| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
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| 2861488 | M | 09/25/2025 |
COVID19-2 |
MODERNA |
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Urticaria
Urticaria
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hives/previously developing hives from a Moderna COVID booster; This spontaneous case was reported b...
hives/previously developing hives from a Moderna COVID booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/previously developing hives from a Moderna COVID booster) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The patient's past medical history included Sinus infection. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (over the past 4-5 years). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included Diabetes. Concomitant products included Methylprednisolone (Medrol) for Sinus infection. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In 2023, the patient experienced URTICARIA (hives/previously developing hives from a Moderna COVID booster). The patient was treated with Fexofenadine hydrochloride (Allegra) in 2023 for Hives, at a dose of 6 weeks. In 2023, URTICARIA (hives/previously developing hives from a Moderna COVID booster) had resolved. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as none. The patient had no medical history, concomitant disease or risk factors. The patient had several shots before without any adverse reactions. Patient was on oral steroids called Medrol Pack while he had his last Moderna COVID-19 vaccine in 2023. A couple of years ago, a patient had the Moderna booster, stating he had several Moderna COVID shots over the past 4-5 years, starting with the original ones that came out in 2020 or 2021. And one of the boosters he received in July of 2023, a couple of weeks after he got that booster, he developed hives. He received multiple vaccines previously without developing hives. When he had the shot, he was on steroids. So, when the patient came off, when he came for a sinus infection, so when he came off the steroids, 2 weeks after that, the hives started. So, it's essentially the same as 2 weeks after the vaccine. The hives stopped. He had no other side effects but just the itching and the hives. Patient switched to Pfizer COVID-19 boosters for the past 2 years and had no reaction aside from the sore arm. He had no systemic reaction from the Pfizer COVID-19 vaccine. It did last like 6 weeks, and it was annoying. Patient had probably about 5 or 6 Moderna COVID-19 vaccines and probably about maybe 3 Pfizer COVID-19 boosters. There were no lab data/results available. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. Patient took Allegra for 6 weeks, an antihistamine before the hives stopped. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2025: Live follow-up received: Patient age updated, and reference id added. On 17-Sep-2025: Live follow-up received: Patient age updated, and current condition added. Suspect drug coding and start date updated and reference id added.
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| 2861489 | 69 | F | CA | 09/25/2025 |
COVID19 COVID19 COVID19 FLUX FLUX FLUX |
MODERNA MODERNA MODERNA UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
3042646 3042646 3042646 |
Biopsy, Breath sounds abnormal, Computerised tomogram, Dizziness, Foot deformity...
Biopsy, Breath sounds abnormal, Computerised tomogram, Dizziness, Foot deformity; Imaging procedure, Magnetic resonance imaging, Malaise, Mobility decreased, Pericardial effusion; Pneumonia; Biopsy, Breath sounds abnormal, Computerised tomogram, Dizziness, Foot deformity; Imaging procedure, Magnetic resonance imaging, Malaise, Mobility decreased, Pericardial effusion; Pneumonia
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emergency pericardio window to drain the fluid around her heart; Flinstone feet; starting not to fee...
emergency pericardio window to drain the fluid around her heart; Flinstone feet; starting not to feel well/ feeling woozy; starting not to feel well/ feeling woozy; The loud sound on her chest; Pneumonia/musculoskeletal chest pain; could not get off the floor or get into bed or anything; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (emergency pericardio window to drain the fluid around her heart) and PNEUMONIA (Pneumonia/musculoskeletal chest pain) in a 69-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch nos. 3042646, 3043391 and 3043391) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. The patient's past medical history included Breast cancer (breast cancer survivor) in 2017 and Surgery (breast cancer survivor and undergone another surgery). Previously administered products included for Product used for unknown indication: Pfizer (Dose 1; Lot number: Pfizer ER2613) on 17-Mar-2021, Pfizer (Dose 2; Lot number: Pfizer EW0153) on 15-Apr-2021, Pfizer (Dose 3; Lot number: Pfizer FF2593) on 29-Oct-2021, Pfizer (Dose 4; Lot number: Pfizer FK9895/FF9895) on 30-Mar-2022, COVID-19 vaccine (Dose 5; Lot number: 6H9702) on 20-Sep-2022, Fluzone high dose (Shot 1) in 2023, RSV (Shot 2) in 2023, RSV (Shot 1) in 2023, Fluzone high dose (Shot 2) in 2023 and Spikevax 2023-2024 PFS (Dose 6; Lot number: Moderna 3030371/3030571) on 22-Sep-2023. Past adverse reactions to the above products included No adverse effect with COVID-19 vaccine, Fluzone high dose, Fluzone high dose, Pfizer, Pfizer, Pfizer, Pfizer, RSV, RSV and Spikevax 2023-2024 PFS. On 29-Aug-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 01-Apr-2025, received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2025, received ninth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) dosage was changed to 1 dosage form. On 04-Sep-2025, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 17-Mar-2025, the patient experienced PNEUMONIA (Pneumonia/musculoskeletal chest pain) (seriousness criterion medically significant) and BREATH SOUNDS ABNORMAL (The loud sound on her chest). In 2025, the patient experienced MOBILITY DECREASED (could not get off the floor or get into bed or anything). On 13-Aug-2025, the patient experienced PERICARDIAL EFFUSION (emergency pericardio window to drain the fluid around her heart) (seriousness criteria hospitalization and medically significant). On 17-Sep-2025, the patient experienced MALAISE (starting not to feel well/ feeling woozy) and DIZZINESS (starting not to feel well/ feeling woozy). On an unknown date, the patient experienced FOOT DEFORMITY (Flinstone feet). The patient was hospitalized from sometime in August 2025 to sometime in August 2025 due to PERICARDIAL EFFUSION. The patient was treated with Surgery (emergency pericardio window to drain the fluid around heart) for Pericardial effusion. At the time of the report, PERICARDIAL EFFUSION (emergency pericardio window to drain the fluid around her heart) had not resolved and PNEUMONIA (Pneumonia/musculoskeletal chest pain), MALAISE (starting not to feel well/ feeling woozy), FOOT DEFORMITY (Flinstone feet), BREATH SOUNDS ABNORMAL (The loud sound on her chest), MOBILITY DECREASED (could not get off the floor or get into bed or anything) and DIZZINESS (starting not to feel well/ feeling woozy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2025, Computerised tomogram: did not saw any break or any problem. In 2025, Imaging procedure: undergone numerous imaging procedures to determine if had a broken rib but the imaging resulted to no broken rib to be found. In 2025, Magnetic resonance imaging: did not saw any break or any problem. On an unknown date, Biopsy: During the biopsy, the doctors found out that the patient had pneumonia. Concomitant medication included antibiotic treatment. The patient went through an emergency pericardio window to drain the fluid around her heart and was in the ICU for 4 days. The fluid around her heart was building up again despite the draining. The procedure emergency pericardio window did not end the problem. The patient never had a problem with heart in her whole life. The patient was a breast cancer survivor and undergone another surgery, biopsy, a month later looking for lung cancer. The patient was currently on antibiotic treatment and had 2 more days left of the regimen, but her coughing had not stopped. On 17-Mar-2025, the patient heard a loud sound on her chest which felt like a broken rib and since then she was not feeling well. She had not been normal since the 17-Mar-2025. The loud sound on her chest was like she was going through chiropractic procedures but was a bit louder. The patient could not get off the floor or get into bed or anything for it seemed like 4 months really bad like she had to beg the doctor for a muscle relaxer just to sleep. As per the patient it might be the pneumonia that was causing a tremendous amount of pain. The patient had flintstone feet which shared to be a very big sign. The patient had to look every single day to see if ankles and feet look swollen because it could happen again. The patient's cardiologist was currently doing all kinds of massive testing like nuclear things. The patient experienced musculoskeletal chest pain (rib cage pain that goes back and forth on the right and left side), chest discomfort due to coughing dyspnea (difficult/labored breathing), dyspnea at rest, dyspnea exertional and lethargy. There was no history of COVID-19 infection nor any history of myocarditis/pericarditis. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2025: Live follow-up received contains non-significant information (reference number was added).; Reporter's Comments: Causality for Pneumonia was assessed as not related, due to lack of biological plausibility. Causality for Pericardial effusion and Breath sounds abnormal 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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| 2861490 | 74 | F | 09/25/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Flushing, Histamine intolerance, Myalgia, Pruritus, Pyrexia; Rash, Swelling face
Flushing, Histamine intolerance, Myalgia, Pruritus, Pyrexia; Rash, Swelling face
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experienced an allergic reaction after 8 hours/bodily itching, flushed face; experienced an allergic...
experienced an allergic reaction after 8 hours/bodily itching, flushed face; experienced an allergic reaction after 8 hours/bodily itching, flushed face; experienced an allergic reaction after 8 hours/ right cheek was not terrible but slightly puffy, swollen on the right side; Histamine reaction; had a rash on legs and arms. It was not like that fine rash. It was more like bigger and elongated rash. It just a weird looking rash; muscular aches; low-grade fever; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (experienced an allergic reaction after 8 hours/bodily itching, flushed face), FLUSHING (experienced an allergic reaction after 8 hours/bodily itching, flushed face), SWELLING FACE (experienced an allergic reaction after 8 hours/ right cheek was not terrible but slightly puffy, swollen on the right side), HISTAMINE INTOLERANCE (Histamine reaction) and RASH (had a rash on legs and arms. It was not like that fine rash. It was more like bigger and elongated rash. It just a weird looking rash) in a 74-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Sep-2025, the patient received fourth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced PRURITUS (experienced an allergic reaction after 8 hours/bodily itching, flushed face), FLUSHING (experienced an allergic reaction after 8 hours/bodily itching, flushed face) and SWELLING FACE (experienced an allergic reaction after 8 hours/ right cheek was not terrible but slightly puffy, swollen on the right side). September 2025, the patient experienced HISTAMINE INTOLERANCE (Histamine reaction), MYALGIA (muscular aches) and PYREXIA (low-grade fever). September 2025, the patient experienced RASH (had a rash on legs and arms. It was not like that fine rash. It was more like bigger and elongated rash. It just a weird looking rash). The patient was treated with Cetirizine hydrochloride (Zyrtec) in September 2025 at an unspecified dose and frequency and Paracetamol (Tylenol) in September 2025 for Itching, at an unspecified dose and frequency. In September 2025, RASH (had a rash on legs and arms. It was not like that fine rash. It was more like bigger and elongated rash. It just a weird looking rash) had resolved. At the time of the report, PRURITUS (experienced an allergic reaction after 8 hours/bodily itching, flushed face), FLUSHING (experienced an allergic reaction after 8 hours/bodily itching, flushed face), SWELLING FACE (experienced an allergic reaction after 8 hours/ right cheek was not terrible but slightly puffy, swollen on the right side), HISTAMINE INTOLERANCE (Histamine reaction), MYALGIA (muscular aches) and PYREXIA (low-grade fever) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient experienced an allergic reaction after 8 hours of vaccination. Allergy was described as bodily itching, flushed face. The patient's right cheek was not terrible but slightly puffy, swollen on the right side. 16 hours after receiving the vaccine, upon waking up, the patient had a rash on legs and arms. It was not like that fine rash. It was more like a bigger and elongated rash, just a weird looking rash. The rash went away within a half hour or so, it did not last. The patient called her doctor and took a Zyrtec that next morning. She did not have any rash on hand on that night, so she just took a Tylenol when she had itching. This was her 4th dose of Moderna vaccine, and she never had a problem with it, and usually experienced the typical muscular aches and a low-grade fever for a little bit. The patient's primary care provider stated that she had a histamine reaction. It was unknown if the patient experienced any additional symptoms/events.
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| 2861491 | 65 | F | 09/25/2025 |
COVID19 |
MODERNA |
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Vaccination site mass, Vaccination site rash, Vaccination site urticaria
Vaccination site mass, Vaccination site rash, Vaccination site urticaria
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"Moderna arm" as a rash at the injection site; later mentioned more like a reaction, like ...
"Moderna arm" as a rash at the injection site; later mentioned more like a reaction, like hot hives; later mentioned more like a reaction, like six-inch bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH ("Moderna arm" as a rash at the injection site), VACCINATION SITE URTICARIA (later mentioned more like a reaction, like hot hives) and VACCINATION SITE MASS (later mentioned more like a reaction, like six-inch bump) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH ("Moderna arm" as a rash at the injection site), VACCINATION SITE URTICARIA (later mentioned more like a reaction, like hot hives) and VACCINATION SITE MASS (later mentioned more like a reaction, like six-inch bump). At the time of the report, VACCINATION SITE RASH ("Moderna arm" as a rash at the injection site), VACCINATION SITE URTICARIA (later mentioned more like a reaction, like hot hives) and VACCINATION SITE MASS (later mentioned more like a reaction, like six-inch bump) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medication was not reported. The patient did not receive any other vaccinations within the past 4 weeks of receiving a Covid-19 shot. It was reported that, patient experienced the Moderna arm with the original Moderna shot several times. First it was described as the Moderna arm as a rash at the injection site but later mentioned more like a reaction, like hot hives and a six-inch bump. Patient was unable to provide the specific year as to when this happened, but it was during the beginning of COVID-19 when Moderna released the first COVID-19 vaccine doses. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. Reporter did not allow further contact
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| 2861492 | F | 09/25/2025 |
COVID19 |
MODERNA |
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Headache, Heavy menstrual bleeding, Menstrual clots, Menstruation delayed, Pelvi...
Headache, Heavy menstrual bleeding, Menstrual clots, Menstruation delayed, Pelvic pain
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pelvic pain; large golf ball size clots; abnormally heavy bleeding; I experienced severe headache; S...
pelvic pain; large golf ball size clots; abnormally heavy bleeding; I experienced severe headache; Started menstruating 2 days later than usual (Tuesday); This spontaneous case was reported by a consumer and describes the occurrence of PELVIC PAIN (pelvic pain), MENSTRUAL CLOTS (large golf ball size clots), MENSTRUATION DELAYED (Started menstruating 2 days later than usual (Tuesday)), HEAVY MENSTRUAL BLEEDING (abnormally heavy bleeding) and HEADACHE (I experienced severe headache) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 12-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 16-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced MENSTRUATION DELAYED (Started menstruating 2 days later than usual (Tuesday)). On 17-Sep-2025, the patient experienced PELVIC PAIN (pelvic pain), MENSTRUAL CLOTS (large golf ball size clots), HEAVY MENSTRUAL BLEEDING (abnormally heavy bleeding) and HEADACHE (I experienced severe headache). The patient was treated with Ketorolac tromethamine (Toradol) at an unspecified dose and frequency. At the time of the report, PELVIC PAIN (pelvic pain), MENSTRUAL CLOTS (large golf ball size clots), MENSTRUATION DELAYED (Started menstruating 2 days later than usual (Tuesday)), HEAVY MENSTRUAL BLEEDING (abnormally heavy bleeding) and HEADACHE (I experienced severe headache) had resolved. No concomitant medications were provided. Patient received vaccine on 12-Sep-2025 (Friday morning). Patient started menstruating 2 days later than usual on 16-Sep-2025 (Tuesday and Wednesday). The patient experienced severe headache and pelvic pain, abnormally heavy bleeding and large golf ball size clots. Patient was sent to the emergency room by an urgent care doctor. Patient received IV fluids and Toradol. It was unknown if the patient experienced any additional symptoms/events.
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| 2861493 | 80 | F | 09/25/2025 |
COVID19 |
MODERNA |
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Vaccination site erythema
Vaccination site erythema
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got that, what they call COVID arm, like, it got red; This spontaneous case was reported by a consum...
got that, what they call COVID arm, like, it got red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (got that, what they call COVID arm, like, it got red) in an 80-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: flu shots (feel a little feverish) and flu shots (sometimes arm is sore for a day). Past adverse reactions to the above products included Feverish with flu shots; and Pain in arm with flu shots. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (got that, what they call COVID arm, like, it got red). The patient was treated with Diphenhydramine hydrochloride (Benadryl) for Vaccination site erythema, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (got that, what they call COVID arm, like, it got red) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not reported. It was reported that patient had 6 or 7 doses in total. Patient's husband had 6 doses. They both had like 6 Moderna shots already. They had missed the last booster. The only reaction she ever had was with the very first shot of Moderna. she got COVID arm like it got red and she had to take some Benadryl, and it went away. After that, she never had any more reactions. She was at the website and was reading the information and it says, if you have had a severe reaction to any dose, she wouldn't call that her arm turned red and had that for a couple of days, but after that, then none of the other shots did it. She was still going to get a vaccine. Patient always gotten flu shots and all these other things, and sometimes her arm was sore for a day or felt a little feverish, for one day, or something like that. But that's been typical of flu shots and any kind of shot. Patient wanted to know the difference between Spikevax and mNEXSPIKE. It was unknown if the patient experienced any additional symptoms/events. Reporter did not allow further contact
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| 2861494 | 76 | F | 09/25/2025 |
COVID19 |
MODERNA |
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Hyperhidrosis, Movement disorder, Myalgia, Nausea
Hyperhidrosis, Movement disorder, Myalgia, Nausea
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profuse sweating; mobility issues; muscle aches; nausea; This spontaneous case was reported by a con...
profuse sweating; mobility issues; muscle aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (profuse sweating), MOVEMENT DISORDER (mobility issues), MYALGIA (muscle aches) and NAUSEA (nausea) in a 76-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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (profuse sweating), MOVEMENT DISORDER (mobility issues), MYALGIA (muscle aches) and NAUSEA (nausea). At the time of the report, HYPERHIDROSIS (profuse sweating), MOVEMENT DISORDER (mobility issues), MYALGIA (muscle aches) and NAUSEA (nausea) was resolving. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient had severe side effects such as profuse sweating, muscle aches, nausea, and mobility issues after receiving the COVID-19 vaccine and was inquiring about the duration of these symptoms. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Reporter causality was not reported.
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| 2861495 | 57 | F | MD | 09/25/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Arthralgia, Fatigue, Myalgia, Vaccination site pain; Arthralgia, Fatigue, Myalgi...
Arthralgia, Fatigue, Myalgia, Vaccination site pain; Arthralgia, Fatigue, Myalgia, Vaccination site pain
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muscle aches; Joint aches; fatigue; Injection site pain starting a few hours after vaccine administr...
muscle aches; Joint aches; fatigue; Injection site pain starting a few hours after vaccine administration; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (muscle aches), ARTHRALGIA (Joint aches), FATIGUE (fatigue) and VACCINATION SITE PAIN (Injection site pain starting a few hours after vaccine administration) in a 57-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. The patient's past medical history included COVID-19 in August 2024. On 20-Sep-2025, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 20-Sep-2025, the patient experienced MYALGIA (muscle aches), ARTHRALGIA (Joint aches), FATIGUE (fatigue) and VACCINATION SITE PAIN (Injection site pain starting a few hours after vaccine administration). The patient was treated with Ibuprofen (Advil) 21-Sep-2025 for Muscle pain, Joint pain and Vaccination site pain, at a dose of 400 milligram once and Ibuprofen (Advil) 22-Sep-2025 for Muscle pain, Joint pain and Vaccination site pain, at a dose of 400 milligram once. In September 2025, MYALGIA (muscle aches), ARTHRALGIA (Joint aches) and FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site pain starting a few hours after vaccine administration) had not 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. No concomitant medications were reported. The patient had no medical history, concomitant disease or risk factor. The patient received Influenza vaccine at the same time in the opposite arm. It was reported that, the patient's injection site pain started a few hours after vaccine administration, followed by muscle aches, joint aches and fatigue. Improved gradually over the next 48 hours. Currently she had mild injection site pain only. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.
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| 2861496 | M | FL | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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Had Covid 3 times; Had Covid 3 times; This is a spontaneous report received from a Consumer or other...
Had Covid 3 times; Had Covid 3 times; This is a spontaneous report received from a Consumer or other non HCP. A 67-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Rheumatoid arthritis; "Overactive bladder" (unspecified if ongoing), notes: Overactive bladder; "Slightly elevated blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure increased. The patient also took other concomitant therapy. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Had Covid 3 times". Therapeutic measures were taken as a result of covid-19, drug ineffective. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500186983 Same patient, drug and event, different dose, separated in time;US-PFIZER INC-202500186984 Same patient, drug and event, different dose, separated in time;
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| 2861497 | M | FL | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood test, COVID-19, Vaccination failure
Blood test, COVID-19, Vaccination failure
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came back positive for Covid; came back positive for Covid; This is a spontaneous report received fr...
came back positive for Covid; came back positive for Covid; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Rheumatoid arthritis; "Overactive bladder" (unspecified if ongoing), notes: Overactive bladder; "Slightly elevated blood pressure" (unspecified if ongoing); "covid 19" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] as dose number unknown, single; LOSARTAN taken for blood pressure increased, start date: 2025. The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 (DOSE 1), for covid-19 immunization; Bnt162b2 (DOSE 2), for covid-19 immunization; Bnt162b2 (DOSE 3), for covid-19 immunization; Bnt162b2 (DOSE 4), for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Sep2025, outcome "unknown" and all described as "came back positive for Covid". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results; COVID-19: (16Sep2025) Positive. Clinical course: Patient reported been vaccinated with Pfizer covid vaccine and has gotten all 5 vaccine. First time with Covid was 2022 or was 2 and half years after Covid pandemic broke out. Had Covid 3 times, got all 5 vaccines. Had it 2 times before this time, this is third time. When clarifying date he was made aware of Covid this time, caller states, earlier in week, was at friend's house, who's wife got sick, he was staying there couple days. Friend called Sunday, to tell him wife tested positive for Covid. It was Tuesday, 16Sep2025, he had sore throat, and same day, took self test that came back positive for Covid. Paxlovid was just prescribed yesterday. Last covid 19 vaccine one was not that long ago. was late last year, 2024, or early this year, 2025. The last time, had both flu shot and Covid booster at same time. Never had any negative reaction to any shot.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500186707 Same patient/AE, different vaccination (dose) and timeframe;
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| 2861498 | M | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, SARS-CoV-2 test, Vaccination failure
COVID-19, SARS-CoV-2 test, Vaccination failure
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tested positive for Covid today/just had Covid shots 2 weeks ago; tested positive for Covid today/ju...
tested positive for Covid today/just had Covid shots 2 weeks ago; tested positive for Covid today/just had Covid shots 2 weeks ago; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Sep2025 as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid, notes: We've taken Paxlovid once before. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Sep2025, outcome "unknown" and all described as "tested positive for Covid today/just had Covid shots 2 weeks ago". The event "tested positive for covid today/just had covid shots 2 weeks ago" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2025) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical courses: The patient tested positive for Covid on 21Sep2025 and the Urgent Care Clinic at the hospital prescribed Paxlovid. He just came home and went to bed. He's not feeling great. The patient has taken Paxlovid once before and he had a good experience seemingly. They have one doctor in (name withheld) who they really respect said, 'If it's Covid, you really got to do the Paxlovid'. The patient just had Covid shots 2 weeks ago. He had the Pfizer. No follow-up attempts are possible.
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| 2861499 | M | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Genital infection fungal, Genital odour, Investigation
Genital infection fungal, Genital odour, Investigation
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Genital yeast infection; I have a stinky penis; This is a spontaneous report received from a Consume...
Genital yeast infection; I have a stinky penis; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENITAL INFECTION FUNGAL (non-serious), outcome "unknown", described as "Genital yeast infection"; GENITAL ODOUR (non-serious), outcome "unknown", described as "I have a stinky penis". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient stated that he was just calling to report some adverse reactions about Pfizer vaccine (Pfizer COVID-19 Vaccine) for COVID." Patient stated, So about 2 days after he gotten the vaccine, he started to, so before he get into all that he just want to let you know that he went to my doctor about it and she provided me with some information and she wanted me to put it in a report will that be okay. Patient stated, Couple of days after he get the vaccine, he started noticing he was dealing with some very heavy genital yeast infection. Patient stated, so when he was went to see his doctor, she did a genital Examination for him. Patient further stated, She did a genital examination for me and during the examination she was concerned because she noticed that his penis was not circumcised and she was also really concerned because she just telling him that it does not just look like he do any cleaning and then she was also telling him he have a stinky penis. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2861500 | F | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Genital infection fungal
Genital infection fungal
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Heavy genital yeast infections; This is a spontaneous report received from a Consumer or other non H...
Heavy genital yeast infections; This is a spontaneous report received from a Consumer or other non HCP. A female patient (unknown if pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENITAL INFECTION FUNGAL (non-serious), outcome "unknown", described as "Heavy genital yeast infections". Additional information: The patient reported that two days after she had the Covid vaccine, she started to experience very heavy genital yeast infections and a whole lot of redness and irritation and itchiness and there was also some discharge that was tested by her doctor. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2861501 | 83 | M | 09/25/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Arthralgia, Headache, Pain, Pain in extremity, Peripheral swelling; Vaccination ...
Arthralgia, Headache, Pain, Pain in extremity, Peripheral swelling; Vaccination site erythema, Vertigo
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his arm was hurting him; redness at the site/injection site redness; he had a tremendous headache; h...
his arm was hurting him; redness at the site/injection site redness; he had a tremendous headache; his whole body ached/whole body ache; vertigo/Developed vertigo; Swelling in my arm; all my joints hurt me; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 83-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 16Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "had knee replacements" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE (Pfizer manufacturer)), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE (Pfizer manufacturer)), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE (Pfizer manufacturer)), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Sep2025, outcome "recovered" (Sep2025), described as "Swelling in my arm"; ARTHRALGIA (non-serious) with onset Sep2025, outcome "unknown", described as "all my joints hurt me"; VERTIGO (non-serious) with onset Sep2025, outcome "not recovered", described as "vertigo/Developed vertigo"; HEADACHE (non-serious) with onset 17Sep2025, outcome "not recovered", described as "he had a tremendous headache"; PAIN IN EXTREMITY (non-serious) with onset 17Sep2025, outcome "unknown", described as "his arm was hurting him"; PAIN (non-serious) with onset 17Sep2025, outcome "recovered" (Sep2025), described as "his whole body ached/whole body ache"; VACCINATION SITE ERYTHEMA (non-serious) with onset 17Sep2025, outcome "recovered" (Sep2025), described as "redness at the site/injection site redness". Additional information: Patient was received the 2025/2026 Comirnaty vaccine a week ago from reported day. The next morning patient got up his arm was hurting him, he had redness at the site, his whole body ached, and he had a tremendous headache. patient stated a week has gone by in which the redness and body aches are gone, however he ended up with vertigo and still has a headache. patient provided that he has received 3 Pfizer Covid-19 vaccines prior to this vaccination and prefers to stick with Pfizer as "they worked." Patient provided that he called his doctor and was waiting for a call back. he was trying to rule out the possibilities of what could be causing these issues and he stated "it could be an ear infection, but he was not sure." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2861502 | F | PA | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9550 |
Hypersensitivity, Urticaria
Hypersensitivity, Urticaria
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developing hives; Non-severe allergic reaction; This is a spontaneous report received from an Other ...
developing hives; Non-severe allergic reaction; This is a spontaneous report received from an Other HCP from medical information team. A 28-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 11Sep2025 as dose 1, 0.3 single (Lot number: MY9550, Expiration Date: 12Jun2026) at the age of 28 intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "seizure disorder" (unspecified if ongoing); "Cerebral palsy" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: HYPERSENSITIVITY (non-serious) with onset 12Sep2025, outcome "not recovered", described as "Non-severe allergic reaction"; URTICARIA (non-serious) with onset 12Sep2025, outcome "not recovered", described as "developing hives". Therapeutic measures were taken as a result of urticaria, hypersensitivity. Additional information: Patient reports she had hives that started within a few days after receiving the vaccine and then has persisted for about a week. Treatment: patient was taking Benadryl at home over the counter when hives started. She was put on a steroid pack and hydroxyzine HCL as of 23Sep2025.Outcome: caller is reading notes from the provider which states the hives rash persisted for approximately two weeks with episodes of disappearance and reemergence. This was clarified and documented as confirmed.
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| 2861503 | F | NJ | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dysgeusia, Dyspnoea, Food allergy
Dysgeusia, Dyspnoea, Food allergy
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Had an alpha-gal allergy reaction; metallic taste in her mouth; shortness of breath; This is a spont...
Had an alpha-gal allergy reaction; metallic taste in her mouth; shortness of breath; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 17Sep2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOOD ALLERGY (non-serious) with onset Sep2025, outcome "unknown", described as "Had an alpha-gal allergy reaction"; DYSGEUSIA (non-serious) with onset Sep2025, outcome "unknown", described as "metallic taste in her mouth"; DYSPNOEA (non-serious) with onset Sep2025, outcome "unknown", described as "shortness of breath". Additional information: Had an alpha-gal allergy reaction and the patient wanted to know if Comirnaty has any mammalian ingredients, namely, any bovine, casein, gelatin ingredients that are the ones that make the patient have a reaction. The patient did some research online before getting the vaccine and it seemed fine, but she had a reaction once she got the vaccine. She was trying to get an idea of what is in the vaccine, trying to narrow down if she had developed an new allergy that could be causing. She had side effects that were not unexpected. She had a metallic taste in her mouth and the more serious adverse effect was shortness of breath. She received the Pfizer covid 19 vaccine last week on Wednesday (17Sep2025) she thought. She did not have lot, ndc, or expiration date to provide. She wanted to ask since she had alpha gal allergy if there is any mammal preparation in the covid 19 vaccine or if the vaccine has any mammalian ingredients. 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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| 2861504 | M | NJ | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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I get my vaccines in the past, I paid- I get from Pfizer/ask for financial assistance for Paxlovid; ...
I get my vaccines in the past, I paid- I get from Pfizer/ask for financial assistance for Paxlovid; I get my vaccines in the past, I paid- I get from Pfizer/ask for financial assistance for Paxlovid; This is a spontaneous report received from a Consumer or other non HCP. A 65-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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE NUMBER UNKNOWN,SINGLE), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I get my vaccines in the past, I paid- I get from Pfizer/ask for financial assistance for Paxlovid". Clinical course: During an inbound call to the Pfizer Service Center, a representative reported having a caller on the line requesting financial assistance for Paxlovid. The call was then transferred to the appropriate department for further support. Once connected, the patient, (Withheld), stated that he was trying to enroll his name and his wife, His wife was the same, she had COVID today, both are. Went to the doctor and he said Both are. Also stated they did not had insurance and later, (Withheld) stated patient have- he get his vaccines in the past, he paid- he get from Pfizer...he was going to call his doctor again, so he was sure what he was going to do. But he has to talk to his doctor because he prescribed him something for (Withheld). 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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| 2861505 | F | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pyrexia
Pyrexia
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fever; This is a spontaneous report received from a Consumer or other non HCP. A female patient rec...
fever; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever". 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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| 2861506 | 09/25/2025 |
MEN |
UNKNOWN MANUFACTURER |
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Incorrect route of product administration
Incorrect route of product administration
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menquadfi 0.1 amount of the vaccine was administered intradermally instead of intramuscularly with n...
menquadfi 0.1 amount of the vaccine was administered intradermally instead of intramuscularly with no reported ae; menquadfi 0.1 amount of the vaccine was administered intradermally instead of intramuscularly with no reported ae; menquadfi 0.1 amount of the vaccine was administered intradermally instead of intramuscularly with no reported ae; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient who had received Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] 0.1 amount of the vaccine was administered intradermally instead of intramuscularly with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.1 (units unspecified) dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection (strength, expiry date and lot number not reported) via intradermal route instead of intramuscularly in unknown administration site for immunization with no reported ae (incorrect route of product administration) (incorrect dose administered) (underdose) (same day latency) . 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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| 2861507 | 75 | F | PA | 09/25/2025 |
FLU3 |
SANOFI PASTEUR |
U8837DA |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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FLUZONE HD injection that was administered inappropriate use due to potential subcutaneous administr...
FLUZONE HD injection that was administered inappropriate use due to potential subcutaneous administration, with no reported adverse event; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 75 years old female patient as INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] injection that was administered inappropriate use due to potential subcutaneous administration, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Sep-2025, the patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE dose 0.5 ml 1x(Once) Suspension for injection in pre-filled syringe (strength unknown) lot U8837DA expiry date-30-Jun-2026 via subcutaneous route in the left arm for immunization inappropriate use due to potential subcutaneous administration, with no reported adverse event (incorrect route of product administration) (same day latency). 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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| 2861508 | 17 | M | TN | 09/25/2025 |
MEN MNQ |
UNKNOWN MANUFACTURER NOVARTIS VACCINES AND DIAGNOSTICS |
U8493AA |
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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received MENQUADFI and Menveo, both meningococcal A, C, W, Y conjugate vaccines, on the same day wit...
received MENQUADFI and Menveo, both meningococcal A, C, W, Y conjugate vaccines, on the same day with no reported AE; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old male patient received Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] and Meningococcal vaccine A/C/Y/W conj (CRM197) [Menveo], both meningococcal A, C, W, Y conjugate vaccines, on the same day with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Sep-2025, the patient received 0.5ml (dose 1) of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection, (unknown strength) expiry date 30-May-2028 and lot U8493AA via intramuscular route in the left arm and received unknown dose of Menveo, not produced by Sanofi Pasteur (unknown forumulation, strength and expiry date) lot number not reported via unknown route in the right arm both for prophylactic vaccination [immunization], on the same day with no reported adverse event (extra dose administered) (Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2861509 | 6 | M | TX | 09/25/2025 |
IPV |
SANOFI PASTEUR |
W1C751M |
Extra dose administered
Extra dose administered
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inappropriate use due to administration of extra dose of IPOL with no reported adverse event; Initia...
inappropriate use due to administration of extra dose of IPOL with no reported adverse event; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 years old male patient who was inappropriately administered an extra dose of IPV (Vero) [IPOL] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) and Influenza vaccine (Flu) for Immunisation. On 23-Sep-2025, the patient received an extra dose of 0.5mL (dose 5) of suspect IPV (Vero), Suspension for injection (lot W1C751M, expiry date 18-Nov-2025, strength standard and frequency once) via intramuscular route in the right deltoid for Immunization, with no reported adverse event (extra dose administered) (latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2861510 | 09/25/2025 |
FLUX |
UNKNOWN MANUFACTURER |
No batch number |
Dyspnoea, Nasopharyngitis
Dyspnoea, Nasopharyngitis
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I get a cold/cold symptoms; I can't even breathe/difficulty breathing; I'm very frail; Thi...
I get a cold/cold symptoms; I can't even breathe/difficulty breathing; I'm very frail; This spontaneous case, initially received on 18-Sep-2025, was reported by a non health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for Indication not reported., Dose regimen: not reported, Route of administration: Unknown, Anatomical location: not reported, Lot number: No batch number available and will not be requested as no consent to follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced I get a cold/cold symptoms (outcome: Unknown), I can't even breathe/difficulty breathing (outcome: Unknown), I'm very frail (outcome: Not Reported). It had been reported that they (the poster) were off to a bad start. Before this happened, the patient had been getting the flu vaccine for a lifetime. Unfortunately, the patient was very frail and when the patient gets a cold, the patient can not even breathe. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter assessed the events I get a cold/cold symptoms, I can't even breathe/difficulty breathing as non-serious and causality was provided as unknown. The reporter did not provide seriousness and causality assessment for event I'm very frail.; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes
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| 2861530 | CA | 09/25/2025 |
HIBV HIBV HIBV |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No additional AE; an inadvertent 3rd dose was administered to a 6-month-old patient today, 9/15/2025...
No additional AE; an inadvertent 3rd dose was administered to a 6-month-old patient today, 9/15/2025; This spontaneous report was received from a physician and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates in 2025, the patient was vaccinated with first and second doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (dose, route of administration, anatomical site, lot # and expiration date were not reported) as prophylaxis. Then, on 15-Sep-2025, the patient inadvertently received a third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), 0.5 mL, total, (route of administration,anatomical site, lot # and expiration date were not reported) as prophylaxis (inappropriate schedule of product administration). No adverse event. Batch/Lot number is being requested and will be submitted if received.
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| 2861531 | NV | 09/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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We had 6 Employees Who Have Received Their First Dose of Heplisav-B, But Are Anywhere From 2-8 Month...
We had 6 Employees Who Have Received Their First Dose of Heplisav-B, But Are Anywhere From 2-8 Months Late In Receiving The Second Dose; Initial report received on 28-Aug-2025. A reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient is late in receiving the second dose. No medical history or concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 28-Aug-2025, after receiving HEPLISAV-B, the reporter noted that the patient, who is an employee, was 2-8 months late in receiving their second dose of HEPLISAV-B. No side effects were reported. Reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2861532 | NV | 09/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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We had 6 Employees Who Have Received Their First Dose of Heplisav-B, But Are Anywhere From 2-8 Month...
We had 6 Employees Who Have Received Their First Dose of Heplisav-B, But Are Anywhere From 2-8 Months Late In Receiving The Second Dose; Initial report received on 28-Aug-2025. A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient is late in receiving the second dose. No medical history or concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 28-Aug-2025, after receiving HEPLISAV-B, the reporter noted that the patient, who is an employee, was 2-8 months late in receiving their second dose of HEPLISAV-B. No side effects were reported. Reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2861533 | NV | 09/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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We had 6 Employees Who Have Received Their First Dose of Heplisav-B, But Are Anywhere From 2-8 Month...
We had 6 Employees Who Have Received Their First Dose of Heplisav-B, But Are Anywhere From 2-8 Months Late In Receiving The Second Dose; Initial report received on 28-Aug-2025. A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient is late in receiving the second dose. No medical history or concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 28-Aug-2025, after receiving HEPLISAV-B, the reporter noted that the patient, who is an employee, was 2-8 months late in receiving their second dose of HEPLISAV-B. No side effects were reported. Reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2861534 | NV | 09/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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We had 6 Employees Who Have Received Their First Dose of Heplisav-B, But Are Anywhere From 2-8 Month...
We had 6 Employees Who Have Received Their First Dose of Heplisav-B, But Are Anywhere From 2-8 Months Late In Receiving The Second Dose; Initial report received on 28-Aug-2025. A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient is late in receiving the second dose. No medical history or concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 28-Aug-2025, after receiving HEPLISAV-B, the reporter noted that the patient, who is an employee, was 2-8 months late in receiving their second dose of HEPLISAV-B. No side effects were reported. Reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2861535 | NV | 09/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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We had 6 Employees Who Have Received Their First Dose of Heplisav-B, But Are Anywhere From 2-8 Month...
We had 6 Employees Who Have Received Their First Dose of Heplisav-B, But Are Anywhere From 2-8 Months Late In Receiving The Second Dose; Initial report received on 28-Aug-2025. A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient is late in receiving the second dose. No medical history or concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 28-Aug-2025, after receiving HEPLISAV-B, the reporter noted that the patient, who is an employee, was 2-8 months late in receiving their second dose of HEPLISAV-B. No side effects were reported. Reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2861536 | M | 09/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Incomplete course of vaccination
Incomplete course of vaccination
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First Dose on July 15th 2025 and Has Not Received Second Dose; Initial report received on 29-Aug-202...
First Dose on July 15th 2025 and Has Not Received Second Dose; Initial report received on 29-Aug-2025. A consumer reported that his son, a male, received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 15-Jul-2025 but has not received the second dose. No medical history or concomitant medications were reported. On 15-Jul-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. As of 29-Aug-2025, 46 days after receiving HEPLISAV-B, the patient has not had the second dose. Reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2861537 | NY | 09/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Incomplete course of vaccination, No adverse event
Incomplete course of vaccination, No adverse event
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Had One Dose of Heplisav-B In June 2025, and Has Not Had Their Second Dose; Initial report received ...
Had One Dose of Heplisav-B In June 2025, and Has Not Had Their Second Dose; Initial report received on 02-Sep-2025. A pharmacist reported that a patient received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not had the second dose. No medical history or concomitant medications were reported. In Jun-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, and site not available)] intramuscularly. At the time of this report on 02-Sep-2025, after receiving HEPLISAV-B, the patient has not had the second dose of HEPLISAV-B. The reporter noted that the patient will be given a different hepatitis B vaccine as the reporter's facility does not carry HEPLISAV-B. No other side effects were reported. Reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2861538 | NY | 09/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
944608 |
Incomplete course of vaccination
Incomplete course of vaccination
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Patient Had First Dose of Heplisav-B in June of 2024, Hasn't Received The Second Dose; Initial ...
Patient Had First Dose of Heplisav-B in June of 2024, Hasn't Received The Second Dose; Initial report received on 02-Sep-2025. A pharmacist reported that a 40-year-old female received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Jun-2024 and has not received the second dose. Medical history included allergies to penicillin, imidazole, and COX-2 inhibitors No concomitant medications were reported. In Jun-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 944608, expiration date 27-Apr-2026; NDC number not available)] intramuscularly in the left deltoid. At the time of this report, the patient had not received the second dose of HEPLISAV-B. The patient had no other side effects reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2861539 | IN | 09/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945664 |
Fatigue, Injection site pain
Fatigue, Injection site pain
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Had One Dose of HEPLISAV-B on 8/29/2025 Another Dose On 8/30/2025; Injection Site Pain; Fatigue; Ini...
Had One Dose of HEPLISAV-B on 8/29/2025 Another Dose On 8/30/2025; Injection Site Pain; Fatigue; Initial report received on 09-Sep-2025. A pharmacist reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and one day later received another dose of HEPLISAV-B. The patient also experienced injection site pain and fatigue. No medical history or concomitant medications were reported. On 29-Aug-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 945664, expiration date 31-Jan-2027, and NDC number 43528-0003-05)] intramuscularly in the left deltoid. On 30-Aug-2025, 1 day after receiving the first dose of HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot number 945664, expiration date 31-Jan-2027, and NDC number 43528-0003-05)] intramuscularly in the left deltoid. The patient received the second dose one day after the first dose at a different pharmacy from the first dose. The reporter stated that the patient also experienced injection site pain and fatigue. No other side effects were reported. No other information was available. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
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| 2861540 | MI | 09/25/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Product storage error
Product storage error
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potentially outside the stability conditions and given to a patient; This non-serious case was repor...
potentially outside the stability conditions and given to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: potentially outside the stability conditions and given to a patient). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 04-SEP-2025 The Vaccine Administration Facility was the same as Primary Reporter The Medical Facility Supervisor reported that a Boostrix vaccine was transferred from the hospital to the office, without any devices to measure the temperature, in a cooler where the ice melted when it got to the office The reporter enquired what happens if the vaccine is administered to a patient.
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| 2861541 | 62 | F | 09/25/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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Headache; Headache
Headache; Headache
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headache that's just not stopping; This spontaneous case was reported by a consumer and describ...
headache that's just not stopping; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache that's just not stopping) in a 62-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache that's just not stopping). At the time of the report, HEADACHE (headache that's just not stopping) had not resolved. No concomitant medication was reported. The patient had a variety of Moderna and Pfizer in the past and had a headache that was not stopping. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to MOD-2025-789595 (Patient Link).
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| 2861542 | M | 09/25/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
8080473 UT8409CA |
COVID-19, Urticaria; COVID-19, Urticaria
COVID-19, Urticaria; COVID-19, Urticaria
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Covid; severe rash and hives/quickly developed into welts/The welts all over his body were recurring...
Covid; severe rash and hives/quickly developed into welts/The welts all over his body were recurring; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid) and URTICARIA (severe rash and hives/quickly developed into welts/The welts all over his body were recurring) in an adult male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080473) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Fluzone) for an unknown indication. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (he did not have any problems in 2023). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included Hypertrophic cardiomyopathy. 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. In 2024, the patient experienced COVID-19 (Covid) and URTICARIA (severe rash and hives/quickly developed into welts/The welts all over his body were recurring). The patient was treated with Diphenhydramine hydrochloride (Benadryl) in 2024 at an unspecified dose and frequency; Levocetirizine dihydrochloride (Xyzal) in 2024 at an unspecified dose and frequency and Famotidine (Pepcid) in 2024 at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid) outcome was unknown and URTICARIA (severe rash and hives/quickly developed into welts/The welts all over his body were recurring) had resolved. He received the Spikevax and flu vaccine on the same day last year and had a 4 1/2-month-long reaction, severe rash and hives. He had taken it every year (the Spikevax vaccine) it had been available, and this was his first adverse reaction. He had a serious heart condition, hypertrophic cardiomyopathy, that puts him at risk (it was genetic). He was on some really powerful drugs that precluded him from taking Paxlovid, so his health professionals wanted him to take Spikevax. It was one of the worst reactions they had ever seen. His symptoms started with rashes at various locations on his body (eyes, lips) and quickly developed into welts. The welts all over his body were recurring. The welts were 2 inches in diameter all over his body, on his eyes and routinely on his lips. He phased off eventually after 4 or 5 months and kept trying alternate and, finally, the reaction subsided in his body, and he was free of the issues. He was symptom-free. The patient did not want to go through COVID again, he had been through it and could not take Paxlovid as he did not want to risk his chance of dying. It was unknown if the patient experienced any additional symptoms/events. The immediate treatment was Benadryl. It made him draggy, sleepy and feel yucky. He was living on Benadryl until he started on Xyzal. He actually started with a daily antihistamine, and it provided him with some relief, but he would still sporadically develop hives. Then he tried Pepcid in addition to that. The cocktail of Xyzal and Pepcid allowed him to stop Benadryl. The overnight antihistamine, Xyzal and Pepcid (an antacid which goes to one of the receptors on the histamine). Reporter causality was not provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789512 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789512:Invalid case with multiple people
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| 2861543 | 11 | M | NJ | 09/25/2025 |
TDAP |
SANOFI PASTEUR |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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The patient received an extra dose of adacel again today with no reported adverse event; Initial in...
The patient received an extra dose of adacel again today with no reported adverse event; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old male patient who administered an extra dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel], again today with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication were provided. On 02-Sep-2025, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation). On 23-Sep-2025 he also received an additional (dose 7) (0.5 ml dose) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, lot number and expiry date not reported , strength: standard, frequency: once, via intramuscular route in the left deltoid for immunization, again today with no reported adverse event (extra dose administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly,Receptionist called on behalf of healthcare provider to report that a patient received an extra dose of adacel. The patient received a dose of on 02-SEP-2025 and again today, 23-SEP-2025. Action taken was Not Applicable This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2861544 | 31 | M | CA | 09/25/2025 |
FLU3 HEP IPV VARCEL |
SEQIRUS, INC. DYNAVAX TECHNOLOGIES CORPORATION SANOFI PASTEUR MERCK & CO. INC. |
406986 946909 Y1A212M Z004245 |
Dizziness, Fall, Loss of consciousness, Syncope, Tremor; Dizziness, Fall, Loss o...
Dizziness, Fall, Loss of consciousness, Syncope, Tremor; Dizziness, Fall, Loss of consciousness, Syncope, Tremor; Dizziness, Fall, Loss of consciousness, Syncope, Tremor; Dizziness, Fall, Loss of consciousness, Syncope, Tremor
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Patient fainted and fell off of his chair immediately after receiving the 4 vaccinations. H regained...
Patient fainted and fell off of his chair immediately after receiving the 4 vaccinations. H regained consciousness after a few seconds but felt dizzy, shaky and was sweating. He was observed for 20 minutes and he recovered. Patient reports fear of needles. His wife came to collect him.
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| 2861545 | 99 | F | TN | 09/25/2025 |
PNC20 |
PFIZER\WYETH |
LX4483 |
Extra dose administered
Extra dose administered
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Was administering vaccines at an assisted living facility and verified the vaccine registry in our p...
Was administering vaccines at an assisted living facility and verified the vaccine registry in our pharmacy management system which stated that this patient was recommended for a pneumonia vaccine with last vaccine reported to registry as being a PCV 13 in 2015. Administered the Prevar 20 and upon billing to medicare was noted that patient had received the lifetime maximum of pnemonia vaccine doses.
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| 2861546 | 3 | F | IL | 09/25/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
2010730 Z008197 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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PATIENT WAS GIVEN VARICELLA AND PROQUAD INSTEAD OF VARICELLA AND MMR.
PATIENT WAS GIVEN VARICELLA AND PROQUAD INSTEAD OF VARICELLA AND MMR.
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| 2861547 | 70 | F | 09/25/2025 |
FLU3 |
SANOFI PASTEUR |
u8764db |
Pain, Pain in extremity
Pain, Pain in extremity
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arm is throbbing
arm is throbbing
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| 2861548 | 51 | F | MD | 09/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
GJ952 |
Erythema, Hypersensitivity, Rash, Rash pruritic
Erythema, Hypersensitivity, Rash, Rash pruritic
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Patient says Flare-ups started on 09/04/2025 with redness and bumps of different parts of the body, ...
Patient says Flare-ups started on 09/04/2025 with redness and bumps of different parts of the body, the arms, the chest and stomach, the legs and groin areas. It was painful and itching.. Patient informed her Doctor who asked her to come in for evaluation. Patient says the Doctor said it was an allergic reaction and recommended Benadryl. Patient says Benadryl helped and says there are still ongoing Flare-ups with itching.
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| 2861549 | 76 | M | 09/25/2025 |
PNC21 RSV |
MERCK & CO. INC. PFIZER\WYETH |
Z002626 MM9167 |
Chills, Hyperhidrosis, Injection site pain, Nausea, Pain; Chills, Hyperhidrosis,...
Chills, Hyperhidrosis, Injection site pain, Nausea, Pain; Chills, Hyperhidrosis, Injection site pain, Nausea, Pain
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Patient had chills, sweating, nausea, aches and pain (pain especially localized at the injection sit...
Patient had chills, sweating, nausea, aches and pain (pain especially localized at the injection site).
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| 2861550 | 80 | F | MI | 09/25/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
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Fall, Loss of consciousness; Fall, Loss of consciousness
Fall, Loss of consciousness; Fall, Loss of consciousness
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Patient fell and was unconscious the morning after getting the vaccines. She went to the hospital.
Patient fell and was unconscious the morning after getting the vaccines. She went to the hospital.
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| 2861551 | 17 | M | NM | 09/25/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
49M9N |
Arthralgia, Myalgia
Arthralgia, Myalgia
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Muscle pain and a 99.8 low grade fever after the vaccine on Thursday 9/18. He developed joint pain a...
Muscle pain and a 99.8 low grade fever after the vaccine on Thursday 9/18. He developed joint pain as well on ankles and wrists. Started feeling pain on Friday. No rash, trouble breathing, or diarrhea.
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| 2861552 | 42 | F | MD | 09/25/2025 |
VARCEL |
MERCK & CO. INC. |
Z008428 |
Injection site erythema, Injection site pruritus, Injection site swelling
Injection site erythema, Injection site pruritus, Injection site swelling
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Patient says she has a red swollen and itchy node on the area of injection.
Patient says she has a red swollen and itchy node on the area of injection.
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| 2861562 | 65 | F | TX | 09/25/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EL 3248 EL 3248 |
Basal cell carcinoma, Haemorrhage, Injection site reaction, Injection site swell...
Basal cell carcinoma, Haemorrhage, Injection site reaction, Injection site swelling, Lymphadenopathy; Pain in extremity
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Reported 1st reaction in 2/2021. NOW reporting Basal cell cancer at injection site as there has alw...
Reported 1st reaction in 2/2021. NOW reporting Basal cell cancer at injection site as there has always been a pea size raised bump there. Been bleeding for no reason at times, but gotten worst over last few weeks and achy arm.
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| 2861563 | 0.75 | F | CA | 09/25/2025 |
HPV9 |
MERCK & CO. INC. |
Y009051 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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HPV was given by mistake; no symptoms or signs were reported.
HPV was given by mistake; no symptoms or signs were reported.
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| 2861564 | 69 | M | PA | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dizziness, Dry mouth, Pain, Vertigo
Dizziness, Dry mouth, Pain, Vertigo
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vertigo, dizziness, faintness, body aches, dry mouth
vertigo, dizziness, faintness, body aches, dry mouth
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| 2861565 | 75 | F | 09/25/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
pk9c5 |
Neck pain, Pain
Neck pain, Pain
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Shooting pain up into the neck
Shooting pain up into the neck
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