| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
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| 2866438 | 29 | M | CA | 10/16/2025 |
FLU3 |
SANOFI PASTEUR |
U8863AA |
Extra dose administered
Extra dose administered
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Patient received flu vaccine previously in August and received second flu vaccine 10/16/25.
Patient received flu vaccine previously in August and received second flu vaccine 10/16/25.
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| 2866439 | F | WA | 10/16/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Conjunctival haemorrhage; Conjunctival haemorrhage
Conjunctival haemorrhage; Conjunctival haemorrhage
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subconjunctival hemorrhage; This spontaneous case was reported by a consumer and describes the occur...
subconjunctival hemorrhage; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. On 06-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 09-Oct-2025, the patient experienced CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage) outcome was unknown. No concomitant medication was reported. After receiving the Moderna Covid vaccine and the flu vaccine on the afternoon of 06-Oct-2025, the patient suffered a subconjunctival hemorrhage overnight on 09-Oct to 10-Oct-2025. On 10-Oct-2025, the patient awoke with an eye that was half-filled with blood. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.
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| 2866440 | 8 | M | WI | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9548 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Vaccine given, provider in clinic and patients pcp notified. patient cleared to leave
Vaccine given, provider in clinic and patients pcp notified. patient cleared to leave
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| 2866441 | 10 | M | MN | 10/16/2025 |
FLUN3 |
MEDIMMUNE VACCINES, INC. |
YF3413 |
Contraindication to vaccination
Contraindication to vaccination
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pt was taking medication costenyx, the contraindication for the medication is no live vaccines. staf...
pt was taking medication costenyx, the contraindication for the medication is no live vaccines. staff was not alerted that pt was taking this med, contraindication questions were asked and guardian answered no to the patient diagnosis of immunocompromised.
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| 2866442 | 76 | F | NH | 10/16/2025 |
COVID19-2 |
MODERNA |
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COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
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mild case of Covid (headache, fatigue and sore throat) after traveling in (withheld country) back in...
mild case of Covid (headache, fatigue and sore throat) after traveling in (withheld country) back in 09/2023; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (mild case of Covid (headache, fatigue and sore throat) after traveling in (withheld country) back in 09/2023) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1) in February 2021, Moderna COVID-19 vaccine (Dose 2) in March 2021, Moderna COVID-19 vaccine (Dose 3) in September 2021, Spikevax (Dose 4) in April 2022, Moderna COVID-19 Vaccine and Bivalent (Original and Omicron BA.4/BA.5) (Dose 5) in September 2022. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Spikevax. In April 2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In September 2023, the patient experienced COVID-19 (mild case of Covid (headache, fatigue and sore throat) after traveling in (withheld country) back in 09/2023). At the time of the report, COVID-19 (mild case of Covid (headache, fatigue and sore throat) after traveling in (withheld country) back in 09/2023) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2023, SARS-CoV-2 test: Positive. At the time of reporting, the patient was 78 years old and had no underlying medical conditions. No concomitant medication was reported. It was reported that the patient tested positive for COVID-19 in September 2023 after traveling in (withheld country). She had mild symptoms of headache, fatigue, and sore throat. The patient received Moderna immunizations in June 2024, September 2024 and the last being a Spikevax booster on 14-Aug-2025. No treatment information was provided.
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| 2866443 | 83 | 10/16/2025 |
COVID19 |
MODERNA |
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Eczema
Eczema
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severe case of late-onset eczema; This spontaneous case was reported by a consumer and describes the...
severe case of late-onset eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (severe case of late-onset eczema) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced ECZEMA (severe case of late-onset eczema). At the time of the report, ECZEMA (severe case of late-onset eczema) had not resolved. No concomitant and treatment medication were provided. Patient experienced late-onset eczema shortly after first Moderna booster in 2021. The condition persists but was controlled with medication. Although each time patient got booster and had an eczema outbreak for about a month. Hence patient asked guidance on receiving new vaccine given tolerability of eczema versus risk of COVID. This case was linked to US-MODERNATX, INC.-MOD-2025-790142 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790142:Booster dose
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| 2866444 | F | 10/16/2025 |
COVID19 |
MODERNA |
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Chills, Illness, Malaise, Nausea
Chills, Illness, Malaise, Nausea
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she always get sick with Moderna; chills; nauseous; not feeling well for two weeks; This spontaneous...
she always get sick with Moderna; chills; nauseous; not feeling well for two weeks; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well for two weeks), ILLNESS (she always get sick with Moderna), CHILLS (chills) and NAUSEA (nauseous) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Immunocompromised. Concomitant products included COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) and Influenza vaccine (Flu) for an unknown indication. 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 MALAISE (not feeling well for two weeks), ILLNESS (she always get sick with Moderna), CHILLS (chills) and NAUSEA (nauseous). At the time of the report, MALAISE (not feeling well for two weeks) had resolved and ILLNESS (she always get sick with Moderna), CHILLS (chills) and NAUSEA (nauseous) outcome was unknown. It was asked if mNEXSPIKE was the new version of Spikevax as she saw on social media ads from Moderna that it was really pushing on mNEXSPIKE as a better choice for people 65 years and older. Then it was asked about efficacy of mNEXSPIKE per data of the clinical trial, it's side effects and if she should be getting it along with influenza vaccine. Patient was immunocompromised and was over 65 years old, at the later part of the call that she was over 70 years old. She had negative reactions with each of her Moderna COVID-19 vaccines she had received. It was asked about mNEXSPIKE availability in the US. It was stated she was looking at Novavax, which was a totally different company and totally different formula, because she always got sick with Moderna. However, she would always get Moderna because she had read that it was better than Pfizer for older people and immunocompromised people like her. She always got Moderna, even though it made her sick. She was looking, well, one time she got the Novavax, and it was amazing. She didn't get sick. It was like she didn't even have a shot, didn't feel the needle going in, didn't get a sore arm, didn't get sick. It was like nothing happened. But with Moderna there had been times she was like not feeling well for two weeks, like chills and nauseous and but to her that was kind of a good thing because she knew it was in her system. She didn't really want it all to be reported because she really wanted to continue Moderna because she thought it was more effective than Pfizer. But she really, really like getting the Novavax but she can't find any studies or comparisons of Novavax compared to Moderna. She was due for her vaccine and wanted to do it on Monday, so she was trying to make a decision. It was inquired if it was okay to receive the flu shot along with mNEXSPIKE on Monday as she typically didn't get the flu vaccine the same day she gets her Moderna COVID-19 vaccine considering her specific health conditions, if she could handle the two products at the same time but was considering doing such because she had a procedure coming up and had to have any vaccines taken care prior. Also, if it was better to wait since she was immunocompromised and elderly. It was asked that if so, does it affect the efficiency of both vaccines. It was stated, she was just wondering if adding the flu shot at the same time as the Moderna was going to lower the effectiveness of those vaccines. She was on some medications that hinder the effectiveness of the vaccines. After getting all these vaccines over the years that they were probably not helping enough and reading studies about the drugs that she was on. The vaccines didn't fare well up against the medicine she was on either. It was already diminished, but she was wondering if adding a flu shot onto that could her body handle dealing with two vaccines and building two different sets of antibodies at the same time. she had other procedure coming up and had to have any vaccines taken care of, so she had many weeks ahead of time. She had side effects after every Moderna. She had 13 vaccines and boosters so far for COVID. When she had Novavax, the one time she had no, no side effects at all. But then there was one time with Moderna when she had no side effects. She didn't know what that was about. But every other time she did. So that was just odd because she was all prepared for side effects and then it didn't happen. Treatment medication was not reported. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2025: Live Follow up received contains non-significant information received: Reference added.
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| 2866445 | 81 | M | 10/16/2025 |
COVID19 |
MODERNA |
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Pain
Pain
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aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PA...
aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pains) in an 81-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN (aches and pains). At the time of the report, PAIN (aches and pains) outcome was unknown. Concomitant medication was not provided. It was reported that the patient had received the Spikevax vaccine last September (2024), experienced aches, pains and stuff like and stated those side effects were pretty common though what he. The patient got Spikevax every year. He mentioned that each time he received the vaccine, he experienced side effects. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790153 (E2B Linked Report). This case was linked to MOD-2025-790152 (Patient Link). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790153:Invalid case many people
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| 2866446 | 79 | M | CA | 10/16/2025 |
COVID19 |
MODERNA |
3052550 |
Vaccination site pain
Vaccination site pain
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starting to get a little, a little pain (the injection site); This spontaneous case was reported by ...
starting to get a little, a little pain (the injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (starting to get a little, a little pain (the injection site)) in a 79-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052550) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu vaccine (received in arm) on 07-Oct-2025. Past adverse reactions to the above products included Pain with Flu vaccine. On 10-Oct-2025, the patient received eleventh dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 10-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced VACCINATION SITE PAIN (starting to get a little, a little pain (the injection site)). At the time of the report, VACCINATION SITE PAIN (starting to get a little, a little pain (the injection site)) outcome was unknown. Concomitant medication use information was not provided by reporter. The patient received a pneumonia vaccine on 07-Oct-2025, one in each arm. On 10-Oct-2025, around noon, the patient received the Spikevax vaccine. The patient received millions of shots and had a reaction to Moderna before. After each vaccine, the body changed each time. It was reported that for millions of people, if the arm hurts, it means the vaccine had worked. The patient had pain from past vaccines, but right now, it was early, it did not feel like the arm hurts yet. It had only been about an hour or so. The patient had 10 shots of Moderna and felt pain at the injection site every time. Before (referencing previous shots), it hurt, and they said that it was because of the immune response at the shot site. This time, it was not quite hurting yet. Based on research, sometimes it hurts, sometimes it did not, depending on the shot and the person. The patient had his 11th shot on 10-Oct-2025, and it was kind of starting to get a little pain at the injection site. It was reported that in terms of human death, in the history of the world, over the last 6000-7000 years, the largest number of people were killed by COVID-19. Treatment medication use information was not provided by reporter. This case was linked to MOD-2025-790156 (Patient Link).
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| 2866447 | 74 | F | 10/16/2025 |
COVID19 |
MODERNA |
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Extensive swelling of vaccinated limb, Vaccination site erythema, Vaccination si...
Extensive swelling of vaccinated limb, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
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Arm was hot; The arm, it started from the site where got the shot and went all across the top of the...
Arm was hot; The arm, it started from the site where got the shot and went all across the top of the, you know, the side of arm all the way around over bicep muscle; Arm was itchy; Arm was really red; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was hot), EXTENSIVE SWELLING OF VACCINATED LIMB (The arm, it started from the site where got the shot and went all across the top of the, you know, the side of arm all the way around over bicep muscle), VACCINATION SITE PRURITUS (Arm was itchy), VACCINATION SITE ERYTHEMA (Arm was really red) and VACCINATION SITE SWELLING (Arm was swollen) in a 74-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included No adverse effect with Spikevax NOS. On 06-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 07-Oct-2025, the patient experienced VACCINATION SITE WARMTH (Arm was hot), EXTENSIVE SWELLING OF VACCINATED LIMB (The arm, it started from the site where got the shot and went all across the top of the, you know, the side of arm all the way around over bicep muscle), VACCINATION SITE PRURITUS (Arm was itchy), VACCINATION SITE ERYTHEMA (Arm was really red) and VACCINATION SITE SWELLING (Arm was swollen). The patient was treated with Naproxen sodium (Aleve) in October 2025 at a dose of UNK UNK, bid and Ibuprofen in October 2025 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm was hot), EXTENSIVE SWELLING OF VACCINATED LIMB (The arm, it started from the site where got the shot and went all across the top of the, you know, the side of arm all the way around over bicep muscle), VACCINATION SITE PRURITUS (Arm was itchy), VACCINATION SITE ERYTHEMA (Arm was really red) and VACCINATION SITE SWELLING (Arm was swollen) had not resolved. Concomitant medication use information was not provided by reporter. Patient received Aleve this week (presumably starting on 06-Oct-2025). The patient received the COVID vaccine on Monday, 06-Oct-2025, and had a reaction that the patient had never experienced before. The patient always received Moderna in the past and had never had any issues. Unfortunately, it was not known whether the patient received Spikevax or mNEXSPIKE (did not keep the paperwork because the patient never had any issues in the past). The patient started experiencing a reaction by Tuesday; the arm was really red, swollen, hot, and itchy. The reaction started from the site where the shot was administered and spread all across the top of the arm, all the way around over the bicep muscle. It improved somewhat but still had not resolved. The patient had been taking Aleve twice a day and still feels kind of itchy, though not as bad as it was 2 days ago. The patient went back to the pharmacy, and they advised taking ibuprofen, so she had been taking Aleve all week. The patient was not sure if she should go to ready care (urgent care). The patient did not have a regular PCP but agreed to seek advice from the pharmacist on duty at the pharmacy, as she was going to go to the store later at the time of reporting. They advised her to try to find out which vaccine was received (mNEXSPIKE or Spikevax) and call back with that information. The patient did not have a headache and was not sick to her stomach. It was unknown if the patient experienced any additional symptoms/events.
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| 2866448 | 82 | F | 10/16/2025 |
COVID19 |
MODERNA |
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Chills, Hypersomnia
Chills, Hypersomnia
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slept most of the day; chill; This spontaneous case was reported by a consumer and describes the occ...
slept most of the day; chill; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept most of the day) and CHILLS (chill) in an 82-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Concomitant products included Influenza vaccine from 28-Sep-2025 to 28-Sep-2025 for an unknown indication. On 06-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 07-Oct-2025, the patient experienced HYPERSOMNIA (slept most of the day) and CHILLS (chill). On 08-Oct-2025, HYPERSOMNIA (slept most of the day) and CHILLS (chill) had resolved. The patient received the flu vaccine 8 days before the covid 19 vaccination and indicated no significant medical history. On 06-Oct-2025, the patient received the Moderna COVID-19 vaccination. On 07-Oct-2025, she experienced violent chills for the entire day and slept most of the day. This was the first time it had happened. The symptoms were gone the next day, on 08-Oct-2025. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.
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| 2866449 | 77 | F | GA | 10/16/2025 |
COVID19 |
MODERNA |
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Nausea
Nausea
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she only got nauseated/she felt nausea; This spontaneous case was reported by a consumer and describ...
she only got nauseated/she felt nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (she only got nauseated/she felt nausea) in a 77-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Concurrent medical conditions included Arthritis. Concomitant products included Apixaban (Eliquis) for Anticoagulant therapy, Paracetamol (Tylenol) for Arthritis. On 11-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In October 2025, the patient experienced NAUSEA (she only got nauseated/she felt nausea). At the time of the report, NAUSEA (she only got nauseated/she felt nausea) outcome was unknown. The patient was interested in knowing if mNEXSPIKE was available everywhere because she saw the add on TV and last Saturday, she went to have a Covid 19 vaccine thinking she would have a choice, but then they gave her a general one, not mNEXSPIKE. The patient was 77 and that when the vaccines became available at the pharmacies like that it would be an automatic choice for elderly people. She got upset when she found out she was just going to receive a general Covid shot because she was expecting a special shot for over 65, specifically mNEXSPIKE. As per the ad on TV she was led to believe that all the places in the (withheld country) would have it. However, it was not the case. The patient expressed concern regarding other elderly people like herself that might be seeking to get this new shot, they needed to know that they have to ask the pharmacy first if they have it. The patient was worried because she did not even know if it was an up-to-date shot that they gave her. She was happy not to have any side effects from this last shot, but she was unable to say which vaccine they gave her. She did not have any written documentation regarding it. She thought they might have said Pfizer, but she was not sure. The patient explained that in the past when she had the COVID shots, she had always gotten real sick afterwards, and she did after this one too but not quite as bad as the last three that she had. In the past, she had not been prepared, and it always threw her off guard, because she was waking up with the nausea, achy for a whole day and nauseated and dizzy. But, once, she did not remember which time it was, but she got it at pharmacy, and she got the sickest the nausea bad to throwing up and a super bad headache. And then she was achy for a couple of days. That one was the worst. But this time, she only got nauseated and she did not get the headache. Only when she got up in the night, she felt nausea. She did not have any problems until then. The patient referred having had a nausea pill and having laid down for a time and then she took two Tylenols of the extra straight for arthritis. The patient reported that she could not take Advil or Aleve because she was on Eliquis which was a blood thinner. This case was linked to MOD-2025-790219 (Patient Link). Reporter did not allow further contact
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| 2866450 | 10/16/2025 |
COVID19 |
MODERNA |
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Arthralgia, Chills, Pyrexia
Arthralgia, Chills, Pyrexia
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fever; chills; joint aches; This spontaneous case was reported by a consumer and describes the occur...
fever; chills; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint aches) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. 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 PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint aches). At the time of the report, PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint aches) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as unknown. No concomitant medication was reported. Patient had a reaction to the earlier version (fever, chills, joint aches). It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.
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| 2866451 | F | TN | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
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C-reactive protein, Investigation, Polymyalgia rheumatica, Vomiting
C-reactive protein, Investigation, Polymyalgia rheumatica, Vomiting
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Polymyalgia Rheumatic with extremely high inflammation markers; Patient had episode where she could ...
Polymyalgia Rheumatic with extremely high inflammation markers; Patient had episode where she could not move and was vomiting; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jul2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Allergy: steroids, notes: Stated she was allergic to one of the steroids provided so they gave her a new one. The following information was reported: VOMITING (hospitalization) with onset Jul2025, outcome "recovering", described as "Patient had episode where she could not move and was vomiting"; POLYMYALGIA RHEUMATICA (hospitalization, medically significant) with onset Jul2025, outcome "recovering", described as "Polymyalgia Rheumatic with extremely high inflammation markers". The patient was hospitalized for polymyalgia rheumatica, vomiting (start date: 2025, discharge date: 2025, hospitalization duration: 1 day(s)). The event "polymyalgia rheumatic with extremely high inflammation markers" required emergency room visit. The patient underwent the following laboratory tests and procedures: C-reactive protein: extreme inflammation; Sedimentation test: extreme inflammation. Therapeutic measures were taken as a result of polymyalgia rheumatica, vomiting. Clinical course: Patient was unable to move body and was in extreme pain . Dr prescribed two separate Medrol does packs and it came back. Went to ER and rant multiple test. C reactive and Sedimentation test showed extreme inflammation. Patient had episode where she could not move and was vomiting. Hospitalized for 24 to 36 hours thinking it was a stroke but vaccine considered the cause.. Did steroid IV followed by 40 MG steroid orally. Problem continues. Diagnosed with Polymyalgia Rheumatic with extremely high inflammation markers. Vomiting and inability to move continue when not on steroids. Advised to never have vaccine again and not to have a flu shot this year. Stated she was allergic to one of the steroids provided so they gave her a new one. 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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| 2866452 | F | NY | 10/16/2025 |
PNC20 |
PFIZER\WYETH |
LN4928 |
Injection site cellulitis, Injection site erythema, Pruritus, Rash, Tenderness
Injection site cellulitis, Injection site erythema, Pruritus, Rash, Tenderness
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Erythema to the injection site; had like a little bit tenderness; Itching; Cellulitis at the injecti...
Erythema to the injection site; had like a little bit tenderness; Itching; Cellulitis at the injection site; Rash; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old female patient received pneumococcal 20-valent conjugate vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4928, Expiration Date: Jun2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Erythema to the injection site"; TENDERNESS (non-serious), outcome "unknown", described as "had like a little bit tenderness"; PRURITUS (non-serious), outcome "unknown", described as "Itching"; VACCINATION SITE CELLULITIS (non-serious), outcome "unknown", described as "Cellulitis at the injection site"; RASH (non-serious), outcome "unknown". Additional information: The reporter stated they had one of the lot numbers of Prevnar 20 and they had reactions for 3 of the 4 patients that they gave the injections to. 3 patients give the same lot number had a reaction. The patient had erythema to the injection site and they also had like a little bit tenderness, itching, cellulitis at the injection site and rash. It happened like couple of days after the vaccine so, within 3 to 4 days, the patient had a reaction. NDC number of Prevnar 20: 0005-2000-10. Causality for "erythema to the injection site", "had like a little bit tenderness", "itching", "cellulitis at the injection site" and "rash" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500202794 same reporter/drug/event, different patient;US-PFIZER INC-202500202597 same reporter/drug/event, different patient;
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| 2866453 | 68 | M | NC | 10/16/2025 |
COVID19 COVID19 COVID19 COVID19 FLUX FLUX FLUX FLUX |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Bacterial infection, Blindness, Choking sensation, Confusional state, Deafness; ...
Bacterial infection, Blindness, Choking sensation, Confusional state, Deafness; Dyspnoea, Eye disorder, Fear, Full blood count, Fungal foot infection; Gait disturbance, Headache, Mental impairment, Oedema peripheral, Pain in extremity; Peripheral swelling, Renal disorder, Thrombosis, Yellow skin; Bacterial infection, Blindness, Choking sensation, Confusional state, Deafness; Dyspnoea, Eye disorder, Fear, Full blood count, Fungal foot infection; Gait disturbance, Headache, Mental impairment, Oedema peripheral, Pain in extremity; Peripheral swelling, Renal disorder, Thrombosis, Yellow skin
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Not hearing/Hearing loss; can't breathe; he feels like in a tunnel and edema in left and right ...
Not hearing/Hearing loss; can't breathe; he feels like in a tunnel and edema in left and right legs; Feels like I am choking; left foot he has fungus; he also has what looks like some kind of bacteria that was growing on the bottom of his left foot/I have infection, bacteria on my feet; Swollen left, right, lower legs, yellowish color; Swollen left, right, lower legs, yellowish color; eyes are closing; problems with his kidneys; he is fearful; very painful feet; mental confusion; cannot walk; Headache, splitting headache very painful; he was diagnosed with blood clot; vision loss; mental fog; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 68-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Oct2025 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 12Oct2025 as dose number unknown, single for immunisation. The patient's relevant medical history included: "Asthma diagnosed years ago" (unspecified if ongoing); "COPD diagnosed years ago" (unspecified if ongoing); "Anxiety diagnosed years ago" (unspecified if ongoing); "PTSD diagnosed years ago" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunization; Moderna (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: CHOKING SENSATION (hospitalization) with onset Oct2025, outcome "unknown", described as "Feels like I am choking"; HEADACHE (non-serious) with onset Oct2025, outcome "unknown", described as "Headache, splitting headache very painful"; DEAFNESS (hospitalization, medically significant) with onset Oct2025, outcome "unknown", described as "Not hearing/Hearing loss"; YELLOW SKIN (hospitalization), PERIPHERAL SWELLING (hospitalization) all with onset Oct2025, outcome "unknown" and all described as "Swollen left, right, lower legs, yellowish color"; DYSPNOEA (hospitalization) with onset Oct2025, outcome "unknown", described as "can't breathe"; GAIT DISTURBANCE (non-serious) with onset Oct2025, outcome "unknown", described as "cannot walk"; EYE DISORDER (hospitalization) with onset Oct2025, outcome "unknown", described as "eyes are closing"; BACTERIAL INFECTION (hospitalization) with onset Oct2025, outcome "unknown", described as "he also has what looks like some kind of bacteria that was growing on the bottom of his left foot/I have infection, bacteria on my feet"; OEDEMA PERIPHERAL (hospitalization) with onset Oct2025, outcome "unknown", described as "he feels like in a tunnel and edema in left and right legs"; FEAR (hospitalization) with onset Oct2025, outcome "unknown", described as "he is fearful"; THROMBOSIS (medically significant) with onset Oct2025, outcome "unknown", described as "he was diagnosed with blood clot"; FUNGAL FOOT INFECTION (hospitalization) with onset Oct2025, outcome "unknown", described as "left foot he has fungus"; CONFUSIONAL STATE (non-serious) with onset Oct2025, outcome "unknown", described as "mental confusion"; MENTAL IMPAIRMENT (medically significant) with onset Oct2025, outcome "unknown", described as "mental fog"; RENAL DISORDER (hospitalization) with onset Oct2025, outcome "unknown", described as "problems with his kidneys"; PAIN IN EXTREMITY (hospitalization) with onset Oct2025, outcome "unknown", described as "very painful feet"; BLINDNESS (medically significant) with onset Oct2025, outcome "unknown", described as "vision loss". The patient was hospitalized for deafness, dyspnoea, oedema peripheral, choking sensation, fungal foot infection, bacterial infection, yellow skin, peripheral swelling, eye disorder, renal disorder, fear, pain in extremity (start date: Oct2025). The patient underwent the following laboratory tests and procedures: Full blood count: (Oct2025) Unknown results. Therapeutic measures were taken as a result of bacterial infection, yellow skin, peripheral swelling, thrombosis. Clinical course: The patient wanted to know, currently he was in the hospital and needed information for his medical team about not hearing he feels like in a tunnel and edema in left and right legs. Consumer stated, "I am having an adverse reaction. I am hospitalized in (withheld), (withheld). I was given the Pfizer Covid vaccine (COVID-19 Vaccine) a few days ago. I think about two weeks ago. I am not sure and it was reported to CDC. When paraphrased the concern, consumer stated, I am not sure what day because, It affected me in a whole bunch way. When requested for further probing, consumer stated, you can have an hour if you need it. I said you can have hour, it was 10 minutes right, I will give you an hour. My symptoms were that bad. Now I did not understand you. When probed for symptoms, consumer stated, I have edema. I have hearing loss. I have vision loss. I have mental confusion, mental fog. I have edema. I have infection, it was like, have bacteria on my feet. Swollen left, right, lower legs, yellowish color. Headache, splitting headache very painful. It feels like I am choking. I have something maybe wrong with my heart. I cannot walk, and my skin is like, it's falling off the bottom of my left foot and it looks like white mucus growth. The right was swollen and somewhat infected but I am being treated in the hospital with antibiotics and I am wondering if there was any other addition things that my doctor needs to be given and told by Pfizer, because you all deal with adverse reaction and I was given the Pfizer vaccine in (withheld) as a test subject for Pfizer and I was given it originally and I was in a block, a prison unit with people that were actively infected, people that were transported into the infected area and then they were eventually created in an isolation unit. So, all those things were experimented with while I was in prison. Now the prison next door, (withheld), (withheld) in (withheld) was also another test subject area and my was in (withheld). A (withheld) that was a (withheld) Antibodies of the people that had been infected were given to some people (As the number of patients was unknown hence, split was not made) because there were no other things and then the test subjects either expired or got better. When probed to clarify that the consumer received the COVID-19 shot in prison, consumer stated, yes, the only Covid they gave us, but while I was there. I was trained in science, I examined the information and the test result form (withheld) and the Moderna was better and safe vaccine (Unspecified Vaccine). Now bring me two weeks ago whenever I cannot remember, I went to (withheld) on landmark street in (withheld), (withheld) and I took the flu shot (Suspect captured as Unspecified Flu Shot) and the COVID (Pfizer COVID-19 Vaccine) because I felt good but I had few days and if I felt bad, I would recover and I had taken Moderna twice (Further not clarified when consume received the Moderna vaccine) before that. I was not paying attention. I was not warned. Maybe you should not take anything other than Moderna but only thing that was an offered was Pfizer so I took it and since then, I have all kinds of terrible symptoms and I am in the hospital now because I am afraid of blood clots and seizures and death. When probed for date of hospitalization, consumer stated, the first time was that (withheld), (withheld). I was treated and then let go home with the discharge plan. I am not sure the date but that was when the first signs were, I do not feel good. This was more than I should have expected. Then the next time. When again probed for date of hospitalization, consumer stated, today. When probed to clarify if it was 13Oct2025, consumer stated, 12Oct was that today was, We are Monday. I came here at 5:30 or 6 o'clock this morning because I could not walk and it like my feet. I am at (withheld) in (withheld), (withheld). Yes, I am in the hospital being treated. I am still suffering from the same complication also had a CBC report and I want my doctor to be given any available and all available information that can make me fully restored. They were going to keep me here at least a today, maybe two for observation and they gave me anticoagulant (Unspecified Medication). Consumer stated, I was hung up on, first of all by an (withheld) person by the name of (withheld). They hung up on purpose, and I was supposed to be talking to medical records information of Pfizer in (withheld). This was the fourth time I have been hung up on by Pfizer. Consumer stated, I have a adverse reaction and I would like to speak with an authority at Pfizer in (withheld), last time you did this when I called, your department hung up on me in (withheld), your department hung up on me twice. When clarified that want to talk to someone in Pfizer drug safety: Consumer stated, yes, and I do not want to be hung up on again. That was the origin of the first batch that he was given. After that, he was very much concerned with the shelf life and he had switched to Moderna, and he had two subsequent inoculations of the COVID through Moderna through (withheld). Subsequently, he went to the (withheld) because he has access to the extra benefits at (withheld). He was at the pharmacy 24-hour place and the pharmacist just said that he got the vaccine and go ahead and gave him the vaccine. The pharmacist did not give him any warning that he was doing a different vaccine or did not advise that the formulator process had changed from 21 until now. He was not advised that there was a new formula thing. He does not know how many mutations or genetic modifications have been made from 21 until now. So, he took the virus. COVID virus inoculation. He said that was not in dispute and it was by Pfizer but that's not an issue. The reality was that after he took it, he had subsequently had loss of hearing, back hearing then loss of hearing, then back hearing. Right now, he was in a state where he can hardly hear. He also said that he can breathe then he cannot breathe (he was having problems with breathing that seems to be happening today). He was choking and he cannot breathe. The other thing was his legs below the knee are yellow or tin and yellow, and his feet were like clubs swollen with edema and on his left foot he has fungus that either was created because of formulary or bacterial infusion into that match because it looks like mucus or mushroom on a log in the forest and on his left toe on the bottom of his feet and right toe, and his other foot was swollen. Both with edema and very painful and the right foot has not gotten the bacterial thing but right now it was like the bottom of his foot has rotted and those two areas that he does not know if the skin has reattached itself. Caller was also having problems with his kidneys and he also said that it feels like the center of his head, the pineal gland or whatever going on in there, he had a massive headache so bad that his eyes were closing, it was closing as he talks about it, it feels like someone driving a stake between his eyeballs and he does not know but it was affecting his lymphatic system and hypothalamus or whatever was in his brain. Caller said that he was currently in the hospital (withheld), (withheld) and he was suffering from adverse effects of the Pfizer vaccine. Caller said that the reason he was calling was that he wanted his doctors to be given every detailed solution possibility for anything that may occur to him because of the swelling and pain in his brain, he is concerned about what might have mutated and may cause him a stroke or that from a blood clot or some other complication. So he would like every bit of medical advice and professional opinions to be given to his doctors or the whole team. He only took it because he was imprisoned and the prison that he was in gave that only, but the prison next door gave Moderna. He got Pfizer by chance, that when they were there they were also a major infection rate because the ones that were infected and given virus vaccines were kept in the same unit with people that were newly infected new arrivals and they were measuring the transfer of infection. He wrote a letter to the health and human services guy at the prison and they immediately created isolation, within the house so they know that he knows what they did, and he wrote in writing, so there was a historical record. Caller said that Pfizer has a responsibility for him to at least attempt to save his life if something goes belly up. Caller wants Pfizer to try to figure out what happened with him so they can pinpoint what happened, caller said that Pfizer used him as a guinea pig before and they were gonna have to agree to terms on the new guinea pig so that was gonna have to be done with legal. Caller said something reasonable has happened to him and he should have been offered a continuation of Moderna or refused to give him a Pfizer but because he believes there was a contract, (withheld) only used Pfizer at that specific place and they did not offer him an alternative. Legally (withheld) and Pfizer have entered into a business commerce agreement and it was protected under the commerce act of the (withheld). Caller said that because we were recording, he just knows he had legal rights. He has legal standing, and he also had medical rights. Caller said that he was fearful that he may have something affect his brain or put him in a coma or permanently disable him. Caller requested a direct line and a reference number that can be called up that he can provide to his doctor. Caller said that he's been hung up on 4 times and he does not find that very exciting. Caller was having problems with breathing that seems to be happening today and he had to have his asthma medication and the trilogy which he gets for COPD, he said that his prior conditions were being exacerbated, his present situation. He was in the hospital and had two nurses administering healthcare to him. He was calling about the Pfizer covid vaccine. He was having an adverse reaction and he would like his medical team to be given possible solutions, all available solutions since Pfizer weaseled their way out of liability. He wanted to record this and stated he will call congress since Pfizer should never had a waiver of responsibility. Stated he was homeless but he does have an address to provide. He was not sure when he got the Pfizer covid vaccine. He got it at (withheld) on Landmark Street in (withheld), (withheld), its a 24 hour (withheld). The pharmacist's name there was (withheld) and the pharmacist reported this to the (withheld). Believed the Pfizer covid vaccine was administered in left arm. He had almost within an hour of receiving the vaccine experienced a reaction. States he also got a flu vaccine the same day as the Pfizer covid vaccine. He does not know the name of the flu vaccine and does not have lot number for the flu vaccine. He does not have lot, ndc, or expiration date to provide for the Pfizer covid vaccine. Describes the reaction that he has had cascading reactions such as loss of hearing and then return of hearing, loss of vision and then return of vision, now he cannot hear but it feels like he is in a tunnel and this has been now several days later. He was in the hospital because the edema in his left and right legs and feet and he also has what looks like some kind of bacteria that was growing on the bottom of his left foot, it was on the little toe and on the big toe. He went to the hospital immediately after he left Fitness Center, thinks this was about two days ago he was not sure. Confirms he was currently admitted into the hospital. When querying treatment, states he has gotten a (withheld) of his heart, pictures of his lungs and both legs. He was given a blood thinner due to fear of clots, fear of having blood clot move into lungs, brain, etc. Clarified he does not have a blood clot and was put on a blood thinner as precaution since his theory was due to the swelling in his legs and has had an increase with mucus in the lungs like he was drowning. Confirms he was diagnosed with blood clot. When querying other medications, states to get that from his doctor. 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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| 2866454 | 70 | F | MD | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
GJ3277 |
Headache, Tinnitus
Headache, Tinnitus
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had a slight headache every time; tinnitus/it gets worse every time I get a covid vaccine; This is a...
had a slight headache every time; tinnitus/it gets worse every time I get a covid vaccine; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 3 (booster), 0.3 ml, single (Lot number: GJ3277) at the age of 70 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 06Apr2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "Headache", "Tinnitus"; BNT162b2 (DOSE 2, 0.3 mL, SINGLE, Lot number: FG3527, Intramuscular i n the right arm), administration date: 08Nov2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "Headache", "tinnitus/gets worse every time I get a covid vaccine". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "had a slight headache every time"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus/it gets worse every time I get a covid vaccine". Additional information: The patient experienced headache which has been her reaction to previous COVID-19 vaccines. She has a slight headache every time. Also, she experienced tinnitus and it got worse every time she gets a COVID vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500192477 same patient/suspect vaccine; different dose; similar events;
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| 2866455 | 16 | M | AR | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
FA7484 |
Alopecia
Alopecia
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losing hair; This is a spontaneous report received from a Consumer or other non HCP from medical inf...
losing hair; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 21-year-old male patient received BNT162b2 (BNT162B2), on 26Jun2021 as dose 1, single (Lot number: FA7484) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "losing hair". Additional information: Reporter informed that her 21 year old grandson took the Pfizer Covid-19 vaccine and he was losing his hair.
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| 2866456 | 28 | F | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
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Allergy to animal, Food allergy, Hypersensitivity
Allergy to animal, Food allergy, Hypersensitivity
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allergic to pistachios; I have recently developed multiple hypersensitivity reactions; Cat allergy; ...
allergic to pistachios; I have recently developed multiple hypersensitivity reactions; Cat allergy; This is a spontaneous report received from a Consumer or other non HCP. A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 28 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE1, SINGLE), for covid-19 immunisation. The following information was reported: ALLERGY TO ANIMAL (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Cat allergy"; HYPERSENSITIVITY (non-serious) with onset 01Nov2021, outcome "recovered with sequelae", described as "I have recently developed multiple hypersensitivity reactions"; FOOD ALLERGY (non-serious) with onset 2024, outcome "recovered with sequelae", described as "allergic to pistachios". Therapeutic measures were taken as a result of hypersensitivity, allergy to animal, food allergy. Clinical course: Patient did not received any other vaccines within 4 weeks PRIOR to the vaccine for which you are reporting. Patient was not taking any other medications within 2 weeks of the event starting. Patient had recently developed multiple hypersensitivity reactions. Recently allergic to pistachios, and recent allergy symptoms to cats. Cat allergy started in 2021 and pistachio allergy developed in 2024. Treatment received for the adverse event Cetirizine . No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2866457 | M | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
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Device malfunction
Device malfunction
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patient's heart defibrillator shocked him; This is a spontaneous report received from a Consume...
patient's heart defibrillator shocked him; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier(s): 2025SA279798 (Sanofi). A 74-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; sarilumab (KEVZARA), since Jul2025 at 150 mg (150 mg, every other week (qow) strength: 150mg/1.14ml), subcutaneous for polymyalgia rheumatica. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious) with onset 2025, outcome "unknown", described as "patient's heart defibrillator shocked him". The action taken for sarilumab was unknown. Additional information: In Jul2025, the patient started taking KEVZARA (SARILUMAB) Solution for injection (strength: 150mg/1.14ml) at dose 150 mg QOW subcutaneous for Polymyalgia rheumatica. On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur lot number not reported. On an unknown date in 2025 the patient developed a non-serious event "patient heart defibrillator shocked him" (unknown latency) following the first dose intake (unknown batch number and expiry date) of SARILUMAB. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "patient daughter reported that the patient heart defibrillator shocked him today at 5:30 am. The patient daughter stated that she will let his and know about that. They advised they had Kevzara on hold due to some adverse effects, but now believe it was due to reaction to covid booster. No additional information was provided." It was not reported if the patient received corrective treatment for the event (Patient's heart defibrillator shocked him). At time of reporting, the outcome was Unknown for the event patient's heart defibrillator shocked him. Additional information was received on 19-Sep-2025 from patient: New suspect COVID-19 VACCINE added. Text amended. Company causality for drug KEVZARA and event reported as not related. 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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| 2866458 | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
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Allergy to vaccine, COVID-19, Drug ineffective, SARS-CoV-2 test
Allergy to vaccine, COVID-19, Drug ineffective, SARS-CoV-2 test
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i have covid; i have covid; allergic to the vaccine; This is a spontaneous report received from a Co...
i have covid; i have covid; allergic to the vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mast Cell Activation Syndrome (MCAS)" (unspecified if ongoing); "Interstitial Cystitis (IC)" (unspecified if ongoing); "chronic stomach ulcer" (unspecified if ongoing); "immune comprimsed" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "i have covid"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic to the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: i have covid, notes: I took home test i have covid. Clinical course: The patient took a home test and had COVID. The patient was allergic to the vaccine. It was advised by Pfizer and Moderna not to get a 3rd shot. Patient had Mast Cell Activation Syndrome (MCAS)/ Interstitial Cystitis (IC) and a chronic stomach ulcer. The patient was immune compromised. The patient was asking that whether COVID medication right or not. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2866459 | 71 | F | 10/16/2025 |
COVID19 FLUX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
MY9550 U8764DB |
COVID-19; COVID-19
COVID-19; COVID-19
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Had a vaccine about 3 weeks ago and I ended up within that short amount of time getting COVID; Initi...
Had a vaccine about 3 weeks ago and I ended up within that short amount of time getting COVID; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 71-year-old female patient (147 cm and 58.51 kg) who had a vaccine about 3 weeks ago and i ended up within that short amount of time getting covid after receiving Nirmatrelvir, Ritonavir (Paxlovid), Covid-19 Vaccine And Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Levothyroxine Sodium (Synthroid); And Hydrochlorothiazide (Hydrochlorothiazide) for Hypertension. On an unknown date, the patient received an unknown dose of suspect COVID-19 vaccine produced by unknown manufacturer (lot MY9550) via intramuscular route in the left deltoid and received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot U8764DB) via unknown route in the right deltoid and received an unknown dose of suspect Paxlovid not produced by Sanofi Pasteur (lot number-unknown) via unknown route in unknown administration site all with (strength, formulation and expiry date-unknown) for Prophylactic vaccination (Immunisation). On an unknown date the patient had a vaccine about 3 weeks ago and i ended up within that short amount of time getting covid (covid-19) (unknown latency). 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 Unknown for the event.
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| 2866460 | WA | 10/16/2025 |
FLU3 |
SANOFI PASTEUR |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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prepared two fluzone hd doses instead of the regular fluzone with no reported adverse event; Initial...
prepared two fluzone hd doses instead of the regular fluzone with no reported adverse event; Initial information received on 09-Oct-2025 regarding an unsolicited non-valid non-serious case received from a other health professional. This case involves 2 patients for whom as reporter prepared two INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] doses instead of the regular fluzone with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, 2 patients received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and reporter prepared two fluzone HD instead of the regular fluzone with no reported adverse event (product preparation error) (same day latency). It was reported "Caller stated that two patient's had called in wanting to get their flu vaccine and gave him their date of birth, but he did the math wrong in his head.Caller stated that he prepared two FLUZONE HD doses instead of the regular FLUZONE" Action taken- not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2866463 | MA | 10/16/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
No batch number No batch number |
Asthenia, Dizziness, Headache, Injection site pain, Malaise; Pain in extremity
Asthenia, Dizziness, Headache, Injection site pain, Malaise; Pain in extremity
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Soreness of arm; Headache; Weakness; Felt very sick; Pain at the injection site; Dizziness; This spo...
Soreness of arm; Headache; Weakness; Felt very sick; Pain at the injection site; Dizziness; This spontaneous case from United States, initially received on 30-Sep-2025, was reported by a health professional and concerns a patient of unknown age and gender. Administration of company suspect drug: On 30-SEP-2025 10:00, the patient received Flucelvax (TIV) for Indication not reported, dose: not reported, route of administration: not reported, anatomical location: not reported. Lot number: No batch number available and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Soreness of arm (outcome: Not Reported), Headache (outcome: Not Reported), Weakness (outcome: Not Reported), Felt very sick (outcome: Not Reported), Pain at the injection site (outcome: Not Reported), Dizziness (outcome: Not Reported). Patient received a Flucelvax vaccine at the office at 10 AM on Tuesday, 30-Sep-2025. Patient typically experienced side effects after getting vaccinated, and this time was not an exception. Medical Product: Flucelvax (patient did not know the batch number) Adverse Event: soreness of arm, headache, weakness (on the day patient received it, felt very sick and slept right after work), pain at the injection site, dizziness. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter id not provided seriousness and causality for Soreness of arm, Headache, Weakness, Felt very sick, Pain at the injection site, Dizziness.; Reporter's Comments: Due to the spontaneous nature of the case, events are considered related for reporting purposes.
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| 2866467 | CA | 10/16/2025 |
HEPA |
MERCK & CO. INC. |
Z010429 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; Medical assistant reported that VAQTA which underwent a temperature excursion was ...
No additional AE; Medical assistant reported that VAQTA which underwent a temperature excursion was administered to a patient; This spontaneous report was received from a Physician Assistant (reported as medical assistant) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-OCT-2025, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) prefilled syringe, 0.5 mL, administered as prophylaxis (lot number Z010429 has been verified to be valid for Hepatitis A Vaccine, Inactivated [VAQTA], expiration date 09-OCT-2026; dose number, route of administration and anatomical site of injection were not reported). The vaccine was administered after undergoing a temperature excursion (TE) at 47.7 degree Fahrenheit (F) for 30 minutes, with not previous TE (Product storage error). No symptoms or additional adverse event was reported for the patient. This is one of several reports from the same reporter.
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| 2866469 | M | 10/16/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Erythema, Herpes zoster, Mobility decreased, Skin burning sensation, Vaccination...
Erythema, Herpes zoster, Mobility decreased, Skin burning sensation, Vaccination failure
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her father burning breaking out face red etc/ had the Shingles and he was admitted in the hospital; ...
her father burning breaking out face red etc/ had the Shingles and he was admitted in the hospital; could hardly move; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In AUG-2025, 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), shingles (Verbatim: her father burning breaking out face red etc/ had the Shingles and he was admitted in the hospital) (serious criteria hospitalization) and mobility decreased (Verbatim: could hardly move) (serious criteria hospitalization). The outcome of the vaccination failure, shingles and mobility decreased were not reported. It was unknown if the reporter considered the vaccination failure, shingles and mobility decreased to be related to Shingles vaccine. The company considered the vaccination failure, shingles and mobility decreased to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 07-OCT-2025 This case was reported by a patient via interactive digital media. Consumer reported that had 2 shingles shots and reminded my ex to get his he said that he had already about 2months. The reporter mentioned daughter called and told something was wrong with her father burning breaking out face red etc. and could hardly move they took him to the hospital he also had other health issues. The reporter mentioned a senior He had the Shingles, and he was admitted in the hospital. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles 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, Herpes zoster, Mobility decreased, on an unknown time after receiving unknown dose of Shingles vaccine, in an adult male patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
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| 2866471 | 79 | F | FL | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Rash
Rash
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Bad rash; This is a spontaneous report received from a Nurse. A 79-year-old female patient received...
Bad rash; This is a spontaneous report received from a Nurse. A 79-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 09Oct2025 as dose 1, single (Lot number: NA0589, Expiration Date: 23Jun2026) at the age of 79 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (ongoing), notes: Glaucoma; "Arthritis" (ongoing), notes: Arthritis; "hearing aid", start date: 2023 (ongoing), notes: hearing aid Has had 2.5 years. Concomitant medication(s) included: FLUZONE HIGH DOSE taken for immunisation, on 09Oct2025 as dose number unknown, single; TYLENOL oral taken for arthritis (ongoing); ALEVE oral taken for arthritis (ongoing); TIMOLOL ophthalmic taken for glaucoma (ongoing); LATANOPROST ophthalmic taken for glaucoma (ongoing). The following information was reported: RASH (medically significant) with onset 10Oct2025, outcome "not recovered", described as "Bad rash". Therapeutic measures were taken as a result of rash. Clinical course: Bad Rash she got the shot last Thursday, confirmed as, 09Oct2025. Then 24 hours got bad rash. Seriousness Criteria: Confirms as medically significant. The bad rash was completely surrounding the trunk of body. It was enough to call and report. The patient took all the anti-itch medications that are available at the drug store. Causality: 98% would say yes. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The AE did not require a visit to the Emergency Room. The AE did not require a visit to a Physician's Office. The patient previously received the Pfizer suspect vaccine. The patient was not allergic to any previous vaccination, medications, food or other products.; Sender's Comments: Based on the available information and product safety profile, a causal relationship between the reported serious event- ( Rash ) and suspect drug is assessed as possible. 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 event. 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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| 2866472 | 84 | F | 10/16/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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COVID-19, Chapped lips, Condition aggravated, Eating disorder, Food allergy; Gin...
COVID-19, Chapped lips, Condition aggravated, Eating disorder, Food allergy; Gingival abscess, Gingival swelling, Investigation, Lip erythema, Lip swelling; Mouth haemorrhage, Oral discomfort, Oral mucosal blistering, Pain, Speech disorder; Swollen tongue, Tongue disorder
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my alpha gal numbers were up a little bit; Her mouth broke out in blisters, bleeding, gums are swoll...
my alpha gal numbers were up a little bit; Her mouth broke out in blisters, bleeding, gums are swollen.; mouth broke out with blisters; got little split places on my tongue my gums are swollen, my lips are swollen and the corners of mouth is splitting it's getting worse instead of getting better; got little split places on my tongue my gums are swollen, my lips are swollen and the corners of mouth is splitting it's getting worse instead of getting better; got little split places on my tongue my gums are swollen, my lips are swollen & corners of mouth is splitting it's getting worse instead of getting better / has like cracks inside her lips; Her tongue is all swollen; her lips felt like they were on fire, all red and swollen; Gums are starting to get abscesses on them; it was getting a lot worse; got little split places on my tongue my gums are swollen, my lips are swollen and the corners of mouth is splitting it's getting worse instead of getting better; She is having trouble speaking clearly and eating / wasn't really eating anything; She is having trouble speaking clearly and eating; sore; covid; her lips felt like they were on fire, all red and swollen / anything i put in my mouth like food burns in my mouth; it's getting worse instead of getting better/the mouth progressively getting worse/It's worse, not better; This is a spontaneous report and received from Consumer or other non HCPs from medical information team. An 84-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 23Sep2025 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "I had covid" (unspecified if ongoing), notes: before vaccine, but getting the vaccine she was fine. she was sick 3-4 weeks; "alpha gal numbers", start date: 2021 (ongoing), notes: just got tested again & alpha gal numbers were up a little bit from last year; "aortic dissection", start date: 2014 (unspecified if ongoing), notes: and I was in the ICU for 3 weeks; "blood pressure" (unspecified if ongoing); "shoulder replacement", start date: 17Apr2025 (unspecified if ongoing), notes: Replaced left shoulder & was doing PT 2 days after surgery & it reverse shoulder went wonderful.; "Osteoporosis" (ongoing), notes: supposed to start 2 shots once a month for a year to slow it down; "mouth broke out", start date: 2022 (unspecified if ongoing); "tick bite", start date: 2022 (unspecified if ongoing); "She had breast cancer" (unspecified if ongoing), notes: she had to recover from the radiation. She didn't do chemo; "radiation" (unspecified if ongoing), notes: and it was to the radiation all over upper body, she was in agony; "she was in agony" (unspecified if ongoing), notes: and it was to the radiation all over upper body, she was in agony; "allergies are environmental" (unspecified if ongoing), notes: gives her the runs; "Allergies: gluten" (unspecified if ongoing), notes: gives her the runs; "gives her the runs" (unspecified if ongoing); "ICU", start date: 2014 (unspecified if ongoing), notes: for 3 weeks. Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement, start date: 2014; HYDRALAZINE; NEBIVOLOL; DOXAZOSIN; LEVOTHYROXINE; VITAMIN D3 (ongoing); VITAMIN B12 [VITAMIN B12 NOS] (ongoing). The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, got it every year), for Covid-19 immunization; Flu shot, for Covid-19 immunization. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2025, outcome "unknown", described as "it's getting worse instead of getting better/the mouth progressively getting worse/It's worse, not better"; SPEECH DISORDER (non-serious) with onset 25Sep2025, outcome "not recovered", described as "She is having trouble speaking clearly and eating"; EATING DISORDER (non-serious) with onset 25Sep2025, outcome "not recovered", described as "She is having trouble speaking clearly and eating / wasn't really eating anything"; COVID-19 (non-serious) with onset 25Sep2025, outcome "recovering", described as "covid"; ORAL DISCOMFORT (non-serious) with onset 25Sep2025, outcome "unknown", described as "her lips felt like they were on fire, all red and swollen / anything i put in my mouth like food burns in my mouth"; PAIN (non-serious) with onset 25Sep2025, outcome "unknown", described as "sore"; GINGIVAL ABSCESS (non-serious) with onset 27Sep2025, outcome "not recovered", described as "Gums are starting to get abscesses on them; it was getting a lot worse"; MOUTH HAEMORRHAGE (non-serious) with onset 27Sep2025, outcome "not recovered", described as "Her mouth broke out in blisters, bleeding, gums are swollen."; SWOLLEN TONGUE (non-serious) with onset 27Sep2025, outcome "not recovered", described as "Her tongue is all swollen"; CHAPPED LIPS (non-serious) with onset 27Sep2025, outcome "not recovered", described as "got little split places on my tongue my gums are swollen, my lips are swollen & corners of mouth is splitting it's getting worse instead of getting better / has like cracks inside her lips"; TONGUE DISORDER (non-serious), GINGIVAL SWELLING (non-serious), LIP SWELLING (non-serious) all with onset 27Sep2025, outcome "not recovered" and all described as "got little split places on my tongue my gums are swollen, my lips are swollen and the corners of mouth is splitting it's getting worse instead of getting better"; LIP ERYTHEMA (non-serious) with onset 27Sep2025, outcome "not recovered", described as "her lips felt like they were on fire, all red and swollen"; ORAL MUCOSAL BLISTERING (non-serious) with onset 27Sep2025, outcome "not recovered", described as "mouth broke out with blisters"; FOOD ALLERGY (non-serious) with onset Oct2025, outcome "unknown", described as "my alpha gal numbers were up a little bit". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter stated, she took it on 23Sep2025 and she had a bad, she has taken it ever since it came out and she never had a reaction to it, she had covid before the vaccine, but getting the vaccine she has been fine, she never had a reaction or anything else but this time when she took it, she was, the next morning she took it in the afternoon, but the next morning she had it about lunch time she guess or something like that, on 25Sep2025, she cannot get out of bed she was sick, she was sore, she got covid, and from it, that was fine, a few days later she was okay by the middle of the week she was okay but then her mouth broke out with blisters and she got little split places on her tongue her gums are swollen, her lips are swollen and the corners of mouth was splitting it was getting worse instead of getting better, that started when she was still feeling kind of sick covid the next Saturday, she think it was a Thursday when she got the vaccine but she started feeling better from the feeling she had covid, the mouth progressively getting worse, she called her allergist, first she called the pharmacist and she said this was probably a reaction, they had this type of reaction from it, but she figured this will go away but it was getting worse instead of going away and we're into Oct2025 now anything she put in her mouth like food burns in her mouth, it was terrible so she thought, well then she also called her allergist because she just got tested again and her alpha gal numbers were up a little bit from last year, so she ended up in the emergency room 4 years ago because of alpha gal. So, the mouth was getting worse instead of getting better, so she just wondering, her allergist said we don't know what was in it that patient was allergic to. So, she decided to call to see what she can do or what was going on, she gets it every year and she never had a reaction to it at all, this year her arm didn't even hurt. She has been getting this so long and did not bother her, finally something she can tolerate. Confirmed inquiry, if after taking the vaccine she had problems with her mouth, reporter confirmed. Reporter added, she had something similar to this years ago when she developed, she has been taking losartan, she had aortic dissection in 2014 and she was in the ICU for 3 weeks Covid shots, she has been taking blood pressure medications since then, she developed after many years same thing that was going on now to the losartan that she was taking for a number of years that's not how you get allergic to this things right away so she stopped that and they put her in a different blood pressure medication and that went away but this was not going away this time so she was not sure. All the pharmacy all the you know called the companies there was nothing in the things she taking in. On 23Sep2025, she got the Pfizer Covid vaccine. She has been getting Pfizer ever since they came out. She had Covid before the vaccine came out and she did ok, she was sick 3-4 weeks. She was 84 years old now. On 23Sep2025, she got the vaccine. She had to hold off getting it, it was due in Jul or Aug2025, but she had shoulder replacement, and the surgeon told her to wait. Never really had a reaction, maybe sore spot on the arm but not even as bad as a flu shot just you know you had it. It never bothered her. States with this she couldn't get out of bed for 2 days. After 5 days that was gone. Her mouth broke out in blisters, bleeding, gums are swollen. It was worse, not better. Her pharmacist said probably a reaction to the vaccine. There was nothing else new she has done that can cause this. She talked to her allergist because she has allergies. He said there was no real way to test something new in vaccine. She was having trouble speaking clearly and eating, it was not getting better. She can't trace this to anything else but the vaccine at this point. She was worried because she wants to get it, it was important. She has been getting it every year and never had a reaction; she was kind of concerned. Wants it to go away but doesn't seem to be getting better. She has pretty bad Osteoporosis and was supposed to start 2 shots once a month for a year to slow it down, but she was scared to start that. She has alpha gal and that number went up this year. This was from tick bite 5 years ago. She has been very, very careful. If it has any mammal in it that could be what was going on. Clarifies she has like cracks inside her lips and when she opens her mouth wide the corners are splitting. Her tongue was all swollen and has little cracks in it. Her gums are swollen. Started feeling sick immediately that night, she got the vaccine in the afternoon. For the gum thing she thinks she was so sick she wasn't really eating anything. States it was not the next day but the next day after that, 25Sep2025. States it started with tongue swelling and the inside of her lips felt like they were on fire, all red and swollen. Her coffee has to be cold because it hurts. Gums are starting to get abscesses on them; it was getting a lot worse. She has a paper from (withheld). It says Pfizer Covid vaccine 2025/2026 0.3ml Liquid. White. Does not see lot or expiry. She called her allergist and was told it was so new there was no way to test what would be in it to see if she might be allergic to that with all her allergies. Doesn't know if what was in it was different. States she didn't even feel the shot at all, there was no pain in her arm at all. States she gets it every year, she started in Sep. Does not have dates of previous vaccine to provide. Does not have NDC, lot or expiry to provide for previous vaccines. She was hoping this doesn't prevent her getting this in the future. Shoulder replacement was 17Apr2025. Concomitant Medication: States she was taking blood pressure medication since 2014 after the aortic dissection. Hydralazine 10mg tablet 3 times a day has been taking for a long time. Nebivolol 10mg twice a day for a few years. Doxazosin 1mg twice a day for a few years. Levothyroxine she has taking many years a low dose that has never changed. Taking since menopause. She developed an allergy similar to this when she was taking Losartan for years since her episode and guesses it's been 3 years ago all of a sudden, her mouth broke out like this and turned out to be Losartan and another medication she was taking. She doesn't recall the name of it. Manufacturer and lot unknown. She got the tick bite around the same time. They had to change her blood pressure medications. With 1st shoulder replacement she had a bad reaction. She had breast cancer, and it was to the radiation all over upper body, she was in agony. They delayed her first should surgery back like 3 years ago. Her left shoulder. They discovered breast cancer, and she had to recover from the radiation. She didn't do chemo. Replaced her left shoulder and was doing PT 2 days after surgery and it was a reverse shoulder that went wonderful. This shoulder because the osteoporosis was worse didn't go as smoothly because the osteoporosis was worse. She broke out from the antiseptic they paint your shoulder with and the tape. She was a bloody mess there and had to keep it on for a few weeks. When her mouth broke out after the pharmacist said they were pretty sure it was a reaction to the Covid vaccine because they are getting more of those with this vaccine. The allergist said her alpha gal number was up. If there was any mammal in the covid vaccine that could be what was going on. Has to find out so she knows. Takes Vitamin D3 and Vitamin B12 and are all vegan and she has been taking for years. Most of her allergies are environmental, and gluten issue gives her the runs. 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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| 2866473 | 71 | F | MD | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
HG2282 |
Headache, Tinnitus
Headache, Tinnitus
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slight headache every time; tinnitus and it gets worse every time I get a covid vaccine; This is a s...
slight headache every time; tinnitus and it gets worse every time I get a covid vaccine; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, 0.3 ml single (Lot number: HG2282) at the age of 71 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, lot number: FG3527, intramuscular in the right arm, dose: 0.3 ml single), administration date: 08Nov2021, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "headache", "tinnitus that gets worse"; BNT162b2 (dose 2, lot number: GJ3277, intramuscular in the right arm, dose: 0.3 ml single), administration date: 12Oct2022, when the patient was 70-year-old, for COVID-19 immunisation, reaction(s): "headache", "tinnitus that gets worse". The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "slight headache every time"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus and it gets worse every time I get a covid vaccine".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500192477 same patient/suspect vaccine; different dose; similar events;
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| 2866474 | F | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
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Investigation, Pain in extremity
Investigation, Pain in extremity
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this year my arm didn't even hurt/maybe sore spot on the arm; This is a spontaneous report and ...
this year my arm didn't even hurt/maybe sore spot on the arm; This is a spontaneous report and received from Consumer or other non HCPs from medical information team. An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: before the vaccine; "aortic dissection", start date: 2014 (unspecified if ongoing), notes: In the ICU for 3 weeks; "In the ICU for 3 weeks" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "alpha gal numbers", start date: 2021 (ongoing); "Osteoporosis" (ongoing), notes: pretty bad Osteoporosis; "mouth broke out", start date: 2022 (unspecified if ongoing); "tick bite", start date: 2022 (unspecified if ongoing); "She had breast cancer" (unspecified if ongoing), notes: She had to recover from the radiation. She didn't do chemo.; "radiation" (unspecified if ongoing), notes: and it was to the radiation all over upper body, she was in agony; "she was in agony" (unspecified if ongoing), notes: and it was to the radiation all over upper body, she was in agony; "allergies are environmental" (unspecified if ongoing); "Allergies: gluten" (unspecified if ongoing), notes: gives her the runs; "gives her the runs" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement, start date: 2014; HYDRALAZINE; NEBIVOLOL; DOXAZOSIN; LEVOTHYROXINE; VITAMIN D3 (ongoing); VITAMIN B12 [CYANOCOBALAMIN] (ongoing). Vaccination history included: Flu shot, for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "this year my arm didn't even hurt/maybe sore spot on the arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that, Patient has been getting Pfizer vaccine ever since they came out. Never really had a reaction, maybe sore spot on the arm but not even as bad as a flu shot just you know you had it. It never bothered her. She has been getting it every year and never had a reaction. Patient get covid vaccine every year and she never had a reaction to it at all, this year her arm didn't even hurt. She have been getting this so long and did not bother her, finally something she can tolerate. Patient have been taking losartan, She had an aortic dissection and was in the ICU for 3 weeks in 2014 before the Covid shots, She have been taking blood pressure medications since then, She developed after many years to the losartan that she was taking for a number of years that's not how you get allergic to this things right away so she stopped that and they put her in a different blood pressure medication and that went away. She developed an allergy when she was taking Losartan for years since her episode and guesses it's been 3 years ago all of a sudden, her mouth broke out and turned out to be Losartan and another medication she was taking. She doesn't recall the name of it. Manufacturer and lot unknown. She got the tick bite around the same time. They had to change her blood pressure medications. She has pretty bad Osteoporosis and was supposed to start 2 shots once a month for a year to slow it down, but she was scared to start that. She has alpha gal, This is from tick bite 5 years ago. She has been very, very careful. Concomitant Medication: States she was taking blood pressure medication since 2014 after the aortic dissection. Hydralazine 10mg tablet 3 times a day has been taking for a long time. Nebivolol 10mg twice a day for a few years. Doxazosin 1mg twice a day for a few years. Levothyroxine she has taking many years a low dose that has never changed. Taking since menopause. She had breast cancer, and it was to the radiation all over upper body, she was in agony. They delayed her first shoulder surgery back like 3 years ago. Her left shoulder. They discovered breast cancer, and she had to recover from the radiation. She didn't do chemo. Takes Vitamin D3 and Vitamin B12 and are all vegan and she has been taking for years. Most of her allergies are environmental, and gluten issue gives her the runs. She ended up in the emergency room 4 years ago because of alpha gal. This was from tick bite 5 years ago. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2866475 | 37 | F | 10/16/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Headache, Pain, Pain in extremity; Headache, Pain, Pain in extremity
Headache, Pain, Pain in extremity; Headache, Pain, Pain in extremity
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sore arm; general body aches; headache; This is a spontaneous report received from a Consumer or oth...
sore arm; general body aches; headache; This is a spontaneous report received from a Consumer or other non HCP. A 37-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 14Oct2025 at 10:45 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 14Oct2025 as dose number unknown, single, in right arm. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset 14Oct2025, outcome "not recovered", described as "general body aches"; HEADACHE (non-serious) with onset 14Oct2025, outcome "not recovered"; PAIN IN EXTREMITY (non-serious) with onset 14Oct2025, outcome "not recovered", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity, pain, headache. Additional information: Patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s). Patient reported taking other medications within 2 weeks of the event starting. Patient has no allergy. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2866476 | M | NY | 10/16/2025 |
MNP |
PFIZER\WYETH |
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Influenza like illness
Influenza like illness
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flu-like symptoms; This is a spontaneous report received from an Other HCP from a sales representati...
flu-like symptoms; This is a spontaneous report received from an Other HCP from a sales representative. A 17-year-old male patient received meningococcal group abcwy vaccine (PENBRAYA), on 13Oct2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 14Oct2025, outcome "unknown", described as "flu-like symptoms". It was unknown if therapeutic measures were taken as a result of influenza like illness. Additional information: The parent of the patient called the provider to state that he was experiencing muscle aches and flu-like symptoms the day after he was administered Penbraya. Facility where vaccine was administered was doctor's office/urgent care. It was unknown whether the patient received any other vaccines on the same date of the vaccination. It was unknown whether the patient received any other vaccines within 4 weeks prior to the vaccination. It was unknown whether the patient was taking any other medication within 2 weeks of the event starting. The information on the batch/lot number for meningococcal group abcwy vaccine will be requested and submitted if and when received.
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| 2866477 | M | FL | 10/16/2025 |
UNK |
UNKNOWN MANUFACTURER |
U8832DA |
No adverse event, Occupational exposure to product
No adverse event, Occupational exposure to product
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accidental exposure because pharmacy staff member inadvertently may have gotten vaccine in his eye w...
accidental exposure because pharmacy staff member inadvertently may have gotten vaccine in his eye with no reported ae; accidental exposure because pharmacy staff member inadvertently may have gotten vaccine in his eye with no reported adverse event; Initial information received on 10-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 21 years old male patient who had accidental exposure because pharmacy staff member inadvertently may have gotten vaccine in his eye with no reported adverse event while they took the rubber stopper off the influenza trivalent recombinant vaccine [Flublok TIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Oct-2025, the influenza trivalent recombinant vaccine, Solution for injection strength: not reported (lot U8832DA; expiry date: 31-May-2026) for Immunization, accidental exposure because pharmacy staff member inadvertently may have gotten vaccine in his eye no reported adverse event (accidental exposure to product) (exposure via eye contact) (latency: same day). Reporter states that a 21 year old male pharmacy technician took the rubber stopper off of the FLUBLOK, and may have gotten an exceedingly small amount of the product in his left eye today (10-Oct-2025). He is not experiencing any side effects at this time. Action taken: Not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2866479 | 8 | F | ID | 10/16/2025 |
FLU3 FLUN3 |
SANOFI PASTEUR MEDIMMUNE VACCINES, INC. |
U8827AA YF3413B |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Patient receive Flu injectable vaccine after receiving flumist. No symptoms.
Patient receive Flu injectable vaccine after receiving flumist. No symptoms.
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| 2866480 | 83 | F | MI | 10/16/2025 |
UNK |
UNKNOWN MANUFACTURER |
Fluad |
Contusion, Haemorrhage, Immediate post-injection reaction, Peripheral swelling
Contusion, Haemorrhage, Immediate post-injection reaction, Peripheral swelling
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Patient received a vaccine from an intern and had an immediate reaction where her arm swelled up and...
Patient received a vaccine from an intern and had an immediate reaction where her arm swelled up and bruised right after the vaccine. patient also was bleeding.
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| 2866481 | 0.5 | F | HI | 10/16/2025 |
COVID19 |
MODERNA |
8146670 |
Incorrect dose administered
Incorrect dose administered
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Baby was given 0.5mg (12 and up dose) instead of 6 mos to 4 year old dose.
Baby was given 0.5mg (12 and up dose) instead of 6 mos to 4 year old dose.
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| 2866482 | 61 | M | VA | 10/16/2025 |
PNC20 |
PFIZER\WYETH |
MA2505 |
Pain in extremity
Pain in extremity
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PATIENT RECEIVED PREVNAR 20 ON 09-19-2025 AND HE STATES THAT HIS ARM IS STILL SORE TODAY 10-16-2025 ...
PATIENT RECEIVED PREVNAR 20 ON 09-19-2025 AND HE STATES THAT HIS ARM IS STILL SORE TODAY 10-16-2025 AND HE WILL BE GOING TO THE DOCTOR ABOUT IT.
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| 2866483 | 64 | F | CO | 10/16/2025 |
PNC21 |
MERCK & CO. INC. |
Z007870 |
Injection site erythema, Injection site rash, Injection site warmth
Injection site erythema, Injection site rash, Injection site warmth
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Patient reports redness, rash and warmth at injection site started two days post vaccine and still p...
Patient reports redness, rash and warmth at injection site started two days post vaccine and still present at day 5.
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| 2866484 | 70 | M | OR | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
na0590 |
Mobility decreased, Oedema peripheral, Pain in extremity
Mobility decreased, Oedema peripheral, Pain in extremity
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Woke up on second day with sore arm that felt "typical just got a shot" by day 3 was "...
Woke up on second day with sore arm that felt "typical just got a shot" by day 3 was "unable to lift arm up to shoulder" has a "small lump in left armpit" No treatment tried.
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| 2866485 | 50 | F | 10/16/2025 |
FLU3 HEP HEPA PNC21 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
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Chills, Erythema, Peripheral swelling; Chills, Erythema, Peripheral swelling; Ch...
Chills, Erythema, Peripheral swelling; Chills, Erythema, Peripheral swelling; Chills, Erythema, Peripheral swelling; Chills, Erythema, Peripheral swelling
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local redness and swelling on right arm, chills and possible fever
local redness and swelling on right arm, chills and possible fever
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| 2866494 | 19 | M | OH | 10/16/2025 |
FLU3 HEP MMR TDAP VARCEL |
SANOFI PASTEUR DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. |
tfaa2545 946909 y015995 u8669aa z009470 |
Asthenia, Dizziness, Hyperhidrosis; Asthenia, Dizziness, Hyperhidrosis; Asthenia...
Asthenia, Dizziness, Hyperhidrosis; Asthenia, Dizziness, Hyperhidrosis; Asthenia, Dizziness, Hyperhidrosis; Asthenia, Dizziness, Hyperhidrosis; Asthenia, Dizziness, Hyperhidrosis
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He started to feel week and light headed and was sweating. He recovered quickly after lying down wi...
He started to feel week and light headed and was sweating. He recovered quickly after lying down with some ice packs.
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| 2866495 | 79 | F | 10/16/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
f4ac3 f4ac3 |
Contusion, Erythema, Oedema peripheral, Pain, Skin warm; Swelling
Contusion, Erythema, Oedema peripheral, Pain, Skin warm; Swelling
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area was red, hot to touch, swollen, bruise, tennis ball size ball in axillary region, painful
area was red, hot to touch, swollen, bruise, tennis ball size ball in axillary region, painful
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| 2866497 | 74 | F | IL | 10/16/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052669 407242 |
Back pain, Pain in extremity; Back pain, Pain in extremity
Back pain, Pain in extremity; Back pain, Pain in extremity
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patient stated she started having sharp pains in her arm and back 5 days after receiving vaccine
patient stated she started having sharp pains in her arm and back 5 days after receiving vaccine
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| 2866498 | 69 | F | MI | 10/16/2025 |
FLU3 |
SEQIRUS, INC. |
407263 |
Erythema, Skin warm, Urticaria
Erythema, Skin warm, Urticaria
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By 3pm on 10/15/25, patient broke out in hives on her upper chest, neck, and ears. These areas were...
By 3pm on 10/15/25, patient broke out in hives on her upper chest, neck, and ears. These areas were red and warm to the touch. Patient took 2 doses of benadryl on 10/15/25 and all symptoms are resolved as of 7 pm 10/16/25.
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| 2866499 | 67 | F | IA | 10/16/2025 |
FLU3 |
SEQIRUS, INC. |
407252 |
Psoriasis
Psoriasis
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Patient had psoriasis outbreak on legs after flu shot.
Patient had psoriasis outbreak on legs after flu shot.
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| 2866500 | 53 | F | TX | 10/16/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood glucose decreased, Confusional state, Dyspnoea, Headache, Initial insomnia...
Blood glucose decreased, Confusional state, Dyspnoea, Headache, Initial insomnia; Injection site pain, Pain, Pyrexia
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TROUBLE BREATHING; SOME CONFUSION, PAIN AT THE INFECTION SITE, FEVER, BODY ACHES, SEVERE HEADACHES; ...
TROUBLE BREATHING; SOME CONFUSION, PAIN AT THE INFECTION SITE, FEVER, BODY ACHES, SEVERE HEADACHES; TROUBLE SLEEPING, LOW BLOOD SUGARS THROUGHTOUT THE DAY. THIS HAS BEEN GOING ON SINCE ABOUT 7:00 PM ON 10/15/20025 INTO TODAY. ALL i TOOK WAS TYLENOL AND IBUPROFEN, ALTERNATING THEM.
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| 2866501 | 0.25 | M | NY | 10/16/2025 |
FLU3 |
SEQIRUS, INC. |
410514 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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A 3-month-old patient received an influenza vaccine, which is not indicated for children under 6 mon...
A 3-month-old patient received an influenza vaccine, which is not indicated for children under 6 months of age. The error was identified after administration when the parents contacted the office to report that their infant had received the flu shot and to ask if this was appropriate. The patient has remained well since vaccination, with no reported adverse symptoms such as fever, irritability, feeding difficulty, or local reaction at the injection site. No medical intervention was required. Parents were reassured that receiving the vaccine at this age is not known to be harmful but is not effective and is not recommended for children under 6 months of age.
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| 2866502 | 22 | F | SD | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Amnesia, Hyperhidrosis, Pallor, Syncope
Amnesia, Hyperhidrosis, Pallor, Syncope
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pt experienced 5-10 second sycope after receiving shot, patient was given water offered food and col...
pt experienced 5-10 second sycope after receiving shot, patient was given water offered food and cold compress after, pt did not hurt head or any other part of body upon syncope, pt had white pallor diaphoersis and amnesia.
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| 2866503 | 64 | F | FL | 10/16/2025 |
PNC20 PNC20 TDAP TDAP |
PFIZER\WYETH PFIZER\WYETH SANOFI PASTEUR SANOFI PASTEUR |
lx4482 lx4482 u8638aa u8638aa |
Cough, Injection site erythema, Injection site pain, Injection site swelling, Na...
Cough, Injection site erythema, Injection site pain, Injection site swelling, Nasopharyngitis; Pain; Cough, Injection site erythema, Injection site pain, Injection site swelling, Nasopharyngitis; Pain
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Patient developed a large oval, egg shaped, raised, pink, bump at the injection site where Prevnar w...
Patient developed a large oval, egg shaped, raised, pink, bump at the injection site where Prevnar was given. She said it was very painful. She had pain radiating under her armpits. She also had body aches, cough and cold. Her major complaint was the bump (as wide as the width of a had across 4 fingers)
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| 2866504 | 60 | F | OK | 10/16/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
4ZS72 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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SWELLING , REDNESS , PAIN AT SITE
SWELLING , REDNESS , PAIN AT SITE
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