| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2873846 | 69 | F | TN | 11/20/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4457 |
Mobility decreased
Mobility decreased
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Patient reported immobility/paralysis, that the following day after the vaccine she was unable to ge...
Patient reported immobility/paralysis, that the following day after the vaccine she was unable to get off of her couch to use the restroom. Claimed it took her roughly 30 minutes to go from her downstairs to her upstairs.
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| 2873849 | 68 | F | OH | 11/20/2025 |
COVID19 |
MODERNA |
3053756 |
Neurological symptom, Pain in extremity, Synovial cyst
Neurological symptom, Pain in extremity, Synovial cyst
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The next morning patient started have pain and nerve symptoms in calf after a few days she went to t...
The next morning patient started have pain and nerve symptoms in calf after a few days she went to the dr and had tests to ensure she did not have a dvt. tests had ruled out dvt and she was diagnosed with baker's cyst behind her calf. a few days later the other leg stated having the same symptoms, which resulted in the other leg having a baker's cyst above the knee. patient is stable and sees dr in December.
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| 2873859 | 49 | M | FL | 11/20/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
9484 9484 |
Arthralgia, Asthenia, Chills, Diarrhoea, Hyperhidrosis; Libido decreased, Migrai...
Arthralgia, Asthenia, Chills, Diarrhoea, Hyperhidrosis; Libido decreased, Migraine
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the second day I had swet, chills. 6 days of diarrhea, no energy, pain in my joints, migraines, and ...
the second day I had swet, chills. 6 days of diarrhea, no energy, pain in my joints, migraines, and not sexual desire. I have been taking ibuprofen 600 mg every day.
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| 2873860 | 43 | F | CO | 11/20/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
027H21B 003B21A 047B21A |
Paraganglion neoplasm, Retroperitoneal mass; Paraganglion neoplasm, Retroperiton...
Paraganglion neoplasm, Retroperitoneal mass; Paraganglion neoplasm, Retroperitoneal mass; Paraganglion neoplasm, Retroperitoneal mass
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retroperitoneal mass, paraganglioma
retroperitoneal mass, paraganglioma
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| 2873902 | 11/20/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
8080473 UT8409CA |
COVID-19, Urticaria; COVID-19, Urticaria
COVID-19, Urticaria; COVID-19, Urticaria
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covid-19; urticaria; This spontaneous case was reported by a non-healthcare professional and describ...
covid-19; urticaria; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of COVID-19 (covid-19) and URTICARIA (urticaria) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080473) for COVID-19. The suspect product included Pre-filled Syringe injection (batch no. 8080473) for COVID-19 and non-company product included Influenza vaccine (Fluzone) for an unknown indication. No Medical History information was reported. On 12-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine (Fluzone) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2024, the patient experienced COVID-19 (covid-19) and URTICARIA (urticaria). At the time of the report, COVID-19 (covid-19) outcome was unknown and URTICARIA (urticaria) had resolved. No concomitant medications were provided. The patient's past medical history, medical treatments, vaccinations and family history were not provided. In 2024, the patient developed COVID-19 and urticaria approximately few months following the Spikevax and Fluzone (Influenza Quadrival A-B Multidose Vaccine Preserved). Expiry date was not reported for both suspect products. It was not reported if the patient received corrective treatment for both the events.
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| 2873903 | 69 | F | OH | 11/20/2025 |
COVID19 |
MODERNA |
1070803 |
Alopecia, Blister, Tooth loss
Alopecia, Blister, Tooth loss
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messing with the skin, causing it to swell up in bubbles; losing tooth; losing hair; This spontaneou...
messing with the skin, causing it to swell up in bubbles; losing tooth; losing hair; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (messing with the skin, causing it to swell up in bubbles), TOOTH LOSS (losing tooth) and ALOPECIA (losing hair) in a 69-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 1070803) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 1070803) for COVID-19 prophylaxis. No Medical History information was reported. In November 2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced BLISTER (messing with the skin, causing it to swell up in bubbles), TOOTH LOSS (losing tooth) and ALOPECIA (losing hair). At the time of the report, BLISTER (messing with the skin, causing it to swell up in bubbles) and ALOPECIA (losing hair) had not resolved and TOOTH LOSS (losing tooth) outcome was unknown. No concomitant medications were provided. The patient had received 3 Moderna COVID-19 vaccine doses and was experiencing severe side effects. The patient described an ongoing situation where different things were happening to skin, which patient did not like. The patient expressed concern that chemicals were being given. It was mentioned that these chemicals went into the body where they did not belong, and it was messing with the skin, causing it to swell up in bubbles. It was also reported that the patient was losing tooth and hair and all of that. It was reported that the healthcare provider did all she could. The patient did not have a medical card longer as it ended, and the funding thing was over with. The patient was tired of the current healthcare situation. It was reported that returning to the healthcare provider was not an option, as those services were shut down. The patient received the vaccine on last week. No treatment medication was provided. This case was linked to MOD-2025-791373 (Patient Link).
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| 2873904 | F | 11/20/2025 |
COVID19 |
MODERNA |
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Chills, Headache, Muscular weakness
Chills, Headache, Muscular weakness
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Weakness of the limbs; Chills; Headache; This spontaneous case was reported by a consumer and descri...
Weakness of the limbs; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness of the limbs), CHILLS (Chills) and HEADACHE (Headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MUSCULAR WEAKNESS (Weakness of the limbs), CHILLS (Chills) and HEADACHE (Headache). In 2021, MUSCULAR WEAKNESS (Weakness of the limbs), CHILLS (Chills) and HEADACHE (Headache) had resolved. No concomitant medications provided by the reporter. It was reported that the patient got Moderna COVID-19 shots twice a year since 2021. She received 3 in the first year (in January and February, and then again halfway through the year). It was reported that after each shot, the patient had a day in bed where she would have chills, headache and weakness of the limbs and things like that and it would subside after 24 hours. No treatment medications provided by the reporter. This case was linked to MOD-2025-791037 (Patient Link).
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| 2873905 | F | 11/20/2025 |
COVID19 RVX |
MODERNA UNKNOWN MANUFACTURER |
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Ankle fracture, COVID-19, Chills, Headache, Muscular weakness; Ankle fracture, C...
Ankle fracture, COVID-19, Chills, Headache, Muscular weakness; Ankle fracture, COVID-19, Chills, Headache, Muscular weakness
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weakness of the limbs; chills; headache; broken ankle; COVID, in her nose, residual cough; This spon...
weakness of the limbs; chills; headache; broken ankle; COVID, in her nose, residual cough; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness of the limbs), ANKLE FRACTURE (broken ankle), CHILLS (chills), HEADACHE (headache) and COVID-19 (COVID, in her nose, residual cough) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product RSV VACCINE for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of RSV VACCINE (unknown route) 1 dosage form. In September 2022, the patient experienced COVID-19 (COVID, in her nose, residual cough). In 2025, the patient experienced ANKLE FRACTURE (broken ankle). On an unknown date, the patient experienced MUSCULAR WEAKNESS (weakness of the limbs), CHILLS (chills) and HEADACHE (headache). In 2022, COVID-19 (COVID, in her nose, residual cough) had resolved. At the time of the report, MUSCULAR WEAKNESS (weakness of the limbs), CHILLS (chills) and HEADACHE (headache) had resolved and ANKLE FRACTURE (broken ankle) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications provided by the reporter. It was reported that the patient got Moderna COVID-19 shots twice a year since 2021. She received 3 in the first year (in January and February, and then again halfway through the year), and 2 a year afterwards and she was now on shot number 11. It was reported that after each shot, the patient had a day in bed where she would have chills, headache and weakness of the limbs and things like that and it would subside after 24 hours. The patient had a broken ankle this year and was laid up and did not get her COVID vaccine when she wanted to get it, and the patient also got the flu shot 2 weeks before her COVID vaccine. The patient received the mNEXSPIKE on 09-OCT-2025 and has had absolutely no reaction. She used to get the COVID vaccine and the RSV vaccine together. She got the RSV vaccine twice in consecutive years, 2 years ago. On Sep-2022, the patient came down with COVID halfway through a cruise where everybody was vaccinated on the cruise and 98% of the passengers were vaccinated. The patient had just liked a bad cold that started at night, and it was overwhelming, in her nose and everything but by the end of the day it was just a residual cough. The patient had to stay isolated for the rest of the cruise, but she did not really have any terrible symptoms, and the patient was fine within the 5 days. No treatment medications provided by the reporter. This case was linked to MOD-2025-791542 (Patient Link).
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| 2873906 | F | 11/20/2025 |
COVID19 |
MODERNA |
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Cough, Nasopharyngitis, Oropharyngeal pain
Cough, Nasopharyngitis, Oropharyngeal pain
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cold; sore throat; coughs; This spontaneous case was reported by a consumer and describes the occurr...
cold; sore throat; coughs; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), OROPHARYNGEAL PAIN (sore throat) and COUGH (coughs) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), OROPHARYNGEAL PAIN (sore throat) and COUGH (coughs). At the time of the report, NASOPHARYNGITIS (cold), OROPHARYNGEAL PAIN (sore throat) and COUGH (coughs) had not resolved. The patient had no relevant medical conditions. Patient did not have any other vaccines when she got the Moderna vaccine. No concomitant medication was reported. The patient wanted to get the COVID booster shot, but she had a mild cold, a mild sore throat. Sometimes she blows her nose and sometimes she coughs. She was wondering if she should wait until this was over to get the booster shot, or whether it was okay for her to get it. Her last booster was a Moderna vaccine, and she did not remember when. It was a while ago; It was about a year ago, probably. The patient could not remember when it was. Her symptoms were not because of the vaccine. It was unknown if the patient experienced any additional symptoms/events. Reporter did not allow further contact
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| 2873907 | 70 | F | 11/20/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of...
COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) in a 70-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Asthma (with severe asthma, it started before she had her Moderna COVID-19 vaccines and had it all her life). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infection) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID-19 infection) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that, the patient wanted to know the names of Moderna's current COVID-19 vaccines. She had always gotten Moderna and wanted another dose. She wanted to know which between mNEXSPIKE and Spikevax was best for her as someone who had severe asthma, which was started before she had her Moderna COVID-19 vaccines and had it all her life. She had a COVID-19 infection in the past and was hospitalized. The patient did not experience any additional symptoms/events. No treatment information was provided.; Reporter's Comments: Company Comment: The benefit-risk relationship of the product is not affected by this report.
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| 2873908 | F | 11/20/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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COVID-19, Fibrin D dimer, Fibrin D dimer increased, Hypertension, Vaccination si...
COVID-19, Fibrin D dimer, Fibrin D dimer increased, Hypertension, Vaccination site erythema; Vaccination site pruritus
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Very itchy, don't have systemic itching or anything else. It's all localized on the arm th...
Very itchy, don't have systemic itching or anything else. It's all localized on the arm that got the injection; COVID arm, where it gets all like almost looks purple from like shoulder to elbow in a big round circle; Very sick with COVID; Severe hypertension; Elevated D-dimer; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Very sick with COVID) and HYPERTENSION (Severe hypertension) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2024, the patient experienced COVID-19 (Very sick with COVID) (seriousness criterion life threatening), HYPERTENSION (Severe hypertension) (seriousness criterion life threatening) and FIBRIN D DIMER INCREASED (Elevated D-dimer). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Very itchy, don't have systemic itching or anything else. It's all localized on the arm that got the injection) and VACCINATION SITE ERYTHEMA (COVID arm, where it gets all like almost looks purple from like shoulder to elbow in a big round circle). At the time of the report, COVID-19 (Very sick with COVID), HYPERTENSION (Severe hypertension), FIBRIN D DIMER INCREASED (Elevated D-dimer), VACCINATION SITE PRURITUS (Very itchy, don't have systemic itching or anything else. It's all localized on the arm that got the injection) and VACCINATION SITE ERYTHEMA (COVID arm, where it gets all like almost looks purple from like shoulder to elbow in a big round circle) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2024, Fibrin D dimer: elevated. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medications were not reported. It was reported that patient had Moderna vaccines in the past for COVID, and it has been a couple of years though. And last year patient got very sick with COVID and had an elevated D-dimer and severe hypertension. The patient was at risk for blood clots if patient get COVID again, so the patient was looking at getting a booster, just wanted to make sure, it was unclear with the primary doctor if there was an elevated risk of blood clots from the vaccine itself, or if it was only like myocarditis risks from the vaccine. Patient had received vaccine in January or February of 2021, patient was in one of the first batches. It was reported that whenever patient had Moderna in the past, patient had the big, it was COVID arm, where it gets all like almost looks purple from like the shoulder to my elbow in a big round circle, but it's very hard. And it gets very itchy, but patient don't have systemic itching or anything else. It was all localized on the arm that got the injection on. Patient was told earlier on when that happened that it was probably just a really robust immune response and it definitely wasn't mNEXSPIKE, and don't even know if it was Spikevax that patient had left. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.; Reporter's Comments: Causality for Hypertension, COVID-19 and Fibrin D dimer increased was assessed as not related, due to long latency. The benefit-risk relationship of product is not affected by this report.
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| 2873909 | 69 | F | OH | 11/20/2025 |
COVID19 |
MODERNA |
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Alopecia, Blister, Ear haemorrhage, Mass, Tooth loss
Alopecia, Blister, Ear haemorrhage, Mass, Tooth loss
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ears bleed; Something growing on spine; losing teeth /losing tooth; messing with skin, causing it to...
ears bleed; Something growing on spine; losing teeth /losing tooth; messing with skin, causing it to swell up in bubbles; losing hair; This spontaneous case was reported by a consumer and describes the occurrence of EAR HAEMORRHAGE (ears bleed), MASS (Something growing on spine), TOOTH LOSS (losing teeth /losing tooth), BLISTER (messing with skin, causing it to swell up in bubbles) and ALOPECIA (losing hair) in a 69-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EAR HAEMORRHAGE (ears bleed), MASS (Something growing on spine), TOOTH LOSS (losing teeth /losing tooth), BLISTER (messing with skin, causing it to swell up in bubbles) and ALOPECIA (losing hair). At the time of the report, EAR HAEMORRHAGE (ears bleed), BLISTER (messing with skin, causing it to swell up in bubbles) and ALOPECIA (losing hair) had not resolved and MASS (Something growing on spine) and TOOTH LOSS (losing teeth /losing tooth) outcome was unknown. No concomitant medications were provided. The patient experienced severe side effects. The patient described an ongoing situation where different things were happening to skin, which patient did not like. The patient expressed concern that chemicals were being given. It was mentioned that these chemicals went into the body where they did not belong, and it was messing with the skin, causing it to swell up in bubbles. It was also reported that the patient was losing tooth and hair and all of that. It was reported that the healthcare provider did all she could. The patient did not have a medical card longer as it ended, and the funding thing was over with. The patient was tired of the current healthcare situation. It was reported that returning to the healthcare provider was not an option, as those services were shut down. No treatment medication was provided. This case was linked to MOD-2025-791456 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Nov-2025: Live follow up received which contains significant information, reporter details and events added.
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| 2873910 | F | 11/20/2025 |
COVID19 |
MODERNA |
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Heart rate increased
Heart rate increased
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Experienced a mild side effect, such as a rapid heartbeat; This spontaneous case was reported by a p...
Experienced a mild side effect, such as a rapid heartbeat; This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (Experienced a mild side effect, such as a rapid heartbeat) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Experienced a mild side effect, such as a rapid heartbeat). At the time of the report, HEART RATE INCREASED (Experienced a mild side effect, such as a rapid heartbeat) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medications were not reported. It was reported that during an inquiry about mNEXSPIKE, the healthcare professional mentioned that one of the older female patients experienced a mild side effect, such as a rapid heartbeat, after receiving Moderna's Spikevax, but has since recovered. Reporter was considering mNEXSPIKE for this patient due to its lower dosage, which may present a reduced risk of side effects. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.
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| 2873911 | 58 | M | 11/20/2025 |
COVID19 |
MODERNA |
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COVID-19, Drug hypersensitivity, Joint swelling, Metastases to bone, Prostate ca...
COVID-19, Drug hypersensitivity, Joint swelling, Metastases to bone, Prostate cancer stage IV
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Prostate cancer stage 4/turbo cancer; The prostate cancer was usually pretty slow, it grew in a year...
Prostate cancer stage 4/turbo cancer; The prostate cancer was usually pretty slow, it grew in a year or two and went to the bones; highly allergic to the spike protein; Covid-19; Ankle swelled up/Chronic inflammation; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATE CANCER STAGE IV (Prostate cancer stage 4/turbo cancer) and METASTASES TO BONE (The prostate cancer was usually pretty slow, it grew in a year or two and went to the bones) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: VARICELLA ZOSTER VACCINE. Past adverse reactions to the above products included No adverse effect with VARICELLA ZOSTER VACCINE. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced JOINT SWELLING (Ankle swelled up/Chronic inflammation). In December 2021, the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced PROSTATE CANCER STAGE IV (Prostate cancer stage 4/turbo cancer) (seriousness criterion medically significant), METASTASES TO BONE (The prostate cancer was usually pretty slow, it grew in a year or two and went to the bones) (seriousness criterion medically significant) and DRUG HYPERSENSITIVITY (highly allergic to the spike protein). At the time of the report, PROSTATE CANCER STAGE IV (Prostate cancer stage 4/turbo cancer) had not resolved, METASTASES TO BONE (The prostate cancer was usually pretty slow, it grew in a year or two and went to the bones), COVID-19 (Covid-19) and DRUG HYPERSENSITIVITY (highly allergic to the spike protein) outcome was unknown and JOINT SWELLING (Ankle swelled up/Chronic inflammation) had resolved. No concomitant medications were provided. It was reported that back in 2021, the patient got 2 Moderna shots. It was reported that a month later the patient's ankle swelled up almost chronically in nature and lasted about a year or so. It was reported that in late May-2021 his left ankle swelled up mainly the left ankle was swollen, and then it flipped to the right ankle, quarter by quarter the swelling would go away and then a month later it would come back and then go away and come back. It was reported that it was off and on chronic inflammation for 2 years and then it led to cancer. It was stage 4 prostate cancer. The oncologist called it turbo cancer, and you never see anything like it. The prostate cancer was usually slow, however at 62 years of age, it grew in a year or two and went to the bones. The patient caught COVID in Dec-2021, and his ankles blew up again and he caught COVID again sometime in mid-year of 2022 (maybe early spring) and his ankles swelled again. It was reported that he did not have an episode in a few years, and he believed that he was highly allergic to the spike protein. The reporter states that in the past year he had gotten the shingles vaccine. No other details provided. No treatment medication was provided.; Reporter's Comments: Causality for Prostate cancer stage IV and Metastases to bone has been assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
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| 2873912 | 75 | F | 11/20/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Urticaria; Urticaria
Urticaria; Urticaria
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hiving; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (...
hiving; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hiving) in a 75-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The non-company product included Influenza vaccine for an unknown indication. Concurrent medical conditions included Soy allergy. On 20-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 (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced URTICARIA (hiving). At the time of the report, URTICARIA (hiving) had not resolved. No concomitant medication was reported. The reporter asked for Moderna's recommendation to treat her hiving following administration of Moderna COVID-19 vaccine on 20-Oct-2025, which she had been continuously experiencing since then up to present. She had a soy allergy and connected the reaction to the Moderna COVID-19 vaccine. The patient's hiving started pretty soon after being administered with the Moderna COVID-19 vaccine but did not clarify when exactly it started. The patient did not experience any additional symptoms/events. No treatment medication was reported.
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| 2873913 | 70 | F | 11/20/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Movement disorder, Myalgia, Pain; Movement disorder, Myalgia, Pain
Movement disorder, Myalgia, Pain; Movement disorder, Myalgia, Pain
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I couldn't hardly move. I was just like frozen; pain with body aches; body aches; This spontane...
I couldn't hardly move. I was just like frozen; pain with body aches; body aches; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (I couldn't hardly move. I was just like frozen), PAIN (pain with body aches) and MYALGIA (body aches) in a 71-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine (Flu) for an unknown indication. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Patient took the Moderna shot 2- 2.5 years ago and it didn't bother her. During the pandemic, she got a little sick, but she had taken the Moderna shot and so she didn't get very sick.). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included Endometrial cancer (The patient stated that she had endometrial cancer, but Keytruda had almost eliminated it at that point. She added that she was still receiving infusions every three weeks and had been on the treatment for over 2.5 years.). Concomitant products included Pembrolizumab (Keytruda) for Endometrial cancer. In November 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2024, the patient experienced MOVEMENT DISORDER (I couldn't hardly move. I was just like frozen), PAIN (pain with body aches) and MYALGIA (body aches). In 2024, MOVEMENT DISORDER (I couldn't hardly move. I was just like frozen), PAIN (pain with body aches) and MYALGIA (body aches) had resolved. It was reported that in the previous year, she had taken her flu shot and her COVID-19 shot about two to three weeks apart, around the second to fourth week of November. She stated that after receiving the vaccine, she experienced what she described as a terrible reaction. She clarified that it was not related to her heart, as she had read about such issues, but explained that she had felt almost frozen and was in severe pain with body aches, barely able to move. She mentioned that this condition lasted for at least 12 hours and possibly up to 24 hours. She expressed disbelief at the severity of the reaction and recalled thinking that she hoped she would be okay. The patient added that she was now considering not taking the Moderna vaccine again but then thought that it might have been reformulated. She said she was thinking about taking the Pfizer vaccine instead because a friend in (withheld) had taken Pfizer without any problems. The patient emphasized her worry about the previous year's reaction although she eventually recovered. She described herself as healthy apart from requiring Keytruda for cancer treatment and noted that her heart and overall health were otherwise good. She was unable to provide lot numbers for the vaccines. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.
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| 2873916 | M | SC | 11/20/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
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Okay, that's probably when we had COVID before. This is our second COVID, and we had all the va...
Okay, that's probably when we had COVID before. This is our second COVID, and we had all the vaccines except for the very last one... And it was Pfizer.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE), for COVID-19 Immunisation. The following information was reported: COVID-19 (non-serious) with onset Nov2025, outcome "unknown", described as "Okay, that's probably when we had COVID before. This is our second COVID, and we had all the vaccines except for the very last one... And it was Pfizer.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Additional information: Patient's wife had then been transferred to redacted. Once the call was transferred, the patient's wife stated she was on Paxlovid her husband and she both have COVID, and patient probably got it a couple of days before she did. So, patient's wife assumed she caught it from the patient. Then patient's wife didn't test, until it was Thursday of last week, she believes, and when she tested both positive. So, then both called our doctor and told them, both had COVID, and they called in a prescription. They go to different doctors. So, patient doctor called his in and her doctor called her in. Well, patient went to the pharmacy and got his. Then it was several hours later and the pharmacy called patient's wife and they said that they were out of it when her doctor sent her prescription in so finally, they got it filled, and she went to pick it up and when she picked it up. When asked for the date patient's wife medication was purchased, patient's wife stated yes, it was on 06Nov2025. After advising that an enrollment would need to be completed, patient's wife would have to take more Paxlovid if she get sicker or don't get well. After advising of the options for enrollment, after advising patient's wife that an account created in Jan2024 was located for her, patient's wife stated, okay, that's probably when they had COVID before. This is their second COVID, and they had all the vaccines except for the very last one. And it was Pfizer. You probably have information on patient's wife because they had the Pfizer vaccine, her husband and patient's wife when offered to be redacted. Patient's wife stated, well, sh thought it's working, they're better. Okay, she would. Patient was about worn out now, though, but it won't be much longer. patient's wife continued to state she started out with a sore throat, but the patient, he didn't have a sore throat, and patient doesn't have one now. But she has still got a terrible sore throat. Her throat was very red. After transferring to the redacted patient's wife stated, just pray for us to get well and that's Paxlovid to work..
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| 2873917 | 26 | F | IL | 11/20/2025 |
RSV |
PFIZER\WYETH |
MM9147 |
Accidental exposure to product
Accidental exposure to product
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she accidentally sprayed some of the vaccine in her eye; This is a spontaneous report received from ...
she accidentally sprayed some of the vaccine in her eye; This is a spontaneous report received from a Pharmacist from medical information team. A 26-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 12Nov2025 as dose number unknown, single (Lot number: MM9147, Expiration Date: Oct2026) at the age of 26 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACCIDENTAL EXPOSURE TO PRODUCT (non-serious) with onset 12Nov2025, described as "she accidentally sprayed some of the vaccine in her eye". Additional information: Incident occurred, not while attempting to administer product, but while "drawing up the vaccine". Reported that when she was drawing up the vaccine she accidentally sprayed some of the vaccine in her eye. Abrysvo presentation: Act-O-Vial Stated that this occurred around 10:30am-10:45am today, 12Nov2025. Causality for "she accidentally sprayed some of the vaccine in her eye" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
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| 2873920 | 85 | F | TX | 11/20/2025 |
COVID19 |
PFIZER\BIONTECH |
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Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
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This is the first time she got Covid; This is the first time she got Covid; This is a spontaneous re...
This is the first time she got Covid; This is the first time she got Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 86-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "This is the first time she got Covid". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 02Nov2025 to 06Nov2025. Clinical course: Patient had 5 of the Pfizer covid vaccines. This was the first time she got Covid. She didn't know how she got it because she lived alone and didn't go out that much. She was pretty sick and this stuff, when she started taking it she had a fever and a bad headache and by the next day they were gone. Took it for 5 days. She had a cough that was getting better, she could hardly talk so she didn't call sooner. She got a cough afterwards and thought that was part of the deal. She went to a party the day before and woke up the next day feeling hot. Her boyfriend said she might have a fever and she was 100.2 so she tested for Covid and it took 2 seconds and it was positive.
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| 2873921 | M | 11/20/2025 |
FLUX PNC20 |
UNKNOWN MANUFACTURER PFIZER\WYETH |
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Jaundice; Jaundice
Jaundice; Jaundice
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jaundice; This is a spontaneous report received from a Consumer or other non HCP from a sales repres...
jaundice; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An elderly male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 27Oct2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Oct2025 as dose number unknown, single 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: JAUNDICE (hospitalization) with onset 03Nov2025, outcome "unknown". It was unknown if therapeutic measures were taken as a result of jaundice. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2873922 | 72 | F | NY | 11/20/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9548 |
Diarrhoea, Nausea, Tachycardia, Vomiting, Weight decreased
Diarrhoea, Nausea, Tachycardia, Vomiting, Weight decreased
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Vomiting/vomit came out of her mouth/after vomit, all night; Started her tachycardia; lost in one ni...
Vomiting/vomit came out of her mouth/after vomit, all night; Started her tachycardia; lost in one night 4 to 5 pounds; diarrhea/(withheld came out of her (withheld); Was so nauseous afterward she couldn't lift her head/ still sick and I am still nauseous 5 days later; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 09Nov2025 as dose 1, single (Lot number: MY9548, Expiration Date: 26Jun2026) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "immuno-compromised" (unspecified if ongoing); "Ig G deficiency" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: GAMUNEX taken for immune system disorder, igg deficiency. The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: 2020, for COVID-19 immunization, reaction(s): "sick"; Bnt162b2 (Dose 2, Single), administration date: 2021, for COVID-19 immunization, reaction(s): "sick"; Bnt162b2 (Dose 3 (Booster), Single), administration date: 2022, for COVID-19 immunization, reaction(s): "sick"; Bnt162b2 (Dose 4 (Booster), Single), administration date: 2023, for COVID-19 immunization, reaction(s): "sick"; Bnt162b2 (Dose 5 (Booster), Single), administration date: 2024, for COVID-19 immunization, reaction(s): "sick". The following information was reported: TACHYCARDIA (non-serious) with onset Nov2025, outcome "unknown", described as "Started her tachycardia"; VOMITING (medically significant) with onset Nov2025, outcome "not recovered", described as "Vomiting/vomit came out of her mouth/after vomit, all night"; NAUSEA (non-serious) with onset Nov2025, outcome "not recovered", described as "Was so nauseous afterward she couldn't lift her head/ still sick and I am still nauseous 5 days later"; DIARRHOEA (non-serious) with onset Nov2025, outcome "not recovered", described as "diarrhea/(withheld) came out of her (withheld)"; WEIGHT DECREASED (non-serious) with onset Nov2025, outcome "unknown", described as "lost in one night 4 to 5 pounds". Therapeutic measures were taken as a result of vomiting. Clinical course: She claimed COVID-19 vaccine Comirnaty made her and her husband exceptionally sick. She was sick for 4 and a half days. She was vomiting. She was having diarrhea. She was very sick. She lost in one night 4 to 5 pounds. She was so nauseous afterward she couldn't lift her head. She mentioned this vaccine is dangerous, if it was given to an older person they would have died. She got Gamunex infusion (Treatment) to make her immune system normal. She was like a normal person with that, but with this COVID vaccine, she thought she was going to die. (withheld) came out of her (withheld) and vomit came out of her mouth. It would not stop. She was still sick and still nauseous 5 days later. She was so sick that she had to get an infusion for hydration with a medicine to stop her vomiting, Zofran. This started her tachycardia so. She was just angry because she lost a week of her life and next time she will be taking the Moderna one. She was just not feeling well because she feel like she was going to vomit because even Indocin was not working on her after she had a Zofran yesterday (13Nov2025). Treatment: She had a infusion, yesterday (13Nov2025), she have to go and get an infusion of saline with Zofran and Toradol because she was in so much pain and sick. She can't swallow medicine, because every time she do, she would vomit some since she have had the vaccine. She suffered, and spent a week in bed. She mentioned like after vomit, all night. She feel like she have broken ribs. She have to see a doctor to see if her ribs are broken from vomiting so much. When probed if patient was suffering from any other medical conditions or taking any other medication: She take other medications, but she was healthy. She walk, before she had the shot. She walked 2 miles at the gym and she was healthy 72 years old that cooks and paint and lives her life. She have conditions but she was fine. She was fine, vaccine medicine poisoned her. No Lab work Within 2 weeks. A vaccine she have had, She had vaccine since 2020, that was Pfizer, 2021, 2022, 2023, 2024, none of them made her this sick. She was sick. She was in bed or stayed at home for a day and a half maybe, no big deal. A whole week, from Sunday to Friday is same as getting covid. That's what when She had COVID before, she would be sick for week and then she have complications, it was not good, but this felt like she had COVID. She was immuno-compromised. She get infusions of Gamunex. When she get there every month, so she have a normal immune system but because she was immuno-compromised because Ig G deficiency. She need to take a covid vaccine or she will die. So, She felt she need to take it and she trusted Pfizer. She lost a week of her life in bed.
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| 2873923 | 64 | M | CT | 11/20/2025 |
COVID19 |
PFIZER\BIONTECH |
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Asthenia, Dizziness, Neuralgia
Asthenia, Dizziness, Neuralgia
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Bilateral nerve foot pain on the bottom of feet/ This pain has happened with previous covid injectio...
Bilateral nerve foot pain on the bottom of feet/ This pain has happened with previous covid injections; dizziness; weakness; This is a spontaneous report received from a Consumer or other non HCP. A 64-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "myelopathy" (unspecified if ongoing); "pernicious anemia" (unspecified if ongoing); "radiculopathy" (unspecified if ongoing); "lacunar infractract" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: Aug2020. The following information was reported: NEURALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Bilateral nerve foot pain on the bottom of feet/ This pain has happened with previous covid injections"; DIZZINESS (non-serious) with onset 2021, outcome "unknown"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weakness". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2873925 | ID | 11/20/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9547 |
Device material issue
Device material issue
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syringe that broke when trying to uncap it; This is a spontaneous report received from an Other HCP ...
syringe that broke when trying to uncap it; This is a spontaneous report received from an Other HCP from product quality group. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Lot number: MY9547, Expiration Date: 15Jun2026) for covid-19 immunisation, Device Lot Number: MY9547, Device Expiration Date: 15Jun2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MATERIAL ISSUE (non-serious), outcome "unknown", described as "syringe that broke when trying to uncap it". Causality for "syringe that broke when trying to uncap it" was determined associated to device constituent of BNT162b2 omicron (lp.8.1) (malfunction).
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| 2873926 | PA | 11/20/2025 |
COVID19 |
PFIZER\BIONTECH |
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Breast cancer
Breast cancer
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I found out I had Breast CA a few months after my 2nd dose in 2021.; This is a spontaneous report re...
I found out I had Breast CA a few months after my 2nd dose in 2021.; 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), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: BREAST CANCER (medically significant) with onset 2021, outcome "unknown", described as "I found out I had Breast CA a few months after my 2nd dose in 2021.". Clinical course: The patient stated that "I know they are finding the covid vaccine is possibly linked to helping lung and skin cancer. I think it helped my breast cancer to. I found out I had Breast CA a few months after my 2nd dose in 2021. Everything they know about my type was different than they normally see. I only had 1 lump with type normally there are many. Normally mine kind spreads to surrounding tissue and mine had not. Normally my kind was in lymphnodes, mine was not. They really might want to look into this." The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2873927 | M | KY | 11/20/2025 |
UNK |
UNKNOWN MANUFACTURER |
AX5812A |
Cough, Underdose
Cough, Underdose
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Coughing; Only half of the Afluria dose was administered after the patient; This spontaneous case, i...
Coughing; Only half of the Afluria dose was administered after the patient; This spontaneous case, initially received on 07-Nov-2025, was reported by a health professional and concerns a male patient of unknown age. Concomitant Medications and Medical History were reported as Unknown . Administration of company suspect drug: On 07-Nov-2025, the patient received Afluria (TIV) for Prevention of Influenza Disease, dose: not reported, route of administration: not reported, anatomical location: not reported. Lot number: AX5812A. No additional suspect drugs. Adverse reactions/events and outcomes: On 07-Nov-2025, the patient experienced Coughing (outcome: Unknown), Only half of the Afluria dose was administered after the patient (outcome: Not Reported). The nurse reported that only half of the Afluria dose was administered after the patient began coughing during the administration. Afluria (TIV) action taken: Not Applicable Reporter's assessment: The reporter assessed Coughing, Only half of the Afluria dose was administered after the patient as non-serious and causality was not provided.; Reporter's Comments: Due to the spontaneous nature of the case, event Coughing is considered related for reporting purposes. Only half of the Afluria dose was administered after the patient is not related due to nature of event (special situation).
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| 2873930 | 79 | F | NV | 11/20/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052733 ut8763ha |
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 received an extra dose of flu shot. The received one from their doctor on 10/08/25 and anoth...
Patient received an extra dose of flu shot. The received one from their doctor on 10/08/25 and another dose today 11/20/25. No adverse effects reported at this time.
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| 2873936 | 2 | F | OR | 11/20/2025 |
COVID19 |
MODERNA |
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Blister rupture, Injection site erythema, Injection site vesicles
Blister rupture, Injection site erythema, Injection site vesicles
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Moderna Covid vaccine to 2 year olds thigh. Injection site turned into a very red and large, 3D bli...
Moderna Covid vaccine to 2 year olds thigh. Injection site turned into a very red and large, 3D blister filled with fluid. Blister ruptured 5 days post injection. She still has a very red marking where the blister is healing. Took her to doctor 5 days post injection to look at reaction.
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| 2873941 | 63 | F | MD | 11/20/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cerebrovascular accident, Chronic kidney disease, Dialysis, Glomerular filtratio...
Cerebrovascular accident, Chronic kidney disease, Dialysis, Glomerular filtration rate decreased
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Chronic kidney disease and stroke
Chronic kidney disease and stroke
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✓ | ✓ | ||||
| 2873461 | F | NJ | 11/19/2025 |
PNC20 |
PFIZER\WYETH |
MA2505 |
Chills, Feeling hot, Swelling
Chills, Feeling hot, Swelling
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feeling febrile; chills; swelling; The initial case was missing the following minimum criteria: unsp...
feeling febrile; chills; swelling; The initial case was missing the following minimum criteria: unspecified adverse effect. Upon receipt of follow-up information on 12Nov2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, 0.5 ml single (Lot number: MA2505, Expiration Date: 30Sep2026) intramuscular for immunisation, Device Lot Number: MA2505, Device Expiration Date: 30Sep2026. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (medically significant) with onset 16Sep2025, outcome "recovering"; PYREXIA (medically significant) with onset 16Sep2025, outcome "recovering", described as "feeling febrile"; SWELLING (medically significant) with onset 16Sep2025, outcome "recovering". The events "feeling febrile", "chills" and "swelling" required emergency room visit. Therapeutic measures were taken as a result of pyrexia, chills, swelling. Clinical course: the patient experienced an adverse event after taking a Pfizer product. The patient was not taking any other medications within 2 weeks prior to the event onset. No other diagnosed illnesses/medical history/chronic health conditions. On16Sep2025, feeling febrile and had chills, swelling, progressively worsened. The patient went to ER on 19Sep2025. The event was reported as non-serious. The patient underwent the treatment for the adverse events which included IV fluids and antibiotics. Causality for "feeling febrile", "chills" and "swelling" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
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| 2873462 | M | GA | 11/19/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Antinuclear antibody, Biopsy skin, Full blood count, Histology, Metabolic functi...
Antinuclear antibody, Biopsy skin, Full blood count, Histology, Metabolic function test; Morphoea, Physical examination, Red blood cell sedimentation rate
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novel occurrence of generalized morphea profunda arising in close temporal association with the COVI...
novel occurrence of generalized morphea profunda arising in close temporal association with the COVID-19 messenger ribonucleic acid vaccination series; This is a literature report for the following literature source(s). An 80-year-old man with coronary artery disease and insulin-dependent type II diabetes mellitus presented with numerous areas of firm, tight skin across his trunk and extremities with associated itching and burning. His first lesion developed on his left forearm approximately one month after completing the Pfizer-BioNTech COVID-19 mRNA vaccination series. The lesions then spread to both upper extremities, both lower extremities, and across his waistline. As the plaques enlarged and thickened, he reported significant nocturnal pruritus and feelings of stiffness with movement. He denied any preceding illnesses, including COVID-19, and denied any other recent vaccinations. He also denied symptoms of systemic sclerosis including stiffness of his fingers, shortness of breath, Raynaud phenomenon, and joint pain/swelling. Of note, the patient was previously seen by an outside dermatologist who biopsied the patient and histopathology from his right forearm was read as septal panniculitis consistent with erythema nodosum; he sought a second opinion prior to receiving any treatment. Physical examination revealed indurated, hyperpigmented plaques on the bilateral dorsal forearms, symmetric, indurated plaques with central areas of porcelain-white color change on the anterior waistline, and indurated plaques with sclerotic yellow centers and erythematous borders on the bilateral legs. There was no evidence of sclerodactyly or inflammatory arthritis. Punch biopsies of the left anterior leg and calf showed thickened collagen bundles in the reticular dermis, diminished periadnexal fat, and a perivascular and interstitial mononuclear cell infiltrate. The hyalinizing fibrosing reaction extended into the fat and was manifested by a striking pattern of expansion of the interlobular septa of the fat by dense collagen. Complete blood count, comprehensive metabolic panel, erythrocyte sedimentation rate, and antinuclear antibody were within normal limits. Based on clinical presentation, histopathology, and laboratory testing, the patient was diagnosed with generalized morphea profunda and started on methotrexate 10mg weekly, titrated to 15mg weekly within 8 weeks. Prednisone was avoided owing to concerns for hyperglycemia in the setting of diabetes mellitus. After four weeks of treatment, the patient's symptoms of pruritus and burning were improved. At 14-month follow-up, the involved sites were softer, less indurated, and nearly asymptomatic.; Sender's Comments: The event morphoea is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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| 2873463 | 11/19/2025 |
UNK |
UNKNOWN MANUFACTURER |
948402 |
Thyroiditis subacute
Thyroiditis subacute
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Subacute thyroiditis; This spontaneous case, initially received on 07-Nov-2025, was reported by a no...
Subacute thyroiditis; This spontaneous case, initially received on 07-Nov-2025, was reported by a non-health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On 16-Oct-2025, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: Not reported, Route of administration: Intramuscular, Anatomical site: Left Deltoid, Lot number: 948402. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced subacute thyroiditis (outcome: Not Reported). The patient developed subacute thyroiditis a few days after flu shot. The patient was in the midst of testing/ultrasound however this is the current diagnosis and it's not fun to say the least. The patient received the flu shot at patient current workplace. The patient had submitted a VAERS adverse event form online. The patient can't find much literature on the web about subacute thyroiditis following flu vaccine and was hoping for some information from you. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, the event is considered related for reporting purposes.
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| 2873490 | 67 | F | 11/19/2025 |
COVID19 COVID19 FLUX FLUX |
PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
LM2216 LM2216 48429CA 48429CA |
Angina pectoris, Blood pressure increased, Blood thyroid stimulating hormone, Bl...
Angina pectoris, Blood pressure increased, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, Free thyroxine index; Hyperthyroidism, Swelling, Tachycardia, Thyroid mass, Thyroiditis subacute; Angina pectoris, Blood pressure increased, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, Free thyroxine index; Hyperthyroidism, Swelling, Tachycardia, Thyroid mass, Thyroiditis subacute
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Subclinical hyperthyroidism/abnormal thyroid labs; Angina/chest pain; subacute thyroiditis; elevated...
Subclinical hyperthyroidism/abnormal thyroid labs; Angina/chest pain; subacute thyroiditis; elevated BP; thyroid nodules; had a low TSH; swelling in her neck; tachycardia/palpitations; Initial information received on 05-Nov-2025 regarding an unsolicited valid serious case received from a physician. This case involves a 67 years old female patient who had subclinical hyperthyroidism/abnormal thyroid labs, angina/chest pain, subacute thyroiditis, elevated bp, tachycardia/palpitations, had a low tsh, swelling in her neck and thyroid nodules while receiving vaccine INFLUENZA VACCINE and while treated with TOZINAMERAN [COMIRNATY]. The patient's past medical treatment included COVID-19 vaccine mRNA on 05-SEP-2021 with Batch: FC3183; Expiry date: 21-oct-2021, COVID-19 vaccine mRNA on 15-APR-2022 with Batch: FJ9943; Exp: 07may2022, COVID-19 vaccine mRNA on 13-OCT-2022 with Lot: Gj3277; Exp: 31jul2023 and COVID-19 vaccine mRNA on 12-OCT-2023 with Lot: GH4664: Exp: 31-dec-2023. The patient's past medical history, vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rash. Concomitant medications included ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]) for Hyperlipidaemia; and VALSARTAN (VALSARTAN) for Hypertension. On an unknown date, the patient started taking COMIRNATY (TOZINAMERAN) Unknown dosage unknown intramuscular for Immunisation. On 12-Sep-2024, the patient received a dose of 0.3 (units unspecified) of suspect Influenza Vaccine produced by unknown manufacturer (lot 48429CA and expiry date- 30-JUN-2025) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation). On an unknown date the patient developed a serious subclinical hyperthyroidism/abnormal thyroid labs (hyperthyroidism), angina/chest pain (angina pectoris), subacute thyroiditis (thyroiditis subacute), elevated bp (blood pressure increased), thyroid nodules (thyroid mass) (unknown latency). On 23-SEP-2024 the patient developed a tachycardia/palpitations (tachycardia) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake (LM2216 and expiry date on 10-Mar-2025) of TOZINAMERAN. On 19-NOV-2024 the patient developed had a low tsh (blood thyroid stimulating hormone decreased), swelling in her neck (swelling), (unknown latency). Relevant laboratory test results included: Blood thyroid stimulating hormone - On an unknown date: 0.09 UNK [o.09] Free thyroxine index - On an unknown date: 1.6 UNK [1.6] Action taken was not applicable. The patient was treated with AMLODIPINE BESILATE (AMLODIPINE [AMLODIPINE BESILATE]) for Blood pressure increased. At time of reporting, the outcome was Recovering / Resolving for the event subclinical hyperthyroidism/abnormal thyroid labs, was Recovering / Resolving for the event had a low tsh, was Unknown for the event swelling in her neck, was Not Recovered / Not Resolved for the event thyroid nodules, was Recovering / Resolving for the event elevated bp, was Recovering / Resolving for the event subacute thyroiditis, was Recovered / Resolved on an unknown date for the event angina/chest pain and was Recovering / Resolving for the event tachycardia/palpitations. Seriousness Criteria- The event of angina pectoris and Hyperthyroidism was considered as medically significant.; Sender's Comments: Sanofi company comment dated 18-NOV-2025: This case involves a 67 years old female patient who had subclinical hyperthyroidism/abnormal thyroid labs, angina/chest pain, subacute thyroiditis, elevated bp, tachycardia/palpitations, had a low tsh, swelling in her neck and thyroid nodules while receiving vaccine INFLUENZA VACCINE and while treated with TOZINAMERAN [COMIRNATY].. Further information regarding allergic history, medical history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
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| 2873552 | 70 | M | MA | 11/19/2025 |
COVID19 |
MODERNA |
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Arthralgia, Headache, Myalgia
Arthralgia, Headache, Myalgia
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headache, muscle aches with some sharp pains, joint aches, fever. Lasted about 48 hours. Took motr...
headache, muscle aches with some sharp pains, joint aches, fever. Lasted about 48 hours. Took motrin 200mg to relieve the pain and aches.
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| 2873567 | 41 | F | FL | 11/19/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Full blood count, Immune thrombocytopenia, Platelet count decreased
Full blood count, Immune thrombocytopenia, Platelet count decreased
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GSK tDAP
GSK tDAP
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✓ | |||||
| 2873570 | 31 | F | MA | 11/19/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EK9231 EL9262 FJ1620 MY9547 |
Arthralgia, Back pain; Arthralgia, Back pain; Arthralgia, Back pain; Arthralgia,...
Arthralgia, Back pain; Arthralgia, Back pain; Arthralgia, Back pain; Arthralgia, Back pain
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I?ve been having chronic shoulder pain since 2021. It is right shoulder and upper back. Have not bee...
I?ve been having chronic shoulder pain since 2021. It is right shoulder and upper back. Have not been to orthopedic since I?m currently unemployed.
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| 2873575 | 14 | F | ME | 11/19/2025 |
COVID19 |
MODERNA |
3052860 |
Incorrect dose administered
Incorrect dose administered
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Patient is 14 years old but was given 25 mcg/0.25mL dose which is for ages 6 months - 11 years old.
Patient is 14 years old but was given 25 mcg/0.25mL dose which is for ages 6 months - 11 years old.
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| 2873577 | 78 | F | GA | 11/19/2025 |
COVID19 |
PFIZER\BIONTECH |
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Mobility decreased, Muscular weakness, Pain in extremity, X-ray limb normal
Mobility decreased, Muscular weakness, Pain in extremity, X-ray limb normal
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The day after the injection my arm was sore more than usual after receiving a vaccine. I have recei...
The day after the injection my arm was sore more than usual after receiving a vaccine. I have received every Covid vaccine so this was unusual. After about 4 days I was unable to raise my arm and my ability grip things was weak. I thought I'd torn my rotator cuff and scheduled a visit with my orthopedic surgeon.
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| 2873578 | 72 | M | AR | 11/19/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase i...
Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Back pain, Blood alkaline phosphatase increased; Blood bilirubin increased, Chromaturia
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day 2 post vaccine- dark brown urine with back and abdominal pain. resolved in 14 days.... day 21 ...
day 2 post vaccine- dark brown urine with back and abdominal pain. resolved in 14 days.... day 21 post vaccine Extremely elevated labs...AST-145; ALT- 452; ALKALINE PHOSPHATASE 272; BIBIRUBIN 1.3. One month earlier labs were all normal. continued back and abdomen discomfort. ultrasound for liver ordered.
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| 2873582 | 44 | M | AL | 11/19/2025 |
COVID19 |
MODERNA |
3052035 |
Immediate post-injection reaction, Injection site reaction, Urticaria
Immediate post-injection reaction, Injection site reaction, Urticaria
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Patient was receiving both flu and covid shots in the same arm (right). Flublok was administered fir...
Patient was receiving both flu and covid shots in the same arm (right). Flublok was administered first with no visible reaction. Immediately upon injecting the mNEXSpike, a noticeable welt formed but patient stated it didn't hurt and he felt fine. RPh recommended icing when he gets home and to inform us of any changes.
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| 2873588 | 82 | F | NJ | 11/19/2025 |
FLU3 |
SANOFI PASTEUR |
UT8794AA |
Chills, Muscular weakness, Pyrexia
Chills, Muscular weakness, Pyrexia
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Patient stated approximately 7pm she had a high fever of 103F , chills and muscle weakness in her le...
Patient stated approximately 7pm she had a high fever of 103F , chills and muscle weakness in her legs. She went to the ER and the dr said it was likely the flu vaccine. She stayed overnight in the hospital
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| 2873593 | 66 | M | ID | 11/19/2025 |
COVID19 |
PFIZER\BIONTECH |
P-NA0738 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Patient was accidentally given covid vaccine instead of prevnar. Patient was informed and did not ha...
Patient was accidentally given covid vaccine instead of prevnar. Patient was informed and did not have any side affects.
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| 2873602 | 11 | F | CO | 11/19/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4459 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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The patient is 11 years of age, and outside of the Comirnaty (12yr + Up) vaccination schedule.
The patient is 11 years of age, and outside of the Comirnaty (12yr + Up) vaccination schedule.
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| 2873604 | F | NE | 11/19/2025 |
DTPPVHBHPB DTPPVHBHPB PNC20 PNC20 RV5 RV5 |
MSP VACCINE COMPANY MSP VACCINE COMPANY PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. |
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Abdominal X-ray, Haematochezia, Intussusception, Rotavirus test positive, Ultras...
Abdominal X-ray, Haematochezia, Intussusception, Rotavirus test positive, Ultrasound abdomen normal; X-ray normal; Abdominal X-ray, Haematochezia, Intussusception, Rotavirus test positive, Ultrasound abdomen normal; X-ray normal; Abdominal X-ray, Haematochezia, Intussusception, Rotavirus test positive, Ultrasound abdomen normal; X-ray normal
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Blood stool with small bowel - small bowel intussusception that resolved spontaneously
Blood stool with small bowel - small bowel intussusception that resolved spontaneously
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| 2873605 | 43 | F | MA | 11/19/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4452 |
Paraesthesia
Paraesthesia
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tingling in toes
tingling in toes
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| 2873607 | 72 | F | IN | 11/19/2025 |
COVID19 COVID19 COVID19 PNC20 PNC20 PNC20 |
MODERNA MODERNA MODERNA PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
3052087 3052087 3052087 LJ5281 LJ5281 LJ5281 |
Asthenia, Blood test normal, Computerised tomogram head normal, Fall, Gait distu...
Asthenia, Blood test normal, Computerised tomogram head normal, Fall, Gait disturbance; Head injury, Loss of consciousness, Pain, Sensory disturbance, Tremor; Vomiting projectile; Asthenia, Blood test normal, Computerised tomogram head normal, Fall, Gait disturbance; Head injury, Loss of consciousness, Pain, Sensory disturbance, Tremor; Vomiting projectile
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Patient received vaccine and said she felt "wavy" on her drive home. By evening time, she ...
Patient received vaccine and said she felt "wavy" on her drive home. By evening time, she felt achy all over and went to bed shaking all over. At 2:30pm, she went to the bathroom but could not get there unassisted. She ended up losing consciousness and fell and hit her head on her ceramic tile bathroom floor. When regaining consciousness, she sat up and projectile vomited everywhere. She said she spent the next day in bed all day due to weakness. She ended up going to the ER 2 days after her vaccine and received a contrast CT scan and blood work. Blood work showed no signs of infection and the CT scan showed no bleeding and no cracked skull. Patient has now recovered.
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| 2873609 | 42 | F | FL | 11/19/2025 |
COVID19 FLU3 HEP HEPA TYP |
MODERNA SEQIRUS, INC. DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
3046714 406982 945656 Z27PB Y2A04P1 |
Condition aggravated, Headache, Hypoaesthesia, Inflammation, Raynaud's phen...
Condition aggravated, Headache, Hypoaesthesia, Inflammation, Raynaud's phenomenon; Condition aggravated, Headache, Hypoaesthesia, Inflammation, Raynaud's phenomenon; Condition aggravated, Headache, Hypoaesthesia, Inflammation, Raynaud's phenomenon; Condition aggravated, Headache, Hypoaesthesia, Inflammation, Raynaud's phenomenon; Condition aggravated, Headache, Hypoaesthesia, Inflammation, Raynaud's phenomenon
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Severe headaches - right side cervicogenic in nature. I had some of these since the February acciden...
Severe headaches - right side cervicogenic in nature. I had some of these since the February accident but way more severe and recurring after the vaccines than ever before. I also had significantly worsening Raynauds symptoms and recurring numbness throughout my full right side of my body, mostly arm and leg. Dr. prescribed Butalb-acetamin-caff to treat the headaches and meloxicam to reduce inflammation. These symptoms persisted for approx. 3 weeks.
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| 2873611 | 1 | M | AZ | 11/19/2025 |
COVID19 |
MODERNA |
3052550 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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accidently administered 12+ COVID vaccine to child; notified my supervisor immediately, and called m...
accidently administered 12+ COVID vaccine to child; notified my supervisor immediately, and called mom to let her know, mom states she is not too worried about it and states she understands that mistakes happen, will go to doctor or ER if child experiences any life threatening emergencies
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| 2873612 | 69 | F | IN | 11/19/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0590 |
Injection site mass, Injection site pain, Paraesthesia
Injection site mass, Injection site pain, Paraesthesia
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Patient came in 3 weeks after receiving vaccine reporting a very tender lump that appeared at the in...
Patient came in 3 weeks after receiving vaccine reporting a very tender lump that appeared at the injection site. She said that it has been very sore for the past week or so. She also reported tingling in her right arm (which is the injection arm) all the way down to her hand.
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| 2873614 | 4 | M | AZ | 11/19/2025 |
COVID19 |
MODERNA |
3052550 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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N/A
N/A
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| 2873620 | 64 | M | MD | 11/19/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR |
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Cardiac stress test, Echocardiogram, Electrocardiogram ambulatory, Heart rate de...
Cardiac stress test, Echocardiogram, Electrocardiogram ambulatory, Heart rate decreased, Implantable cardiac monitor insertion; Ultrasound abdomen; Cardiac stress test, Echocardiogram, Electrocardiogram ambulatory, Heart rate decreased, Implantable cardiac monitor insertion; Ultrasound abdomen
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2 Weeks after vaccination my Apple Watch started notifying me that my heart rate has dropped below 4...
2 Weeks after vaccination my Apple Watch started notifying me that my heart rate has dropped below 45 BPM for more than 10 minutes. These happened on several days so I went and saw my Cardiologist who ran several tests and have now also implanted a loop monitor to further study it. I have a follow up appointment in Dec 2025. These episodes of low heart rate started happening after the vaccines and I could not think of any thing else that might have triggered these. My primary care Dr. advised me to report these so that these could be investigated and studied.
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