| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2863535 | 5 | OK | 10/06/2025 |
UNK |
UNKNOWN MANUFACTURER |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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administered FLUBLOK to a five-year-old patient with no adverse event; Initial information received ...
administered FLUBLOK to a five-year-old patient with no adverse event; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old and unknown gender patient who was administered Influenza Trivalent Recombinant Vaccine [Flublok Tiv] with no 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 of 5 years old received a dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site as immunization with no adverse event (product administered to patient of inappropriate age) (latency: same day). 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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| 2863540 | 9 | CA | 10/06/2025 |
HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
2018414 Y013768 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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No additional AE; received a 3rd dose. 3rd dose was administered 10/1/2025; This spontaneous report ...
No additional AE; received a 3rd dose. 3rd dose was administered 10/1/2025; This spontaneous report was received from a medical assistant and refers to a(n) 11-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-Oct-2023 when the patient was 9 years old, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection, dose number 1, (dose, lot # and expiration date were not reported). On 04-Sep-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection (lot #2018414, expiration date: 11-Dec-2025), dose number 2.On 01-Oct-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection (lot #Y013768, expiration date: 12-Feb-2027), dose number 3 (Inappropriate schedule of product administration). All doses were administered for Prophylaxis. No adverse event was reported. Batch/Lot number is being requested and will be submitted if received.
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| 2863548 | F | NV | 10/06/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Headache, Influenza like illness, Myalgia, Nausea; Headache, Influenza like illn...
Headache, Influenza like illness, Myalgia, Nausea; Headache, Influenza like illness, Myalgia, Nausea
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2nd dose not received yet; Nausea; Headache; she experienced muscle pain,; Flu-like symptoms; This n...
2nd dose not received yet; Nausea; Headache; she experienced muscle pain,; Flu-like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included non-insulin-dependent diabetes mellitus (NIDDM), chronic pain (Chronic pain States that she takes two pain medications, but did not wish to name them.), fibromyalgia and hypertension. The patient received the 1st dose of Shingrix and did not receive 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), headache (Verbatim: Headache), muscle pain (Verbatim: she experienced muscle pain,), influenza-like symptoms (Verbatim: Flu-like symptoms) and incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the nausea, headache, muscle pain and influenza-like symptoms were resolved (duration 1 day) and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the nausea, headache, muscle pain and influenza-like symptoms to be related to Shingrix. It was unknown if the company considered the nausea, headache, muscle pain and influenza-like symptoms to be related to Shingrix. Additional Information: GSK Receipt Date: 23-SEP-2025 The patient stated that she received her first dose of Shingrix about a year ago but was not sure of the timing. She had not received the second dose. She reported that the day after receiving her Shingrix shot, she experienced muscle pain, headache, nausea and flu-like symptoms. This lasted one day and then resolved. She was not forthcoming with her medications, but stated all medications were long-term medications at the time of the Shingrix shot.
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| 2863549 | 83 | M | IL | 10/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3273H |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Late 2nd dose; This non-serious case was reported by a other health professional via call center rep...
Late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 83-year-old male patient who received Herpes zoster (Shingrix) (batch number 3273H, expiry date 31-MAR-2027) for prophylaxis. Previously administered products included Shingrix (received first dose on 28 Dec 2020 batch lot CE4DE). On 24-JUN-2025, the patient received the 2nd dose of Shingrix. On 24-JUN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 01-OCT-2025 The patient who got the first dose of Shingrix on 28Dec 2020, 2nd dose on 24 Jun 2025. However, the patient did not remember getting the 1st dose but pharmacy in the shows he got the first dose.
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| 2863550 | 45 | M | MA | 10/06/2025 |
COVID19 |
MODERNA |
3052741 |
Feeling hot, Myalgia, Night sweats, Pain in extremity
Feeling hot, Myalgia, Night sweats, Pain in extremity
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sore arm; feeling hot; sweating overnight; muscle aches; This spontaneous case was reported by a con...
sore arm; feeling hot; sweating overnight; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING HOT (feeling hot), NIGHT SWEATS (sweating overnight) and MYALGIA (muscle aches) in a 45-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052741) for COVID-19 prophylaxis. Patient had no current or past health conditions. On 27-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) .5 milliliter. On 27-Sep-2025, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING HOT (feeling hot), NIGHT SWEATS (sweating overnight) and MYALGIA (muscle aches). On 28-Sep-2025, FEELING HOT (feeling hot) and MYALGIA (muscle aches) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved and NIGHT SWEATS (sweating overnight) outcome was unknown. No concomitant medication was reported. Patient had no other vaccines in the four weeks before getting the Moderna product. No results from medical tests or lab tests reported. It was stated that he experienced sore arm the same day as receiving the vaccine on 27-Sep-2025, followed by muscle aches, feeling hot, and sweating overnight, but it was not a serious event. Patient had the sore arm, muscle aches and feeling hot into the next day (28-Sep-2025). The muscle aches and feeling hot resolved 28-Sep-2025, but the sore arm continued. Patient was not treating by physician. No treatment or medicine taken by patient in response to the adverse event. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2025: Live significant follow-up received: Onset date for events (Muscle ache, feeling hot, Pain in arm) was updated. Outcome for events Muscle ache, feeling hot updated to recovered. Outcome for event Pain in arm updated to not recovered. On 29-Sep-2025: Live non-significant follow-up received: Dosage information updated.
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| 2863551 | F | CA | 10/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Facial paralysis, Illness
Facial paralysis, Illness
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facial muscle paralysis; got really sick from the vaccine; This is a spontaneous report received fro...
facial muscle paralysis; got really sick from the vaccine; This is a spontaneous report received from a Nurse. 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: FACIAL PARALYSIS (medically significant) with onset 2025, outcome "unknown", described as "facial muscle paralysis"; ILLNESS (non-serious) with onset 2025, outcome "unknown", described as "got really sick from the vaccine". Therapeutic measures were taken as a result of facial paralysis. Clinical course: During call reporter stated that over the past month she has a friend, she got really sick from the vaccine. Employers made them get it. It is stated that because of that patient have facial muscle paralysis. She couldn't recall the name of the vaccine. She had surgery and she looks like a completely different person now. Caller stated that was the Covid vaccine, but she doesn't know if it was Pfizer or redacted. 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: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162B2 OMICRON (LP.8.1) cannot be excluded for the reported events. The detailed information would be helpful for further assessment. The case will be reassessed based on the follow-up information. 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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| 2863553 | 82 | F | LA | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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medication error due to administration of an extra dose, patient already had their FLUZONE HD vaccin...
medication error due to administration of an extra dose, patient already had their FLUZONE HD vaccine but they still asked for it with no reported adverse event; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 82 years old female patient who received 2 doses of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] in one day with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Oct-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation) and patient also received 0.5ml dose of same vaccine, (Strength: High Dose, Frequency Once) lot UT879BA and Expiry date 30-Jun-2026 via intramuscular route in the deltoid NOS (not otherwise specified) for immunisation, with no reported adverse event (extra dose administered) (Latency Same day). Reportedly, Pharmacist said that the patient was given with Fluzone HD, 30 minutes ago and their daughter came 10 minutes ago saying that the patient was confused. Patient already had their Fluzone HD vaccine from their provider's office earlier today but they still asked for it instead of getting their Covid vaccine. 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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| 2863554 | 64 | 10/06/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
U8847CA |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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inappropriate use due to inadvertent administration of FLUZONE HD instead of regular dose with no ae...
inappropriate use due to inadvertent administration of FLUZONE HD instead of regular dose with no ae; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case was linked to US-SA-2025SA295575 This case involves a 64-year-old patient of unknown gender who inadvertently received Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone HD] instead of Influenza USP Trival A-B Subvirion 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 01-Oct-2025, the patient received unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, Frequency once, Strength 0.5mL lot U8847CA and expiry date 30-Jun-2026 via intramuscular route in the right arm for immunisation instead of an unknown dose of suspect Influenza Usp Trival A-B Subvirion Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation) with no reported adverse event (wrong product administered) (latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA295575:
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| 2863555 | 18 | F | NH | 10/06/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
80777040060 49281072510 |
Syncope; Syncope
Syncope; Syncope
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PATIENT RECEIVED VACCINE AT (WITHHELD NAME) COLLEGE. AFTER RECEIVING THE VACCINE SHE STATED THAT ...
PATIENT RECEIVED VACCINE AT (WITHHELD NAME) COLLEGE. AFTER RECEIVING THE VACCINE SHE STATED THAT LAST YEAR SHE FAINTED AT HER DOCTOR'S OFFICE AFTER RECEIVING VACCINE. ON THE SCREENING QUESTIONS SHE HAD MARKED NO ON QUESTION 3, INDICATING THAT SHE HAD NEVER HAD A SERIOUS REACTION OR FAINTED AFTER RECEIVING A VACCINATION. SHE STATED SHE THOUGHT IT WS A ONE TIME THING. AMBULANCE CAME CHECKED VITALS, PATIENT DID RECOVER AND REFUSED ANY OTHER TREATMENT.
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| 2863556 | 92 | F | IA | 10/06/2025 |
RSV |
PFIZER\WYETH |
HY1813 |
Expired product administered
Expired product administered
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Patient came in to get vaccination, it was not noticed until after giving the shot that it had expir...
Patient came in to get vaccination, it was not noticed until after giving the shot that it had expired on 9/30/25.
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| 2863557 | 68 | F | 10/06/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
MY9548 U8875AA |
Injection site erythema, Injection site warmth, Myalgia; Injection site erythema...
Injection site erythema, Injection site warmth, Myalgia; Injection site erythema, Injection site warmth, Myalgia
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Patient reports sore muscle on saturday (1 day after administration) which resolved completely . Sh...
Patient reports sore muscle on saturday (1 day after administration) which resolved completely . She states a red area appeared on saturday 4 to 5 inches below the vaccination site and it is approximately 2x4 inches. She said it is red and warm to the touch. She said it does not hurt and it is not itchy. She said she would keep an eye on it and let us know if it gets larger or if anything changes.
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| 2863558 | 9 | M | NY | 10/06/2025 |
UNK |
UNKNOWN MANUFACTURER |
Pneumococcal va |
Erythema, Muscle swelling
Erythema, Muscle swelling
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Pt received pneumococcal vaccine at hospital. Pt had swelling and erythema of right deltoid. Curren...
Pt received pneumococcal vaccine at hospital. Pt had swelling and erythema of right deltoid. Currently being worked up for cellulitis on iv abx in hospital.
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| 2863559 | 58 | F | GA | 10/06/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
U8864BA MA2506 |
Injection site pruritus, Injection site rash; Injection site pruritus, Injection...
Injection site pruritus, Injection site rash; Injection site pruritus, Injection site rash
More
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Patient has a rash and itching at and around site of injection on both arms for the past 2 days. It ...
Patient has a rash and itching at and around site of injection on both arms for the past 2 days. It has subsided since it first started on Saturday evening.
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| 2863560 | 13 | F | AR | 10/06/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8562AA U8389AA |
Syncope; Syncope
Syncope; Syncope
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Patient experienced syncope and fainted about 10 minutes after vaccine upon standing up from bench o...
Patient experienced syncope and fainted about 10 minutes after vaccine upon standing up from bench out front. EMS was called and looked patient over. They said everything was fine and the patient was free to go if they chose so.
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| 2863561 | 69 | F | NY | 10/06/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
unknown unknown unknown |
Abdominal pain upper, Dizziness, Fall, Headache, Loss of consciousness; Mobility...
Abdominal pain upper, Dizziness, Fall, Headache, Loss of consciousness; Mobility decreased, Nausea, Pain, Skin laceration, Syncope; Vomiting
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Starting from 9am on 10/4/25 (18 hours after vaccine) Nausea, dizziness, stomach pain, fainting, thr...
Starting from 9am on 10/4/25 (18 hours after vaccine) Nausea, dizziness, stomach pain, fainting, throwing up, temperature of 99.7 (my normal temperature is 96.8), body aches, headache. Realized I had hit my head on the bathroom floor while unconscious and had a large bump and cuts on my forehead. Did not seek treatment; stayed in bed all day since I was unable to move. Started feeling better at 7PM on 10/4/25.
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| 2863562 | 65 | F | OH | 10/06/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
U8859CA MA2488 |
Erythema, Pain in extremity; Erythema, Pain in extremity
Erythema, Pain in extremity; Erythema, Pain in extremity
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Spoke with patient over the phone (did not physically examine patient) - Per patient, stated that sh...
Spoke with patient over the phone (did not physically examine patient) - Per patient, stated that she had "cellulitis" on the administration arm after receiving the vaccines. Stated that it was red and painful, primary care provider received pictures from patient and recommended going to nearby hospital for treatment. Post-treatment was not discussed as patient was in route to hospital while talking to pharmacist.
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| 2863563 | 63 | M | MO | 10/06/2025 |
COVID19 |
MODERNA |
3052669 |
Chest discomfort
Chest discomfort
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Chest tightness, HR greater than 180 bpm requiring medications to resolve
Chest tightness, HR greater than 180 bpm requiring medications to resolve
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| 2863564 | 76 | F | PA | 10/06/2025 |
PNC20 |
PFIZER\WYETH |
LG5579 |
Chills, Injection site rash, Injection site swelling
Chills, Injection site rash, Injection site swelling
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The patient came in, and said that she got her vaccine on 10/3/25. Later that night she felt that sh...
The patient came in, and said that she got her vaccine on 10/3/25. Later that night she felt that she had chills, and then the following day she developed a rash at the injection site and a small bump. The patient said she saw her doctor today, who prescribed her prednisone.
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| 2863565 | 7 | F | 10/06/2025 |
FLU3 |
SEQIRUS, INC. |
407249 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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7 year old patient was administered FLUAD (high dose flu vaccine) instead of the age appropriate Flu...
7 year old patient was administered FLUAD (high dose flu vaccine) instead of the age appropriate Flu vaccine. This occurred today and we will be following up with them over the next few days to assess side effects.
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| 2863566 | 62 | F | UT | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8794DA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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NOTHING AT TIME OF ADMINISTRATION
NOTHING AT TIME OF ADMINISTRATION
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| 2863567 | 70 | F | VT | 10/06/2025 |
FLU3 |
SEQIRUS, INC. |
407255 |
Arthralgia, Paraesthesia
Arthralgia, Paraesthesia
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Patient received Fluad vaccine on 10/01/2025. She called the pharmacy back on 10/02/2025 and stated ...
Patient received Fluad vaccine on 10/01/2025. She called the pharmacy back on 10/02/2025 and stated that she was experiencing issues with shoulder pain and tingling that only began after she had received her vaccine and she thought the vaccine was administered into her shoulder.
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| 2863568 | 7 | M | OH | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2502 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Patient was given flublok 9 years and older instead of the pediatric dose for his age (7 years 10 mo...
Patient was given flublok 9 years and older instead of the pediatric dose for his age (7 years 10 months). Patient stayed around the clinic after injection for 15 minutes and no adverse/side effects were reported. The provider noticed the medication error right after the patient had left the clinic (15 minutes after the shot was given). Provider's manager was immediately notified.
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| 2863577 | 5 | M | CA | 10/06/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0590 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Patient received Cominarty Covid Vaccine for 12 years old and above instead of Pfizer covid vaccine ...
Patient received Cominarty Covid Vaccine for 12 years old and above instead of Pfizer covid vaccine for below 12 years old. No apparent adverse effect. Dr. notified and to notify the family. No known adverse effect.
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| 2863578 | 42 | F | 10/06/2025 |
FLU3 PNC21 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
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Erythema, Injection site erythema, Injection site pain, Injection site urticaria...
Erythema, Injection site erythema, Injection site pain, Injection site urticaria, Urticaria; Erythema, Injection site erythema, Injection site pain, Injection site urticaria, Urticaria
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PAINFUL HIVES AND REDNESS AROUND THE INJECTION SITE AND CONTINUOUSLY SPREADING ON HER UPPER PART OF ...
PAINFUL HIVES AND REDNESS AROUND THE INJECTION SITE AND CONTINUOUSLY SPREADING ON HER UPPER PART OF HER BODY ESPECIALLY THE BACK.
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| 2863579 | 63 | F | FL | 10/06/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Ageusia, Anosmia, Arthralgia, Brain fog, Diarrhoea; Fatigue, Gastrointestinal tu...
Ageusia, Anosmia, Arthralgia, Brain fog, Diarrhoea; Fatigue, Gastrointestinal tube insertion, Hypoaesthesia, Loss of consciousness, Muscle spasms; Myalgia, Pain in extremity, Seizure, Unresponsive to stimuli, Vomiting; Wheelchair user
More
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July 23, 2025 I am writing to inform you of serious injury to my Wife due to the effects of the c...
July 23, 2025 I am writing to inform you of serious injury to my Wife due to the effects of the covid 19 vaccine and booster. Before the Covid Pfizer shot on 7/21/2021 and followed by the booster on 8/26/2021 my wife had raised eight children. She homeschooled 5 of them. She was socially active. She was President of a committee for nine years. She was a stay-at-home mother totally committed to her Family and her community. After her Pfizer shots she experienced vomiting, diarrhea, and passing out. This resulted in two emergency visits on December 17 and 21, 2021. She was admitted to the hospital from 2/26/2022 until 4/12/2022. At that point she was totally unresponsive and she experienced as many as 9 major seizures in one day. Because hospital did not have the proper equipment and personnel to diagnose her, she was medically transported to another hospital for further diagnosis of her seizures. She was medically transported back to hospital (from 4/24/2022 until 5/12/2022) still unresponsive and fed through a stomach tube. They in turn medically transported her to Rehab (5/13/2022 to 6/14/2022). Then she was medically transported to another Rehab (6/15/2022 to 8/16/2022). At that point she could eat a little bit and talk somewhat, and was wheelchair bound. Because of recurring medical problems, she was admitted to hospital again for a short stay and medically transported to rehab from 3/10/2023 to 4/18/2023. She is now home and recovering slowly from all the devastating effects of the vaccines. She still has other symptoms related to post vaccine injuries such as serious fatigue, muscle and joint pain, brain fog, lost of taste and smell, leg pain and cramps and numbness in her feet and her knees, and much more. We have hospital records for all the above mentioned hospital and rehab care. Any compensation for all the expenses incurred and for loss of her ability to return to her former way of life would be appreciated. Your response would be much appreciated. God bless you for what you are doing for our country!
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| 2863580 | 64 | M | AZ | 10/06/2025 |
COVID19 |
JANSSEN |
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Cardiac fibrillation, Cardioversion, Medical induction of coma
Cardiac fibrillation, Cardioversion, Medical induction of coma
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Was D fibrillation and Induced into a coma for 21 days in the hospital for 2 months permantley Disa...
Was D fibrillation and Induced into a coma for 21 days in the hospital for 2 months permantley Disabled
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โ | โ | โ | |||
| 2863581 | 41 | F | FL | 10/06/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
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Blister, Dysphonia, Eyelids pruritus, Nasal congestion, Rash; Swelling of eyelid
Blister, Dysphonia, Eyelids pruritus, Nasal congestion, Rash; Swelling of eyelid
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1.5 hours after receiving flublok vaccine I started to have a familiar itching feeling on my eyelids...
1.5 hours after receiving flublok vaccine I started to have a familiar itching feeling on my eyelids (i had 1 anaphylaxis before, so I know), and 1 eyelid- right eyelid got swollen, like two blisters on the eyelid. Also my nose got fully stuffed and I was not able to breath using my nose. Voice became harsh and low, but no feeling of blocking or swelling in the throat. There was a bit of rash on my chest. I came home and took 3 zyrtec tablets, 10 mg each. Put drops of Pataday in eyes. My nose opened up. After 3 zyrtecs, 1.5 hours later my eyelid is still swollen but less. My voice is back to normal.
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| 2863582 | 46 | M | TN | 10/06/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Back pain, Brain fog, Fatigue, Hypoaesthesia, Impaired driving ability; Peripher...
Back pain, Brain fog, Fatigue, Hypoaesthesia, Impaired driving ability; Peripheral swelling, Sleep disorder, Somnolence
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Chronic fatigue, Can only sleep 3.5 hours at a time, brain fog, swollen legs and arms, Numbness in b...
Chronic fatigue, Can only sleep 3.5 hours at a time, brain fog, swollen legs and arms, Numbness in both arms and legs, Driving a car only lasts about an hour before I get sleepy, upper back pain. Still have all of these adverse affects from the shots.
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| 2863583 | 69 | M | NV | 10/06/2025 |
FLU3 |
SEQIRUS, INC. |
IM PFS 2025-26 |
Abdominal pain upper, Asthenia, Diarrhoea, Faeces pale, Lethargy
Abdominal pain upper, Asthenia, Diarrhoea, Faeces pale, Lethargy
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It began with severe stomach pain and severe diarrhea that lasted for twenty-four hours, followed by...
It began with severe stomach pain and severe diarrhea that lasted for twenty-four hours, followed by white stool and intermittent diarrhea 72 hours later. I was extremely lethargic, too weak to stand through a shower on the first morning after the injection. After sleeping about fifteen hours, my stamina gradually resumed.
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| 2863584 | 50 | F | KS | 10/06/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052296 948402 |
Anaemia; Anaemia
Anaemia; Anaemia
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Per daughter, pt is anemic
Per daughter, pt is anemic
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| 2863585 | 87 | F | FL | 10/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
ek225 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No adverse events at this time. The patient has been doing fine so far.
No adverse events at this time. The patient has been doing fine so far.
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| 2863586 | 75 | F | WI | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
U8859CA |
Arthralgia, Pain, Pain in extremity, Pyrexia
Arthralgia, Pain, Pain in extremity, Pyrexia
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Patient's daughter called to ask for "batch number" of vaccine because her mother was...
Patient's daughter called to ask for "batch number" of vaccine because her mother was having pain in her arm after receiving the vaccination and wanted to report it. Daughter said she was the mom's healthcare power of attorney and was given the lot number. Called and spoke to patient who said that she was having pain in her shoulder and it was painful for her to move her arm. Patient said that she felt a slight temperature at around 3pm and took acetaminophen. Patient did not use thermometer to check her temperature. Said her nurse friends that live on her block recommended she use cold compress and warm compresses and she neither was making her arm feel better. She did not contact doctor.
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| 2863587 | 65 | F | IA | 10/06/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
NA0739 407252 |
Blood creatine phosphokinase increased, Fall, Fatigue, Gait disturbance, Musculo...
Blood creatine phosphokinase increased, Fall, Fatigue, Gait disturbance, Musculoskeletal disorder; Blood creatine phosphokinase increased, Fall, Fatigue, Gait disturbance, Musculoskeletal disorder
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Patient went through our vaccine clinic and received both flu and covid vaccines. She has received ...
Patient went through our vaccine clinic and received both flu and covid vaccines. She has received both before with no problems. She returned to the pharmacy today and stated the evening of her vaccines she was getting tired so decided to get ready for bed early. She was in her bedroom and stated her legs started not working right. She felt as though she had lost the ability to walk. She tried to make it to her bed but fell before she got there. She had to call the ambulance and then spent two days in the hospital. She told me her enzymes were elevated but could only remember the doctor mentioning creatinine.
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| 2863588 | 61 | F | CA | 10/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3EG9B |
Injected limb mobility decreased, Pain in extremity
Injected limb mobility decreased, Pain in extremity
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Patient has soreness in the injected arm, she cannot move the arm due to pain.
Patient has soreness in the injected arm, she cannot move the arm due to pain.
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| 2863589 | 73 | F | FL | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8781DA |
Injected limb mobility decreased, Pain, Product administered at inappropriate si...
Injected limb mobility decreased, Pain, Product administered at inappropriate site
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PATIENT STATED INJECTION WAS GIVEN MUCH HIGHER THAN NORMAL. PATIETN STATED SHE COULD NOT RAISE HER A...
PATIENT STATED INJECTION WAS GIVEN MUCH HIGHER THAN NORMAL. PATIETN STATED SHE COULD NOT RAISE HER ARM AND THAT THIS IS NOT THE NORMAL SORENESS SHE USSLY EXPERIENCES WITH HER YEARLY FLUVACCINE. SHE HAS A LIMITED RANGE OF MOTION ALMOST A WEEK LATER (ADMINISTERED 9/30/25). SHE HAS BEEN TAKEN ADVIL/TYLENOL TO HELP WITH THE PAIN. SHE WANTED TO REPORT, JUST IN CASE SHE NEEDED TO CONSULT HER DOCTOR REGARDING TREATMENT.
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| 2863590 | 79 | F | FL | 10/06/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
MY9550 UT8781DA |
Disorientation, Pyrexia; Disorientation, Pyrexia
Disorientation, Pyrexia; Disorientation, Pyrexia
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THE PATIENTS SIGNIFICANT OTHER REPORTED THE PATIENT HAD A FEVER OF 103 DEGREES AND FELT DISORIENTED....
THE PATIENTS SIGNIFICANT OTHER REPORTED THE PATIENT HAD A FEVER OF 103 DEGREES AND FELT DISORIENTED. SHE WENT TO THE ER FOR OBSERVATION.
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| 2863591 | 20 | F | CA | 10/06/2025 |
JEV1 YF |
INTERCELL AG SANOFI PASTEUR |
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No adverse event, Product preparation error; No adverse event, Product preparati...
No adverse event, Product preparation error; No adverse event, Product preparation error
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Yellow Fever vaccine (YF-Vax) reconstituted with sterile water diluent vs sodium chloride that was i...
Yellow Fever vaccine (YF-Vax) reconstituted with sterile water diluent vs sodium chloride that was included with the vaccine. Per manufacturer, dose invalid and repeat needed for a valid dose not to be given any sooner than 28 days from previous dose. Consulted with patient and no adverse reactions reported. Scheduled repeat vaccine greater than 28 days apart from last dose of YF-Vax
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| 2863592 | 37 | F | MD | 10/06/2025 |
COVID19 |
MODERNA |
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Pallor, Urticaria
Pallor, Urticaria
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Diffuse urticaria. Arms, chest and back. Started around 9am 10/6/25. I thought it was bug bites or ...
Diffuse urticaria. Arms, chest and back. Started around 9am 10/6/25. I thought it was bug bites or an odd rash. It was not until 9pm that I looked closer and realized it was urticaria. Irregular wheal, blanchable, changed locations thought the day.
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| 2863606 | 80 | F | FL | 10/06/2025 |
FLU3 |
SANOFI PASTEUR |
U8959AA |
Chills, Dizziness, Headache, Loss of consciousness
Chills, Dizziness, Headache, Loss of consciousness
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Fri 9/14 Flu shot 1230pm chills & headache 10:00 pm severe dizziness during night passed out 7:3...
Fri 9/14 Flu shot 1230pm chills & headache 10:00 pm severe dizziness during night passed out 7:30 am 9/20/25 B/P remained low 85/20 though Sunday night 9/22/25 Treatment - BEDREST - B/P check:
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| 2863607 | 82 | F | TN | 10/06/2025 |
COVID19 COVID19 FLU3 FLU3 |
MODERNA MODERNA SEQIRUS, INC. SEQIRUS, INC. |
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Arthralgia, Fatigue, Injection site pain, Lymphadenopathy, Myalgia; Product admi...
Arthralgia, Fatigue, Injection site pain, Lymphadenopathy, Myalgia; Product administered at inappropriate site; Arthralgia, Fatigue, Injection site pain, Lymphadenopathy, Myalgia; Product administered at inappropriate site
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A tech - not a pharmacist, gave me the two shots. He said this is where I gave my mother her shot. S...
A tech - not a pharmacist, gave me the two shots. He said this is where I gave my mother her shot. She didn't have any pain. When I got home and saw location of shot, located next to uper arm next to shoulder bone. When it started hurting, swelling of lymph nodes. I knew something was wrong. 5 days later went to Dr. primary care - I told NPT - she said it was administrator error. I have had fatigue - muscle pain and joint pain - til today 9-24
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| 2863609 | AZ | 10/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
C9X3R |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
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Patient developed a raised, red area starting at administration site. This increased in diameter ove...
Patient developed a raised, red area starting at administration site. This increased in diameter over the period of 3 days. Vaccine was given 9/30 & pt was seen 10/3 for concerns of reaction. This area in question also developed a "tail" at the bottom of the site. Area on left deltoid after administration developed a red, raised area which was hot to the touch, painful & patient complained of extreme itching sensation. 9/30/25 vaccine administered 10/2/25 patient report area where vaccine was given developed the size of a "softball" per patient. She was asked to stop by the PCP office prior to the weekend. 10/3/25 Patient stopped into PCP office and area in question was still very red, raised & warm to the touch. Official measurements of area within vaccine administration site & "tail" that had developed overnight (from 10/2 to 10/3) are as such: -area surrounding vaccine site 4.5 in (H) x 3.75 in (W) -tail that developed at bottom of area: 2.5 in long
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| 2863215 | 61 | F | MI | 10/05/2025 |
COVID19 COVID19 FLU3 FLU3 |
NOVAVAX NOVAVAX SEQIRUS, INC. SEQIRUS, INC. |
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Arthralgia, Chills, Diarrhoea, Injected limb mobility decreased, Migraine; Pyrex...
Arthralgia, Chills, Diarrhoea, Injected limb mobility decreased, Migraine; Pyrexia, Tinnitus; Arthralgia, Chills, Diarrhoea, Injected limb mobility decreased, Migraine; Pyrexia, Tinnitus
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Flu vaccine was 2nd injection but unsure which flu shot was given. Fever, chills, severe joint pain....
Flu vaccine was 2nd injection but unsure which flu shot was given. Fever, chills, severe joint pain. Could not move right arm upon awakening for several minutes ... had not slept on it. Severe .migraine. ears ringing. Diarrhea.
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| 2863216 | 68 | F | MO | 10/05/2025 |
COVID19 |
PFIZER\BIONTECH |
EW0196 |
Death, Myocardial infarction
Death, Myocardial infarction
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Received second Covid_19 Pfizer vaccine on 07-14-2021 (first Covid-19 Pfizer vaccine on 06-23-2021)....
Received second Covid_19 Pfizer vaccine on 07-14-2021 (first Covid-19 Pfizer vaccine on 06-23-2021). Death occurred overnight, reported as heart attack on death certificate. No autopsy was performed.
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| 2863217 | 11 | F | IN | 10/05/2025 |
MENB |
PFIZER\WYETH |
HP9987 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Patient presented to clinic with parents for Tdap and meningococcal A,C,W,Y. Medical history, allerg...
Patient presented to clinic with parents for Tdap and meningococcal A,C,W,Y. Medical history, allergies and reason for appointment reviewed with patient and parents. Tdap was successfully given, however, I accidently administered meningococcal B vaccine instead of the intended immunization. Health department representative contacted me, regarding the incident and they would contact the family. Health department rep said they would wait 1 week and then go to health department for correct vaccination. Denied any adverse reaction since receiving injection.
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| 2863218 | 16 | F | GA | 10/05/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
PX7E2 |
Injection site erythema, Injection site pain, Injection site reaction, Wound
Injection site erythema, Injection site pain, Injection site reaction, Wound
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Patient described the vaccine injury as looking like a burn and was very painful. Patient's mot...
Patient described the vaccine injury as looking like a burn and was very painful. Patient's mother attempted to treat the injury with a cold pack, which she reported did not help. Patient and her mother came to the pharmacy to show the pharmacist the injury and to ask for advice. While pulling off the bandaid, it pulled off some of the patient's skin showing an open wound at the site of injection. Pharmacist suggested applying neosporin and gauze to the injury and holding in place with medical tape to help prevent more skin from being pulled off from a regular bandaid. Patient's mother indicated that she would take the patient to an urgent care for further care.
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| 2863219 | 59 | F | NY | 10/05/2025 |
UNK |
UNKNOWN MANUFACTURER |
Z002626 |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Erythema and swelling, left upper extremity, extending from shoulder to elbow with swelling, esp tow...
Erythema and swelling, left upper extremity, extending from shoulder to elbow with swelling, esp towards elbow. Sx started evenin g of the vaccine, worsened for about 48 hours, then started improving. Very minimal sx remaining at time of eval on 9/30/25. No signs of cellulitis.
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| 2863220 | 73 | M | SC | 10/05/2025 |
PNC20 |
PFIZER\WYETH |
MA2523 |
Extra dose administered
Extra dose administered
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Pt had previously been given a Prevnar 20 vaccine on 03/06/2023.
Pt had previously been given a Prevnar 20 vaccine on 03/06/2023.
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| 2863221 | 61 | F | SC | 10/05/2025 |
RSV |
PFIZER\WYETH |
u8823ba |
Extra dose administered
Extra dose administered
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System shows she had previously received Arexvy on 11/15/2024. Pt denies this.
System shows she had previously received Arexvy on 11/15/2024. Pt denies this.
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| 2863223 | 30 | F | WA | 10/05/2025 |
COVID19 COVID19 UNK UNK |
MODERNA MODERNA UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Cough, Eye swelling, Headache, Injection site erythema, Injection site swelling;...
Cough, Eye swelling, Headache, Injection site erythema, Injection site swelling; Lymph node pain, Lymphadenopathy, Ocular hyperaemia, Sneezing; Cough, Eye swelling, Headache, Injection site erythema, Injection site swelling; Lymph node pain, Lymphadenopathy, Ocular hyperaemia, Sneezing
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Headache, head pain when coughing or sneezing, red mark and swelling at injection site, red marks a...
Headache, head pain when coughing or sneezing, red mark and swelling at injection site, red marks and swelling under both eyes, left lymph node painfully swollen
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| 2863224 | 16 | M | CO | 10/05/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
na0590 tfaa2537 |
Loss of consciousness; Loss of consciousness
Loss of consciousness; Loss of consciousness
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the patient lost consciousness after administering both vaccines, ( per parents reaction runs in the...
the patient lost consciousness after administering both vaccines, ( per parents reaction runs in the family on male site during medical procedures) , the patient regain consciousness right away
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