| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2858958 | F | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID-19; COVID; This is a spontaneous report received from a Consumer or other non HCP from medical...
COVID-19; COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 83-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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), for Covid 19 immunization; Covid 19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, Manufacturer unknown), for Covid 19 immunization. The following information was reported: COVID-19 (medically significant) with onset 08Sep2025, outcome "unknown", described as "COVID"; DRUG INEFFECTIVE (medically significant) with onset 08Sep2025, outcome "unknown", described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller would like to know if Paxlovid would still do anything for the patient if they've been diagnosed with COVID and it's past 5 days. Caller provided a brief history: both she and her husband were diagnosed with COVID yesterday. Her husband has been sick since thursday, and she just really developed symptoms on sunday. Neither one of them has a temperature (fever). Caller said they were prescribed Paxlovid and she is under the impression from everything she's read and heard. She is aware that the medication should be started within the 5-day period of symptom onset. Caller said that her husband is already past that since he had it since thursday, so she would like to know if it would help him at all or not. They haven't started taking the medication. Caller mentioned that they have no fever and are outside of the symptom window. Both she and her husband have been fully vaccinated, including some shots from Pfizer. She is asking if they might have developed some immunity to COVID-19. PMI offered DSU transfer, caller declined. DSU: e-transmitting potential AE; Caller declined DSU transfer. Question: Caller mentioned that they have no fever and are outside of the symptom window. Both she and her husband have been fully vaccinated, including some shots from Pfizer. She is asking if they might have developed some immunity to COVID-19. 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-202500179020 Same reporter/product/event, different patient;
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| 2858959 | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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Device issue, Underdose
Device issue, Underdose
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the needle came of and did not receive the full dose; the needle came of and did not receive the ful...
the needle came of and did not receive the full dose; the needle came of and did not receive the full dose; This is a spontaneous report received from a Pharmacist from medical information team. A patient (age and gender not provided) 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: UNDERDOSE (non-serious), DEVICE ISSUE (non-serious) and all described as "the needle came of and did not receive the full dose". Causality for "the needle came of and did not receive the full dose" was determined associated to device constituent of BNT162b2 omicron (lp.8.1) (malfunction). Additional information: a pharmacy was asking for additional information on what to do as they have a patient who got the Pfizer COVID-19 vaccine and the needle came of and did not receive the full dose. The patient who received an incomplete dose of Comirnaty 2025-2026 (12+). The needle came off when being administered.
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| 2858960 | M | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Illness
COVID-19, Drug ineffective, Illness
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COVID; COVID; Her husband has been sick since Thursday; This is a spontaneous report received from a...
COVID; COVID; Her husband has been sick since Thursday; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 04Sep2025, outcome "unknown", described as "Her husband has been sick since Thursday"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 08Sep2025, outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Caller provided a brief history: both she and her husband were diagnosed with COVID yesterday. Her husband has been sick since Thursday, and she just really developed symptoms on Sunday. Neither one of them has a temperature (fever). Caller said they were prescribed Paxlovid and she is under the impression from everything she's read and heard. She is aware that the medication should be started within the 5-day period of symptom onset. Caller said that her husband is already past that since he had it since Thursday, so she would like to know if it would help him at all or not. They haven't started taking the medication. Caller mentioned that they have no fever and are outside of the symptom window. Both she and her husband have been fully vaccinated, including some shots from Pfizer. She is asking if they might have developed some immunity to COVID-19. 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-202500178698 Same reporter/product/event, different patient;
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| 2858961 | 70 | F | VA | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
FH8027 |
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 70-year-old female patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: FH8027, Expiration Date: 28Feb2022) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing), notes: for 30 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EM9810, Site: Injection in the arm), administration date: 03Feb2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Sore Arm", "down with energy a little"; BNT162b2 (DOSE 2, SINGLE, Lot: EN6198, Site: Injection in the arm), administration date: 26Feb2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "sore arm", "down with energy a little". 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". Additional information: The report was not related to a study or programme. No other Conditions. No investigations. No other Products. 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. She got her 7th booster dose from Moderna and the Moderna vaccine activated her MS and had to go on steroids due to complications. 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. Her final booster was Moderna and it activated her MS. 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 was on a immunosuppressant at the time she had the Moderna vaccine. Caller said that she was not immunosuppressed, but was modulated. 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. Caller said that she was calling about the new Comirnaty to see if it was suitable for someone older than 65 and immunocompromised that is modulated. She does not want it to come back and bite her like she did with the Moderna vaccine where she struggled to get out of bed for a couple of weeks. The Pfizer Covid-19 vaccines don't really have a negative, because she did not have the robust response like she did with the Moderna Covid-19 Vaccine. Her response was a level 1-2 as opposed to a level 9-10 like she had with Moderna. It is a big difference. It was way way less than the shingles vaccines. It is not even on her radar. She was calling because what she read was that the new Pfizer Covid-19 vaccine was termed to have a robust response. She has never had Covid anyway. She was completely mobile. Stated that the Moderna Covid-19 Vaccine kicked her butt. Patient took dose 5 on 19May2023 and dose 6 on 13Sep2023. Nothing that showed up and she was stable on her MRI's and did not show any active lesions or anything. Only needed steroids after the Moderna dose. She had no issue with Pfizer or the Pfizer Covid shots. It was just that she wanted to try and do a little bit of investigation and when she she saw the thing of a robust response, she questioned whether she wanted it or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500177753 same patient/SD/AE, different dose;
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| 2858962 | 70 | F | VA | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
FN2908 |
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 70-year-old female patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 70 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing), notes: for 30 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Lot: EM9810, Site: Injection in the arm), administration date: 03Feb2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "sore arm", "down with energy a little bit"; BNT162b2 (Dose 2, single, Lot: EN6198, Site: Injection in the arm), administration date: 26Feb2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "sore arm", "down with energy a little bit"; BNT162b2 (Dose 3 (booster), single, Lot: FH8027 Expiry: 28Feb2022, Site: Injection in the Right arm), administration date: 22Oct2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "sore arm", "down with energy a little bit". 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". Additional information: The report was not related to a study or programme. No other Conditions. No investigations. No other Products. 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. She got her 7th booster dose from Moderna and the Moderna vaccine activated her MS and had to go on steroids due to complications. 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. Her final booster was Moderna and it activated her MS. 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 was on a immunosuppressant at the time she had the Moderna vaccine. Caller said that she was not immunosuppressed, but was modulated. 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. Caller said that she was calling about the new Comirnaty to see if it was suitable for someone older than 65 and immunocompromised that is modulated. She does not want it to come back and bite her like she did with the Moderna vaccine where she struggled to get out of bed for a couple of weeks. The Pfizer Covid-19 vaccines don't really have a negative, because she did not have the robust response like she did with the Moderna Covid-19 Vaccine. Her response was a level 1-2 as opposed to a level 9-10 like she had with Moderna. It is a big difference. It was way way less than the shingles vaccines. It is not even on her radar. She was calling because what she read was that the new Pfizer Covid-19 vaccine was termed to have a robust response. She has never had Covid anyway. She was completely mobile. Stated that the Moderna Covid-19 Vaccine kicked her butt. Patient took dose 5 on 19May2023 and dose 6 on 13Sep2023. Nothing that showed up and she was stable on her MRI's and did not show any active lesions or anything. Only needed steroids after the Moderna dose. She had no issue with Pfizer or the Pfizer Covid shots. It was just that she wanted to try and do a little bit of investigation and when she she saw the thing of a robust response, she questioned whether she wanted it or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500177753 same patient/SD/AE, different dose;
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| 2858963 | 71 | F | VA | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
CJ3270 |
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 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19May2023 as dose 5, single (Lot number: CJ3270) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: pre-existing for 30 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 SINGLE; EM9810), administration date: 03Feb2021, for COVID-19 immunization; BNT162b2 (DOSE 2 SINGLE; EN6198), administration date: 26Feb2021, for COVID-19 immunization; BNT162b2 (DOSE 4 SINGLE; FN2908), administration date: 10May2022, for COVID-19 immunization. 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". Additional Information: It was reported that caller on the line calling about the Comirnaty previous formulation/Covid-19 vaccines and reported that she had MS for 30 years. 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. She got her 7th booster dose from Moderna and the Moderna vaccine activated her MS and had to go on steroids due to complications. 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. Her final booster was Moderna and it activated her MS. 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 was on a immunosuppressant at the time she had the Moderna vaccine. Caller said that she is not immunosuppressed, but is modulated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500177753 same patient/SD/AE, different dose;
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| 2858964 | 72 | F | PA | 09/15/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Balance disorder, Blood pressure measurement, Bone pain, Feeding disorder, Heada...
Balance disorder, Blood pressure measurement, Bone pain, Feeding disorder, Headache; Hypotension, Nausea, Pain, Presyncope
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Blood pressure went low; blood pressure was still very low/My reading was as low as 90 over 48; coul...
Blood pressure went low; blood pressure was still very low/My reading was as low as 90 over 48; couldn't get out of bed/ wasn't able to stand; Queasy/queasiness/ Severely nauseous/severe nausea; headache; Severe body and bone ache; Severe body and bone ache; felt passing out; Could not eat; This is a spontaneous report received from a Nurse. A 72-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in right arm (right shoulder) for covid-19 immunisation. The patient's relevant medical history included: "Gastroparesis" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing), notes: it did not require medication; "Migraine" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); the patient had these medical conditions many years and she had been on medication for many years. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, in 2025 (weeks before 07Sep2025) and the patient did not have a reaction at all; LOSARTAN as 100 mg; AJOVY [FREMANEZUMAB] taken for migraine. The patient had been on AJOVY for many years and never had reactions, no issues. The patient also took other concomitant therapy, routine medication daily. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization, reaction(s): "viral flu symptoms". The following information was reported: HYPOTENSION (medically significant) with onset 08Sep2025, outcome "recovering", described as "Blood pressure went low; blood pressure was still very low/My reading was as low as 90 over 48"; FEEDING DISORDER (non-serious) with onset 08Sep2025, outcome "recovering", described as "Could not eat"; NAUSEA (non-serious) with onset 08Sep2025, outcome "recovering", described as "Queasy/queasiness/ Severely nauseous/severe nausea"; PAIN (non-serious), BONE PAIN (non-serious) all with onset 08Sep2025, outcome "recovering" and all described as "Severe body and bone ache"; BALANCE DISORDER (non-serious) with onset 08Sep2025, outcome "recovering", described as "couldn't get out of bed/ wasn't able to stand"; PRESYNCOPE (non-serious) with onset 08Sep2025, outcome "recovering", described as "felt passing out"; HEADACHE (non-serious) with onset 08Sep2025, outcome "recovering". The events "blood pressure went low; blood pressure was still very low/my reading was as low as 90 over 48", "couldn't get out of bed/ wasn't able to stand", "queasy/queasiness/ severely nauseous/severe nausea", "headache", "severe body and bone ache", "felt passing out" and "could not eat" required physician office visit. Therapeutic measures were not taken as a result of hypotension, balance disorder, headache, pain, bone pain, presyncope, feeding disorder. Therapeutic measures were taken as a result of nausea. The patient was calling to report a real adverse reaction. The patient had taken your COVID vaccine up until to the mensuration which she had on Monday. The patient did not have anything unusual other than her viral flu symptoms in past, but this time she had an adverse reaction. She was up to date on her COVID vaccine, and she got this last one on Sunday (07Sep2025) early in the morning between 9 and 11 AM. All day Sunday was fine. Monday (08Sep2025), the patient woke up, she had severe reaction. She was not feeling well and she tried to get up to the bathroom and could not do it. The patient couldn't get out of bed, and she just felt queasy and headache and severe body and bone ache. The patient tried to get out of bed, and she wasn't able to stand, and 'wind started getting dark' and she had terrible severe nausea. So, she laid herself down on the floor because she felt she was passing out and she just laid there for an hour or two and they called eventually called into the bathroom. The patient was severely nauseous, and 'the heat put it in and increasing up'. So that belongs for an hour and so, the patient had some medication for nausea, and she took it, and the nausea calm down, but the queasiness never did and all day she was in bed. The patient could not eat, and her blood pressure went low. Her reading was as low as 90 over 48. The patient saw her doctor on the reporting date (10Sep2025) and the doctor said it was adverse reaction. The patient was still not feeling herself. Monday (08Sep2025) was the worse, Wednesday (10Sep2025) she was pretty much better, she could move around. The patient would return to her doctor office the next day for check, follow up. When probed for treatment for all events, the patient stated there was a change in medication because her blood pressure was very low during episodes and so she personally withheld her Losartan this morning (10Sep2025) because her blood pressure was still very low; When she went to the doctor, the doctor adjusted the Losartan to instead of a 100 milligrams and decreased it to 50 milligrams, the patient took that in the afternoon when she got home. The patient did not have any treatments, so she stayed at home in bed. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.; Sender's Comments: Given the compatible time association, the reasonable possibility that the events are related to BNT162B2 OMICRON (LP.8.1) administration cannot be excluded. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product 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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| 2858965 | F | PA | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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Influenza
Influenza
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viral flu symptoms; This is a spontaneous report received from a Nurse. A 72-year-old female patien...
viral flu symptoms; This is a spontaneous report received from a Nurse. A 72-year-old 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 included: "Gastroparesis" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing), notes: did not require medication; "Migraine" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ajovy, notes: has been for many years and never had reactions, no issues. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "viral flu symptoms". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2858966 | F | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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lost 2 aunts; This is a spontaneous report received from a Consumer or other non HCP. A female pati...
lost 2 aunts; This is a spontaneous report received from a Consumer or other non HCP. A 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 and concomitant medications were not reported.The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "lost 2 aunts". The date and cause of death for the patient were unknown. Clinical course: Question:What are 3 things that Pfizer could immediately do to become more patient-centric that you would notice right away. Answer: Never, reporter lost 2 aunts and 2 sisters now have health related issues thanks to the covid vaccine. 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-PV202500109914 same reporter/drug/AE, different patient;; Reported Cause(s) of Death: Unknown cause of death
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| 2858967 | 52 | F | TX | 09/15/2025 |
COVID19 COVID19 FLUX FLUX |
PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Acute psychosis, Aggression, Anger, Anxiety, Paranoia; Persecutory delusion, Sui...
Acute psychosis, Aggression, Anger, Anxiety, Paranoia; Persecutory delusion, Suicidal ideation, Thinking abnormal; Acute psychosis, Aggression, Anger, Anxiety, Paranoia; Persecutory delusion, Suicidal ideation, Thinking abnormal
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suicidal ideation; Acute psychosis onset day 3; Paranoia; feelings of persecution; aggression; anger...
suicidal ideation; Acute psychosis onset day 3; Paranoia; feelings of persecution; aggression; anger; disorganized thoughts; anxiety; This is a spontaneous report received from a Consumer or other non HCP. A 52-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Sep2025 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 06Sep2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "Fybromyalgia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "alcoholism" (unspecified if ongoing); "bipolar disorder" (unspecified if ongoing); "anxiety disorder" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "cptsd" (unspecified if ongoing). Patient had no known allergies. There were no concomitant medications. There was no other vaccine in four weeks, no other medications in two weeks. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: ACUTE PSYCHOSIS (disability) with onset 08Sep2025, outcome "not recovered", described as "Acute psychosis onset day 3"; PARANOIA (disability) with onset 08Sep2025, outcome "not recovered"; AGGRESSION (disability) with onset 08Sep2025, outcome "not recovered"; ANGER (disability) with onset 08Sep2025, outcome "not recovered"; ANXIETY (disability) with onset 08Sep2025, outcome "not recovered"; THINKING ABNORMAL (disability) with onset 08Sep2025, outcome "not recovered", described as "disorganized thoughts"; PERSECUTORY DELUSION (disability) with onset 08Sep2025, outcome "not recovered", described as "feelings of persecution"; SUICIDAL IDEATION (disability, medically significant) with onset 08Sep2025, outcome "not recovered". Clinical course: Acute psychosis onset day 3. Paranoia, feelings of persecution, aggression, anger, disorganized thoughts, anxiety and suicidal ideation. Events were resulted in Disability or permanent damage. Therapeutic measures were taken as a result of suicidal ideation, acute psychosis, paranoia, persecutory delusion, aggression, anger, thinking abnormal, anxiety which included antipsychotics, anxiety medications and ketamine. 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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| 2858968 | M | CT | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood test, C-reactive protein increased, Chills, Hyperhidrosis, Pyrexia
Blood test, C-reactive protein increased, Chills, Hyperhidrosis, Pyrexia
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it was so saturated with sweat/never in my life have I sweat like that; It's just a reaction li...
it was so saturated with sweat/never in my life have I sweat like that; It's just a reaction like the chills or something; the chills is always a fever and I could have had a high fever to warm; CR-P was highly elevated; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 73-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Sep2025 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (primary immunisation series complete), for covid-19 immunisation. The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "it was so saturated with sweat/never in my life have I sweat like that"; CHILLS (non-serious), outcome "unknown", described as "It's just a reaction like the chills or something"; PYREXIA (non-serious), outcome "unknown", described as "the chills is always a fever and I could have had a high fever to warm"; C-REACTIVE PROTEIN INCREASED (non-serious), outcome "unknown", described as "CR-P was highly elevated". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hyperhidrosis, chills, pyrexia, c-reactive protein increased. Additional information: Caller states he had called this morning to report a reaction he had to the new Covid vaccine if they should take Pfizer next time it comes time for a shot. Caller verified the product as the Comirnaty 2025/2026 presentation, got it last Friday. Caller states, he is concerned because he has taken Pfizer from day 1, he wouldn't take Moderna; and he never had a reaction. He woke up Saturday, that night after he took it, he had to change the bed in the middle of the night, it was so saturated with sweat, never in his life have he sweat like that. He don't know if that is considered adverse or severe, he don't have to take another shot for quite a while or next year. Caller states, he don't think it's considered severe, he read quite a bit last night. It's just a reaction like the chills or something, but the chills is always a fever and he could have had a high fever to warm. So, he should be protected, they say the bigger reaction you have the more protection you are from Covid, he don't know how true that is either. It means your immunity in your system really worked itself up and your body was fighting off the injection. He haven't had Covid and he don't intend to get it. He stick with Pfizer, he won't go with Moderna, he don't like them. In an analysis of all unsolicited adverse events reported following any dose, includes night sweats. Complainant does not have the product with them at the time of call. Consumer stated, "Could you just, general thing, I had a Covid vaccine (Clarified as Pfizer Covid-19 vaccine) about a week ago on a Friday. I think it was Friday the 5th and that night, in the middle of the night (incomplete sentence). You know, I have had Pfizer, I specifically asked for Pfizer ever since you came out with it. Never had a reaction and I woke up with, my wife woke me up at 2 in the morning. A reaction, my wife woke me up because the bed was saturated. I had broken out into such a sweat that I am telling you, I never had a reaction to the vaccine and I think I lost half my body fluids. You know that we had to get up in the middle of the night and change the sheets and the mattress, cover everything because I sweat so much. Next day I called the doctor, she said that is definitely a reaction to the vaccine. I am just reporting it, I don't know. They don't give me anything other than the date and you know I have nothing on it, no." Consumer further stated, "It's a new, it is a new one. I had just gotten it in three days before, so I know it's the new one, the only thing I know is that the CR-P was highly elevated. You know, the doctor said that that is due to the vaccines." Consumer stated, "Yes, I just take it for blood pressure and Cholesterol. Do not ask me what I take, I have no clue." When probed if consumer receive any other vaccines on the same date as the Pfizer Covid-19 vaccine, consumer stated, "No." When probed if there were any other vaccinations within four weeks prior taking the Vaccine, consumer stated, "No." Route of administration (For Covid-19 vaccine): Consumer stated, "Well, vaccine is a needle, just the needle in the arm." 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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| 2858969 | 59 | F | PA | 09/15/2025 |
PNC20 |
PFIZER\WYETH |
MA2505 |
Fatigue
Fatigue
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mild fatigue; This is a spontaneous report and received from Consumer or other non HCPs. A 59-year-...
mild fatigue; This is a spontaneous report and received from Consumer or other non HCPs. A 59-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 12Sep2025 as dose number unknown, single (Lot number: MA2505) at the age of 59 years, in left deltoid for immunisation, Device Lot Number: MA2505. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: remote history; "atypical celiac disease" (unspecified if ongoing). The patient had no known allergies. Concomitant vaccines and prior vaccinations within 4 weeks were none. Concomitant medication(s) included: VITAMIN D3; CALCIUM CARBONATE; FAMOTIDINE. The following information was reported: FATIGUE (non-serious) with onset 12Sep2025 at 1:00 pm (as reported), outcome "recovered" (12Sep2025), described as "mild fatigue". Therapeutic measures were not taken as a result of fatigue. Additional information: The patient mentioned that she felt mild fatigue around 2 hours after receiving the vaccine. She did not have any other symptoms.
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| 2858970 | F | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Influenza, Pain
Influenza, Pain
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It was minor symptoms, flu; flu and achy like symptoms; This is a spontaneous report received from a...
It was minor symptoms, flu; flu and achy like symptoms; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 80-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2025 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. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunisation. The following information was reported: INFLUENZA (non-serious) with onset 2025, outcome "unknown", described as "It was minor symptoms, flu "; PAIN (non-serious) with onset 2025, outcome "unknown", described as "flu and achy like symptoms". Additional information: Caller inquired about the appropriate interval for receiving a COVID-19 vaccine booster (2025-2026 formula) and its availability near their location. Consumer reported that she is working with little children and she hasn't had a COVID 19 vaccine since May2025. How soon she should get it? Last she heard it had to be 6 months. She is reluctant to work at a school at 80 years old with multiple physical conditions without having a recent Covid shot. She has done OK with the Pfizer vaccine, except for a little bit at one time. She don't really remember what happened but it was earlier this year, either in May2025 or 4 months before that. It was minor symptoms, flu and achy like symptoms, for 1 day. She never had it before and always had Pfizer vaccine." Replied COMIRNATY is administered as a single dose for individuals 5 years of age and older. For individuals previously vaccinated with any COVID-19 vaccine, administer the dose of COMIRNATY at least 2 months after the last dose of COVID-19 vaccine. Comirnaty (2025-2026 Formula) is available in pharmacies, hospitals, and clinics. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2858971 | 37 | M | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Headache, Neck pain
Headache, Neck pain
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Prolonged neck aches; head aches and acute frontal lobe pain; This is a spontaneous report received ...
Prolonged neck aches; head aches and acute frontal lobe pain; This is a spontaneous report received from a Consumer or other non HCP. A 37-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 06Sep2025 at 02:45 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 06Sep2025 as dose number unknown, single, in right arm. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]. The following information was reported: NECK PAIN (non-serious) with onset 08Sep2025, outcome "not recovered", described as "Prolonged neck aches"; HEADACHE (non-serious) with onset 08Sep2025, outcome "not recovered", described as "head aches and acute frontal lobe pain". Therapeutic measures were not taken as a result of neck pain, headache. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the vaccine reporting. Patient took other 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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| 2858972 | LA | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Allergy to vaccine
Allergy to vaccine
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I had/have an allergic reaction to my Covid vaccine; This is a spontaneous report received from a Co...
I had/have an allergic reaction to my Covid vaccine; 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 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "I had/have an allergic reaction to my Covid vaccine". 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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| 2858973 | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Postural orthostatic tachycardia syndrome
Postural orthostatic tachycardia syndrome
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diagnosed with POTS; This is a spontaneous report received from a Consumer or other non HCP. A pati...
diagnosed with POTS; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown", described as "diagnosed with POTS". Additional Information: Reporter was asked 3 things that Pfizer could immediately do to become more patient-centric that patient would notice right away. Reporter stated they need to be more informative of the side effects of the Covid vaccine. Reporter have not been the same since the reported was in 2021. Reporter was diagnosed with POTS as a result. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2858974 | 72 | F | NH | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19
COVID-19
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COVID after Pfizer Shot; This is a spontaneous report received from a Consumer or other non HCP. A ...
COVID after Pfizer Shot; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 09Sep2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 09Sep2025, outcome "unknown", described as "COVID after Pfizer Shot". Additional information: During an inbound call for financial assistance for Paxlovid, the patient stated she had Pfizer shot yesterday i.e. on 09Sep2025, and she came down with COVID last night as the patient was so sick.
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| 2858975 | TX | 09/15/2025 |
IPV |
SANOFI PASTEUR |
Y1A201M |
No adverse event, Product storage error
No adverse event, Product storage error
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couple of excursions for opened ipol: high temperature of 46.6F and was out of range for 45 minutes,...
couple of excursions for opened ipol: high temperature of 46.6F and was out of range for 45 minutes, the vaccine was also administered to the patient with no reported adverse event; Initial information received on 03-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves elderly and unknown gender patient who was received IPV (VERO) [IPOL] that had couple of excursions were at high temperature of 46.6f and was out of range for 45 minutes, 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 IPV (VERO) lot (Y1A201M) Suspension for injection (lot number- Y1A201M and expiry date-31-Jan-2027) via unknown route in unknown administration site for Immunization that had couple of excursions were at high temperature of 46.6f and was out of range for 45 minutes, with no reported adverse event (poor quality product administered) (latency-1 day). Reportedly-The second excursion took place on June 2, 2025. The vaccine reached a high temperature of 47.5F and was out of range for 1 hour. 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.w
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| 2858976 | OK | 09/15/2025 |
FLU3 |
SANOFI PASTEUR |
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Expired product administered, No adverse event
Expired product administered, No adverse event
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expired dose of FLUZONE HD was administered to a patient with no reported adverse event; Initial inf...
expired dose of FLUZONE HD was administered to a patient with no reported adverse event; Initial information received on 09-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who had expired dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Sep-2025, the patient received an expired dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (lot number, strength, dose not reported) (Expiry: Jun-2025) via unknown route in unknown administration site as influenza with no reported adverse event (expired product administered) (Latency: same day). Information regarding batch number corresponding to the one at time 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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| 2858977 | 0.5 | CA | 09/15/2025 |
DTAP DTAP |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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No adverse event, Product administered to patient of inappropriate age, Wrong pr...
No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered
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TDAP to a 6-month old baby. They were suppose to administer DTAP with no reported adverse event; Ini...
TDAP to a 6-month old baby. They were suppose to administer DTAP with no reported adverse event; Initial information received on 09-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 6 month old and unknown gender patient who recieved Diphtheria, Tetanus And Acellular Pertussis Vaccine instead of DTAP 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 Diphtheria, Tetanus And Acellular Pertussis Vaccine produced by unknown manufacturer lot number, strength and expiry date-unknown) via unknown route in unknown administration site instead of DTAP for prophylactic vaccination (Immunisation) and TB skin test (Skin test) (wrong product administered) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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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| 2858978 | GA | 09/15/2025 |
MEN |
UNKNOWN MANUFACTURER |
U8193AA |
No adverse event, Product storage error
No adverse event, Product storage error
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Menquadfi was administered post-excursion, fridge malfunction, max/low temperature reached: negative...
Menquadfi was administered post-excursion, fridge malfunction, max/low temperature reached: negative 2.4 c duration: 13 hours and 30 minutes with no reported adverse event; Initial information received on 09-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 was administered with Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] that had temperature excursion due to, fridge malfunction, where max/low temperature reached: negative 2.4 c duration: 13 hours and 30 minutes 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 2025, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot U8193AA and expiry date-30-Sep-2025) via unknown route in unknown administration site for Immunization that had temperature excursion due to, fridge malfunction, where max/low temperature reached: negative 2.4 c duration: 13 hours and 30 minutes with no reported adverse event (poor quality product administered) (latency- same day) Reportedly-There was no previous excursion. extended stability data does not cover the excursion, human error was not involved, The product was administered. 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-2025SA270817:menquadfi
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| 2858979 | FL | 09/15/2025 |
RAB |
SANOFI PASTEUR |
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Incomplete course of vaccination, No adverse event
Incomplete course of vaccination, No adverse event
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received the first imovax pre-exposure dose but missed the second scheduled dose with no reported ad...
received the first imovax pre-exposure dose but missed the second scheduled dose with no reported adverse event; Initial information received on 10-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who received the first RABIES (HDC) VACCINE [IMOVAX RABIES] pre-exposure dose but missed the second scheduled dose with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Aug-2025, the patient received a Dose 1 of suspect RABIES (HDC) Vaccine Powder and solvent for suspension for injection (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site as pre-exposure prophylaxis. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. The patient was scheduled for administration of second dose on 29-Aug-2025, but missed the same with no reported adverse event (Routine immunisation schedule not administered) (Latency: 7 days) from 1st dose of suspect. Reportedly, As of 10-SEP-2025, the pharmacy already has "the vaccine in stock" and informed the patient they could come and receive it. The patient then expressed concern about needing to restart the dosage schedule. The pharmacist wanted to know whether the patient has to "restart the entire series or can they just get it as soon as possible. Pharmacist provided the lot number and expiration date of the second IMOVAX dose scheduled to be given to the patient as Lot: Y1A86P1, Expiry: 28-Feb-2025. 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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| 2858980 | 12 | M | ND | 09/15/2025 |
MEN |
UNKNOWN MANUFACTURER |
U8493AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
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used sterile water as a diluent for menquadfi with no reported adverse event; Initial information re...
used sterile water as a diluent for menquadfi with no reported adverse event; Initial information received on 10-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old male patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] and sterile water was used as a diluent 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 Tetanus vaccine (Tetanus vaccine) for Immunisation. On 08-Sep-2025, the patient received 0.5 ml of dose 1 of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection with standard strength (expiry date- 31-MAY-2028 and lot U8493AA) once via intramuscular route in the left arm for Immunization and sterile water was used as a diluent for Menquadfi with no reported adverse event (product preparation error) (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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| 2858981 | 0.17 | M | VA | 09/15/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
|
Expired product administered, No adverse event
Expired product administered, No adverse event
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dose provided was 8 days expired with no reported adverse event; Initial information received on 10-...
dose provided was 8 days expired with no reported adverse event; Initial information received on 10-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (Patient's Parent). This case involves a 2 months old male patient to whom dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] provided was 8 days expired 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 HEPATITIS B VACCINE and ROTAVIRUS VACCINE for Immunisation. On 08-Sep-2025, the patient received a dose 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Powder and suspension for suspension for injection once (lot number, strength, dose and expiry not reported) via unknown route in the thigh nos (not otherwise specified) as Immunization which was 8 days expired with no reported adverse event (expired product administered) (Latency: same day). Information regarding batch number and expiration date corresponding to the one at time 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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| 2858982 | 1.25 | M | TX | 09/15/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK232AB |
No adverse event, Product preparation error
No adverse event, Product preparation error
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reconstitution of the powder part with sterile water instead of the provided diluent with no reporte...
reconstitution of the powder part with sterile water instead of the provided diluent with no reported adverse event; Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 15 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] that was reconstituted with powder part with sterile water instead of the provided diluent 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 pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation. On 08-Sep-2025, the patient received Dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection of standard strength, frequency once with lot UK232AB and expiry date 31-AUG-2026 via intramuscular route in the left thigh for Immunization that was reconstituted with powder part with sterile water instead of the provided diluent with no reported adverse event (product preparation error) (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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| 2858998 | 09/15/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Injection site pain
Injection site pain
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Arm where put the needle in hurt me for at least 3 months; This non-serious case was reported by a c...
Arm where put the needle in hurt me for at least 3 months; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: Arm where put the needle in hurt me for at least 3 months). The outcome of the injection site pain was resolved. It was unknown if the reporter considered the injection site pain to be related to RSV vaccine. It was unknown if the company considered the injection site pain to be related to RSV vaccine. Additional Information: GSK Receipt Date: 04-SEP-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had it and didn't have any side effects as per except, for arm where they put the needle in was it hurt for at least 3 months.
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| 2858999 | 68 | M | MI | 09/15/2025 |
FLU3 RSV TDAP |
SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
407271 No batch number No batch number |
Muscular weakness; Muscular weakness; Muscular weakness
Muscular weakness; Muscular weakness; Muscular weakness
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Weakness bilateral in lower extremities; This spontaneous case, initially received on 09-Sep-2025, w...
Weakness bilateral in lower extremities; This spontaneous case, initially received on 09-Sep-2025, was reported by a health professional and concerns an elderly male patient. Past medical history included lumbar puncture. At the time of the event the patient had Hypertension, Hyperlipidemia, Vitamin D Deficiency, Benign Neoplasm Of Left Renal Pelvis, aortic aneurysm, Chronic Kidney Disease Stage 3A, Elevated PSA(Prostatic specific antigen). Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On 28-Aug-2025, the patient received Fluad (TIV) for Active immunization against influenza disease, Dose regimen: 0.5 ml, Route of administration: Not reported, Anatomical site: Not reported, Lot number: 407271. Expiration date: 01-May-2026. Non-company suspect drugs: On 28-Aug-2025, patient received Arexvy (RSV vaccine prot. subunit PreF3), Indication: Not reported, Dose regimen: not reported, Route of administration: Not reported, Anatomical site: Not reported. On 28-Aug-2025, patient Boostrix (Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid), Indication: Not reported, Dose regimen: not reported, Route of administration: Not reported, Anatomical site: Not reported.. Adverse reactions/events and outcomes: On 05-Sep-2025, the patient experienced Weakness bilateral in lower extremities (Hospitalized, outcome: Not recovered / Not resolved). The patient got his vaccine on 28-Aug-2025, and the day previous this report was sent and admitted to the hospital. Office manager adds: The patient was experiencing weakness bilateral in lower extremities. They saw him in the office, and sent him to a neurologist, that sent him to the hospital, where he was admitted on 08-Sep-2025. Start date of event: 05-Sep-2025 Stop date of event: patient was in the hospital at the time of reporting, so reporter assumed the issue was still ongoing Patient received RSV vaccine Arexvy and Boostrix at the same time as Fluad Fluad (TIV) action taken: Not Applicable Treatment measures associated with event: lumbar puncture Reporter's assessment: The reporter provide seriousness as unknown and did not provide the causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Related considering plausible temporality (7 days after fluad vaccine administration). Underlying conditions of At the time of the event the patient had Hypertension, Hyperlipidemia, Vitamin D Deficiency, Benign Neoplasm Of Left Renal Pelvis, aortic aneurysm, Chronic Kidney Disease Stage 3A provide plausible etiology for the event reported.
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| 2859000 | 74 | F | NH | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9550 |
Erythema, Pain, Skin warm
Erythema, Pain, Skin warm
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Soreness begininng a day later, redness which appeared a day to 3 days later, area covering roughly ...
Soreness begininng a day later, redness which appeared a day to 3 days later, area covering roughly 5 inches across, area is hot to the touch, sore, and slightly painful. Patient was seen for other matters, provider inspected and did not believe it to be cellulitis.
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| 2859001 | 86 | F | NY | 09/15/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052549 u8764bb |
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 had swelling, redness and heat on the right arm in the vicinity of the two injections. Arm...
Patient had swelling, redness and heat on the right arm in the vicinity of the two injections. Arm able to move without restriction and no pain.
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| 2859002 | 11 | F | LA | 09/15/2025 |
TDAP |
SANOFI PASTEUR |
U8122AA |
Product storage error
Product storage error
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Patient was administered tdap vaccination after being drawn up for longer than 24 hours. Vaccine was...
Patient was administered tdap vaccination after being drawn up for longer than 24 hours. Vaccine was drawn up on 9/11/125 and administered 9/15/25.
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| 2859003 | 53 | F | CO | 09/15/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
76BN2 76BN2 |
Pruritus, Rash, Rash pruritic, Sciatica, Sensory disturbance; Throat irritation,...
Pruritus, Rash, Rash pruritic, Sciatica, Sensory disturbance; Throat irritation, Wheezing
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ITCHY WITHIN 6 HOURS, WHEN I BREATE IN I FEEL WHEEZY AND LIKE I NEED TO COUGH OR CLEAR THROAT, LARGE...
ITCHY WITHIN 6 HOURS, WHEN I BREATE IN I FEEL WHEEZY AND LIKE I NEED TO COUGH OR CLEAR THROAT, LARGE QUARTER SIZE ITCHY LUMPY ON FOREARMS, SMALLER PEA SIZED BUMPS UNDER ARMPUT THAT GO FROM ITCHY TO FEELING LIKE A BRUISE, ITCHY ON MY FOREHEAD, SCIATICA RIGHT SIDE FLARE UP WITHIN 6 HOOURS THAT HAS NOT LET UP SAME WITH VIBRATING IN RIGHT SIDE OF BACK
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| 2859005 | 58 | F | CO | 09/15/2025 |
COVID19 |
MODERNA |
3051995 |
Chills, Headache, Nausea, Vomiting
Chills, Headache, Nausea, Vomiting
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shivers, headache, nausea and vomiting
shivers, headache, nausea and vomiting
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| 2859006 | 63 | M | MI | 09/15/2025 |
FLU3 PNC21 RSV |
SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Tfaa2501 z002626 |
Circumstance or information capable of leading to medication error, Injection si...
Circumstance or information capable of leading to medication error, Injection site rash; Circumstance or information capable of leading to medication error, Injection site rash; Circumstance or information capable of leading to medication error, Injection site rash
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Patient came to the counseling window this afternoon stating that he got immunized on Fri 9/12/25 an...
Patient came to the counseling window this afternoon stating that he got immunized on Fri 9/12/25 and the person "gave them in the wrong spot" and he showed me a rash on his arm in the bicep area that wrapped towards his underarm. I apologized to him and told him it looked like he was having an allergic reaction to one of the vaccines. He stated he has never had a reaction to the flu shot in the past. He also received Capvaxive and Arexvy. He was given all 3 shots in the same arm. I verified with tech all 3 given in same arm because in clincal it shows rsv was given in the right arm. I asked him if he called his doctor yet. He stated that he had not and he was trying to avoid it. I told him I wanted him to call his doctor. I also advised him to take benadryl and to call here in the am to let us know if any better. I told him I would fill out an incident report and report to Vaers. He mentioned he had been using ice at the advice of his daughter who is a pharmacy tech at Meijer. He said he took a pic of his arm and sent it to her and she showed her boss and was told they were given in the wrong area. He showed me on his arm that the bandaids were placed lower where his rash was vs the deltoid area. He stated the same tech also gave the imz to his wife and hers were fine as in correct location and no reaction. I talked with the immunizing tech and asked her if she remembered anything else about that patient encounter. I asked to show me on my arm how and where she gave the imzs. She demonstrated proper area. She remembered that as soon as she pulled the first cap of the needle to give him his shots he immediately tensed up his arm as if he was frightened. She stated his wife did not do that, but remembered him doing that.
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| 2859007 | 22 | F | MO | 09/15/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
A5DP7 |
Syncope
Syncope
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Syncope
Syncope
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| 2859008 | 8 | M | MO | 09/15/2025 |
FLU3 |
SEQIRUS, INC. |
406986 |
Skin warm, Swelling
Skin warm, Swelling
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PER MOM, PT EXPERIENCED SWELLING ABOUT 5 INCHES IN DIAMETER, WARM TO TOUCH, HAS HAD FLU SHOT PREVIOU...
PER MOM, PT EXPERIENCED SWELLING ABOUT 5 INCHES IN DIAMETER, WARM TO TOUCH, HAS HAD FLU SHOT PREVIOUS WITHOUT REACTION SO WAS JUST DOUBLE CHECKING W/US WHETHER IS COMMON. PT STILL WENT TO SCHOOL AS REGULAR ROUTINE WITH NO FEVER. ADVISED MOM TO GIVE PT SOME BENADRYL AND GIVE SOME COLD PRESSES TO HELP GET SWELLING DOWN. TOLD PT TO CALL US BACK IF AREA GETS WORSE.
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| 2859009 | 77 | F | CA | 09/15/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Chills, Decreased appetite, Dizziness, Fatigue, Headache; Nausea, Pain, Pyrexia
Chills, Decreased appetite, Dizziness, Fatigue, Headache; Nausea, Pain, Pyrexia
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Chills, body aches, headache, very dizzy (could not drive safely), loss of appetite, nausea, great f...
Chills, body aches, headache, very dizzy (could not drive safely), loss of appetite, nausea, great fatigue, fever (100.9 - fever broke today); self-treatment includes drinking fluids, Ibuprofen and or Tylenol, sleeping a lot - my doctor was not helpful
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| 2859010 | 51 | F | FL | 09/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7523j |
Erythema, Pruritus, Urticaria
Erythema, Pruritus, Urticaria
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Pt developted large red welt on arm that has subsided but still is present 8 days later. Itchy and r...
Pt developted large red welt on arm that has subsided but still is present 8 days later. Itchy and red
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| 2859011 | 54 | F | WA | 09/15/2025 |
FLU3 HEP VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
N733B N733B E754F |
Injection site cellulitis; Injection site cellulitis; Injection site cellulitis
Injection site cellulitis; Injection site cellulitis; Injection site cellulitis
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cellulitis left upper arm. treated with antibiotics.
cellulitis left upper arm. treated with antibiotics.
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| 2859014 | 73 | F | FL | 09/15/2025 |
FLU3 |
SANOFI PASTEUR |
UT8781AA |
Urticaria, Urticaria papular
Urticaria, Urticaria papular
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Urticaria both macular and papular areas
Urticaria both macular and papular areas
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| 2859015 | 77 | M | KS | 09/15/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
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Arthralgia, Asthenia, Decreased appetite, Muscular weakness, Pain in extremity; ...
Arthralgia, Asthenia, Decreased appetite, Muscular weakness, Pain in extremity; SARS-CoV-2 test negative, Somnolence
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Sore arm the next day. Feeling tired. Mild fever on day 2, inceasing slightly ever since. Up to 9...
Sore arm the next day. Feeling tired. Mild fever on day 2, inceasing slightly ever since. Up to 99.7, from a normal of 97.7. Now no energy, sore, weak legs, very sore shoulders, arm weakness. No appetite, just want to sleep.
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| 2859016 | 50 | F | MN | 09/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93N4J |
Injected limb mobility decreased, Injection site erythema, Injection site pain, ...
Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
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Patient reports increased pain, swelling, redness at shoulder & top of arm of injection site. In...
Patient reports increased pain, swelling, redness at shoulder & top of arm of injection site. Increased over days and has led to immobility of right arm for some days now (currently 13 days post vaccination). Came to pharmacy to report adverse event, went to clinic and was evaluated and prescribed antibiotic for potential infection of injection site.
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| 2859017 | 61 | F | FL | 09/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3t74x |
Injection site erythema, Pruritus
Injection site erythema, Pruritus
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itching all over, significant redness at the injection site starting at the size of a quarter and pr...
itching all over, significant redness at the injection site starting at the size of a quarter and progressing to the size of a golf ball over the span of 2 days, currently using benadryl, and aleve
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| 2859018 | 14 | M | WA | 09/15/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
zh7sn |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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There was a miscommunication on which meningococcal vaccine to give the patient. Meningococcal B was...
There was a miscommunication on which meningococcal vaccine to give the patient. Meningococcal B was given patient isnt due until 03/2027 patient will need to get 2nd dose of meningococcal A at upcoming appointment and 2nd dose of Meningococcal B in 03/2027.Patient tolerated well no signs of sickness or symptoms. The provider was notified as well as the team lead.
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| 2859019 | 12 | F | CA | 09/15/2025 |
FLU3 HPV9 MNQ |
SANOFI PASTEUR MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS |
UT8779LA Y018297 9549B |
Dizziness; Dizziness; Dizziness
Dizziness; Dizziness; Dizziness
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Patient seen pale and reported feeling dizzy. Patient was laid down on exam bed and given apple juic...
Patient seen pale and reported feeling dizzy. Patient was laid down on exam bed and given apple juice. Dr. informed and evaluated patient.
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| 2859020 | 61 | F | NC | 09/15/2025 |
FLU3 FLU3 PNC21 PNC21 |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
U8832BA U8832BA Z006889 Z006889 |
Headache, Injection site erythema, Injection site pain, Injection site warmth, L...
Headache, Injection site erythema, Injection site pain, Injection site warmth, Lethargy; Rash; Headache, Injection site erythema, Injection site pain, Injection site warmth, Lethargy; Rash
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Per patient report at the pharmacy on 9/15/25, following receiving both Capvaxive and Flublok she de...
Per patient report at the pharmacy on 9/15/25, following receiving both Capvaxive and Flublok she developed pain and redness at the injection site as well as headache and mild rash on her chest. The rash had resolved as of 9/15/25 but the was still redness and heat at the injection site. Patient was complaining of continued headache and general lethargy that had been consistent since receiving the vaccine. Per the patients report, she has not had a reaction of this type to any vaccine that she has received in the past.
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| 2859021 | 70 | M | IL | 09/15/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UTB763EA UTB763EA |
Cough, Eye inflammation, Influenza, Kaleidoscope vision, Orchitis noninfective; ...
Cough, Eye inflammation, Influenza, Kaleidoscope vision, Orchitis noninfective; Pain, Rhinorrhoea
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3 days of anomalies: Day 1. mild flu symptooms requiring bed rest; Day 2:Aches inflamation including...
3 days of anomalies: Day 1. mild flu symptooms requiring bed rest; Day 2:Aches inflamation including eyeballs and testicles; Left eye had psychedlic colors that may have been fro pressure on the eye while sleeping; Day 3: Respiratory hacking and continuous running nose that consumed a large box of Leenex.
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| 2859022 | 82 | F | TN | 09/15/2025 |
COVID19 FLU3 RSV |
PFIZER\BIONTECH SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
my9550 u8764bb 52z52 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
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Reporting due to second Arexvy vaccine not recommended. First dose was not reported to agency and pa...
Reporting due to second Arexvy vaccine not recommended. First dose was not reported to agency and patient had no recollection of getting before, but patient had dose 8/2023. No signs or symptoms reported by patient
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| 2859023 | 37 | F | FL | 09/15/2025 |
FLU3 |
SANOFI PASTEUR |
U8823AA |
Hypoaesthesia, Immediate post-injection reaction, Pain in extremity, Paraesthesi...
Hypoaesthesia, Immediate post-injection reaction, Pain in extremity, Paraesthesia
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Patient reported immediately sore arm that progressively got sore throughout the day. About 4-5 hour...
Patient reported immediately sore arm that progressively got sore throughout the day. About 4-5 hours after patient received the vaccine, patient reported she started to experience tingling and numbness down her arm particularly in her fingertips. She was advised to call her doctor and seek medical attention. Unknown at this time if patient has been seen by medical doctor and/or outcome.
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| 2859024 | 22 | F | WA | 09/15/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
948394 948394 |
Dizziness, Hot flush, Nausea, Neck pain, Pain in extremity; Sleep disorder
Dizziness, Hot flush, Nausea, Neck pain, Pain in extremity; Sleep disorder
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Night pain woke me up with extreme sore neck and arm. Then I spent all day nauseous and dizzy with o...
Night pain woke me up with extreme sore neck and arm. Then I spent all day nauseous and dizzy with off and on hot flashes.
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| 2859025 | 75 | F | AZ | 09/15/2025 |
SMALL |
EMERGENT BIOSOLUTIONS |
U8764CB |
Erythema, Pruritus, Swelling face
Erythema, Pruritus, Swelling face
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The patient reported adverse reaction to the flu immunization to the pharmacy on 9/15/25. The patie...
The patient reported adverse reaction to the flu immunization to the pharmacy on 9/15/25. The patient experienced swelling, itching, and redness around the face. The patient's arm where the immunization was given was fine and did not have any reaction at the injection site.
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