| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2872860 | 73 | F | FL | 11/14/2025 |
FLU3 PNC21 RSV VARZOS |
SEQIRUS, INC. MERCK & CO. INC. PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
409159 Z005765 MM9147 4AB32 |
Abdominal distension, Injection site erythema, Injection site pain; Abdominal di...
Abdominal distension, Injection site erythema, Injection site pain; Abdominal distension, Injection site erythema, Injection site pain; Abdominal distension, Injection site erythema, Injection site pain; Abdominal distension, Injection site erythema, Injection site pain
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patient reported swelling in the arm and the injection area was red. The patient also reported pain ...
patient reported swelling in the arm and the injection area was red. The patient also reported pain at the injection site. patient was evaluated and counseled to ice the area and take some Benadryl as well as some otc pain meds like Tylenol or ibuprofen. patient was advised to monitor the area and if the symptoms don't subside within a few days or if they were to get worse, that the patient will need to get evaluated in her doctor office.
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| 2872868 | 11/14/2025 |
COVID19 FLUX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Rhinorrhoea; Rhinorrhoea
Rhinorrhoea; Rhinorrhoea
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sniffing every since took two covid and flu shot; This non-serious case was reported by a consumer ...
sniffing every since took two covid and flu shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sniffles in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving Flu vaccine and COVID-19 vaccine, the patient experienced sniffles (Verbatim: sniffing every since took two covid and flu shot). The outcome of the sniffles was not resolved. It was unknown if the reporter considered the sniffles to be related to Flu vaccine and COVID-19 vaccine. It was unknown if the company considered the sniffles to be related to Flu vaccine and COVID-19 vaccine. Additional Information: GSK Receipt Date: 26-OCT-2025 This case was reported by a patient via interactive digital media The patient stated no more shots, had been sniffing every since took two covid and flu shot. The batch number was not provided and unable to contact the reporter.
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| 2872869 | 11/14/2025 |
FLUX VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Cough, Oropharyngeal pain, Sneezing; Cough, Oropharyngeal pain, Sneezing
Cough, Oropharyngeal pain, Sneezing; Cough, Oropharyngeal pain, Sneezing
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started sneezing; Nasty sore throat; cough; This non-serious case was reported by a consumer via int...
started sneezing; Nasty sore throat; cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sneezing in a 87-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. On 24-SEP-2025, the patient received the 1st dose of Shingles vaccine and Flu vaccine. On 25-SEP-2025, 1 days after receiving Shingles vaccine and Flu vaccine, the patient experienced sore throat (Verbatim: Nasty sore throat) and cough (Verbatim: cough). On 25-SEP-2025 15:00, the patient experienced sneezing (Verbatim: started sneezing). The outcome of the sneezing and cough were not resolved and the outcome of the sore throat was not reported. It was unknown if the reporter considered the sneezing, sore throat and cough to be related to Shingles vaccine and Flu vaccine. It was unknown if the company considered the sneezing, sore throat and cough to be related to Shingles vaccine and Flu vaccine. Additional Information: GSK Receipt Date: 25-OCT-2025 This case was reported by a patient via interactive digital media On 24 SEP 2025, patient received first shingles immunization and the current flu vaccine. Approx 3pm on the 25 Sep 2025 started sneezing, followed by a nasty sore throat and a cough about an hour later. It had been a nasty thing that just won't go away, a month later still sneezing, coughing n blowing. The batch number was not provided and unable to contact the reporter.
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| 2872870 | 11/14/2025 |
VARZOS VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK UNK |
Depression, Herpes zoster, Neuralgia, Pain, Pruritus; Sleep disorder, Vaccinatio...
Depression, Herpes zoster, Neuralgia, Pain, Pruritus; Sleep disorder, Vaccination failure; Depression, Herpes zoster, Neuralgia, Pain, Pruritus; Sleep disorder, Vaccination failure
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Suspected vaccination failure; passed out once; Shingles; nerves on my right breast/ left shoulder a...
Suspected vaccination failure; passed out once; Shingles; nerves on my right breast/ left shoulder and my right arm/ going to nerve or pain management/ shingles can affect the nerves badly; depressed; Praying for healing daily and relief being able to sleep; Dizzy; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), passed out (Verbatim: passed out once) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), nerve pain (Verbatim: nerves on my right breast/ left shoulder and my right arm/ going to nerve or pain management/ shingles can affect the nerves badly), depression (Verbatim: depressed), sleeplessness (Verbatim: Praying for healing daily and relief being able to sleep) and dizziness (Verbatim: Dizzy). The outcome of the vaccination failure, shingles, depression and dizziness were not reported and the outcome of the passed out was resolved and the outcome of the nerve pain and sleeplessness were not resolved. It was unknown if the reporter considered the vaccination failure, passed out, shingles, nerve pain, depression, sleeplessness and dizziness to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and passed out to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, nerve pain, depression, sleeplessness and dizziness to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 30-OCT-2025 This case was reported by a patient via interactive digital media. The patient now had been suffering from the after effect of shingles for 2 years. He/she had both shots and now it was the nerves on his/her right breast where was a small keloid. Also, omega left shoulder and patient's right arm where he/she had a keloid on his/her upper arm. Some days it itches and throbs really bad. The patient was going to a dermatologist getting the needle in the arm and shoulder, he/she had to stop for a while. The patient said that shingles could affect the nerves badly. The patient prayed it would not get any worse. He/she was going to nerve or pain management soon. The patient definitely wished he/she had gotten the shingles sooner. Patient further said, those of you that prayed, please kept him/her in your prayers because sometimes, although patient prayed, he/she gets very depressed. The patient prayed daily for healing and relief, and for being able to sleep. The patient stated that check with the physician or pharmacist, if could continue medication. It had been too strong, and patient was getting dizzy and had passed out once. So, patient mentioned to be careful with pain medicine also. Shingles could be horrible and come back, and it was awful. The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Loss of consciousness, an unknown time after receiving 1st and 2nd dose of Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.
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| 2872872 | M | 11/14/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Drug interaction
Drug interaction
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side effects and interactions between medications; This non-serious case was reported by a consumer ...
side effects and interactions between medications; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug interaction in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug interaction (Verbatim: side effects and interactions between medications). The outcome of the drug interaction was unknown. It was unknown if the reporter considered the drug interaction to be related to Shingrix. It was unknown if the company considered the drug interaction to be related to Shingrix. Additional Information: GSK Receipt Date: 09-Nov-2025 This case was reported by a patient via interactive digital media. The reporter reported that how about the pharmacist be more open about side effects and interactions between medications as he have been through hell from side effects that doctors and pharmacists were not honest with him about as he was being told it couldn't be the medications only to figure out by himself that it was the medications that was prescribed. The batch number was not provided, and we are unable to contact the reporter.
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| 2872878 | M | 11/14/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Chemotherapy, Herpes zoster, Neoplasm malignant, Vaccination failure
Chemotherapy, Herpes zoster, Neoplasm malignant, Vaccination failure
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Suspected vaccination failure; diagnosed with cancer; He got shingles; This serious case was report...
Suspected vaccination failure; diagnosed with cancer; He got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), cancer (Verbatim: diagnosed with cancer) (serious criteria GSK medically significant) and shingles (Verbatim: He got shingles). The outcome of the vaccination failure, cancer and shingles were not reported. It was unknown if the reporter considered the vaccination failure, cancer and shingles to be related to Shingles vaccine. The company considered the vaccination failure and cancer to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-NOV-2025 This case was reported by a daughter/son of the patient via interactive digital media. The reporter said that it blew his/her mind how many (withheld) let their physicians or pharmacists inject them with poison. Reporter further mentioned that his/her dad (patient) got a Shingles vaccine before he was diagnosed with cancer. While he was going through chemo he got shingles. The reporter stated big pharma could not dispense pain medications anymore, so they were pushing all those ridiculous vaccines. The batch number was not provided and unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Neoplasm malignant, an unknown time after receiving Shingles vaccine, in a male patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.
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| 2872883 | 11/14/2025 |
FLUX VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Asthenia, Chills, Pain, Pyrexia; Asthenia, Chills, Pain, Pyrexia
Asthenia, Chills, Pain, Pyrexia; Asthenia, Chills, Pain, Pyrexia
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102 fever; awful chills; body aches; weak for 2 days after; This non-serious case was reported by a ...
102 fever; awful chills; body aches; weak for 2 days after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and Flu vaccine. On an unknown date, less than a day after receiving Shingles vaccine and Flu vaccine, the patient experienced fever (Verbatim: 102 fever), chills (Verbatim: awful chills), general body pain (Verbatim: body aches) and weakness (Verbatim: weak for 2 days after). The outcome of the fever, chills and general body pain were resolved (duration 24 hrs) and the outcome of the weakness was resolved (duration 2 days). It was unknown if the reporter considered the fever, chills, general body pain and weakness to be related to Shingles vaccine and Flu vaccine. It was unknown if the company considered the fever, chills, general body pain and weakness to be related to Shingles vaccine and Flu vaccine. Additional Information: GSK Receipt Date: 11-NOV-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient got the first shingles vaccine along with the flu vaccine at the same time. Patient reported that he/she will not get the second shingles dose. The batch number was not provided, and we are unable to contact the reporter.
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| 2872891 | 11/14/2025 |
COVID19 |
MODERNA |
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Pain in extremity
Pain in extremity
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arm still hurts pretty good; This spontaneous case was reported by a consumer and describes the occu...
arm still hurts pretty good; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm still hurts pretty good) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm still hurts pretty good). At the time of the report, PAIN IN EXTREMITY (arm still hurts pretty good) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. It was reported that, the patient had to stay on pain medications until the doctor told the patient to go off of them because the patient's arm still hurt pretty good.
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| 2872892 | 59 | F | 11/14/2025 |
COVID19 |
MODERNA |
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Influenza
Influenza
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flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu...
flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2021, the patient experienced INFLUENZA (flu). In 2021, INFLUENZA (flu) had resolved. No concomitant medication was reported. Patient had 4 vaccines since they started. She received her first one in Feb-2021 and then went back in March as it was 2 doses but in total since then, 4 doses. Every single vaccine she received was a Moderna product. Patient had the vaccine several times and after 24 hours she had major side effects. She felt like she had the flu for 24 hours. She gets severe body aches and a headache. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-791110 (Patient Link).
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| 2872893 | F | 11/14/2025 |
COVID19 |
MODERNA |
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Influenza like illness
Influenza like illness
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had usually given her flu like symptoms or fatigue; This spontaneous case was reported by a consumer...
had usually given her flu like symptoms or fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had usually given her flu like symptoms or fatigue) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Hypertension and Osteoarthritis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (had usually given her flu like symptoms or fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (had usually given her flu like symptoms or fatigue) had resolved. Patient had no vaccines within the past 4 weeks. No concomitant medications were provided. She had always taken Moderna vaccines which had usually given her flu like symptoms or fatigue for a day or 2 after the vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. This case was linked to MOD-2025-791131 (Patient Link).
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| 2872894 | F | 11/14/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Bundle branch block left, Cardiac fibrillation, Carditis, Chest pain, Inflammati...
Bundle branch block left, Cardiac fibrillation, Carditis, Chest pain, Inflammation; Palpitations, Pericarditis
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went into defib; reoccurring pericarditis, not acute; inflammation went further down into my heart/P...
went into defib; reoccurring pericarditis, not acute; inflammation went further down into my heart/Patient has chronic reoccurring inflammation; within that 30 minutes, immediately started having um chest pain; heart palpitations; left bundle branch block and a lot of heart issues; chronic reoccurring inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FIBRILLATION (went into defib), PERICARDITIS (reoccurring pericarditis, not acute) and CARDITIS (inflammation went further down into my heart/Patient has chronic reoccurring inflammation) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CARDIAC FIBRILLATION (went into defib) (seriousness criterion medically significant), PERICARDITIS (reoccurring pericarditis, not acute) (seriousness criterion medically significant), CARDITIS (inflammation went further down into my heart/Patient has chronic reoccurring inflammation) (seriousness criterion medically significant), BUNDLE BRANCH BLOCK LEFT (left bundle branch block and a lot of heart issues) and INFLAMMATION (chronic reoccurring inflammation). an unknown date, the patient experienced CHEST PAIN (within that 30 minutes, immediately started having um chest pain) and PALPITATIONS (heart palpitations). The patient was treated with Rilonacept (Arcalyst) at an unspecified dose and frequency. At the time of the report, CARDIAC FIBRILLATION (went into defib), CHEST PAIN (within that 30 minutes, immediately started having um chest pain) and PALPITATIONS (heart palpitations) outcome was unknown and PERICARDITIS (reoccurring pericarditis, not acute), CARDITIS (inflammation went further down into my heart/Patient has chronic reoccurring inflammation), BUNDLE BRANCH BLOCK LEFT (left bundle branch block and a lot of heart issues) and INFLAMMATION (chronic reoccurring inflammation) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was reported that patient had one dose of Spikevax a few years ago, might be in 2021 or 2022 within 30 minutes. Patient got vaccine, by the time she went home, within that 30 minutes patient immediately started had chest pain and heart palpitations and it was continued, but it was mild, and so patient just tried to bear with it, but over the summer it finally went even worse and like almost patient went into defib so supposed the inflammation went further down into heart. Patient had a reoccurring pericarditis, not acute. it went deeper into heart because it was messing with electrical and patient was having left bundle branch block and a lot of heart issues. It had debilitated and now she did not. Patient could not even get out of bed most of the time, barely just to get up and used the bedside commode. Patient was healthy, it was thought that she had a heart blockage at one time, heart was completely looked better than that. Patient had no plaque in heart. It was all from that vaccine. And over the summer, patient had been to 5 hospitals. Patient been in and out of the hospital. Patient had chronic reoccurring inflammation. She had been put on arcalyst since the end of July but so far it was not working. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
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| 2872895 | 54 | F | 11/14/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Arthralgia, Burning sensation, Inflammation, Insomnia, Pain; Pruritus, Scar
Arthralgia, Burning sensation, Inflammation, Insomnia, Pain; Pruritus, Scar
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inflammation on her back legs; burning; she cannot sleep; shoulders were sore; itching; pain; scars ...
inflammation on her back legs; burning; she cannot sleep; shoulders were sore; itching; pain; scars that do not heal/scratch/scars everywhere; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PAIN (pain), SCAR (scars that do not heal/scratch/scars everywhere), INFLAMMATION (inflammation on her back legs) and BURNING SENSATION (burning) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Metformin hydrochloride (Metformin) for an unknown indication. Concurrent medical conditions included Type 2 diabetes mellitus. In December 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started Metformin hydrochloride (Metformin) (unknown route) at an unspecified dose. In 2021, the patient experienced PRURITUS (itching), PAIN (pain) and SCAR (scars that do not heal/scratch/scars everywhere). On an unknown date, the patient experienced INFLAMMATION (inflammation on her back legs), BURNING SENSATION (burning), INSOMNIA (she cannot sleep) and ARTHRALGIA (shoulders were sore). The patient was treated with Cefalexin (Cephalexin) at a dose of 500 milligram and Diclofenac sodium (topical) at a dose of 1 % percent. At the time of the report, PRURITUS (itching), PAIN (pain), SCAR (scars that do not heal/scratch/scars everywhere), INFLAMMATION (inflammation on her back legs), BURNING SENSATION (burning), INSOMNIA (she cannot sleep) and ARTHRALGIA (shoulders were sore) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. It was reported that the patient received the Moderna COVID-19 vaccine back in Dec-2020 while living at a homeless shelter as it was mandatory that she had to get it. The reporter stated that it looked like a slave master tied to a tree and whipped back and legs up really bad. The reporter stated that people with type 2 diabetes should not get the vaccine because the side effect was bad. The patient reported that it was cool for 5 weeks and then it started itching and every time she ate something it got itch, so she started to scratch, and all of a sudden it blew out. The reporter stated that she went to the emergency room and the doctor clinic and had given antibiotics and creams, but it did not help, and the pain was that much worse. The reporter stated that she had scars that do not heal. The reporter was given cephalexin 500mg capsule and Diclofenac sodium topical gel 1% but stated that it did not help. The reporter stated that she had bad inflammation on her back legs, and her shoulders were sore. She stated that she had scars everywhere and that she looks like a spotted-up leopard with scars that she did not scratch, and they busted and went down to the scar tissue. The reporter continued to experience pain. When she took Metformin, she stated that it really kicks it off and made the pain and the itching, burning and everything worse. The reporter stated that some days she could not sleep because the pain was too bad. No other details provided. It was unknown if the patient experienced any additional symptoms/events.
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| 2872896 | 64 | F | 11/14/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Influenza; Influenza
Influenza; Influenza
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flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu...
flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu) in a 64-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. Previously administered products included for COVID-19 prophylaxis: moderna covid-19 vaccine (dose 1) in February 2021 and moderna covid-19 vaccine (dose 2) in March 2021. Past adverse reactions to the above products included Flu with moderna covid-19 vaccine and moderna covid-19 vaccine. In 2024, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2024, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu). At the time of the report, INFLUENZA (flu) had resolved. No concomitant medication was reported. Patient had 4 vaccines since they started. She received 4 doses in total. Her last vaccine was administered approximately 1 year ago. Every single vaccine she received was a Moderna product. Patient had the vaccine several times and after 24 hours she had major side effects. She felt like she had the flu for 24 hours. She gets severe body aches and a headache. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-791112 (Patient Link).
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| 2872897 | 75 | F | 11/14/2025 |
COVID19 |
MODERNA |
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Arthralgia, Arthritis, Myalgia
Arthralgia, Arthritis, Myalgia
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severe arthralgia (joint pain)/which made her "barely able to walk"; myalgia (muscle pain)...
severe arthralgia (joint pain)/which made her "barely able to walk"; myalgia (muscle pain), which made her "barely able to walk"; exacerbated her arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (exacerbated her arthritis), ARTHRALGIA (severe arthralgia (joint pain)/which made her "barely able to walk") and MYALGIA (myalgia (muscle pain), which made her "barely able to walk") in a 75-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Hypertension and Osteoarthritis. On 03-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced ARTHRITIS (exacerbated her arthritis). On 03-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced ARTHRALGIA (severe arthralgia (joint pain)/which made her "barely able to walk") and MYALGIA (myalgia (muscle pain), which made her "barely able to walk"). The patient was treated with Paracetamol (Tylenol) in 2025 at an unspecified dose and frequency and Ibuprofen (Advil) in 2025 at an unspecified dose and frequency. On 05-Nov-2025, ARTHRALGIA (severe arthralgia (joint pain)/which made her "barely able to walk") and MYALGIA (myalgia (muscle pain), which made her "barely able to walk") had resolved. At the time of the report, ARTHRITIS (exacerbated her arthritis) was resolving. Patient had no vaccines within the past 4 weeks. No concomitant medications were provided. The patient was experiencing severe arthralgia (joint pain) and myalgia (muscle pain), because of which the patient was barely able to walk. These side effects began within a day of receiving the vaccine and lasted for almost a month, from 03-Oct-2025 to 05-Nov-2025. She still did not feel back to her baseline health level even after the symptoms subsided. The patient had never experienced anything similar to this before, it was scary, and she was afraid that it was going to be a permanent thing. The hypertension and osteoarthritis were pre-existing, but the mNEXSPIKE definitely exacerbated her arthritis. She briefly talked about this with the HCP but never discussed it at length with them. It was unknown if the patient experienced any additional symptoms/events. She took Tylenol and Advil to help with her symptoms. This case was linked to MOD-2025-791148 (Patient Link).; Reporter's Comments: Concurrent medical conditions of osteoarthritis remains as a confounding factor for the events. The benefit-risk relationship of the product is not affected by this report.
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| 2872898 | 69 | F | 11/14/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Vaccination site pain; Vaccination site pain
Vaccination site pain; Vaccination site pain
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cannot even think about moving her shoulder without excrutiating pain. Her arm hurts like a "so...
cannot even think about moving her shoulder without excrutiating pain. Her arm hurts like a "son of a gun" just sitting there; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (cannot even think about moving her shoulder without excrutiating pain. Her arm hurts like a "son of a gun" just sitting there) in a 69-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE. Past adverse reactions to the above products included Pain with COVID-19 VACCINE. On 11-Nov-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced VACCINATION SITE PAIN (cannot even think about moving her shoulder without excrutiating pain. Her arm hurts like a "son of a gun" just sitting there). At the time of the report, VACCINATION SITE PAIN (cannot even think about moving her shoulder without excrutiating pain. Her arm hurts like a "son of a gun" just sitting there) outcome was unknown. The concomitant medication was not reported by the reporter. The patient received flu vaccine on 11-Nov-2025 in the other arm. The patient was pretty sure it was Spikevax but could not get up to check her paperwork to confirm. It was reported that the patient had just gotten the Moderna vaccine and could not even think about moving her shoulder without excruciating pain. Her arm hurts like a son of a gun just sitting there. The patient could kind of move the lower arm with the elbow, but the upper arm there was no way in heck that she could even move it. She had ice packs on it. She had received vaccines before, including the COVID vaccine, and had never had a reaction that badly before. She had experienced little aches and pains before, but in this case, she would have wanted to in tears if she had not been on the phone at that moment. This reaction was more extreme than anything she had ever experienced before. It was unknown if the patient experienced any additional symptoms or events.
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| 2872899 | F | FL | 11/14/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Alopecia, Mental disorder, Mobility decreased, Monoplegia, Neuropathy peripheral...
Alopecia, Mental disorder, Mobility decreased, Monoplegia, Neuropathy peripheral; Osteosarcoma, Pain, Weight decreased
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No Mobility of left shoulder/not able Lift that shoulder or arm; paralized on her left arm; neuropat...
No Mobility of left shoulder/not able Lift that shoulder or arm; paralized on her left arm; neuropathy; My mental health and my daughter has not been the same; great deal of pain; loss of hair, weight; loss of hair, weight; osteosarcoma cancer on her left shoulder; Follow up (03Nov2025): The initial and FU#1 case was missing the following minimum criteria: ICH-Unspecified product. Upon receipt of follow-up information on 03Nov2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 14-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunisation. The following information was reported: OSTEOSARCOMA (caused and prolonged hospitalization, medically significant) with onset 03Nov2023, outcome "recovered with sequelae", described as "osteosarcoma cancer on her left shoulder"; MOBILITY DECREASED (caused and prolonged hospitalization), outcome "unknown", described as "No Mobility of left shoulder/not able Lift that shoulder or arm"; MONOPLEGIA (medically significant), outcome "unknown", described as "paralized on her left arm"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy"; MENTAL DISORDER (non-serious), outcome "unknown", described as "My mental health and my daughter has not been the same"; PAIN (non-serious), outcome "unknown", described as "great deal of pain"; WEIGHT DECREASED (non-serious), ALOPECIA (non-serious), outcome "unknown" and all described as "loss of hair, weight". The patient was hospitalized and prolonged hospitalization for osteosarcoma, mobility decreased (start date: 03Nov2024). Therapeutic measures were taken as a result of osteosarcoma. Clinical course: Patient mother stated that she was diagnosed with breast cancer 4 months after she took the Pfizer vaccines. Stated single mother of 1 daughter; which she too got cancer Osteosercoma in 2023 too and was a care taker to her elderly mother until her passing in 2023. Patient's mom told that life has turn up side since she was diagnosed with cancer, and right after the treatment, patient had to go through the same treatment, worst then mine. Patient's mother mental health and patient has not been the same. I sending this inquiry , so hoping for a compensation. Patient paralized on her left arm. Patient's mother reported that after taking the Pfizer in May2021 (Covid Vaccine). They both was diagnosed with cancer and patient's mother can imagined, after she finish treatment, now here goes patient daughter in 03Nov2023 have cancer, did chemo like patient's mom and now patient has no mobility with her left arm due to the removed of the tumor and replace with bone marrow. 14 years of age then, now patient is 16 years of age. Patient's mom couldn't think anyone can imagined what she have been through as a mother, survivor, and patient mom to care for herself and the patient. Patient's mom have no family close to help. It's been hard. Patient's mom suffering with neuropathy, daily aches, bone issues. Patient's mom, age 50 years old. She took Pfizer in May2021 vaccine due to COVID-19. Unfortunately, patient's mom was diagnosed with breast cancer that Oct2021. It was a shock, scared and only thing that came through my mind at that time. 13 years old daughter and her elderly mom; which passed away in 2023. Right after her mother passed away, daughter at time was 14 years. On 03Nov2023, patient was diagnosed with cancer from taking Pfizer in 2021 as well. Patient's mom and patient was diagnosed with osteosarcoma cancer on the left arm where patient took the vaccine she does not have mobility /not able Lift that shoulder or arm. Patient has been a dancer, all her little life would try to dance, due to her had to do chemo causing her to get eliminated when patient try to audition for dance, due to her mobility of the left arm. They both has suffer a great deal of pain, loss of hair, weight, neuropathy which they dealing daily. Patient's mom asked to be compensate for the damage that vaccine cause to her & child. Which, she is seeking therapy weekly. There's time patient's mom could even get up to go to work or drive. But patient's mom have no other option and financial. She used all the little saving she had for her and daughter to survive that ordeal/disease. When daughter and mom could not eat because of chemo. Had to keep. Tried different things, vitamins, foods, drinks, etc. They both still pushing through each day to live a normal. But that has not been easy for her, especially patient with her mobility of her left shoulder. She still many surgery ahead due to the bone marrow not working/healing. Prior to that patient and patient's mom was very healthy. Asked for compensation for both patient's mom and patient. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500124161 Same reporter, drug and event, different patient.;
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| 2872900 | 68 | M | CT | 11/14/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2215 |
Body height, Generalised tonic-clonic seizure, Weight
Body height, Generalised tonic-clonic seizure, Weight
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Grand mal seizure; This is a spontaneous report received from a Consumer or other non HCP and an Oth...
Grand mal seizure; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. A 68-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Sep2024 as dose 1, 0.3 ml single (Lot number: LM2215) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "epileptic" (ongoing); "heart stent", start date: 2021 (unspecified if ongoing); "stage 4 lymphoma" (unspecified if ongoing); "kidney transplant" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Flu shot (DOSE NUMBER UNKNOWN), for Immunization; Rsv shot (DOSE NUMBER UNKNOWN), for Immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Booster), for COVID-19 immunization. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (hospitalization) with onset 07Sep2024, outcome "unknown", described as "Grand mal seizure". The clinical course was reported as follows: The patient reported that he had been epileptic for 45 years or a long time. He had kidney transplant and received a kidney about 15 or 16 years ago, had stage 4 lymphoma roughly 7 or 8 years ago and he received the vaccine since it came out for the last roughly 5 or 6 years and has been receiving it. On Sep2024 after he received the covid 19 vaccine, the next morning he had a grand mal seizure, he was a very controlled epileptic. He ended up admitted to the hospital for 4 or 5 days since it was a pretty serious two grand mal seizures in a row, one at home and another one once admitted in the hospital. He was discharged from hospital in Sep2024. The patient received extra doses of phenytoin (DILANTIN). The patient also reported he was on blood thinners and on anti-rejection drugs for his kidney transplant. After the event occurrence he consulted with his kidney transplant doctor and with his primary doctor. The patient was hospitalized for generalised tonic-clonic seizure (start date: Sep2024, discharge date: Sep2024). The patient underwent the following laboratory tests and procedures: Body height: little over 5'11'', notes: close to 6 feet; Weight: 200 to 202. Therapeutic measures were taken as a result of generalised tonic-clonic seizure.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500221913 Same patient and product, different dose;
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| 2872901 | F | MA | 11/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chest pain, Dyspnoea
Chest pain, Dyspnoea
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shortness of breath; chest pain; This is a spontaneous report received from a Nurse from a sales rep...
shortness of breath; chest pain; This is a spontaneous report received from a Nurse from a sales representative. An elderly female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Nov2025 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: CHEST PAIN (hospitalization) with onset Nov2025, outcome "unknown"; DYSPNOEA (hospitalization) with onset Nov2025, outcome "unknown", described as "shortness of breath". The patient was hospitalized for chest pain (start date: Nov2025, discharge date: Nov2025, hospitalization duration: 2 day(s)). It was unknown if therapeutic measures were taken as a result of dyspnoea, chest pain. Clinical course: Patient received Comirnaty within the past week but event was reported today 10Nov2025. Patient reported shortness of breath and chest pain within 24 hours of vaccination. Patient was hospitalized and released within 48 hours. No other information reported regarding this event. It is ok to contact the reporter of this event. 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: The events dyspnoea, and chest pain are conservatively assessed as related to the suspect drug BNT162B2 OMICRON (LP.8.1) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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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| 2872902 | 80 | F | NJ | 11/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dizziness, Headache, Vaccination site pain
Dizziness, Headache, Vaccination site pain
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arm pain from injection site; dizziness; maybe a little headache that lasted a day or 2; This is a s...
arm pain from injection site; dizziness; maybe a little headache that lasted a day or 2; 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 (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Apr2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE] (ongoing); LEXAPRO (ongoing); XANAX (ongoing). Vaccination history included: Comirnaty (2024-2025 formula) (DOSE 1), administration date: Oct2024, for COVID-19 immunisation, reaction(s): "Unusual pain in arm she got vaccine in, extremely dizzy ". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2025, 1 day after the suspect product(s) administration, outcome "unknown", described as "arm pain from injection site"; DIZZINESS (non-serious) with onset 2025, 1 week after the suspect product(s) administration, outcome "unknown"; HEADACHE (non-serious) with onset 2025, outcome "unknown", described as "maybe a little headache that lasted a day or 2". Therapeutic measures were taken as a result of vaccination site pain, dizziness, headache. Additional information: The patient had been getting Pfizer Covid vaccines since it came out. The only side effects she had was like, a little bit of sore arm where vaccine was given, maybe a little headache that lasted a day or 2, nothing major. The patient was told that, because she was senior citizen, she should get one every 6 months. Had one vaccine Oct2024, last year then, got one Apr2025. When she got the one in Apr2025, had severe unusual pain in arm that she got vaccine in. Could not even lift arm for almost a week. The thing she was most concerned about was that, she suddenly woke up one day, was extremely dizzy. Was like, the world was spinning out of control, could not stand up, had to crawl into bathroom. That lasted 2 weeks. Had appointment later, for ophthalmologist. This pain experienced after last Covid vaccine received, Apr2025, was that evening. She got vaccine first thing in morning. That evening, started to feel pain. Clarified, the arm she got vaccine and had pain in, was left arm. About a week after, was when it started with dizziness. Did not know if that was possibly due to Covid vaccine, if she would have gotten that immediately, or if possible to get it a week later. Never had this feeling before. The pain lasted about 5 days. Treatment: No, did not know if it could have any interaction with Covid vaccine. Waited 24 hours then, took some Tylenol. Extremely dizzy: Clarified, the dizziness started a week after getting the vaccine in Apr2025, lasted 2 weeks. Treatment: Took Antivert. It was reported that no event required a visit to the Emergency Room or a visit to a Physician's Office. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2872903 | M | NJ | 11/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dizziness, Dysstasia
Dizziness, Dysstasia
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could not stand or drive; he was dizzy; This is a spontaneous report received from a Consumer or oth...
could not stand or drive; he was dizzy; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Apr2025 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: DYSSTASIA (non-serious), outcome "unknown", described as "could not stand or drive"; DIZZINESS (non-serious), outcome "unknown", described as "he was dizzy". Additional information: It was reported that Has anyone reported any side unusual side effects from vaccine given out in Apr2025, this year, While caller reporting about her experience with Pfizer Covid vaccine, she states, her ophthalmologist told her, he got Covid vaccine, had exact same side effects. For 2 weeks, he was dizzy, could not stand or drive. 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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| 2872905 | 82 | F | NJ | 11/14/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
NA0738 NA0738 |
Asthenia, Chills, Dizziness postural, Headache, Hot flush; Pyrexia
Asthenia, Chills, Dizziness postural, Headache, Hot flush; Pyrexia
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Headache; chills; hot flashes; low-grade temp; very weak; couldn't stand w/o feeling dizzy; The...
Headache; chills; hot flashes; low-grade temp; very weak; couldn't stand w/o feeling dizzy; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 10Nov2025, this case now contains all required information to be considered valid. This is a spontaneous report and received from Consumer or other non HCPs, Program ID: . An 82-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 23Oct2025 as dose 1, 0.3 ml single (Lot number: NA0738, Expiration Date: 19Jun2026) at the age of 82 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "asthma", start date: 1981 (ongoing); "Cholesterol", start date: 2010 (ongoing); "TIA", start date: Jun2025 (ongoing); "Allergies" (ongoing); "High blood pressure", start date: 2010 (ongoing); "Bladder problems" (ongoing); "bladder infection", start date: Jul2025 (ongoing); "Gastroesophageal reflux disease", start date: 2021 (ongoing); "Breast cancer", start date: 2017, stop date: 2021; "Breast cancer", start date: 2025 (ongoing). Concomitant medication(s) included: ENCORE [BETAMETHASONE DIPROPIONATE] taken for asthma; ATORVASTATIN taken for blood cholesterol; CLOPIDOGREL taken for transient ischaemic attack; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for multiple allergies; ANASTROZOLE taken for breast cancer; VERAPAMIL taken for hypertension; LOSARTAN taken for hypertension; TOLTERODINE taken for bladder disorder; PANTOPRAZOLE SODIUM taken for gastrooesophageal reflux disease; CEFPROZIL taken for cystitis. The following information was reported: CHILLS (non-serious) with onset 23Oct2025, outcome "recovering"; DIZZINESS POSTURAL (non-serious) with onset 23Oct2025, outcome "recovering", described as "couldn't stand w/o feeling dizzy"; HOT FLUSH (non-serious) with onset 23Oct2025, outcome "recovering", described as "hot flashes"; PYREXIA (non-serious) with onset 23Oct2025, outcome "recovering", described as "low-grade temp"; ASTHENIA (non-serious) with onset 23Oct2025, outcome "recovering", described as "very weak"; HEADACHE (non-serious), outcome "recovering". Therapeutic measures were taken as a result of chills, hot flush, pyrexia, asthenia, dizziness postural, headache.
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| 2872906 | CA | 11/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Vision blurred
Vision blurred
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My vision is now blurry; This is a spontaneous report received from a Consumer or other non HCP, Pro...
My vision is now blurry; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "My vision is now blurry". Additional information: Patient had a reaction to the Covid booster. Patients vision was now blurry. Is blurred vision a side effect noted? PQC Not Applicable. 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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| 2872907 | M | 11/14/2025 |
COVID19 COVID19 FLUX FLUX |
PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Arthralgia, Back pain, Blood glucose, Condition aggravated, Pain; Weight; Arthra...
Arthralgia, Back pain, Blood glucose, Condition aggravated, Pain; Weight; Arthralgia, Back pain, Blood glucose, Condition aggravated, Pain; Weight
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body ache/ body aches (back/knee pain, pre-existing, worsened in the past week); body ache/ body ach...
body ache/ body aches (back/knee pain, pre-existing, worsened in the past week); body ache/ body aches (back/knee pain, pre-existing, worsened in the past week); body ache/ body aches (back/knee pain, pre-existing, worsened in the past week); body ache/ body aches (back/knee pain, pre-existing, worsened in the past week); This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA103739 (Sanofi), AE-021514 (BioNTech). A 68-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 08Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since 08Oct2025 (ongoing) at 300 mg (300 mg, every other week (eow) (300 mg/2 ml)), subcutaneous for chronic obstructive pulmonary disease; influenza vaccine (INFLUENZA VACCINE), on 08Oct2025 as dose number unknown, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LORATADINE taken for rhinorrhoea, start date: Oct2025 (ongoing). Past drug history included: Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "still experiencing red spots", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "dry skin", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "Restless occurred once during the past month", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "patient report difficulty sleeping, occurred once during the past month", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "bleeding sore", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "stinging", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "lesions develop and open", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "Itchy", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "decreased motivation to get up", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "worsened fatigue", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "lightheadedness", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "blood sugar was up", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "1/4 -3/4 inch, looked like eczema", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "skin tore when bandaid removed", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "headache", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "blurry vision/blurred vision", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "feels like he has small mosquito bites but less severe", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "spots on his arms that break open and have rashes", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "runny nose/drainage", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "fluctuations in weight over the last year 10 pounds", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "uncertain about balance", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "dry eyes", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "body ache/ body aches", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "back/knee pain", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "back/knee pain", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously. The following information was reported: BACK PAIN (non-serious), ARTHRALGIA (non-serious), PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Oct2025, outcome "unknown" and all described as "body ache/ body aches (back/knee pain, pre-existing, worsened in the past week)". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for dupilumab was dosage not changed. Additional information: It was reported "he is still experiencing red spots and dry skin, but he just took his second dose today. Advised that the medication may take up to several weeks before he notices an improvement and to contact his doctor in a couple of months if he still sees no improvement. patient reports blood work done week of 28-Apr-2025 resulted 06-May-2025 showed blood sugar was up, md (medical doctor) aware; patient reports since start of therapy skin dryer, itchy, stinging, more red spots, "lesions" develop and open, bleeding sore noted. 06May2025, 1/4-3/4 inch, looked like eczema, applied bandaid, skin tore when bandaid removed, opened Page 10 of 12 another spot, reports since start of therapy: worsened fatigue, light headedness, body aches, decreased motivation to get up, noted 16May2025 to 20May2025, attributes to elevated blood sugar. patient reports difficulty sleeping, restless mentally active, occurred once during the past month, exact date unknown. titration dosing not applicable. Patient report body ache, headache, fatigue, dizziness, and blurry vision. Patient noted that "discussed with doctor to stop another medication concerning those symptoms." but no further information was available. Unknown exact date of adverse event. Patient reports a few days to a week before each dose is due he starts to feel like he has bugs crawling on him and feels like he has small mosquito bites but less severe, symptoms are "all over," patient reports symptoms come and go and he takes lots of baths to manage symptoms, md not aware, patient also states previously reported "spots" on his arms that break open and have rashes are ongoing, unknown if md not aware, patient also states previously reported dry skin is ongoing, reports skin is dryer than normal, unknown if md aware, patient states he now occasionally gets blurry vision and lightheaded with activity, states this is new. Patient states he has recently been monitoring his blood sugar at md instruction, unknown if md aware of new symptoms. No further details provided on dates, timeline, all unknown, last injection given yesterday 30Jul2025. Patient reported after start of therapy has dizziness/lightheadedness/"uncertain about balance," blurred vision, dry eyes, body aches (back/knee pain, pre-existing, worsened in the past week), runny nose/drainage (started loratadine last week Oct2025 - ongoing), fluctuations in weight over the last year (10 pounds). Received covid and flu vaccines on 08Oct2025, same day as Dupixent injection and stated has worsened body aches since then. MD aware". In Oct2025 the patient developed a non-serious event "body aches (back/knee pain, pre-existing, worsened in the past week)" (back pain) (latency: approximately 7 months) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB, COVID-19 VACCINE and Flu vaccine. Batch/lot number is not provided, and it cannot be obtained.
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| 2872908 | CA | 11/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Erythema, Peripheral swelling, Pruritus, Skin hyperpigmentation
Erythema, Peripheral swelling, Pruritus, Skin hyperpigmentation
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after the injection there is still a big mark there where I had the rash.; red/had a very large part...
after the injection there is still a big mark there where I had the rash.; red/had a very large part of my arm swelled, red; itchy below the injection; I had a very large part of my arm swelled; 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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "I had a very large part of my arm swelled"; SKIN HYPERPIGMENTATION (non-serious), outcome "unknown", described as "after the injection there is still a big mark there where I had the rash."; ERYTHEMA (non-serious), outcome "unknown", described as "red/had a very large part of my arm swelled, red"; PRURITUS (non-serious), outcome "unknown", described as "itchy below the injection". Additional Information: I asked for Pfizer vaccine when I had the injection. I have never had a reaction before. This time I had a very large part of my arm swelled, red and itchy below the injection. It was very uncomfortable and lasted about 10 days. After almost 3 weeks after the injection there is still a big mark there where I had the rash. Was this normal. I thought that they gave me Medara by mistake as I have seen where this has this type of reaction but they said no. I also had the flu shot that day too. 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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| 2872909 | 11/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chills, Cough, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Chills, Cough, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
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cold-like symptoms, including chills, coughing, sore throat, and nasal congestion; cold-like symptom...
cold-like symptoms, including chills, coughing, sore throat, and nasal congestion; cold-like symptoms, including chills, coughing, sore throat, and nasal congestion; cold-like symptoms, including chills, coughing, sore throat, and nasal congestion; cold-like symptoms, including chills, coughing, sore throat, and nasal congestion; cold-like symptoms, including chills, coughing, sore throat, and nasal congestion; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . 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: NASOPHARYNGITIS (non-serious), COUGH (non-serious), OROPHARYNGEAL PAIN (non-serious), NASAL CONGESTION (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "cold-like symptoms, including chills, coughing, sore throat, and nasal congestion". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2872910 | F | 11/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Mydriasis, Sleep disorder
Mydriasis, Sleep disorder
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sleeping issues; dilation in her eyes; This is a spontaneous report received from an Other HCP. Othe...
sleeping issues; dilation in her eyes; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 10000433404 (Genentech). A 74-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SLEEP DISORDER (non-serious), outcome "unknown", described as "sleeping issues"; MYDRIASIS (non-serious), outcome "unknown", described as "dilation in her eyes". Additional information: The patient's past medical history, concurrent condition and concomitant medication were not reported. On unknown date, patient started therapy with Pfizer covid vaccine for unknown indication. On unknown date, it was reported that patient a Pfizer Covid shot and had a bad reaction. Patient stated she has sleeping issues and dilation in her eyes. Batch/lot number is not provided, and it cannot be obtained.
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| 2872911 | 59 | F | WI | 11/14/2025 |
COVID19 FLU3 |
UNKNOWN MANUFACTURER SANOFI PASTEUR |
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Extra dose administered, Wrong product administered; Extra dose administered, Wr...
Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered
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Patient received dose of flublok 23-Oct-2025 and after 2.5 weeks other dose on 09-Nov-2025, instead ...
Patient received dose of flublok 23-Oct-2025 and after 2.5 weeks other dose on 09-Nov-2025, instead of Covid-19 vaccine, with no adverse event.; Patient received dose of flublok 23-Oct-2025 and after 2.5 weeks other dose on 09-Nov-2025, instead of Covid-19 vaccine, with no adverse event.; Initial information received on 10-Nov-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 59 years old female patient who received dose of INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK] 23-oct-2025 and after 2.5 weeks other dose on 09-Nov-2025, instead of COVID-19 VACCINE, with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Oct-2025, the patient received influenza trivalent recombinant vaccine, Solution for injection (dose, strength, lot, expiry, route and administration site: unknown) for immunization and on 09-Nov-2025 the patient again received 0.5 ml same vaccine via intramuscular route in left arm instead of covid-19 vaccine (route, dose,formulation, strength, expiry date and lot not reported), with no adverse event (extra dose administered) (wrong product administered) (latency same day). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. 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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| 2872914 | 0.5 | F | CO | 11/14/2025 |
COVID19 FLU3 HEPA MMR PNC20 RV5 VARCEL |
MODERNA SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. |
3053667 U8883AA Z011972 Z005718 MH9572 Z009603 Z008873 |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered
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Patient received Varivax in error when Vaxelis was ordered. This constitutes a vaccine administratio...
Patient received Varivax in error when Vaxelis was ordered. This constitutes a vaccine administration error. The patient was monitored, and no immediate adverse reactions were observed.
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| 2872918 | 69 | M | 11/14/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
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Injection site reaction, Neuralgia, Pain; Injection site reaction, Neuralgia, Pa...
Injection site reaction, Neuralgia, Pain; Injection site reaction, Neuralgia, Pain
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nerve pain at injection site. Painful to raise arm. Symptoms began after vaccination and are still p...
nerve pain at injection site. Painful to raise arm. Symptoms began after vaccination and are still present 2 weeks later
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| 2872920 | 69 | F | NC | 11/14/2025 |
FLU3 |
SANOFI PASTEUR |
U8764AB |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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Patient stated they typically experience redness and swelling after vaccination, but this was signif...
Patient stated they typically experience redness and swelling after vaccination, but this was significantly more than ever experienced. According to the patient, within 3 hours of vaccination the site was red, swollen, and tender. 24 hours after vaccination the area was very red and hot to the touch with redness from the top of the shoulder down to the elbow. Patient reports that the swelling was significantly greater, with a raised area roughly the size of the grapefruit, centered on the injection site. It was tender to the touch but not significantly painful. The redness and swelling have gradually gone down, with the redness being fully resolved for the first time today but swelling is still present. I felt the area of the patient's arm where she said the injection had occurred and noticed that the area was not hot to touch compared to the rest of her arm but there was still swelling present, with a golf ball sized nodule having formed at what could be the injection site.
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| 2872922 | 57 | F | TX | 11/14/2025 |
FLU3 |
SEQIRUS, INC. |
407004 |
Injection site bruising, Injection site haemorrhage, Injection site swelling
Injection site bruising, Injection site haemorrhage, Injection site swelling
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Patient bleed when the vaccination was administered, then the area started swelling, then the area d...
Patient bleed when the vaccination was administered, then the area started swelling, then the area displayed a bruise in the area. Patient reported no pain on vaccination and said the swollen area did not have pain.
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| 2872923 | 12 | F | VT | 11/14/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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12 years aged patient received Comirnaty covid shot for patients 5 to 11 years old.
12 years aged patient received Comirnaty covid shot for patients 5 to 11 years old.
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| 2872924 | 61 | F | NE | 11/14/2025 |
FLU3 |
SEQIRUS, INC. |
406986 |
Injection site pain
Injection site pain
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Patient states she has had pain at injection site on deltoid since vaccine administrated on 9/11/25.
Patient states she has had pain at injection site on deltoid since vaccine administrated on 9/11/25.
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| 2872926 | 26 | F | NY | 11/14/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2LY39 |
Confusional state, Dizziness, Loss of consciousness
Confusional state, Dizziness, Loss of consciousness
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Patient stated they were lightheaded after receiving influenza injection. Patient then passed out. ...
Patient stated they were lightheaded after receiving influenza injection. Patient then passed out. Immunizing technician called for pharmacy to come over. Patient's body shook for approximately 2-3 seconds, before patient woke up. Patient then stood up and appeared to be very startled and confused. Technician assisted patient to sit back down in the chair. Technician and pharmacist stayed with patient to talk about what happened. Patient stated they had passed out in the past have blood drawn. Patient was advised to not receive 2nd planned vaccination (covid-19) in this visit and to follow up with primary care physician. Advised patient to get vaccines in the future at clinics they would have higher levels care of available. After sitting and resting for about 5 minutes, patient felt well enough to walk and leave the store.
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| 2872928 | 30 | F | NC | 11/14/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
p394k |
Erythema, Skin warm, Swelling
Erythema, Skin warm, Swelling
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Pt presented to PCP with raised, warm, reddened area about 3" in diameter and received rx for c...
Pt presented to PCP with raised, warm, reddened area about 3" in diameter and received rx for clindamycin for possible cellulitis. PCP advised pt to inform RPh about reaction. Pt states she has never had rxn to this vaccine in the past. RPh recommended OTC cortisone to help with inflammation and itching.
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| 2872929 | 63 | F | 11/14/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Erythema, Pyrexia, Swelling
Erythema, Pyrexia, Swelling
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Patient had redness, swelling and fever hours after vaccination in her right arm. Patient also rece...
Patient had redness, swelling and fever hours after vaccination in her right arm. Patient also received a Capvaxive in the same arm but it was only the Comirnaty area that reacted. Patient was treated with doxycyline and ondansetron.
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| 2872930 | 62 | M | WA | 11/14/2025 |
FLU3 |
SANOFI PASTEUR |
UT8794CA |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient was given incorrect vaccine for his age. Should have received the Flu Block but received Flu...
Patient was given incorrect vaccine for his age. Should have received the Flu Block but received Fluzone High dose instead.
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| 2872432 | 11/13/2025 |
FLUX |
UNKNOWN MANUFACTURER |
UNK |
Influenza, Vaccination failure
Influenza, Vaccination failure
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Suspected vaccination failure; I got the flu; This serious case was reported by a consumer via inter...
Suspected vaccination failure; I got the flu; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, several weeks after receiving Flu vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and influenza (Verbatim: I got the flu). The outcome of the vaccination failure and influenza were not reported. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine. The company considered the vaccination failure to be unrelated to Flu vaccine. It was unknown if the company considered the influenza to be related to Flu vaccine. Additional Information: GSK Receipt Date: 29-OCT-2025 This case was reported by a patient via interactive digital media. The patient never used to get the flu shot. Then the doctor told him/her into it. Well weeks later the patient got the flu. The patient being a certified nursing assistant (CNA), that got to thinking, the flu is in the shot. Then covid came along. Well, he/she said no, not getting it. The patient never got covid. The patient took care of people that did. Then the patient done some research and found out that where he/she took hydroxychloroquine (hcq) for lupus it protected him/her from getting it. This case was considered as suspected vaccination failure as details regarding time to onset for flu and laboratory confirmation regarding flu were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, several weeks after receiving Flu vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2872435 | 11/13/2025 |
COVID19 |
MODERNA |
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Death
Death
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Three of my neighbors are dead thanks to your vax; This spontaneous case was reported by a non-healt...
Three of my neighbors are dead thanks to your vax; This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (Three of my neighbors are dead thanks to your vax) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. This case was for 3rd patient out of 3 patients. Concomitant medications were not reported. Reporter had not administered the moderna vaccine. It was reported that the individual expresses intense dissatisfaction with the COVID vaccine, attributing the deaths of three neighbors because of the vaccine. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790961 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790961:Patient 3; Reported Cause(s) of Death: Three of my neighbors are dead thanks to your vax
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| 2872457 | F | 11/13/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
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Pain in extremity
Pain in extremity
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had a sore arm; Initial information received on 07-Nov-2025 regarding an unsolicited valid non-serio...
had a sore arm; Initial information received on 07-Nov-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves an unknown age female patient who had a sore arm after receiving NVX-COV2373 (Original) Adjuvanted Vaccine [Nuvaxovid PFS (Pre-filled syringe)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2024, the patient received an unknown dose of suspect NVX-COV2373 (Original) Adjuvanted Vaccine (Once), Injection (unknown strength and expiry date) lot number not reported via intramuscular route in the arm NOS (not otherwise specified) for Prevention of Covid-19 (Covid-19 immunisation). Information regarding batch number corresponding to the one at time of event occurrence is requested. On an unknown date in 2024, the patient had a sore arm (pain in extremity) (latency unknown). It was reported that, "patient received Novavax vaccine last year and felt it was administered a bit high in arm and had a sore arm afterwards" Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.
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| 2872463 | M | TN | 11/13/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Pyrexia
Pyrexia
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Reported Symptoms: 10016558:FEVER; Narrative: Other Relevant HX: Other: FEVER
Reported Symptoms: 10016558:FEVER; Narrative: Other Relevant HX: Other: FEVER
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| 2872464 | 52 | M | AR | 11/13/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Arthralgia, Asthenia, Burning sensation, CSF protein increased, Gait disturbance...
Arthralgia, Asthenia, Burning sensation, CSF protein increased, Gait disturbance; Guillain-Barre syndrome, Immunoglobulin therapy, Immunoglobulins increased, Pain in extremity
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Reported Symptoms: 10040617:SHOULDER PAIN; Narrative: Patient received zoster vaccine recombinant in...
Reported Symptoms: 10040617:SHOULDER PAIN; Narrative: Patient received zoster vaccine recombinant in community living center on 8/28/25. Patient reported symptoms of left hand and right shoulder pain on 9/5/25. Patient continued to experience these symptoms and other symptoms of bilateral burning feet, difficulty walking, and weakness in the following days. Patient was then admitted inpatient where neurology diagnosed the patient with Guillain-Barr? Syndrome on 10/2/25 due to findings of elevated cerebrospinal fluid protein and gamma globulin identified by lumbar puncture. IVIG was administered for five days and patient discharged to community living center in stable condition. Other Relevant HX: Other: Left hand rt shoulder pain
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| 2872516 | 60 | F | 11/13/2025 |
FLU3 |
SANOFI PASTEUR |
U8881CA |
Chest discomfort, Productive cough, Wheezing
Chest discomfort, Productive cough, Wheezing
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wheezing, chest tightness, productive cough
wheezing, chest tightness, productive cough
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| 2872518 | 13 | F | NJ | 11/13/2025 |
FLU3 FLU3 HPV9 HPV9 |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
U8881DA U8881DA Z011090 Z011090 |
Dizziness, Face injury, Lip injury, Loss of consciousness, Rhinalgia; Syncope; D...
Dizziness, Face injury, Lip injury, Loss of consciousness, Rhinalgia; Syncope; Dizziness, Face injury, Lip injury, Loss of consciousness, Rhinalgia; Syncope
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Patient did not wait 15 minutes after receiving the vaccines, patient got up and went to leave the o...
Patient did not wait 15 minutes after receiving the vaccines, patient got up and went to leave the office .Vasovagal syncope- 2/2 vaccines, no breakfast, hot room and heavy sweatshirt Patient received HPV and flu vaccines. Upon leaving office, she became dizzy and passed out for a few seconds. She hit her face on the wall, and suffered lip laceration and nose pain. Lip laceration on upper lip, oral mucosa side. Spontaneous hemostasis <5 min. No nose injuries or epistaxis. Gave patient water and candy. Did not eat breakfast prior to appointment and exam room was hot. Dizziness resolved, able to walk. Repeat vital signs WNL. Discussed standing and walking slowly today, good hydration. Would recommend not horse back riding today.
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| 2872519 | 19 | F | OH | 11/13/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792LA |
Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased,...
Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Muscular weakness, Shoulder injury related to vaccine administration
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Not reaction to medication but suspected shoulder injury related to vaccine administration. Documen...
Not reaction to medication but suspected shoulder injury related to vaccine administration. Documented as Left Deltoid but per patient statement and witnessed by Mother at cart side , the injection was given in right deltoid, very high and anterior with immediate shoulder pain andha experienced progressive pain, reduced motion and weakness since date of injection. Reported to Supervisor on 11/7/2025 as complaints not resolving. It is believed this is likely a shoulder injury related to vaccination administration not a true vaccine allergy
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| 2872522 | 2 | F | MN | 11/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
7FY52 |
Abnormal behaviour, Aggression, Staring, Streptococcus test negative
Abnormal behaviour, Aggression, Staring, Streptococcus test negative
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Aggressive and erratic behavior, staring spells. Tested for strep and negative. Referred to pediatri...
Aggressive and erratic behavior, staring spells. Tested for strep and negative. Referred to pediatric neurology for further evaluation
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| 2872523 | 64 | F | IL | 11/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9c75y |
Anaphylaxis treatment, Breath sounds abnormal, Chest discomfort, Cough, Respirat...
Anaphylaxis treatment, Breath sounds abnormal, Chest discomfort, Cough, Respiratory tract congestion
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Patient came in today for her first shingles vaccine. During her 15min wait time after the vaccine w...
Patient came in today for her first shingles vaccine. During her 15min wait time after the vaccine was given patient stated that was feeling off to the MA. MA notified author RN immediately. We brought patient back to the lab and checker her blood pressure which was 142/82. I asked what she meant by feeling off she explained that she was feeling chest tightness similar to when she has an asthma exacerbation. I was also notified that she had a reaction to receiving the Covid 19 vaccine that started out similarly and she ended up developing minimal hives after a couple of hours. Given her background I instructed the patient to wait an additional 10 minutes to make sure that her symptoms did not worsen. While she was waiting she began coughing and had to use her inhaler. Provider was notified and patient was seen for reaction. Upon assessment by provider patient was positive for congestion and sounded nasally. 50mg of Benadryl IM were given to left arm. vitals were repeated. While patient stated that they were feeling better they were still intermittently coughing. Administered 0.3mg Epipen to left thigh and placed patient on 2L of O2 via NC. EMS called and patient transported to Medical Center in stable condition.
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| 2872524 | 43 | F | 11/13/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0738 |
Injection site erythema, Injection site pain, Injection site swelling, Product a...
Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
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Patient received a Covid shot in her Left arm on 11/07/2025. Patient stated that the area become red...
Patient received a Covid shot in her Left arm on 11/07/2025. Patient stated that the area become red, swollen and painful by the following day and the size continued to grow until it was about the size of a gulf ball. Patient also stated that the injection site was lower in her arm than usual. Patient reported the situation to her nurse who encouraged her to report the situation. As of today, 11/13/25, patient states that the site is completely fine; she reports no pain, swelling or redness. She also reports that her range of motion in 100% in the arm
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| 2872525 | 28 | F | NJ | 11/13/2025 |
COVID19 FLU3 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3053718 CY53G |
Syncope; Syncope
Syncope; Syncope
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Patient received both vaccines then fainted around 6pm 11/12/2025. emergency services were contacted...
Patient received both vaccines then fainted around 6pm 11/12/2025. emergency services were contacted and patient was taken to ER
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| 2872529 | 64 | F | TX | 11/13/2025 |
FLU3 TDAP UNK |
SANOFI PASTEUR SANOFI PASTEUR UNKNOWN MANUFACTURER |
U8864CA U8654AA Z010457 |
Injection site erythema, Injection site induration, Injection site pain, Injecti...
Injection site erythema, Injection site induration, Injection site pain, Injection site warmth; Injection site erythema, Injection site induration, Injection site pain, Injection site warmth; Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
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VACCINE SITES DEVELOPED TENDER SUBCUTANEOUS INDURATION W CIRCULAR SURROUNDING ERYTHEMA AND WARMTH
VACCINE SITES DEVELOPED TENDER SUBCUTANEOUS INDURATION W CIRCULAR SURROUNDING ERYTHEMA AND WARMTH
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