| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2860314 | F | 09/22/2025 |
COVID19 |
MODERNA |
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Influenza
Influenza
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36 hours in bed with flu; This spontaneous case was reported by a consumer and describes the occurre...
36 hours in bed with flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (36 hours in bed with flu) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (36 hours in bed with flu). At the time of the report, INFLUENZA (36 hours in bed with flu) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as unknown. No concomitant medication was reported. The patient had, since the Moderna vaccine was released, consistently kept up with the updates, starting in 2021. Every other Moderna vaccine she received, she experienced about 36 hours in bed with the flu, a sort of feverish and achy skin which she had expected. The patient had always managed it. In the recent vaccine mNEXSPIKE, the patient did not have the usual flu-like symptoms. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-789447 (Patient Link).
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| 2860315 | F | CA | 09/22/2025 |
COVID19 |
MODERNA |
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Gait inability
Gait inability
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unable to walk; This spontaneous case was reported by a consumer and describes the occurrence of GAI...
unable to walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (unable to walk) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Multiple sclerosis. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced GAIT INABILITY (unable to walk). At the time of the report, GAIT INABILITY (unable to walk) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Patient experienced side effects following her first three to four Moderna vaccines. After her initial vaccination in 2021, she was unable to walk for 24 hours. Subsequent vaccinations resulted in similar side effects, but these resolved within 24 hours. There were no lab data/results available. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. No treatment medication was reported. Reporter causality was not reported. This case was linked to MOD-2025-789439 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2025: Live follow-up received: Reference id added.
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| 2860316 | M | 09/22/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Dizziness
Dizziness
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I get dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZIN...
I get dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I get dizzy) in a male patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 15-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced DIZZINESS (I get dizzy). In September 2025, DIZZINESS (I get dizzy) had resolved. No concomitant medication was reported. The patient got the new COVID-19 vaccine on Monday afternoon. The patient got dizzy for a few seconds and then it went away. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
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| 2860317 | 78 | M | RI | 09/22/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Headache, Pain
Headache, Pain
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body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence o...
body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache) and HEADACHE (headache) in a 78-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (Patient was diagnosed with Covid-19.) on 19-May-2025 and Heart attack. On 16-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced PAIN (body ache) and HEADACHE (headache). On 18-Sep-2025, HEADACHE (headache) had resolved. At the time of the report, PAIN (body ache) had resolved. The concomitant medication was not reported by the reporter. The patient had a headache and body ache. It was unknown if the patient experienced any additional symptoms or events. The patient did not have any additional medical history, concomitant disease or risk factor. There was no lab data or results available. The treatment medication was not reported by the reporter.
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| 2860318 | 61 | OH | 09/22/2025 |
TDAP |
SANOFI PASTEUR |
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No adverse event, Off label use
No adverse event, Off label use
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Intentional Off Label Prescription by HCP: Adacel prescribed with off label diagnosis Z22.3 Carrier ...
Intentional Off Label Prescription by HCP: Adacel prescribed with off label diagnosis Z22.3 Carrier of other specified bacterial diseases with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 61 years old and unknown gender patient who was prescribed Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] for carrier of other specified bacterial diseases with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was prescribed 0.5ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, (once)Solution for injection, (unknown strength and expiry date) lot number not reported via intramuscular route in unknown administration site for Carrier of other specified bacterial diseases [bacterial infection], with no reported adverse event (off label use) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence will not be available. Reportedly, Intentional Off Label Prescription by HCP (healthcare professional). Action taken was not applicable.
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| 2860319 | 55 | CA | 09/22/2025 |
FLU3 |
SANOFI PASTEUR |
UT8779JA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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HD syringe was administered in error to a 55-year-old patient, with no reported adverse event; Initi...
HD syringe was administered in error to a 55-year-old patient, with no reported adverse event; Initial information received on 16-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 55 years old and unknown gender patient who was administered to Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] syringe in error, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot UT8779JA, expiry date 30-Jun-2026, strength not eported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and was administered in error to a 55-year-old patient, with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2860320 | 8 | M | 09/22/2025 |
DTAP |
SANOFI PASTEUR |
3CA55C1 |
No adverse event, Product administered to patient of inappropriate age, Product ...
No adverse event, Product administered to patient of inappropriate age, Product prescribing error
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provider ordered daptacel instead of tdap for an 8 year old patient and it was administered with no ...
provider ordered daptacel instead of tdap for an 8 year old patient and it was administered with no adverse event; provider ordered daptacel instead of tdap for an 8 year old patient and it was administered with no adverse event; Initial information received on 16-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an 8-year-old male patient who was administered with diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) due to provider ordering ,with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Sep-2025, the patient of 8 years old received a dose 0.5ml 1x (once) of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE , Suspension for injection (lot 3CA55C1, expiry :31-Aug-2026) via intramuscular route in the left deltoid as immunization instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID produced by unknown manufacturer (lot number, Form and expiry unknown) due to provider ordering error, with no adverse event (Wrong Product administered) (Product administered to patient of inappropriate age) (Latency : Same day ) Information regarding batch number and expiration date corresponding to the one at tine of event occurrence was requested. Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2860321 | 1.5 | M | OK | 09/22/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK226AA |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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pentacel was administered too early so the dose for IPV was given too early as well with no adverse ...
pentacel was administered too early so the dose for IPV was given too early as well with no adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 18 months old male patient who received diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] too early so the dose for IPV was given too early as well with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis a vaccine for Immunisation. On 15-Jul-2025, the patient received 0.5 ml of dose 3 of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength- Standard, expiry date- 31-AUG-2026 and lot UK226AA) once via intramuscular route in the left vastus lateralis for Immunization and the dose was administered too early so the dose for IPV was given too early as well with no adverse event (inappropriate schedule of product administration) (latency- same day). Reportedly, Treatment: No reaction, no treatment 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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| 2860322 | 0.83 | F | IN | 09/22/2025 |
HIBV |
SANOFI PASTEUR |
UK331AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
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This situation is pre-assessed as a medication error/an inappropriate use due to ACTHIB reconstituti...
This situation is pre-assessed as a medication error/an inappropriate use due to ACTHIB reconstitution with a different diluent and was administered with no adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 months old female patient who inappropriately administered HIB (PRP/T) Vaccine [ACT-HIB] which was reconstituted with a different diluent with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 16-Sep-2025, the patient inappropriately received 0.5 ml (dose 3) of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, lot UK331AA, expiry date:31-Jul-2026, strength:Strength = Vaccine was reconstituted with sterile water, via intramuscular route in the left vastus lateralis for immunization which was reconstituted with a different diluent with no adverse event (product preparation error) (latency: same day). Reportedly,Medical Assistant called to ask if the ACTHIB vaccination was valid when it was reconstituted with sterile water instead of the 0.4% sodium chloride diluent. 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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| 2860323 | 15 | M | PA | 09/22/2025 |
FLU3 |
SANOFI PASTEUR |
UT8802MA |
Product storage error
Product storage error
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Temperature excursion: Stored in cooler with ice packsMax/low temperature reached: UnknownDuration: ...
Temperature excursion: Stored in cooler with ice packsMax/low temperature reached: UnknownDuration: 4 hours,with no reported adverse event; Temperature excursion: Stored in cooler with ice packs-Max/low temperature reached: Unknown, Duration: 4 hours and product was administered with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 years old male patient who was administered to Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which went under temperature excursion: negative disposition- stored in cooler with ice packs- max/low temperature reached: unknown, duration: 4 hours with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Sep-2025, the patient received 0.5mL (dose 1) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot UT8802MA, expiry date 30-Jun-2026, strength standard and frequency once) via intramuscular route in the right deltoid for Immunisation - temperature excursion: stored in cooler with ice packs-max/low temperature reached: unknown, duration: 4 hours and product was administered with no reported adverse event (poor quality product administered) (latency same day) and (product storage error). Reportedly, Fluzone NP were stored in a cooler with frozen ice packs, separated by a barrier layer of refrigerated packs to prevent freezing. This storage condition lasted for 4 hours before the vaccines were transferred to a refrigerator with within-range temperature. The clinic supervisor also stated that they could not provide the exact highest temperature that the vaccines reached. No other immunizations. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA281863:for FLUZONE NP US-SA-2025SA281965: 02658701:
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| 2860324 | UT | 09/22/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK110AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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accidentally gave an expired dose of pentacel to a patient with no reported adverse event; Initial i...
accidentally gave an expired dose of pentacel to a patient with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in September 2025, the patient received an unknown dose of an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength- unknown, expiry date- 31-AUG-2025 and lot UK110AA) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (same day latency). 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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| 2860325 | 0.5 | M | CO | 09/22/2025 |
DTAPHEPBIP FLU3 PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
TE499 I4A7R LX2496 |
Rash, Urticaria; Rash, Urticaria; Rash, Urticaria
Rash, Urticaria; Rash, Urticaria; Rash, Urticaria
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Full body rash with hives.
Full body rash with hives.
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| 2860356 | 72 | F | NY | 09/22/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Burning sensation, Dyspnoea exertional, Immediate post-injection reaction, Pain ...
Burning sensation, Dyspnoea exertional, Immediate post-injection reaction, Pain in extremity, Peripheral swelling; Tenderness, Weight increased
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Out of Breath/she gets out of breath when she walks too fast or is rushing; her left arm was sore/le...
Out of Breath/she gets out of breath when she walks too fast or is rushing; her left arm was sore/left arm tender; she has put on extra weight; she experienced a burning in her left shoulder during the administration of the vaccine; she had swelling for about three days after receiving the first dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of exertional dyspnea in a 72-year-old female patient who received fluticasone propionate, salmeterol xinafoate (Advair Diskus) inhalation powder (batch number PX4U, expiry date 31-OCT-2025) for asthma. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included Other Conditions: No. On an unknown date, the patient started Advair Diskus. On 25-JUL-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 25-JUL-2025, an unknown time after starting Advair Diskus and immediately after receiving Shingrix, the patient experienced burning sensation (Verbatim: she experienced a burning in her left shoulder during the administration of the vaccine). On an unknown date, the patient experienced exertional dyspnea (Verbatim: Out of Breath/she gets out of breath when she walks too fast or is rushing), swelling arm (Verbatim: she had swelling for about three days after receiving the first dose of Shingrix), pain in arm (Verbatim: her left arm was sore/left arm tender) and weight gain (Verbatim: she has put on extra weight). Advair Diskus was continued with no change. The outcome of the exertional dyspnea, pain in arm, burning sensation and weight gain were unknown and the outcome of the swelling arm was resolved (duration 3 days). It was unknown if the reporter considered the exertional dyspnea, swelling arm, pain in arm, burning sensation and weight gain to be related to Advair Diskus, Advair Diskus Dry Powder Inhaler Device and Shingrix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. GSK receipt date: 25-AUG-2025 The reporter/patient with Asthma that reported that she gets out of breath when she walks too fast or is rushing, and this started (most recently, but no specific dates provided) while she was on Advair Diskus. The patient has been on Advair Diskus for 20 plus years (no specific dates provided). The patient stated she has put on extra weight, which she is trying to lose. The patient also reported that she received the first dose of Shingrix 25-JUL-2025 in her left arm, and that she experienced a burning in her left shoulder during the administration of the vaccine. The patient also reported that she was already having this burning in her left shoulder four days before receiving the first dose of the Shingrix vaccine. The patient reported that this burning still comes and goes, (is not continuous), like before she received Shingrix. The patient reported that her left arm was sore, tender, and she had swelling for about three days after receiving the first dose of Shingrix. The patient reported that she used ice cubes on this area to relieve the swelling. I have reported all that was provided about these adverse events. Conmed product included Vitamins.
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| 2860357 | M | 09/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 09-SEP-2025 This case was reported by a consumer via interactive digital media. The reporter reported that patient got shingles from the vaccination, not long after. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix, in a adult male patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2860358 | 09/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Eyelid ptosis, Herpes zoster, Ophthalmic herpes zoster, Pruritus, Vaccination fa...
Eyelid ptosis, Herpes zoster, Ophthalmic herpes zoster, Pruritus, Vaccination failure
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Suspected Vaccination failure; Shingles on forehead and eye lids; This serious case was reported by...
Suspected Vaccination failure; Shingles on forehead and eye lids; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on forehead and eye lids). The patient was treated with pregabalin. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-SEP-2025 This case was reported by a patient via interactive digital media. The patient had shingles shot last year in 2024. Got shingles in Mar 2025 on forehead and eye lids. Still suffering horribly with the residual effects of extreme itching day and night every day since Mar 2025. Taking pregabalin which helps minimally. Patient had dropping eyelid from all the scratching. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2860359 | 86 | M | FL | 09/22/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
AZ2A3 |
Blood donor, Hepatitis viral test positive
Blood donor, Hepatitis viral test positive
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Patient tested positive to hepatitis one day after getting Twinrix second dose; This non-serious cas...
Patient tested positive to hepatitis one day after getting Twinrix second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of hepatitis viral test positive in a 86-year-old male patient who received HAB (Twinrix) (batch number AZ2A3, expiry date 05-FEB-2028) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 24-JUL-2025, the patient received the 2nd dose of Twinrix. On 25-JUL-2025, 1 days after receiving Twinrix, the patient experienced hepatitis viral test positive (Verbatim: Patient tested positive to hepatitis one day after getting Twinrix second dose). The outcome of the hepatitis viral test positive was unknown. The reporter considered the hepatitis viral test positive to be possibly related to Twinrix and Twinrix Pre-Filled Syringe Device. The company considered the hepatitis viral test positive to be possibly related to Twinrix and Twinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-AUG-2025 Pharmacist explained that a patient got Twinrix first dose on 16 Jul 2025 and second dose on 24 Jul 2025. Next day after having second dose, patient went to donate blood and they tested positive to hepatitis (unknown antigen). Later, patient's doctor run another blood test and the result was negative for Hepatitis (unknown antigen). They think the results from first test where due to the Twinrix vaccine.
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| 2860360 | F | MA | 09/22/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Blister, Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure; Blis...
Blister, Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure; Blister, Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure
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Suspected vaccination failure; Recent shingles breakthrough on the HCP (that is also the patient); i...
Suspected vaccination failure; Recent shingles breakthrough on the HCP (that is also the patient); intense pain confirmed as PHN; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Recent shingles breakthrough on the HCP (that is also the patient)) and post herpetic neuralgia (Verbatim: intense pain confirmed as PHN). The outcome of the vaccination failure and post herpetic neuralgia were not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 16-SEP-2025 and 17-SEP-2025 The GlaxoSmithKline's sales representative transfers a medical doctor called to ask about advise due to a recent breakthrough of shingles. The medical doctor received the two doses of Shingrix back on twenty twenty no vaccination dates were specified by the medical doctor end. The patient was not taking gabapentin or medication to prevent recurrence, however, every few months she had one or two vesicles come up, but it was very intense pain confirmed post herpetic neuralgia that occurred with that. It was like a recurrence of shingles with only a mild breakout, all 3 of them. The patient would not have known it was shingles had she not just happened to have a dermatology appointment. The patient demographics were obtained in this call. The patient looked for any advice on this matter. No further information was obtained in this call. No specific vaccination date and no vaccine detail were obtained in this call. The vaccine administration facility was the same as primary reporter. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving 1st dose of Shingrix and the 2nd dose of Shingrix, in a adult female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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| 2860361 | 79 | F | 09/22/2025 |
COVID19 |
MODERNA |
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Bedridden, Immunisation reaction
Bedridden, Immunisation reaction
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She always get a pretty bad reaction afterwards; could not move out of the bed; This spontaneous cas...
She always get a pretty bad reaction afterwards; could not move out of the bed; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She always get a pretty bad reaction afterwards) and BEDRIDDEN (could not move out of the bed) in a 79-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She always get a pretty bad reaction afterwards) and BEDRIDDEN (could not move out of the bed). At the time of the report, IMMUNISATION REACTION (She always get a pretty bad reaction afterwards) and BEDRIDDEN (could not move out of the bed) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. It was reported that, the patient was going to be 80 years old, and all the COVID vaccines she had were Moderna. She always got a pretty bad reaction afterwards but liked having the reaction because it felt like it was working. She never had COVID. It was reported that, she had a reaction every single time she had taken the vaccine. She received Moderna vaccine previous day and had zero reaction and felt normal. She received prior dose of Moderna vaccine on last September. Usually, after taking the vaccine, she could not move out of the bed. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-789453 (Patient Link).
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| 2860362 | 32 | F | MA | 09/22/2025 |
FLUX RVX UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
MD5461 3052549 |
Exposure during pregnancy, Fatigue, Pain in extremity; Exposure during pregnancy...
Exposure during pregnancy, Fatigue, Pain in extremity; Exposure during pregnancy, Fatigue, Pain in extremity; Exposure during pregnancy, Fatigue, Pain in extremity
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Mild soreness in arm after injection; mild fatigue for 24 hours; Patient received the vaccine while ...
Mild soreness in arm after injection; mild fatigue for 24 hours; Patient received the vaccine while 35 weeks + 6 days pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild soreness in arm after injection), FATIGUE (mild fatigue for 24 hours) and MATERNAL EXPOSURE DURING PREGNANCY (Patient received the vaccine while 35 weeks + 6 days pregnant) in a 32-year-old female patient (gravida 2) who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. Co-suspect products included non-company products RSV vaccine for an unknown indication and Influenza vaccine (Flu) for an unknown indication. The patient's past medical history included Pregnancy (Patient had 1 previous pregnancy and outcome was reported as spontaneous termination.) on 31-Oct-2024. On 28-Aug-2025, the patient received dose of Influenza vaccine (Flu) (Intramuscular use) 1 dosage form. On 05-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On 07-Sep-2025, the patient received dose of RSV vaccine (Intramuscular use) 1 dosage form. The patient's last menstrual period was on 28-Dec-2024 and the estimated date of delivery was 04-Oct-2025. On 05-Sep-2025, the patient experienced PAIN IN EXTREMITY (Mild soreness in arm after injection), FATIGUE (mild fatigue for 24 hours) and MATERNAL EXPOSURE DURING PREGNANCY (Patient received the vaccine while 35 weeks + 6 days pregnant). The patient received mRNA-1273.251 (Spikevax LP.8.1 PFS) beginning around the thirty-fifth week of the pregnancy, RSV vaccine beginning around the thirty-sixth week of the pregnancy and Influenza vaccine (Flu) beginning around the thirty-fourth week of the pregnancy. On 05-Sep-2025, MATERNAL EXPOSURE DURING PREGNANCY (Patient received the vaccine while 35 weeks + 6 days pregnant) had resolved. On 06-Sep-2025, PAIN IN EXTREMITY (Mild soreness in arm after injection) and FATIGUE (mild fatigue for 24 hours) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2025, Pregnancy test: Positive. Concomitant medication was not reported. Patient did not have allergies to medications, food and other products. Prenatal case has been established. She did not have maternal history of infertility. Patient received the vaccine while 35 weeks + 6 days pregnant. She had mild soreness in arm after injection and mild fatigue for 24 hours but no other symptoms. The patient did not experience any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2025: Live significant follow-up received on 11-sep-2025: Medical history and patient details and pregnancy details updated; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2860363 | F | 09/22/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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eventually contracted COVID; This spontaneous case was reported by a consumer and describes the occu...
eventually contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (eventually contracted COVID) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Surgery. 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 COVID-19 (eventually contracted COVID). At the time of the report, COVID-19 (eventually contracted COVID) outcome was unknown. Concomitant medication was not provided. It was reported that the patient had received the initial COVID vaccine and booster but could not remember subsequent doses due to various health issues and surgery. The patient had contracted COVID despite having intended to be vaccinated again. The patient had inquired that wanted to know if there was an updated COVID vaccine from Moderna that year and where she could get it. The patient wanted to confirm if she could get Spikevax, as she had taken Moderna before and also wanted to know the difference between Spikevax and mNEXSPIKE. It was also reported that the patient wanted to know if the doctors had information about the newest vaccines and wants to know if there was information she can check about the newest vaccines. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.
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| 2860365 | 17 | F | OH | 09/22/2025 |
MENB MNQ |
PFIZER\WYETH NOVARTIS VACCINES AND DIAGNOSTICS |
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Nausea, Road traffic accident, Syncope; Nausea, Road traffic accident, Syncope
Nausea, Road traffic accident, Syncope; Nausea, Road traffic accident, Syncope
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car accident because she fainted; car accident because she fainted; Nauseated; This is a spontaneous...
car accident because she fainted; car accident because she fainted; Nauseated; This is a spontaneous report received from Nurses and Other HCPs. A 17-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 10Sep2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 17 years for immunisation; meningococcal vaccine a/c/y/w conj (CRM197) (MENVEO), on 10Sep2025 as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 10Sep2025, outcome "unknown", described as "Nauseated"; SYNCOPE (medically significant), ROAD TRAFFIC ACCIDENT (non-serious) all with onset 10Sep2025, outcome "unknown" and all described as "car accident because she fainted". Clinical course: Reporter stated that they had a patient that they administered Menveo and Trumenba to a 17 years old patient and, 15 minutes later, after getting the vaccine. She left the office and was involved in a car accident because she fainted. Well, they said that because I asked them did anybody get hurt, and they said no one was hurt. She got nauseated and tried to pull over, reporter was not sure if she hit another vehicle or what the circumstances were. Reporter stated, she got the Menveo and Trumenba together. Menveo, which is the quadrivalent vaccine." The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.; Sender's Comments: Based on the known drug safety profile and temporal relationship, a causal association between suspect product and nausea and SYNCOPE cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 2860366 | F | NM | 09/22/2025 |
RSV |
PFIZER\WYETH |
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Chills, Exposure during pregnancy, Fatigue, Pain, Pain in extremity
Chills, Exposure during pregnancy, Fatigue, Pain, Pain in extremity
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body aches; chills; arm soreness; fatigue; This is a spontaneous report received from a Nurse from a...
body aches; chills; arm soreness; fatigue; This is a spontaneous report received from a Nurse from a sales representative. A female patient in her 30's (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches"; CHILLS (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; FATIGUE (non-serious), outcome "unknown". It was unknown if therapeutic measures were taken as a result of pain, chills, pain in extremity, fatigue. Additional information: Pregnant patient received Abrysvo and ended up having body aches, chills, arm soreness, fatigue, and no fever. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
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| 2860367 | M | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Memory impairment
Memory impairment
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A friend report that his doctor told him memory lapses are a side effect of, specifically, Pfizer CO...
A friend report that his doctor told him memory lapses are a side effect of, specifically, Pfizer COVID vaccines. The friend further stated he was experiencing this,; This is a spontaneous report received from a Consumer or other non HCP. An elderly male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset Sep2025, outcome "unknown", described as "A friend report that his doctor told him memory lapses are a side effect of, specifically, Pfizer COVID vaccines. The friend further stated he was experiencing this,". It was unknown if therapeutic measures were taken as a result of memory impairment. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2860368 | 35 | F | CO | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Neuralgia
Neuralgia
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Patient has had nerve pain in arm the was injected, continued for 2 days at time of reporting; This ...
Patient has had nerve pain in arm the was injected, continued for 2 days at time of reporting; This is a spontaneous report received from an Other HCP. A 35-year-old female patient (unknown if pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 08Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEURALGIA (non-serious) with onset 08Sep2025, outcome "not recovered", described as "Patient has had nerve pain in arm the was injected, continued for 2 days at time of reporting". It was unknown if therapeutic measures were taken as a result of neuralgia. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2860369 | 53 | M | PA | 09/22/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Chills, Headache, Lethargy; Chills, Headache, Lethargy
Chills, Headache, Lethargy; Chills, Headache, Lethargy
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Headache; chills; lethargy; This is a spontaneous report received from a Consumer or other non HCP. ...
Headache; chills; lethargy; This is a spontaneous report received from a Consumer or other non HCP. A 53-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 17Sep2025 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 17Sep2025 as dose 1, single, in right arm. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 18Sep2025 at 08:00, outcome "recovering"; CHILLS (non-serious) with onset 18Sep2025 at 08:00, outcome "recovering"; LETHARGY (non-serious) with onset 18Sep2025 at 08:00, outcome "recovering". Therapeutic measures were not taken as a result of headache. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which they were reporting. The patient was not taking any other medications within 2 weeks of the event starting. Co-suspect drug reported as "Proprietary medicinal product name: Flu". Patient had no past drug allergy. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2860370 | 52 | F | IN | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arthralgia, Fatigue, Headache, Pain in extremity, Wheezing
Arthralgia, Fatigue, Headache, Pain in extremity, Wheezing
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Headache; sore arm; wheezy; fatigue; joint pain (all mild); This is a spontaneous report received fr...
Headache; sore arm; wheezy; fatigue; joint pain (all mild); This is a spontaneous report received from a Consumer or other non HCP. A 52-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 18Sep2025 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "iodine contrast dye allergies" (unspecified if ongoing); "sulfa allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFATURE UNKNOWN), for immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFATURE UNKNOWN), for immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFATURE UNKNOWN), for immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFATURE UNKNOWN), for immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, MANUFATURE UNKNOWN), for immunization. The following information was reported: HEADACHE (non-serious) with onset 18Sep2025 at 10:15, outcome "not recovered"; FATIGUE (non-serious) with onset 18Sep2025 at 10:15, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 18Sep2025 at 10:15, outcome "not recovered", described as "joint pain (all mild)"; PAIN IN EXTREMITY (non-serious) with onset 18Sep2025 at 10:15, outcome "not recovered", described as "sore arm"; WHEEZING (non-serious) with onset 18Sep2025 at 10:15, outcome "not recovered", described as "wheezy". Therapeutic measures were not taken as a result of headache, pain in extremity, wheezing, fatigue, arthralgia. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2860371 | 28 | F | RI | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pain, Vaccination site pain
Pain, Vaccination site pain
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Sore arm at injection site; aches and pains throughout body; This is a spontaneous report received f...
Sore arm at injection site; aches and pains throughout body; This is a spontaneous report received from a Consumer or other non HCP. A 28-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 17Sep2025 at 13:30 as dose 1, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "hyperthyroidism" (unspecified if ongoing); "Amoxicillin allergy" (unspecified if ongoing); "allergy to lamb (when eaten)" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Sep2025 at 04:00, outcome "recovering", described as "Sore arm at injection site"; PAIN (non-serious) with onset 18Sep2025 at 04:00, outcome "recovering", described as "aches and pains throughout body". Therapeutic measures were not taken as a result of vaccination site pain, pain. Additional information: the patient did not receive any other vaccines on the same date as the vaccine, or any other vaccines within 4 weeks prior to the vaccine. The patient took other medications within 2 weeks of the event starting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2860372 | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chills, Fatigue
Chills, Fatigue
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Caller experience tiredness from previous vaccines from Pfizer; Had chills a little bit; This is a s...
Caller experience tiredness from previous vaccines from Pfizer; Had chills a little bit; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 72-year-old 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: FATIGUE (non-serious), outcome "unknown", described as "Caller experience tiredness from previous vaccines from Pfizer"; CHILLS (non-serious), outcome "unknown", described as "Had chills a little bit". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2860373 | 47 | M | CT | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arthralgia, Headache, Heart rate increased, Myalgia, Pyrexia
Arthralgia, Headache, Heart rate increased, Myalgia, Pyrexia
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Elevated heart rate; Fever high at as 101F; muscle aches; headache; joint pain; This is a spontaneou...
Elevated heart rate; Fever high at as 101F; muscle aches; headache; joint pain; This is a spontaneous report received from a Consumer or other non HCP. A 47-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 15Sep2025 at 11:15 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: May2016; ATORVASTATIN, start date: May2022; SKYRIZI [RISANKIZUMAB], start date: Dec2023; DULOXETINE, start date: Jul2025. Past drug history included: Carbamazepine, reaction(s): "Allergy". The following information was reported: HEART RATE INCREASED (non-serious) with onset 16Sep2025 at 03:00, outcome "recovered" (17Sep2025), described as "Elevated heart rate"; PYREXIA (non-serious) with onset 16Sep2025 at 03:00, outcome "recovered" (17Sep2025), described as "Fever high at as 101F"; HEADACHE (non-serious) with onset 16Sep2025 at 03:00, outcome "recovered" (17Sep2025); ARTHRALGIA (non-serious) with onset 16Sep2025 at 03:00, outcome "recovered" (17Sep2025), described as "joint pain"; MYALGIA (non-serious) with onset 16Sep2025 at 03:00, outcome "recovered" (17Sep2025), described as "muscle aches". Therapeutic measures were not taken as a result of heart rate increased, pyrexia, myalgia, headache, arthralgia. Additional information: The patient did not receive any other vaccines on the same date as the vaccines. He did not receive any other vaccines within 4 weeks PRIOR to the vaccines. He was taking medications within 2 weeks of the event starting. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2860374 | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chills, Fatigue, Headache, Influenza like illness, Vomiting
Chills, Fatigue, Headache, Influenza like illness, Vomiting
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Bad reactions; Flu like symptoms; Vomiting; Headache; Fatigue; Chills; This is a spontaneous report ...
Bad reactions; Flu like symptoms; Vomiting; Headache; Fatigue; Chills; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 18Sep2025 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: INFLUENZA LIKE ILLNESS (non-serious) with onset Sep2025, outcome "unknown", described as "Bad reactions; Flu like symptoms"; CHILLS (non-serious) with onset Sep2025, outcome "unknown"; FATIGUE (non-serious) with onset Sep2025, outcome "unknown"; HEADACHE (non-serious) with onset Sep2025, outcome "unknown"; VOMITING (non-serious) with onset Sep2025, outcome "unknown". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2860375 | 31 | M | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9547 |
Influenza like illness, Vaccination site pain
Influenza like illness, Vaccination site pain
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Flu like symptoms and injection site pain; Flu like symptoms and injection site pain; This is a spon...
Flu like symptoms and injection site pain; Flu like symptoms and injection site pain; This is a spontaneous report received from a Consumer or other non HCP. A 31-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 17Sep2025 at 15:30 as dose 1, single (Lot number: MY9547) at the age of 31 years, in right arm for covid-19 immunisation, Device Lot Number: MY9547. The patient's relevant medical history included: "Major depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 17Sep2025 at 18:00, outcome "recovering" and all described as "Flu like symptoms and injection site pain". Therapeutic measures were not taken as a result of influenza like illness, vaccination site pain. Additional information: There is no past drug allergy. The patient didn't receive any other vaccines on the same date as the vaccine(s) Comirnaty (2025-2026 Formula). The patient didn't receive any other vaccines within 4 weeks PRIOR to the vaccine(s) Comirnaty (2025-2026 Formula). It was unknown if the patient was taking any other medication within 2 weeks of the event starting. Facility where vaccine was administered: Pharmacy or Drug Store.
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| 2860376 | 73 | F | TX | 09/22/2025 |
RSV |
PFIZER\WYETH |
LN5489 |
Rash erythematous
Rash erythematous
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red bumps; rash; possible allergic reaction; This is a spontaneous report received from a Pharmacist...
red bumps; rash; possible allergic reaction; This is a spontaneous report received from a Pharmacist from medical information team, Program ID. A 73-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 09Sep2025 as dose 1, single (Lot number: LN5489, Expiration Date: 31Oct2025) at the age of 73 years, in left deltoid for immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing); "fluid overload" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal (ongoing); TORSEMIDE taken for hypervolaemia (ongoing). The following information was reported: RASH PAPULAR (non-serious), outcome "unknown", described as "red bumps"; RASH (non-serious), outcome "unknown"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "possible allergic reaction". Additional information: According to the patient the rash only started a few days ago, the red bumps occurred before the rash occurred.
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| 2860377 | F | CA | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Dermal filler reaction
Dermal filler reaction
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dermal fillers in my face have swelled up a lot/just super-swollen (and hot) face; This is a spontan...
dermal fillers in my face have swelled up a lot/just super-swollen (and hot) face; This is a spontaneous report received from a Consumer or other non HCP. A 53-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 17Sep2025 at 16:00 as dose 1, single (Lot number: NA0589), in right arm (reported as right shoulder) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypersensitivity" (unspecified if ongoing); "dermal fillers injected" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DERMAL FILLER REACTION (non-serious) with onset 18Sep2025 at 01:00, outcome "not recovered", described as "dermal fillers in my face have swelled up a lot/just super-swollen (and hot) face". Therapeutic measures were not taken as a result of dermal filler reaction. Additional information: The dermal fillers in the her face have swelled up a lot in the two days since taking the vaccine. She read online that this can happen. She did not know beforehand that this could happen. There is no swelling in throat or difficulty breathing or anything like that, just super-swollen (and hot) face where fillers had been injected several months ago prior to the vaccine.
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| 2860378 | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pain in extremity, Pyrexia
Pain in extremity, Pyrexia
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arm to hurt; fever; This is a spontaneous report received from a Consumer or other non HCP. A patie...
arm to hurt; fever; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm to hurt"; PYREXIA (non-serious), outcome "unknown", described as "fever". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional information:Patient has received the vaccine and had COVID before. The vaccine caused arm to hurt and fever.
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| 2860379 | M | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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he had All Pfizer Covid Vaccine before but still he got Covid; he had All Pfizer Covid Vaccine befor...
he had All Pfizer Covid Vaccine before but still he got Covid; he had All Pfizer Covid Vaccine before but still he got Covid; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he had All Pfizer Covid Vaccine before but still he got Covid". Clinical course: caller mentioned that he had all Pfizer Covid vaccine before but still he got Covid and caller is high risk. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2860380 | 09/22/2025 |
PNC20 |
PFIZER\WYETH |
MA2505 |
Erythema, Feeling abnormal, Influenza like illness, Peripheral swelling
Erythema, Feeling abnormal, Influenza like illness, Peripheral swelling
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upper arm swelling; redness left arm; flu like symptoms; This is a spontaneous report received from ...
upper arm swelling; redness left arm; flu like symptoms; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 11Sep2025 at 19:15 as dose number unknown, single (Lot number: MA2505) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 12Sep2025 at 10:00, outcome "unknown", described as "flu like symptoms"; ERYTHEMA (non-serious) with onset 12Sep2025 at 10:00, outcome "unknown", described as "redness left arm"; PERIPHERAL SWELLING (non-serious) with onset 12Sep2025 at 10:00, outcome "unknown", described as "upper arm swelling". Additional information: On 11Sep2025 at 7:15 pm, the patient received Prevnar 20 Syringe with Lot Number: MA2505 at a local pharmacy. The next day at 10:00 AM, the patient had flu like symptoms, upper arm swelling and redness left arm when injection was given. The patient felt miserable for 3 days. The patient was healthy with no major problems. Currently received every vaccine for age group and have NEVER had any side effects.
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| 2860381 | F | PA | 09/22/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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COVID-19, SARS-CoV-2 test; COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test; COVID-19, SARS-CoV-2 test
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two different tests, and I definitely have COVID/ got really sick, like 24 hours after the vaccine; ...
two different tests, and I definitely have COVID/ got really sick, like 24 hours after the vaccine; This is a spontaneous report received from a Nurse. A 68-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid, notes: a couple of years ago. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "two different tests, and I definitely have COVID". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: During an inbound call for assistance with an online enrollment, when asked if the physician had given a prescription for Paxlovid the patient, the reporter stated, "she was about to call it in", The reporter was actually a retired nurse, but she know how confusing patients get with this, and now she was one of those confused patients...she had Paxlovid a couple of years ago. She does have a question, though, about one of our other vaccines. She made the mistake of getting the COVID vaccine last weekend, as well as that super high-powered flu. She will have to look at the vaccination card you gave me. The only reason she asks is, because I've always just been you know, lucky or whatever, they've always given me Moderna. And this year, she think they told me that the high powered flu thing was just with Pfizer but I'm not supposed to have Thimerosal, and it turns out, She think the one she had did have that preservative in it, and so, when she got really sick, like 24 hours after the vaccine, she didn't think she had COVID. She thought it was just a reaction to the flu, and then she tested this morning, just to be safe, and you know, two different tests, and she definitely have COVID. You know, she hasn't been out in public, except for the (redacted) meetings, so maybe because she was a leader, that's where she got it from, the boys."
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| 2860382 | F | CA | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. An 81-year-ol...
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. An 81-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "stage 4 Cancer" (unspecified if ongoing), notes: stage 4 Cancer. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization completed), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Clinical course: Patient with covid and laryngitis. Her doctor gave her a prescription for Paxlovid and the worst part is, she have Laryngitis as part of the COVID, she thought she had a bad cold. Had no idea she had covid. She had a booster shot, Pfizer booster shot. She had all shots and two, she shouldn't be quite so sick. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2860383 | CA | 09/22/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
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No adverse event, Product preparation issue; No adverse event, Product preparati...
No adverse event, Product preparation issue; No adverse event, Product preparation issue
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fluzone hd pfs, mixed in with the regular fluzone tri (pf) with no adverse event; Initial informatio...
fluzone hd pfs, mixed in with the regular fluzone tri (pf) with no adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient and reporter stated that influenza USP trival A-B high dose subvirion vaccine [Fluzone HD], mixed in with the regular USP trival A-B SUBVIRION NO preservative vaccine [Fluzone] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Sep-2025 the suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength, lot and expiry date) for Immunization, mixed in with the regular influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection with no adverse event (product preparation error) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Reporter stated that they found a fluzone HD PFS, mixed in with the regular fluzone TRI (PF). A patient was going to be administered the fluzone. The staff member prepared it and attached a needle to it, but before administering it, they noticed that it was the HD. The patient did not receive the fluzone HD. The HD syringe could have been possibly discarded 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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| 2860384 | 8 | M | TX | 09/22/2025 |
FLU3 |
SANOFI PASTEUR |
UT8514KA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient received expired FLUZONE TRIVALENT, with no reported adverse event; Initial information rece...
Patient received expired FLUZONE TRIVALENT, with no reported adverse event; Initial information received on 18-Sep-2025 (With live follow attached on same day) regarding an unsolicited valid non-serious case received from other health professional. This case involves a 8 years old male patient received expired influenza USP trival A-B subvirion NO preservative vaccine [Fluzone], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Sep-2025, the patient received Dose 1 of 0.5 ml of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection Strength: standard, Frequency; Once with lot UT8514KA and expiry date 30-Jun-2025 via intramuscular route in the left arm for Immunization with no reported adverse event (expired product administered) (latency same day) Reportedly, did not return a box of expired fluzone trivalent, which led to it being used for administration to a patient. 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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| 2860385 | 16 | M | VA | 09/22/2025 |
MENB MENB MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
3R33K 3R33K 343DD 343DD |
Arthralgia, Full blood count, Joint swelling, Laboratory test, Peripheral swelli...
Arthralgia, Full blood count, Joint swelling, Laboratory test, Peripheral swelling; Rash, Upper respiratory tract infection; Arthralgia, Full blood count, Joint swelling, Laboratory test, Peripheral swelling; Rash, Upper respiratory tract infection
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8/29/25 developed rash on both legs and Left hand and wrist pain with mild swelling. 9/12 URI sympt...
8/29/25 developed rash on both legs and Left hand and wrist pain with mild swelling. 9/12 URI symptoms and swelling of left hand and a rash.
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| 2860386 | 61 | M | FL | 09/22/2025 |
FLU3 |
SANOFI PASTEUR |
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Arthralgia, Pain
Arthralgia, Pain
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Two days after receiving the flu vaccine injection, I noticed some soreness in my right shoulder. I ...
Two days after receiving the flu vaccine injection, I noticed some soreness in my right shoulder. I had felt this kind of discomfort in my shoulder before, either after very strenuous activity the day before that worked that arm hard or after injuries to that shoulder. I was feeling pain when moving my arm, particularly if I lifted it, for example, above my head. I?m 61 now and am used to feeling soreness or pain after a day of hard physical activity, especially in the areas of my body that were stressed the most. But what puzzled me this time was that I hadn?t done anything physically strenuous in the previous few days. So the pain I was feeling, though I had felt it before, was unexpected. The next day the pain in my right shoulder worsened. Since I have had aches and pains before, I figured I must have aggravated my shoulder somehow. Sometimes when I sleep on my shoulder wrong, it can be sore the next day. But I remember thinking that I had been sleeping well and hadn?t felt I had slept wrong on my shoulder at all. Plus, I sleep on my left side only and this was my right shoulder causing me pain. Throughout the day I would take breaks to try to stretch out my shoulder some, moving through full range of motion slowly, particularly above my head. This was painful, but I figured it would help keep it from getting tight, getting worse. It was at this point that I wondered if my flu shot could be causing this problem. The pain in my right shoulder is still present and my range of motion is still limited.
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| 2860387 | 35 | M | PA | 09/22/2025 |
FLU3 FLU3 TDAP TDAP |
SEQIRUS, INC. SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
58160084252 58160084252 70461065503 70461065503 |
Arthralgia, Chills, Fatigue, Heart rate increased, Myalgia; Night sweats; Arthra...
Arthralgia, Chills, Fatigue, Heart rate increased, Myalgia; Night sweats; Arthralgia, Chills, Fatigue, Heart rate increased, Myalgia; Night sweats
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Intense muscle and joint soreness, chills and sweats overnight, fatigue, elevated resting heart rate...
Intense muscle and joint soreness, chills and sweats overnight, fatigue, elevated resting heart rate (jumped from 58 to 71). lasted 2 days
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| 2860388 | 5 | M | MA | 09/22/2025 |
DTAPIPV MMR |
SANOFI PASTEUR MERCK & CO. INC. |
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Erythema, Oral herpes, Pain, Pyrexia; Erythema, Oral herpes, Pain, Pyrexia
Erythema, Oral herpes, Pain, Pyrexia; Erythema, Oral herpes, Pain, Pyrexia
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large red painful area , fever 101.6 cold sores in corner of mouth
large red painful area , fever 101.6 cold sores in corner of mouth
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| 2860389 | 82 | F | MN | 09/22/2025 |
RSV |
PFIZER\WYETH |
MD55461 |
Diarrhoea, Dyspnoea, X-ray limb
Diarrhoea, Dyspnoea, X-ray limb
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Patient experienced heavy breathing and could not catch her breath. Her heart rate was normal and s...
Patient experienced heavy breathing and could not catch her breath. Her heart rate was normal and symptoms resolved. She had 3 bouts of diarrhea when she returned home.
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| 2860390 | 82 | F | WV | 09/22/2025 |
COVID19 FLU3 PNC21 |
MODERNA SANOFI PASTEUR MERCK & CO. INC. |
3052671 U8837AA Z003579 |
Feeling abnormal, Pain, Pyrexia; Feeling abnormal, Pain, Pyrexia; Feeling abnorm...
Feeling abnormal, Pain, Pyrexia; Feeling abnormal, Pain, Pyrexia; Feeling abnormal, Pain, Pyrexia
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The patient called and reported a low grade fever and feeling achy and not wanting to do much for 2-...
The patient called and reported a low grade fever and feeling achy and not wanting to do much for 2-3 days. Her symptoms resolved and she said she is now fine.
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| 2860391 | 44 | M | TX | 09/22/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
f9k3l |
Dizziness, Flushing, Headache, Hyperhidrosis, Nausea
Dizziness, Flushing, Headache, Hyperhidrosis, Nausea
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Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mi...
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional Details: He had Capvaxive on right arm as well. Lot number Z006076, Exp 09/11/2026. Notified Dr office as well. Talked to staff and notified that patient has sweating, dizziness, little nausea and headache. Patient recovered from all these side effects and was fine when left. Patient was in the store for almost an hour and was fine when he left home. He laso had flu and covid vaccine on left arm and he had them before and no reactions with them. He mentioned that he did not have breakfast
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| 2860392 | 80 | M | NV | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9550 |
Confusional state, Dizziness, Injection site erythema, Injection site swelling, ...
Confusional state, Dizziness, Injection site erythema, Injection site swelling, Rash
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Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic:...
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium
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| 2860393 | 22 | M | CA | 09/22/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3052671 3052671 |
Blood glucose increased, Dizziness, Hypotension, Injection site bruising, Syncop...
Blood glucose increased, Dizziness, Hypotension, Injection site bruising, Syncope; Tremor, Unresponsive to stimuli
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Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Faintin...
Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Mild, Additional Details: Pt received 3 vaccines and after received third one, pt fainted and had body shake. Put pt layed down on the carpet floor. Paramedic came and pt had low BP and high sugar. PT had Type 1 diabetes. Paramedic gave IV fluid and took pt to hospital. , Other Vaccines: VaccineTypeBrand: flucelvax 2025-2026; Manufacturer: seqirus; LotNumber: 948395; Route: IM; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Heplisav-B; Manufacturer: Dynavax Technology; LotNumber: 948203; Route: IM; BodySite: Right arm; Dose: ; VaxDate: UNKNOWN
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| 2860394 | 85 | M | VA | 09/22/2025 |
FLU4 |
SANOFI PASTEUR |
u876488 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Systemic: No adverese events observed at the time in pharmacy-Mild, Additional Details: Patient came...
Systemic: No adverese events observed at the time in pharmacy-Mild, Additional Details: Patient came in stating looking to get new COVID and Flu vaccines. Confirmed multiple times at drop off that patient has not received the new vaccines. When patient filled out the consent forms also confimed that they have not received either vaccines. However, after given both shots, patient states he has taken a flu shot in (withheld state) a few days ago. Called that pahrmacy to confirm because he can't even remember when he got it. Contacted that pahramcy and thay said he did recieve on 9/10/25.
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