthralgia, Aspiration joint
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Pt says he had extreme pain in his shoulder. He went to the doctor and got a bunch of fluid removed ...
Pt says he had extreme pain in his shoulder. He went to the doctor and got a bunch of fluid removed via syringe. He says the doctor expects it to come back and he says it still hurts very bad.
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| 2858250 | 73 | F | KS | 09/11/2025 |
FLU3 PNC21 |
SEQIRUS, INC. MERCK & CO. INC. |
407242 Z006889 |
Injection site erythema, Injection site swelling, Injection site warmth; Injecti...
Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth
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Patient requested both capvaxive and fluad in her left arm because she wanted to received her covid ...
Patient requested both capvaxive and fluad in her left arm because she wanted to received her covid vaccination in her right arm at a later time. The day after, patient noticed a large red/warm/raised area of skin on her arm below injection sites. Patient states it has not been itching at all and she has not tried any medications or ice pack to reduce swelling. Patient presented today to show me the arm and was not very concerned since she thinks the area of inflammation has been reducing. She then mentioned that she forgot to tell us that she has had a history of breast cancer on the left side with lymph node removal. I advised her to avoid vaccinations in her left arm going forward, and to let us and her provider know if the area of inflammation starts to get worse instead of continuing to improve.
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| 2858263 | 36 | F | NE | 09/11/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946907 |
Computerised tomogram head normal, Feeling cold, Hypoaesthesia, Pain in extremit...
Computerised tomogram head normal, Feeling cold, Hypoaesthesia, Pain in extremity
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When symptoms initially reported to the employee Health nurse on 8/14/2025, symptoms were not ruled ...
When symptoms initially reported to the employee Health nurse on 8/14/2025, symptoms were not ruled to be a vaccine reaction due to extenuating circumstances that included: working out at the gym and working a 12-hour hospital shift the day before the vaccine was administered. During this assessment the said individual described " left arm soreness and numbness in left fingertips and left toes. EE then stated "left fingers and toes feel 'cold' but aren't." Phone assessment completed with EE: EE denies tingling sensation, loss of mobility, loss of strength, or loss of balance in left limbs. Denies HA, blurred vision, facial droop, or speech difficulty. Denies pain except for "sore area" to left deltoid region, stating "can't find exact spot of injection, but have a sore spot approximately 4 finger-widths down from top of humerus." In asking if there is any radiation of numbness, EE reports "left finger numbness starts below my elbow all around arm and radiates to fingers. All of my left leg has numbness with my toes worse, and have numbness in my trunk, but left-side only." Discussed recent activity of EE including any possible insult to neck or spinal column -- EE reports worked 8/10/25 at an ICU shift, noticed first symptoms "later Monday (8/11/25) after the vaccine. Noticed them before gym workout but worked out anyway." EE denies any incident or injury at ICU shift or at gym. Result: Discussed reported symptoms are unusual as a vaccine reaction and suggested that EE consider PCP evaluation for concerns of left-sided numbness and if PCP feels symptoms could be from a vaccine reaction, then we can file incident report and VAERS at that time. EE states she will plan to see her PCP. On 9/8/2025 the said individual reported "I wanted to let you know that I have a follow up appointment today about the vaccination I received and the symptoms I'm having". Patient stated, 'It's the only thing I can think of but after getting the vaccine I started having symptoms of numbness from my arm down to my foot, like the day afterwards, 8/12/2025'. In addition, patient stated, "I talked to someone from clinic about the symptoms, but I don't remember who". She further stated, "the thing is, the numbness is intermittent and finally on 8/22/2025 (I think), I went to the ER because I was afraid, I was having a stroke. My head felt numb, I kept looking at my face for drooping, they did a CT scan, and everything came back okay". "I also contacted the HEPLISAV-B company after reading up on the immunization and they indicated they were going to submit a vaccine reaction report, but I haven't heard back from them". "I thought maybe I was having a Gillian Barre event". Patient describes the symptoms as intermittent, on the left side of her body from her head to foot; head, face, arm, torso, hip, buttocks, leg and foot". She stated, "it comes and goes". Patient further stated, "for example, if I'm driving and lean my head back a little bit, it feels like there is a bump in the back of my head but when you feel for a bump, there is no bump, and my face is not numb". She further stated, "if I'm not immune, I'm afraid I won't have another vaccine, I'm too afraid because of what has happened, and I associate the symptoms from when I had the shot".
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| 2858264 | 62 | M | CA | 09/11/2025 |
FLU3 |
SANOFI PASTEUR |
tfaa2503 |
Injection site haemorrhage, Injection site swelling
Injection site haemorrhage, Injection site swelling
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injection in right arm, patient's arm started to swell and bleed the size of about a quarter. s...
injection in right arm, patient's arm started to swell and bleed the size of about a quarter. stopped bleeding after about thirty seconds. still swollen. told patient to ice and take Tylenol if pain
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| 2858265 | 71 | F | FL | 09/11/2025 |
PNC21 |
MERCK & CO. INC. |
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Pain
Pain
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pt says her arm is stinging on and off since vaccine administered 9/6/25 which is unusual
pt says her arm is stinging on and off since vaccine administered 9/6/25 which is unusual
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| 2858266 | 68 | F | HI | 09/11/2025 |
FLU3 |
SEQIRUS, INC. |
407242 |
Chest discomfort
Chest discomfort
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After receiving the shot, patient reported back to the pharmacy and said she felt her chest get tigh...
After receiving the shot, patient reported back to the pharmacy and said she felt her chest get tight.
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| 2858267 | 67 | M | FL | 09/11/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
F4AC3 |
Extra dose administered, Pain in extremity
Extra dose administered, Pain in extremity
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Patient did not have any adverse effects except sore arm, I am reporting because patient was not sup...
Patient did not have any adverse effects except sore arm, I am reporting because patient was not supposed to get this vaccination. Patient already received RSV vaccine on 11/06/2023
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| 2858268 | 0.17 | M | ID | 09/11/2025 |
PNC20 |
PFIZER\WYETH |
LP4946 |
Hypotonia, Pallor
Hypotonia, Pallor
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Pt became pale, limp for about 30 second. Called to the room by parent. Was observed, HR normal. Obs...
Pt became pale, limp for about 30 second. Called to the room by parent. Was observed, HR normal. Observed and administer Tylenol. Patient returned to normal activity.
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| 2858269 | 64 | M | FL | 09/11/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
f4ac3 |
Extra dose administered
Extra dose administered
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Patient received second RSV dose, dose not needed
Patient received second RSV dose, dose not needed
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| 2858270 | 71 | F | CA | 09/11/2025 |
PNC20 |
PFIZER\WYETH |
ma2523 |
Extra dose administered
Extra dose administered
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pt had Prevnar 20 on 2/9/25 and we were not aware because nursing home did not report to vaccine reg...
pt had Prevnar 20 on 2/9/25 and we were not aware because nursing home did not report to vaccine registry, so vaccine was given today
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| 2858271 | 46 | F | FL | 09/11/2025 |
FLU3 MMR VARCEL |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
U8790AA 4N222 Z005233 |
Chest pain, Headache, Injection site induration, Injection site pain, Pain; Ches...
Chest pain, Headache, Injection site induration, Injection site pain, Pain; Chest pain, Headache, Injection site induration, Injection site pain, Pain; Chest pain, Headache, Injection site induration, Injection site pain, Pain
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Patient was contacted yesterday (9/10/25) since she was given the Priorix via IM route rather than S...
Patient was contacted yesterday (9/10/25) since she was given the Priorix via IM route rather than SQ route. Patient said she had soreness after the shot and she is doing fine now. Had also informed that we had contacted the manufacturer and they confirmed that the vaccine need not be repeated even though it was given IM. Patient called today (9/11/25) and stated that she started having a radiating pain from the injection site of the Priorix to her chest and she had headaches since the shot was given and she the injection site of the Priorix is hard on touching. Advised her to keep her arm moving and do compresses to see if there is any relief and to seek medical attention if it becomes really bothersome. Also got her PCP's information so we can call and inform the patients symptoms to them tomorrow. I have told her that we will call and follow up tomorrow.
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| 2858272 | 56 | F | AL | 09/11/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
MA2523 MA2523 |
Hot flush, Injected limb mobility decreased, Injection site erythema, Injection ...
Hot flush, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain; Injection site pruritus, Injection site warmth, Pain, Peripheral swelling, Rash pruritic
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Patient received the vaccine on 08/18/2025. she noticed redness, approx 3 days later she started to ...
Patient received the vaccine on 08/18/2025. she noticed redness, approx 3 days later she started to have itching and then 2 days after that diffuse swelling of the arm with difficult with movement. She was seen in clinic on 08/25 and was found to have an irregularly shaped, mildly indurated right upper extremity with mild warmth to touch and mild tenderness. some central areas of clearing present. mild ttp antecubital fossa. no distal swelling. Rash was itchy. Reported pain, reports hot flashes. Reports taking ibuprofeun before work, temp was 99.6. no recorded fever. no signs of anaphylaxis. Was prescribed antihistamines and steroid cream as well as antibiotic for potential cellutitis, and advised to take if worsening. Patient was contacted several days )(8/30/2025) later and had not had time to pick up medications and reports that redness improved, did not spread, less itchy, not as painful. reports a small lump of swelling under the skin but no redness like before. given strict ER and return to clinic precautions.
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| 2858273 | 1.5 | F | MP | 09/11/2025 |
FLU3 |
SEQIRUS, INC. |
AX4604C |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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PT WAS ADMINISTERED AFLURIA FLU VACCINE WHICH IS OUT OF HER AGE RANGE. PT MOTHER CALLED AND AWARE OF...
PT WAS ADMINISTERED AFLURIA FLU VACCINE WHICH IS OUT OF HER AGE RANGE. PT MOTHER CALLED AND AWARE OF THE EVENT. INFORMED PT MOTHER TO MONITOR CHILD FOR ANY ADVERSE EFFECTS. PT MOTHER ACKNOWLEDGED AND UNDERSTOOD.
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| 2858284 | 17 | F | TX | 09/11/2025 |
MNP |
PFIZER\WYETH |
P7146 |
Dizziness, Vomiting
Dizziness, Vomiting
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Pt began complaining of dizziness at 6:30am on 9/11/15 Mother reports she then threw up and felt a ...
Pt began complaining of dizziness at 6:30am on 9/11/15 Mother reports she then threw up and felt a little better. Pt reported the dizziness returned around 11am on 9/11/25
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| 2776126 | M | CO | 09/10/2025 |
CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK CHIK |
VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. |
23J021 23J021 23J021 23J021 23J021 23J021 23J021 23J021 23J021 |
Acute kidney injury, Alanine aminotransferase increased, Arthralgia, Aspartate a...
Acute kidney injury, Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Asthenia; Blood bilirubin increased, Blood creatinine increased, Blood culture negative, Blood sodium decreased, Brain fog; C-reactive protein normal, Chills, Computerised tomogram head normal, Decreased appetite, Dehydration; Encephalopathy, Fall, Fatigue, Gait disturbance, Headache; Hyponatraemia, Influenza virus test negative, Leukopenia, Magnetic resonance imaging, Magnetic resonance imaging head normal; Malaise, Muscular weakness, Myalgia, Pain, Platelet count decreased; Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Thrombocytopenia, White blood cell count decreased; Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood creatinine increased, Brain fog; C-reactive protein increased, Chills, Dehydration, Encephalopathy, Fall; Immunisation reaction, Influenza virus test negative, Liver function test increased, Magnetic resonance imaging, Malaise; Muscular weakness, Pain, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Arthralgia, Blood test, Brain fog, Chest X-ray, Chills; Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram spine, Fatigue, Gait disturbance; Headache, Hypersomnia, Magnetic resonance imaging head, Myalgia, Pyrexia; Fatigue, Impaired work ability, Loss of personal independence in daily activities, Malaise, Mobility decreased; Myalgia, Pain; Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood creatinine increased, Brain fog; C-reactive protein increased, Chills, Dehydration, Encephalopathy, Fall; Immunisation reaction, Influenza virus test negative, Liver function test increased, Magnetic resonance imaging, Malaise; Muscular weakness, Pain, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Arthralgia, Blood test, Brain fog, Chest X-ray, Chills; Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram spine, Fatigue, Gait disturbance; Headache, Hypersomnia, Magnetic resonance imaging head, Myalgia, Pyrexia; Fatigue, Impaired work ability, Loss of personal independence in daily activities, Malaise, Mobility decreased; Myalgia, Pain; Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood creatinine increased, Brain fog; C-reactive protein increased, Chills, Dehydration, Encephalopathy, Fall; Immunisation reaction, Influenza virus test negative, Liver function test increased, Magnetic resonance imaging, Malaise; Muscular weakness, Pain, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Arthralgia, Blood test, Brain fog, Chest X-ray, Chills; Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram spine, Fatigue, Gait disturbance; Headache, Hypersomnia, Magnetic resonance imaging head, Myalgia, Pyrexia; Fatigue, Impaired work ability, Loss of personal independence in daily activities, Malaise, Mobility decreased; Myalgia, Pain
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AST elevated; ALT elevated; Serum creatinine higher than baseline; Acute kidney injury; Myalgia; Art...
AST elevated; ALT elevated; Serum creatinine higher than baseline; Acute kidney injury; Myalgia; Arthralgia; Fever; Headache; Anorexia; Severe fatigue; Unsteady gait; Encephalopathy; Generalised weakness; Started feeling ill; Body aches; Chills; Brain fog; e; Minor fall out of bed; Dehydration; The following information was downloaded from VAERS official webpage on 08 July 2024. A 83-year-old male vaccinee received one dose of IXCHIQ (Chikungunya virus vaccination, batch number not reported) on 13 June 2024 [in structured field reported as 01 June 2024]. His concomitant medication included allopurinol (300 mg daily), Aspirin (acetylsalicylic acid, 81 mg daily), carvedilol (12.5 mg twice daily), eplerenone (25 mg daily), losartan (25 mg daily), Protonix (pantoprazole, 40 mg twice daily), Crestor (rosuvastatin, 5 mg twice a week alternating with 3 times a week), testosterone pump (as needed) and Vitamin B12 (100). His past medical history included paroxysmal atrial fibrillation, coronary artery disease, stent in the past, hypertension, hyperlipidemia, congestive heart failure, abdominal aortic aneurysm, chronic kidney disease stage II, Barrett's esophagus, gastrooesophageal reflux disease and gout. Additionally chlorhexidine, epinephrine and sulfa drugs were reported [it is unknown if vaccinee had an allergy or if it was past drug history]. The vaccinee was described as very active, he plays golf and is very mobile. Several days after vaccination he started to feel ill, body aches, chills, generalised weakness and brain fog occurred. He had a minor fall out of the bed. On 20 June 2024 he went to the Emergency Department and workup was completed, included MRI and labs. The laboratory values showed mild dehydration and elevated liver function test. Covid, Flu and RSV swabs were negative. He was discharged from the Emergency Department but returned on 24 June 2024 due to ongoing weakness and was hospitalised. Workup was done for left lower extremity weakness, neurology and ID consults. The following laboratory values were provided: 20 June 2024: SCr (serum creatinine) 1.76 (higher than baseline) 26 June 2024: SCr 0.85 26 June 2024: AST/ALT 124/87 (elevated) 24 June 2024: CRP 1.2 On 26 June 2024 the vaccinee was discharged with diagnosis of encephalopathy, generalised weakness. Reactions were suspected to Chikungunya vaccine. The outcome of all events was unknown by time of report. --- Follow up information 1 was created after internal discussion and decision of client on 05 Aug 2024. Adaption and addition of medical assessment, causality and correction of labelling. Causality was changed from excluded to possibly related for the event Dehydration. Labelling was corrected from not labelled to labelled for the events Dehydration, Alanine aminotransferase increased and Aspartate aminotransferase increased. The events Fall, Dehydration, Alanine aminotransferase increased, Aspartate aminotransferase increased and Blood creatinine increased were now also described in the medical assessment. --- Follow up information 2 was created after internal decision of client on 06 Mar 2025. Labelling of malaise was corrected to unexpected, as malaise is not listed in the label of IXCHIQ and it was not assigned correctly and uniformly in case processing. --- Follow up information 3 covers additional information from source docs which were requested from FDA by the regulatory authority and received on 21 Mar 2025. Additional concomitant medication included Cholestyramine, 4 grams twice daily. Additional relevant medical history included allergies to Chlorhexidine, Epinephrine and sulfa drugs. Dosage of concomitant medication of Vitamin B12 was corrected from 100 to 1000 mcg. It was reported that the man never had adverse drug reactions following previous vaccinations. It was also confirmed that the vaccinee was hospitalised over a period of two days (dates not provided). --- Follow up information 4 was received from a literature article. Additional events were reported. Three days after vaccination the vaccinee developed myalgia, arthralgia, fever, headache, anorexia, severe fatigue and unsteady gait. Seven days after vaccination he was diagnosed with acute kidney injury. The outcome was reported es recovered (period to full recovery: three to five weeks). Chronic thrombocytopenia was reported as additional medical comorbidity. New lab values were provided.; Reporter's Comments: Narrative provided by VAERS on 21 Mar 2025: Patient reported to have received Chikungunya vaccine on 6-13-24, in preparation for vacation. At baseline, patient is very active, plays golf, mobile. Several days alter receiving the vaccine, patient started to feel ill, body aches, chills, generalized weakness, and brain fog, and reported minor fall out of bed. On (b) (6) , patient reported to the Emergency Department at (b) (6) (b) (6) , and workup was completed (included MRI and labs). Labs showed mild dehydration, elevated LFTs, and dehydration. Covid, flu, and RSV swab negative. He was discharged from the ED, but returned on (b) (6) with ongoing symptoms of weakness. Pt was admitted and workup done for left lower extremity weakness, neurology and ID consults. Patient discharged on (b) (6) with diagnosis of encephalopathy, generalized weakness, reaction suspected to Chikungunya vaccine.; Sender's Comments: Valneva's medical assessment of FUP 4: The company assessed the events of myalgia, arthralgia, pyrexia, headache, fatigue, pain, chills, malaise, decreased appetite and asthenia as possibly related to IXCHIQ vaccine administration due to temporal association and clinical plausibility. The events (with the exception of decreased appetite, pain and malaise) are listed in the reference safety information of IXCHIQ and are consistent with post-vaccination systemic reactions or chikungunya-like adverse reactions. Causality to aspartate aminotransferase increased and alanine aminotransferase increased is likewise assessed as possibly related due to the known safety profile of IXCHIQ (increased liver function tests are listed in the EU label) and clinical plausibility. Although the patient's advanced age and medical history of gout may be risk factors for gait disturbance, as a likely consequence of fatigue and asthenia, causality to this event cannot be excluded. The company assessed the causality to dehydration and acute kidney injury as not related. Dehydration was likely confounded by the patient's febrile state and elderly age and possibly lead to acute kidney injury by the aggravation of his underlying chronic kidney disease. Causality to blood creatinine increased is likewise excluded, considering this event as a consequence and laboratory sign of acute kidney injury. The company assessed the causality to the events brain fog and encephalopathy as not related, as there is insufficient evidence to implicate IXCHIQ with these events. Notably, medical imaging of the brain showed no acute changes. Apart from brain fog, no additional signs, symptoms or investigative findings were reported to support the diagnosis or establish the etiology of encephalopathy. Based on the available information, the patient's elderly age, multiple underlying comorbidities and medications, as well as his febrile and dehydrated state may be more likely alternative explanations for these events. Causality to fall was assessed as not related, considering its likely accidental nature and the patient's advanced age and presence of gait disturbance, fatigue and asthenia as risk factors. --- Valneva's medical assessment of FUP 3: Follow up information 3 was received on 21 Mar 2025. This elderly man (83 years old) had symptoms of general reaction to vaccination starting "several days" after vaccination (feeling ill, body aches, chills, dehydration, generalized weakness and brain fog = dizziness), considered possibly related to IXCHIQ, aggravated by pre-existing conditions and ongoing medication (paroxysmal atrial fibrillation, coronary artery disease, stent in the past, hypertension, hyperlipidemia, congestive heart failure, abdominal aortic aneurysm, chronic kidney disease stage II, Barrett's esophagus, gastroesophageal reflux disease and gout). The term "encephalopathy" is not supported by the existing information and considered a misnomer. ---- Valneva's medical assessment of FUP 2: Follow up 2 was created on 06 Mar 2025. This elderly multimorbid male (83 years of age) had symptoms of a general reaction to vaccination (feeling ill, body aches, chills, generalized weakness and brain fog = dizziness) considered possibly related to vaccination with IXCHIQ, aggravated by pre-existing conditions and ongoing medication. The term "encephalopathy" is not supported by the existing information and considered a misnomer. Expectedness assessment of the event malaise was corrected from expected to unexpected after internal discussion and following regulatory authority decision. Malaise is not listed in the label of IXCHIQ and it was not assigned correctly and uniformly in case processing. This change in expectedness assessment does not change the assessment of causality for this event which remains possibly related. ---- Valneva's medical assessment of FUP 1: Follow up 1 created after internal discussion and decision of regulatory authority on 05 Aug 2024. Adaption and addition of medical assessment, causality and correction of labelling. For the event dehydration, causality was changed from excluded for IXCHIQ to possibly related, as it is a rare but known side effect of immunisation with IXCHIQ that low amounts of water and sodium in the blood (hypovolaemic hyponatraemia) can be detected, indicative of a dehydration. Nevertheless, for this event, Eplerenone might also be taken into consideration. For the unlabelled events Fall and Blood creatinine increased, causality is assessed as possibly related, given the plausible time to onset, and as this is most likely a consequence of the other reported adverse drug reactions after the vaccination with IXCHIQ, e.g. brain fog, asthenia, dehydration, malaise. However the advanced age of the vaccinated person should also be taken into account. For the events aspartate aminotransferase increased, alanine aminotransferase increased, causality is assessed as possibly related, given the plausible time to onset and the fact that increased liver enzymes are known for IXCHIQ. However, for the events aspartate aminotransferase increased, alanine aminotransferase increased and blood creatinine increased Allopurinol, Losartan and Pantoprazole might also be taken into consideration. For elevated liver enzymes in general, Acetylsalicylic acid, Carvedilol, Rosuvastatin, Testosterone and for the event blood creatinine increased Eplerenone might be of interest. ---- Valneva's medical assessment of initial: Causality assessed as excluded for IXCHIQ, as there is currently no scientific evidence and no similar cases linking IXCHIQ to the occurrence of an encephalopathy. Causality assessed as possible for asthenia, malaise, pain, chills and brain fog, as time of onset is plausible (several days past vaccination) and as these symptoms are known for IXCHIQ, indicative of a systemic vaccination reaction. However, for some events concomitant medications might be taken into consideration.
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| 2857710 | M | NH | 09/10/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arthralgia, Pain in extremity, Vaccination site vesicles
Arthralgia, Pain in extremity, Vaccination site vesicles
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huge water blister at injection site/injection site there is a large water blister; arm and shoulder...
huge water blister at injection site/injection site there is a large water blister; arm and shoulder started getting sore; arm and shoulder started getting sore; This is a spontaneous report received from a Consumer or other non HCP. A 69-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Sep2025 at 12:07 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number unknown), for Covid-19 immunization, reaction(s): "shoulder started getting sore as it has on previous occasions", "arm started getting sore as it has on previous occasions"; Bnt162b2 (Dose 2, single, lot number unknown), for Covid-19 immunization, reaction(s): "shoulder started getting sore as it has on previous occasions", "arm started getting sore as it has on previous occasions"; Bnt162b2 (Dose 3, single, lot number unknown), for Covid-19 immunization, reaction(s): "shoulder started getting sore as it has on previous occasions", "arm started getting sore as it has on previous occasions"; Bnt162b2 (Dose 4, single, lot number unknown), for Covid-19 immunization, reaction(s): "shoulder started getting sore as it has on previous occasions", "arm started getting sore as it has on previous occasions". The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 04Sep2025, outcome "unknown" and all described as "arm and shoulder started getting sore"; VACCINATION SITE VESICLES (non-serious) with onset 05Sep2025, outcome "recovering", described as "huge water blister at injection site/injection site there is a large water blister". The events "arm and shoulder started getting sore" and "huge water blister at injection site/injection site there is a large water blister" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of arthralgia, pain in extremity, vaccination site vesicles. Additional information: On 04Sep2025 at 12:07 caller was administered the vaccine. This was caller's 5th Pfizer vaccine shot. Pretty much knew the drill, what to expect and do. Everything was fine, good injection, didn't feel pinch or prick. He was administered and put a Band-Aid on, he didn't shower and 4 hours later his arm and shoulder started getting sore as it has on previous occasions. He started putting ice and arnica gel on it. Since he had prior experience with previous administration this was not the first time he tried ice and arnica gel. He did that from 4PM until bed, around 11:30 or 12. He slept alright. He woke up the following morning, felt arm and shoulder, felt weird. He rolled up the sleeve of pajamas, looked in mirror, had huge water blister at injection site, about 4.5 inches long (above and below the injection site) by close to 3 inches wide above and below and to the side of the injection site or 2 and 3/4 inches wide. It was a Friday, so he got on phone with triage nurse. Within probably a few hours after woke up, it burst on its own, was so full of water. The patient has active life with sports and different stuff, so has had water blisters before for various things. He knew how to treat it. Basically he just cleaned it with soap and water, put triple antibiotic on it, keeping covered with gauze pad. One nurse said agreed with caller's treatment, and another nurse said maybe get to urgent care. But it was a Friday afternoon, has excellent health care, didn't want to go to emergency room. Doctor and medical health system on Fridays are bad, was "not going to deal with that headache". The caller monitored and treated himself. If he had signs of infection, would go to urgent care. He was treating all weekend, fine since then, like a burn, raw, layers of skin peeled off on its own, looked like was healing. The patient then stated he already contacted his primary healthcare professional and went to urgent care. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2857724 | M | WA | 09/10/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946063 |
No adverse event
No adverse event
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Given HEPLISAV-B When They were 14 Years Old; Initial report received on 06-Aug-2025. A pharmacist ...
Given HEPLISAV-B When They were 14 Years Old; Initial report received on 06-Aug-2025. A pharmacist reported that a 14-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 17-Apr-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 946063, expiration date 31-Aug-2027; NDC number not available) intramuscularly in the right arm. The patient was 14 years old at the time of immunization. No side effects were reported. No other information was available. 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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| 2857725 | M | 09/10/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Interchange of vaccine products, No adverse event
Interchange of vaccine products, No adverse event
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Received a HEPLISAV-B End of April 2025 Then Received TWINRIX; Initial report received on 20-Aug-202...
Received a HEPLISAV-B End of April 2025 Then Received TWINRIX; Initial report received on 20-Aug-2025. A pharmacist reported that a male patient (race and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization first dose and then received TWINRIX as a second dose. No medical history or concomitant medications were reported. At the end of Apr-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot#, expiration date, NDC #, route and site not available). In Aug-2025, after having been vaccinated with HEPLISAV-B, the patient received a dose of TWINRIX (no details provided) as a second dose for hepatitis B vaccination. The reporter stated that the patient had no other side effects reported. No other information was available per the reporter. 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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