| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2861746 | 86 | F | CA | 09/26/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
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Transient ischaemic attack; Transient ischaemic attack
Transient ischaemic attack; Transient ischaemic attack
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TIA
TIA
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| 2861747 | 62 | M | CA | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
U8800CA |
Incorrect dose administered
Incorrect dose administered
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I gave Fluzone high dose instead of regular dose. Patient was 62 y/o with Hx of COPD,Severe alcoho...
I gave Fluzone high dose instead of regular dose. Patient was 62 y/o with Hx of COPD,Severe alcohol use disorder,HTN. But patient hx was not included in the high dose criteria though he's immunocompromise .. Patient was fine and no bad reaction .no side effect.
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| 2861748 | 2 | M | NV | 09/26/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
MB599 |
Extra dose administered
Extra dose administered
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The patient's record was not reviewed correctly, and the dose should not have been administered...
The patient's record was not reviewed correctly, and the dose should not have been administered.
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| 2861749 | 69 | M | 09/26/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Body temperature, COVID-19, Dizziness, Internal haemorrhage, Pericarditis; Pyrex...
Body temperature, COVID-19, Dizziness, Internal haemorrhage, Pericarditis; Pyrexia, Weight
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internal hemorrhage; Patient had Covid about 2 years after his first 2 vaccines/was just a bad cold;...
internal hemorrhage; Patient had Covid about 2 years after his first 2 vaccines/was just a bad cold; extreme dizzy spells; cardiologist diagnosed Pericarditis; fever of 101 degree Fahrenheit to 103 degree Fahrenheit.; This spontaneous case was reported by a consumer and describes the occurrence of INTERNAL HAEMORRHAGE (internal hemorrhage) and PERICARDITIS (cardiologist diagnosed Pericarditis) in a 69-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. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In April 2021, the patient experienced PERICARDITIS (cardiologist diagnosed Pericarditis) (seriousness criterion medically significant). In 2023, the patient experienced COVID-19 (Patient had Covid about 2 years after his first 2 vaccines/was just a bad cold). On an unknown date, the patient experienced INTERNAL HAEMORRHAGE (internal hemorrhage) (seriousness criterion medically significant). In April 2021, the patient experienced DIZZINESS (extreme dizzy spells) and PYREXIA (fever of 101 degree Fahrenheit to 103 degree Fahrenheit.). In 2025, PERICARDITIS (cardiologist diagnosed Pericarditis) had resolved. At the time of the report, INTERNAL HAEMORRHAGE (internal hemorrhage), COVID-19 (Patient had Covid about 2 years after his first 2 vaccines/was just a bad cold), DIZZINESS (extreme dizzy spells) and PYREXIA (fever of 101 degree Fahrenheit to 103 degree Fahrenheit.) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101F to 103F fever. On an unknown date, Weight: Patient had lost like 10 pounds/normal weight was 157 and it went down to 147 because patient did not eat anything for a month. and normal weight was 157. No concomitant medications were reported. Patient's current age reported as 73 years. After the second shot, patient had a severe reaction such as fever, of 101 degree Fahrenheit to 103 degree Fahrenheit. Patient was bedridden for a day. About 4 days afterwards, patient went out for a jog and got extreme dizzy spells running. Patient was a runner, and had been running whole life, and something like that never happened. It kept happening over the next 4 to 6 weeks whenever patient went out for a jog. Patient normally ran 5 miles. At a physical routine, physician referred him to the cardiologist. The cardiologist diagnosed pericarditis. It was reported that the first 1.5 to 2 years were very bad. Patient was never hospitalized. Patient had pericarditis, fluid around the heart, internal bleeding, and really felt bad for quite some time. Most of the worst symptoms when patient tried to play pickleball was getting extremely, extremely dizzy. Patient underwent tests at the hospital and the cardiologist and regular doctor, both agreed that these effects were from the COVID shot. They could prove it to almost 99 percent. Patient also reported having Covid about 2 years after his first 2 vaccines but was never tested for it. Patient played pickleball during COVID. Patient had a bad cold. Patient had survived that phase, but he had lost like 10 pounds. The patient's normal weight was 157. It went down to 147 because he did not eat anything for a month. Patient never got tested for COVID because patient did not believe those tests and did not believe any of the things that doctors were telling about this COVID stuff. Cardiac related signs and symptoms were reported as dizziness, and patient could not even had the strength to go up and down the stairs. The symptoms started from Apr-2021, 4 days after administration of the second Covid vaccine. The symptoms resolved approximately 6 months ago from the point of reporting. Reporter did not allow further contact; Reporter's Comments: The benefit-risk relationship of mRNA-1273 is not affected by this report.
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| 2861750 | 65 | F | AZ | 09/26/2025 |
COVID19 |
MODERNA |
3030368 |
Cerebrovascular accident, Visual impairment
Cerebrovascular accident, Visual impairment
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stroke she is now visually impaired/she cannot see the whole picture there are holes in my vision/do...
stroke she is now visually impaired/she cannot see the whole picture there are holes in my vision/does not have accurate distance or depth perception or contrast of colors anymore; she had a stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (she had a stroke) and VISUAL IMPAIRMENT (stroke she is now visually impaired/she cannot see the whole picture there are holes in my vision/does not have accurate distance or depth perception or contrast of colors anymore) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030368) for COVID-19 prophylaxis. Concurrent medical conditions included Blood pressure abnormal and Allergy (unspecified allergies). On 03-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 10-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced CEREBROVASCULAR ACCIDENT (she had a stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced VISUAL IMPAIRMENT (stroke she is now visually impaired/she cannot see the whole picture there are holes in my vision/does not have accurate distance or depth perception or contrast of colors anymore) (seriousness criterion hospitalization). At the time of the report, CEREBROVASCULAR ACCIDENT (she had a stroke) and VISUAL IMPAIRMENT (stroke she is now visually impaired/she cannot see the whole picture there are holes in my vision/does not have accurate distance or depth perception or contrast of colors anymore) outcome was unknown. Concomitant products included blood pressure medications for blood pressure, and allergy medications for unspecified allergies. It was reported that, prior to the stroke, patient wore glasses but since the stroke patient was now visually impaired. The reporter stated that, medical professionals had told that the stroke damaged the area of brain responsible for vision. The patient did not have accurate distance or depth perception or contrast of colors anymore. When the patient was looking at something, she could not see the whole picture, there were holes in her vision. The patient had been doing everything on her own and had not been given any help. The patient was seriously frustrated all the time because every day, all day, she was struggling to see. The patient honestly believed this was directly related to the vaccine and that she has no proof of that and would likely never have proof of that. It was stated that patient would never again get COVID shot, regardless of brand. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided.; Reporter's Comments: Underlying blood pressure abnormal could be a risk factor for the events. The benefit-risk relationship of product is not affected by this report.
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| 2861751 | 74 | F | PA | 09/26/2025 |
COVID19 |
MODERNA |
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COVID-19, Knee arthroplasty
COVID-19, Knee arthroplasty
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Knee surgery; covid-19/did get COVID/Lack of effect: she had COVID-19 once after 10 vaccines; This s...
Knee surgery; covid-19/did get COVID/Lack of effect: she had COVID-19 once after 10 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of KNEE ARTHROPLASTY (Knee surgery) and COVID-19 (covid-19/did get COVID/Lack of effect: she had COVID-19 once after 10 vaccines) in a 74-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, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced KNEE ARTHROPLASTY (Knee surgery) and COVID-19 (covid-19/did get COVID/Lack of effect: she had COVID-19 once after 10 vaccines). At the time of the report, KNEE ARTHROPLASTY (Knee surgery) and COVID-19 (covid-19/did get COVID/Lack of effect: she had COVID-19 once after 10 vaccines) outcome was unknown. No concomitant medication was reported. It was reported that patient had always gotten Moderna vaccines, the COVID boosters. Patient got COVID and confirmed that she had COVID-19 once after 10 vaccines, it was in the spring of last, not last day, but it was 2, it would be 2 years now. Patient knees were replaced. It was unknown if the patient experienced any additional symptom or events. Patient was going to unspecified therapy. No other treatment information was provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2025: Live non-significant follow-up information received contains reference numbers were added.
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| 2861752 | 70 | F | 09/26/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
3042647 |
Headache, Nausea, Rheumatoid arthritis; Headache, Nausea, Rheumatoid arthritis
Headache, Nausea, Rheumatoid arthritis; Headache, Nausea, Rheumatoid arthritis
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headache; Nausea; rheumatoid arthritis this year (2025); This spontaneous case was reported by a con...
headache; Nausea; rheumatoid arthritis this year (2025); This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis this year (2025)) in an 8-decade-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042647) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On 13-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. In 2025, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis this year (2025)) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) and NAUSEA (Nausea). The patient was treated with Methotrexate sodium (Methotrexate) in 2025 for Rheumatoid arthritis, at an unspecified dose and frequency. In 2025, RHEUMATOID ARTHRITIS (rheumatoid arthritis this year (2025)) had resolved. At the time of the report, HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown. No concomitant medication was reported. The patient got diagnosed with rheumatoid arthritis in year 2025 and she had taken Moderna Covid vaccines before, she was on methotrexate, and she did not believe there was a correlation between the vaccine and arthritis. She said that the diagnosis came later after taking the vaccines. She also experienced fatigue, headache, muscle ache, soreness and tenderness in the arm, nausea, and tiredness after her previous covid vaccines and Flu vaccine. However, she noted that those side effects were not severe enough to require medical assistance or hospitalization. It was unknown if the patient experienced any additional symptoms or events. This case was linked to MOD-2025-789529, MOD-2025-789528, MOD-2025-789530 (Patient Link). Reporter did not allow further contact; Reporter's Comments: Co-suspect product Influenza vaccine is a confounder for the events. The benefit -risk relationship of product is not affected by this report.
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| 2861753 | 65 | M | MA | 09/26/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
3052549 |
Blood pressure measurement, Loss of consciousness; Blood pressure measurement, L...
Blood pressure measurement, Loss of consciousness; Blood pressure measurement, Loss of consciousness
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Loss of consciousness/Cold sweat; This spontaneous case was reported by a consumer and describes the...
Loss of consciousness/Cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness/Cold sweat) in a 65-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1) in January 2021, Moderna COVID-19 vaccine (Dose 3), Moderna COVID-19 vaccine (Dose 7), Moderna COVID-19 vaccine (Dose 5), Moderna COVID-19 vaccine (Dose 6), Moderna COVID-19 vaccine (Dose 2) and Moderna COVID-19 vaccine (Dose 4). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. On 19-Sep-2025, the patient received eighth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 19-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness/Cold sweat) (seriousness criterion medically significant). On 19-Sep-2025, LOSS OF CONSCIOUSNESS (Loss of consciousness/Cold sweat) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 70/50. Concomitant medication was not provided. It was reported that the patient had experienced old sweat and loss of consciousness at a public restaurant and had been transported to the emergency room. The patient had regained consciousness prior to ambulance transport. She was discharged after 4 hours in the emergency room. The doctor had wanted the patient to be admitted. It was further reported that the patient had received the 65+ Flu shot at the same time. Patient underwent Blood test, Urinalysis test, and Chest X-ray at the emergency room; however, no results were reported. It was unknown if the patient experienced any additional symptoms or events. The patient was given IV while enroute to the emergency room. Reporter causality was not reported.; Reporter's Comments: Co-suspect product Influenza vaccine is a confounder for the event. The benefit -risk relationship of product is not affected by this report.
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| 2861754 | 49 | F | HI | 09/26/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA |
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Blood follicle stimulating hormone, Blood pressure measurement, Blood thyroid st...
Blood follicle stimulating hormone, Blood pressure measurement, Blood thyroid stimulating hormone, Body height, Body mass index; Body temperature, HLA-B*27 assay, Haematocrit, Haemoglobin, Heart rate; Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Menopause, Neutrophil count; Oestradiol, Oxygen saturation, Platelet count, Progesterone, Red blood cell count; Red cell distribution width, Respiratory rate, Weight, White blood cell count
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went into menopause; This spontaneous case was reported by a consumer and describes the occurrence o...
went into menopause; This spontaneous case was reported by a consumer and describes the occurrence of MENOPAUSE (went into menopause) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: TDap on 03-Jul-2008; for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1) on 05-Mar-2021 and Moderna COVID-19 vaccine (Dose 2) on 09-Apr-2021; for Drug use for unknown indication: Wellbutrin xl (150 mg XL take 1 tablet every morning with 300 milligram) on 08-Jul-2021, Wellbutrin xl (300 mg XL take 1 tablet by mouth every day) on 08-Jul-2021, Adderall (10 mg Tablet) on 23-Jul-2021, Klonopin (0.5 mg Tablet) on 23-Jul-2021, Flovent hfa (44 mcg/ACT inhale 2 puffs as directed 2 times per day) on 28-Jul-2021, Flonase (50 mcg/ACT 1 spray by per nostril route 1 time per day spray in each nostril) on 11-Jan-2022 and Senna s (Senna 8.6 mg-docusate sodium 50 mg per tablet) on 03-Feb-2022; for Wheezing: Albuterol Hfa (inhale 2 puffs as directed every 4 hrs as needed) on 03-Aug-2021; for Allergy: Zyrtec (take 1 tablet by mouth once per day 10 mg) on 11-Jan-2022. Past adverse reactions to the above products included No adverse effect with Adderall, Albuterol Hfa, Flonase, Flovent hfa, Klonopin, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Senna s, TDap, Wellbutrin xl, Wellbutrin xl and Zyrtec. Concurrent medical conditions included Asthma, Allergy to molds (cough, wheezing High criticality), Cervical facet arthrosis since 12-Sep-2016, Lumbar disc degeneration since 31-Oct-2016, Myofascial pain syndrome since 09-Jan-2017, Iron deficiency since 26-Jan-2018, Post-traumatic stress disorder (PTSD) since 26-Jan-2018, HLA-B*27 positive since 26-Jan-2018, Shoulder pain (Left Shoulder pain unspecified chronicity) on 10-Aug-2018, Ex-smoker (Former Cigarette smoker Quite:) 01-Jan-2001), Allergy (cough, wheezing High critically), Perfume allergy (cough, Headache, Nausea only, wheezing High criticality), Opioid type dependence, Ex-alcohol user (Not Currently 1 (1 unit=0.6 oz pure alcohol)) and Wheezing. Concomitant products included Buprenorphine hydrochloride (Subutex) from 29-Sep-2022 to an unknown date for Opioid type dependence, Salbutamol sulfate (Albuterol) from 10-Jan-2023 to an unknown date for Wheezing, Naproxen (Naprosyn) from 30-Sep-2022 to an unknown date and Vortioxetine hydrobromide (Trintellix) from 29-Sep-2022 to an unknown date for an unknown indication. On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 31-Mar-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MENOPAUSE (went into menopause). At the time of the report, MENOPAUSE (went into menopause) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2018, HLA-B*27 assay: Positive. On 05-Oct-2022, Blood follicle stimulating hormone: 6.3 micro international unit per millilitre. On 05-Oct-2022, Blood pressure measurement: 115/71. On 05-Oct-2022, Blood thyroid stimulating hormone (0.34-5.60 micro international unit per millilitre): 1.95 micro international unit per millilitre TSH normal. FT4 not done. On 05-Oct-2022, Body height: 170.2 centimetre (5'7"). On 05-Oct-2022, Body mass index: 18.32. On 05-Oct-2022, Body temperature: 36.7 degree Celsius. On 05-Oct-2022, Haematocrit (34.1-44.2 %): 39.2 %. On 05-Oct-2022, Haemoglobin (11.6-15.1 g/dL): 12.0 g/dL. On 05-Oct-2022, Heart rate: 81. On 05-Oct-2022, Mean cell haemoglobin (27-33 picogram): 27.0 picogram. On 05-Oct-2022, Mean cell haemoglobin concentration (30-35 g/dL): 30.6 g/dL. On 05-Oct-2022, Mean cell volume (80-100 fL): 88.3 fL. On 05-Oct-2022, Neutrophil count (40-70 %): 40.1 %. On 05-Oct-2022, Oestradiol: 377 picogram per millilitre. On 05-Oct-2022, Oxygen saturation: 97 %. On 05-Oct-2022, Platelet count (150-450 10^9/L): 219 10^9/L. On 05-Oct-2022, Progesterone: 0.20 ng/mL. On 05-Oct-2022, Red blood cell count (3.9-5.2 10^12/L): 4.44 10^12/L. On 05-Oct-2022, Red cell distribution width (11-15 %): 13.9 %. On 05-Oct-2022, Respiratory rate: 14. On 05-Oct-2022, Weight: 53.1 kg (117 lb). On 05-Oct-2022, White blood cell count (3.8-11.2 10^9/L): 5.3 10^9/L. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication included Albuterol Inh (Proventil/Ventolin). Patient never had smokeless tobacco. It was reported that this was patient third Moderna vaccine, a booster shot. Immediately after she took the shot, she went into menopause, that day, with no prior symptoms, five years earlier than usual for her family. This happened in 2022. Patient had the vaccine record somewhere. Patient received the vaccine at clinic in a mall. Patient went to a naturopath, and they were able to jump start her out of menopause with herbs for a few months, but then menopause came on full force again with no prior symptoms. She had since reported these events to her gynecologist and had started Hormone Replacement Therapy. The PHQ-2 total score was 2. It is unknown if there were additional lab data/results available. It was unknown if the patient experienced any additional symptoms/events. The patient did not have any additional medical history, concomitant disease or risk factor.
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| 2861755 | 46 | F | NY | 09/26/2025 |
COVID19 |
MODERNA |
3052586 |
Urticaria
Urticaria
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itchy hives on left & right hands, right underarm & upper arm, right side/torso between hips...
itchy hives on left & right hands, right underarm & upper arm, right side/torso between hips and ribs, left collarbone, left hip and groin area; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (itchy hives on left & right hands, right underarm & upper arm, right side/torso between hips and ribs, left collarbone, left hip and groin area) in a 46-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052586) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer BioNTech COVID-19 vaccine (Dose 1, Lot: EW0150, Site: Left deltoid, Time: 10:10) on 06-Apr-2021, Pfizer BioNTech COVID-19 vaccine (Dose 2, Lot: EW0176 Site: Left deltoid, Time: 5:59 pm) on 30-Apr-2021, Pfizer booster (Dose 3, Lot: FJ8757) on 14-Dec-2021, MMR, Influenza vaccine, Hep B and DTP; for COVID-19 prophylaxis: Moderna bivalent (Dose 4, Lot: 021H22A) on 18-Nov-2022, Spikevax XBB.1.5 (Dose 5, Lot: 3032707) on 24-Nov-2023, Spikevax 2024-2025 formula (Dose 6 and Lot: 3043259) on 21-Sep-2024. Past adverse reactions to the above products included No adverse effect with DTP, Hep B, Influenza vaccine, MMR, Moderna bivalent, Pfizer BioNTech COVID-19 vaccine, Pfizer BioNTech COVID-19 vaccine, Pfizer booster, Spikevax 2024-2025 formula and Spikevax XBB.1.5. On 20-Sep-2025, the patient received seventh dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 21-Sep-2025 at 12:30 AM, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced URTICARIA (itchy hives on left & right hands, right underarm & upper arm, right side/torso between hips and ribs, left collarbone, left hip and groin area). On 21-Sep-2025 at 7:00 AM, URTICARIA (itchy hives on left & right hands, right underarm & upper arm, right side/torso between hips and ribs, left collarbone, left hip and groin area) had resolved. Concomitant medication was not provided. The patient had no medical history, concomitant disease or risk factor. It was reported that the patient had woken up at 12.30 am eastern time on 21-sep-2025 with itchy hives on left and right hands, right underarm and upper arm, right side or torso between hips and ribs, left collarbone, left hip and groin area. The dose had been administered on the patient's left upper arm. Hives had resolved by the time the patient woke up at 7 am on 21-sep-2025. She would monitor whether hives continued to occur. There were no lab data or results available. It was unknown if the patient experienced any additional symptoms or events. It was stated that the hives had not been treated. Reporter causality was not reported. This case was linked to MOD-2025-789550 (Patient Link).
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| 2861756 | 34 | F | MD | 09/26/2025 |
COVID19 COVID19 FLUX FLUX |
MODERNA MODERNA UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Arthralgia, Fatigue, Headache, Myalgia, Nausea; Vaccination site pain; Arthralgi...
Arthralgia, Fatigue, Headache, Myalgia, Nausea; Vaccination site pain; Arthralgia, Fatigue, Headache, Myalgia, Nausea; Vaccination site pain
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injection site pain; muscle aches; Joint aches; headache; nausea; fatigue; This spontaneous case was...
injection site pain; muscle aches; Joint aches; headache; nausea; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (injection site pain), MYALGIA (muscle aches), ARTHRALGIA (Joint aches), HEADACHE (headache) and NAUSEA (nausea) in a 34-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. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On 20-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 50 microgram and dose of Influenza vaccine (unknown route) 1 dosage form. On 20-Sep-2025, the patient experienced VACCINATION SITE PAIN (injection site pain), MYALGIA (muscle aches), ARTHRALGIA (Joint aches), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with Naproxen (oral use) from 21-Sep-2025 to 22-Sep-2025 for Vaccination site pain, Muscle ache and Joint ache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection site pain), MYALGIA (muscle aches), ARTHRALGIA (Joint aches), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications provided by the reporter. It was reported that patient was received influenza vaccine at the same time of Moderna COVID-19 vaccination in the opposite arm. It was reported that the patient experienced symptom of injection site pain after vaccination followed by muscle and joint aches, headache, nausea and fatigue. The Patient took treatment medication of Naproxen orally on 21-Sep-2025 and 22-Sep-2025 for symptoms of injection site pain, muscle and joint aches. The patient did not experience any additional symptoms or events.
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| 2861757 | 57 | M | MD | 09/26/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Arthralgia, Fatigue, Headache, Myalgia, Vaccination site pain; Arthralgia, Fatig...
Arthralgia, Fatigue, Headache, Myalgia, Vaccination site pain; Arthralgia, Fatigue, Headache, Myalgia, Vaccination site pain
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Injection site pain starting a few hours after administration; headache; fatigue; muscle and joint a...
Injection site pain starting a few hours after administration; headache; fatigue; muscle and joint aches; muscle and joint aches; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Injection site pain starting a few hours after administration), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (muscle and joint aches) and ARTHRALGIA (muscle and joint aches) in a 57-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) 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 mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 50 microgram and dose of Influenza vaccine (unknown route) 1 dosage form. On 20-Sep-2025, the patient experienced VACCINATION SITE PAIN (Injection site pain starting a few hours after administration), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (muscle and joint aches) and ARTHRALGIA (muscle and joint aches). The patient was treated with Ibuprofen (Advil) (oral use) on 21-Sep-2025 for Muscle ache and Joint ache, at a dose of 600 milligram. At the time of the report, VACCINATION SITE PAIN (Injection site pain starting a few hours after administration), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (muscle and joint aches) and ARTHRALGIA (muscle and joint aches) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications provided by the reporter. It was reported that patient was received influenza vaccine at the same time of Moderna COVID-19 vaccination in the opposite arm. It was reported that the patient experienced symptom of injection site pain a few hours after vaccination followed by muscle and joint aches, headache, and fatigue. The patient did not experience any additional symptoms or events.
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| 2861758 | 76 | F | 09/26/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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COVID-19, SARS-CoV-2 test; COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test; COVID-19, SARS-CoV-2 test
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I don't feel well. As to COVID disease; This spontaneous case was reported by a consumer and de...
I don't feel well. As to COVID disease; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I don't feel well. As to COVID disease) in a 76-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. No Medical History information was reported. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 22-Sep-2025, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 22-Sep-2025, the patient experienced COVID-19 (I don't feel well. As to COVID disease). At the time of the report, COVID-19 (I don't feel well. As to COVID disease) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2025, SARS-CoV-2 test: Positive. No concomitant medication was reported. She received all the Moderna vaccines available in last year and everything but nothing this year. The patient had Covid, and she took a test on 22-Sep-2025. She was a senior and curious if she needed vaccine after that even though she had tested it. She did not feel well. Regarding the Covid illness she took a test at home and did 2 of them and it was confirmed. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Reporter causality was not reported. Reporter did not allow further contact
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| 2861759 | 70 | F | OR | 09/26/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Cough, Erythema, Lip swelling, Pain, Pruritus; Sneezing, Thirst
Cough, Erythema, Lip swelling, Pain, Pruritus; Sneezing, Thirst
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first thing was like stinging; it felt like stinging nettles to the whole body; excessive thirst, I ...
first thing was like stinging; it felt like stinging nettles to the whole body; excessive thirst, I mean I couldn't drink enough water; swelling lips; bright red palms, feet, ears; right now, I'm just sneezing" and "there's a slight cough; right now, I'm just sneezing" and "there's a slight cough; itching, I mean my eyes were on fire/full body itching/face itching, ears itching, scalp, I mean, full body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (first thing was like stinging; it felt like stinging nettles to the whole body), THIRST (excessive thirst, I mean I couldn't drink enough water), LIP SWELLING (swelling lips), ERYTHEMA (bright red palms, feet, ears) and SNEEZING (right now, I'm just sneezing" and "there's a slight cough) in a 70-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. The patient's past medical history included Surgery (probably the teens) in 2017. Previously administered products included for Drug use for unknown indication: Benadryl in 2017 and EpiPen (she did not use her EpiPen which was last used maybe a year ago.) in 2024; for Product used for unknown indication: Janssen COVID-19 vaccine (Lot number: 0411A21A) on 07-Apr-2021, Pfizer bival (Pfizer bival, Batch number:GL0[or O]447) on 15-Mar-2023 and Pfizer (Batch number: HG9498) on 20-Dec-2023; for COVID-19 prophylaxis: Moderna vaccine (Lot Number : 031H21A) on 03-Dec-2021. Past adverse reactions to the above products included Allergy with Benadryl; and No adverse effect with EpiPen, Janssen COVID-19 vaccine, Moderna vaccine, Pfizer and Pfizer bival. Concurrent medical conditions included Drug allergy (allergic to Benadryl (around 2017)). On 19-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced PAIN (first thing was like stinging; it felt like stinging nettles to the whole body), THIRST (excessive thirst, I mean I couldn't drink enough water), LIP SWELLING (swelling lips), ERYTHEMA (bright red palms, feet, ears), SNEEZING (right now, I'm just sneezing" and "there's a slight cough), COUGH (right now, I'm just sneezing" and "there's a slight cough) and PRURITUS (itching, I mean my eyes were on fire/full body itching/face itching, ears itching, scalp, I mean, full body). The patient was treated with Loratadine in September 2025 at a dose of 10 milligram. At the time of the report, PAIN (first thing was like stinging; it felt like stinging nettles to the whole body), THIRST (excessive thirst, I mean I couldn't drink enough water), LIP SWELLING (swelling lips), ERYTHEMA (bright red palms, feet, ears), SNEEZING (right now, I'm just sneezing" and "there's a slight cough) and COUGH (right now, I'm just sneezing" and "there's a slight cough) outcome was unknown and PRURITUS (itching, I mean my eyes were on fire/full body itching/face itching, ears itching, scalp, I mean, full body) was resolving. It was reported that patient received pneumonia shot vaccination and flu vaccine (NOS) as Concomitant medication for product used for unknown indication within the past 2 weeks before latest Moderna covid-19 Vaccine on Sep-2025. The patient used to carry EpiPens because the patient was highly allergic to just about everything and she did not want to go to the hospital due to an allergic reaction. Patient had a lot of surgery and radiation (all prior to any COVID vaccines) and she was allergic to 58 medications (NOS). Post vaccination patient experienced firstly symptom like stinging; it felt like stinging nettles to the whole body, excessive thirst and patient unable to drink water, the patient had swelling lips, bright red palms, feet, ears, itching. Patient never had a problem with previous COVID Moderna vaccine. After latest Moderna-Covid-19 vaccination patient experienced lip swelling, complete full body itching, complete redness of the hands, face itching, ears itching, scalp, (The patient meant itching full body), like it was stinging nettles. The Patient did not have real bad breathing issues; her eyes were swelled (she felt like somebody poured buckets of sand on her eyes). It was reported that the patient scalp, and her ears were red, and her hands were red. It was reported that currently her symptoms included just sneezing, and there was a slight cough, and it was a slight feeling of the itching which was started to calm down.
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| 2861760 | 24 | M | MD | 09/26/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Arthralgia, Fatigue, Headache, Myalgia, Vaccination site pain; Arthralgia, Fatig...
Arthralgia, Fatigue, Headache, Myalgia, Vaccination site pain; Arthralgia, Fatigue, Headache, Myalgia, Vaccination site pain
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joint pain; headache; fatigue; Injection site pain starting a few hours after administration; muscle...
joint pain; headache; fatigue; Injection site pain starting a few hours after administration; muscle aches; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (joint pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain starting a few hours after administration) and MYALGIA (muscle aches) in a 24-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On 20-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 50 microgram. On an unknown date, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 20-Sep-2025, the patient experienced ARTHRALGIA (joint pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain starting a few hours after administration) and MYALGIA (muscle aches). The patient was treated with Ibuprofen (Advil) (oral use) 21-Sep-2025 for Vaccination site pain and Muscle ache, at a dose of 400 milligram once. On 22-Sep-2025, ARTHRALGIA (joint pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PAIN (Injection site pain starting a few hours after administration) and MYALGIA (muscle aches) had resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications provided by the reporter. It was reported that patient was received influenza vaccine at the same time of Moderna COVID-19 vaccination in the opposite arm. It was reported that the patient experienced symptom of injection site pain a few hours after vaccination followed by muscle and joint aches, headache, and fatigue. The patient did not experience any additional symptoms or events.
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| 2861761 | 65 | F | PA | 09/26/2025 |
COVID19 |
MODERNA |
3052030 |
Dizziness, Incorrect route of product administration, Vaccination site bruising,...
Dizziness, Incorrect route of product administration, Vaccination site bruising, Vaccination site swelling
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administered the vaccine subcutaneous and not intramuscular; dizzy; bump at the injection site and b...
administered the vaccine subcutaneous and not intramuscular; dizzy; bump at the injection site and bruising.; bump at the injection site and bruising; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (dizzy), VACCINATION SITE BRUISING (bump at the injection site and bruising.), VACCINATION SITE SWELLING (bump at the injection site and bruising) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered the vaccine subcutaneous and not intramuscular) in a 65-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052030) for COVID-19 prophylaxis. No Medical History information was reported. On 22-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Subcutaneous use) .2 milliliter. In September 2025, the patient experienced DIZZINESS (dizzy), VACCINATION SITE BRUISING (bump at the injection site and bruising.) and VACCINATION SITE SWELLING (bump at the injection site and bruising). On 22-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered the vaccine subcutaneous and not intramuscular). At the time of the report, DIZZINESS (dizzy), VACCINATION SITE BRUISING (bump at the injection site and bruising.), VACCINATION SITE SWELLING (bump at the injection site and bruising) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered the vaccine subcutaneous and not intramuscular) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Subcutaneous use), the reporter did not provide any causality assessments. The relevant medical history (vaccines within the past 4 weeks, medical conditions) was reported as none. The concomitant medication was not reported by the reporter. The patient said that after receiving the mNEXSPIKE last week, she had a bump at the injection site and bruising. She spoke with the nurse who administered the medication, and the nurse explained that the needle might have hit a fat pocket, that was why the patient had some bruising. The patient also said that after going home, she started seeing stars and felt very dizzy. She was worried that the nurse administered the vaccine subcutaneously instead of intramuscularly. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.
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| 2861762 | 70 | M | 09/26/2025 |
COVID19 |
MODERNA |
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Chest pain, Dysphonia, Speech disorder, Throat tightness, Tongue discomfort
Chest pain, Dysphonia, Speech disorder, Throat tightness, Tongue discomfort
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hoarsness; he was unable to talk; his throat was tight; he has a burning tongue; chest pain; This sp...
hoarsness; he was unable to talk; his throat was tight; he has a burning tongue; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (hoarsness), SPEECH DISORDER (he was unable to talk), THROAT TIGHTNESS (his throat was tight), TONGUE DISCOMFORT (he has a burning tongue) and CHEST PAIN (chest pain) in a 70-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The patient's past medical history included Aortic stenosis. Concurrent medical conditions included Lung cancer and Head and neck cancer. On 08-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 09-Sep-2025, the patient experienced DYSPHONIA (hoarsness), SPEECH DISORDER (he was unable to talk), THROAT TIGHTNESS (his throat was tight), TONGUE DISCOMFORT (he has a burning tongue) and CHEST PAIN (chest pain). The patient was treated with Prednisone at an unspecified dose and frequency. At the time of the report, DYSPHONIA (hoarsness), SPEECH DISORDER (he was unable to talk), THROAT TIGHTNESS (his throat was tight), TONGUE DISCOMFORT (he has a burning tongue) and CHEST PAIN (chest pain) had not resolved. No concomitant medication was reported. It was reported that patient received the vaccine on 08-Sep-2025 and the next day he started having hoarseness, he was unable to talk, his throat was tight, he had a burning tongue and chest pain. It was then stated that at first they thought it was a cold, and patient went to urgent care, and he was prescribed antibiotics and prednisone, but the symptoms continued till today. It was unknown if the patient experienced any additional symptoms/events.
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| 2861763 | F | 09/26/2025 |
PNC20 |
PFIZER\WYETH |
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Swelling
Swelling
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Softball size swelling within a day after vaccination; This is a spontaneous report received from a ...
Softball size swelling within a day after vaccination; This is a spontaneous report received from a Physician from a sales representative. A 54-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (medically significant), outcome "recovered", described as "Softball size swelling within a day after vaccination". Therapeutic measures were taken as a result of vaccination site swelling. Clinical course: Facility where vaccine was administered: Doctor's office/urgent care. Treated with Kelflex Ice and Benadryl. Causality for "softball size swelling within a day after vaccination" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event vaccination site swelling and the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN). 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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| 2861764 | 75 | F | CA | 09/26/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
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COVID-19, Influenza virus test, SARS-CoV-2 test, Vaccination failure
COVID-19, Influenza virus test, SARS-CoV-2 test, Vaccination failure
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COVID-19; COVID-19; This is a spontaneous report received from a consumer from medical information t...
COVID-19; COVID-19; This is a spontaneous report received from a consumer from medical information team. A 75-year-old female patient received BNT162b2 omicron (kp.2) (COVID-19 VACCINE OMICRON KP.2-MANUFACTURER UNKNOWN), in Jul2025 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Sep2025, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Influenza virus test: (22Sep2025) Unknown results; SARS-CoV-2 test: (22Sep2025) Positive. The patient went to a facility yesterday (22Sep2025) as she wasn't feeling well in which she was diagnosed with COVID and prescribed nirmatrelvir/ritonavir (PAXLOVID). The patient has COVID, and she had received a COVID vaccine previously (thinking two months ago was when she got the COVID vaccine but does not remember exactly when). However, she isn't sure who the manufacturer was. The pharmacy was going to charge her over $400 for the Paxlovid in which she did not get. The patient was also prescribed acetaminophen. The patient found that Paxlovid has a program that offers a copay card. The patient was asking if she should go back to her doctor and have them give her Paxlovid once she seeks out financial assistance. Therapeutic measures were taken as a result of covid-19.
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| 2861765 | F | NV | 09/26/2025 |
COVID19 |
PFIZER\BIONTECH |
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Hypersensitivity, Mast cell activation syndrome
Hypersensitivity, Mast cell activation syndrome
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Mast Cell Activation Syndrome; Known allergies; This is a spontaneous report received from an Other ...
Mast Cell Activation Syndrome; Known allergies; This is a spontaneous report received from an Other HCP from a sales representative. A female patient (not 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: MAST CELL ACTIVATION SYNDROME (disability), outcome "not recovered"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Known allergies". Clinical course: Patient believes she acquired Mast Cell Activation Syndrome as a result of the 4 separate Comirnity vaccines she received during the COVID 19 Pandemic. The event result in Disability or permanent damage. The patient had known allergies and she believes this started as a result of the Comirnity vaccination she received during (as reported). Therapeutic measures were taken as a result of mast cell activation syndrome, hypersensitivity included took multiple medications and supplements to keep her condition under control. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event mast cell activation syndrome and the suspect drug BNT162B2 OMICRON (LP.8.1) cannot be excluded. The case will be reassessed once new information is available. 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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| 2861766 | F | 09/26/2025 |
COVID19 |
PFIZER\BIONTECH |
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Gastrointestinal disorder
Gastrointestinal disorder
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gastrointestinal side effects; This is a spontaneous report received from a Pharmacist. A female pa...
gastrointestinal side effects; This is a spontaneous report received from a Pharmacist. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), (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: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "gastrointestinal side effects". It was unknown if therapeutic measures were taken as a result of gastrointestinal disorder. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional information: In meeting with pharmacy regional clinical lead, pharmacist stated that a patient told her she knows of more people who are experiencing gastrointestinal side effects from COVID-19 vaccination this year. No additional information was provided on this AE.
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| 2861767 | 09/26/2025 |
COVID19 |
PFIZER\BIONTECH |
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Autoimmune disorder
Autoimmune disorder
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autoimmune disease; This is a spontaneous report received from a Consumer or other non HCP, Program ...
autoimmune disease; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Clinical course: Covid shot and autoimmune disease
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| 2861768 | F | 09/26/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR |
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Asthenia, Chills, Dizziness, Headache, Myalgia; Vaccination site erythema; Asthe...
Asthenia, Chills, Dizziness, Headache, Myalgia; Vaccination site erythema; Asthenia, Chills, Dizziness, Headache, Myalgia; Vaccination site erythema
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he redness in the injection site was flaming red, not just redness, band in deltoid, and that it las...
he redness in the injection site was flaming red, not just redness, band in deltoid, and that it lasted for 3 days.; muscle ache; head ache; dizziness; chills without fever; feeling weak; This is a spontaneous report received from a Consumer or other non HCP from medical information team. 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; influenza vaccine rha 3v (baculovirus) (FLUBLOK). The patient's family history included: "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered", described as "he redness in the injection site was flaming red, not just redness, band in deltoid, and that it lasted for 3 days."; MYALGIA (non-serious), outcome "unknown", described as "muscle ache"; HEADACHE (non-serious), outcome "unknown", described as "head ache"; DIZZINESS (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown", described as "chills without fever"; ASTHENIA (non-serious), outcome "unknown", described as "feeling weak". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional information: Caller/patient reported that she had redness in the injection site that was flaming red, not just redness, band in deltoid, and that it lasted for 3 days. She wanted to know if this was reported. Caller also mentioned that she had received Flublok on the same arm. Caller wanted some information about Comirnaty 2025-2026 being related to muscle ache, head ache, red injection site, dizziness, chills without fever, feeling weak.
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| 2861769 | 09/26/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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COVID-19, Drug ineffective; COVID-19, Drug ineffective
COVID-19, Drug ineffective; COVID-19, Drug ineffective
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COVID-19 (COVID/had a borderline severe COVID-19); COVID-19 (COVID/had a borderline severe COVID-19)...
COVID-19 (COVID/had a borderline severe COVID-19); COVID-19 (COVID/had a borderline severe COVID-19); This is a spontaneous report received from a Physician. Other Case identifier(s): MOD-2025-789307 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine mrna omicron (jn.1) moderna (SPIKEVAX 2024-2025 FORMULA [COVID-19 VACCINE MRNA OMICRON (JN.1) MODERNA]), as 1 df, single for covid-19 prophylaxis. The patient's relevant medical history included: "Postural orthostatic tachycardia syndrome" (ongoing); "Hypotension" (ongoing); "Marfan's syndrome" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2025, outcome "unknown" and all described as "COVID-19 (COVID/had a borderline severe COVID-19)". Clinical course: In Feb2025, the patient experienced COVID-19 (COVID/had a borderline severe COVID-19). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19, at an unspecified dose and frequency. The patient had suspicion by having all of those boosters and vaccines and prevented contracting COVID before. The patient had COVID one time and suspected that the combination of that and Paxlovid had kept it at bay. The patient had a borderline severe case of COVID-19 and had to take Paxlovid (22 days, but no hospitalization was required) 14 weeks after receiving the Spikevax 2024-2025 vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 OMICRON (KP.2) cannot be fully excluded.
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| 2861770 | F | MO | 09/26/2025 |
MMR MMRV VARCEL |
UNKNOWN MANUFACTURER MERCK & CO. INC. UNKNOWN MANUFACTURER |
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Abortion spontaneous, Antibody test abnormal, Exposure during pregnancy; Abortio...
Abortion spontaneous, Antibody test abnormal, Exposure during pregnancy; Abortion spontaneous, Antibody test abnormal, Exposure during pregnancy; Abortion spontaneous, Antibody test abnormal, Exposure during pregnancy
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the patient has received her MMR and varicella vaccines in the past. The patient was then inadverten...
the patient has received her MMR and varicella vaccines in the past. The patient was then inadvertently given PROQUAD (unknown date) in order to provide a booster for the series.; This spontaneous report was received from a physician assistant (reported as medical assistant and refers to a 27-year-old female patient. The patient's concurrent conditions included drug allergy (minocycline). Historical drugs included minocycline. The patient concomitant therapies, previous drugs reactions and allergies were not reported. On an unknown date (reported as in the past), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (reported as MMR vaccine) (manufacturer unknown, reported as unknown brand name) and with a dose of varicella virus vaccine live (oka-merck) (VARIVAX) (reported as varicella vaccine) (manufacturer unknown reported as unknown brand name) both administered as prophylaxis (strengths, Lot numbers, expirations dates, dose numbers, exact dose quantity volumes, routes and anatomical locations of administration and vaccination scheme frequencies were not provided); that were reconstituted with sterile diluent (Lot No., expiration date, route and indication were not reported). On an unknown date, the patient experienced antibody test abnormal, abortion spontaneous and exposure during pregnancy (captured in PV smart 2331386). On an unknown date, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection (PROQUAD) administered as prophylaxis (Lot No., expiration date, strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided; that were reconstituted with sterile diluent (Lot No., expiration date, route and indication were not reported); in order to provide a booster for the series (product use issue).
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| 2861771 | 15 | M | CA | 09/26/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
LT7C9 |
Wrong product administered
Wrong product administered
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Wrong vaccine administered; This non-serious case was reported by other health professional via call...
Wrong vaccine administered; This non-serious case was reported by other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-year-old male patient who received Men B NVS (Bexsero) (batch number LT7C9, expiry date 31-OCT-2027) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. On 27-AUG-2025, the patient received the 1st dose of Bexsero. The patient did not receive Menveo. On 27-AUG-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Wrong vaccine administered). The outcome of the wrong vaccine administered 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: 28-AUG-2025 The reporter reported that another medical assistant had administered Bexsero to a 15-year-old patient in error instead of Menveo a day before day of reporting.
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| 2861772 | 13 | M | MO | 09/26/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
DD72H |
Wrong product administered
Wrong product administered
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Bexsero instead of Boostrix; This non-serious case was reported by a other health professional via c...
Bexsero instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 13-year-old male patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. Concomitant products included meningococcal vaccine a/c/y/w conj (crm197) (Menveo). On 02-SEP-2025, the patient received the 1st dose of Bexsero. The patient did not receive Boostrix. On 02-SEP-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero instead of Boostrix). The outcome of the wrong vaccine administered 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: 03-SEP-2025 The Medical Assistant explained that on 2nd September 2025 they gave the wrong vaccine to a 13-year-old patient, since patient needed to get Boostrix, but they gave Bexsero instead. Also, caller mentioned that they gave Menveo (1-vial) on the same day. The Medical Assistant was not aware of prior Tetanus, Diphtheria or Pertussis vaccines, or Meningitis B vaccines for this patient.
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| 2861773 | 20 | F | CA | 09/26/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
na5552 406986 |
Asthenia, Dizziness, Dyspnoea; Asthenia, Dizziness, Dyspnoea
Asthenia, Dizziness, Dyspnoea; Asthenia, Dizziness, Dyspnoea
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After receiving the shots ( flu and covid), patient felt faint, weak, was dizzy, short of breath. We...
After receiving the shots ( flu and covid), patient felt faint, weak, was dizzy, short of breath. We had her sit down in the lobby area and we put a chair under her feet, gave her water. Her mom was with her. Every 5-7 minutes the pharmacist went out to check on her. They stayed for about 30 minutes until the patient felt better then went home.
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| 2861774 | 52 | M | AL | 09/26/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Acute disseminated encephalomyelitis, Alcohol intolerance, Aphasia, Atrial fibri...
Acute disseminated encephalomyelitis, Alcohol intolerance, Aphasia, Atrial fibrillation, Blindness unilateral; Carbohydrate intolerance, Central nervous system lesion, Demyelination, Encephalitis autoimmune, Exercise tolerance decreased; Extrasystoles, Fatigue, Gluten sensitivity, Hypoaesthesia, Immunoglobulin therapy; Inflammation, Influenza like illness, Influenza virus test negative, Lactose intolerance, Loss of personal independence in daily activities; Magnetic resonance imaging head abnormal, Mobility decreased, Pyrexia, SARS-CoV-2 test negative, Sensory processing disorder; Temperature intolerance
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12/30/2021 received the Pfizer mRNA booster Lot# FH8028 01/10/2022 Started running low grade fever 0...
12/30/2021 received the Pfizer mRNA booster Lot# FH8028 01/10/2022 Started running low grade fever 01/17/2022 Started running high fever & tested neg for flu/Covid and continued to feel like I had the flu for the next 3 weeks 02/16/2022 Lost my ability to speak and the right side of my body went numb and I thought I was having a stroke 02/17/2022 Neurologist told me I had demyelization occurring in my brain. They ran a battery of test with no conclusive results and sent me home. My condition continued to worsen and I became 90% bedridden. MRI showed 3 areas of lesions 03/15/2021 went to Dr. and he diagnosed me Vaccine Induced Acute Disseminating Encephalitis 04/2022 MRI showed 7 areas of lesions 05/2022 IVIG infusions started 12/2022 Lost visions in my right eye 01/2023 Started low doze steroids' with no help, but it improved my fatigue. 04/2023 MRI showed a slight reduction in inflammation in one area and Dr. started seeing me as a patience per other Dr.'s request. 05/2023 Started having heart issues. My heart skipping beats 06/2023 1st Confirmed AFiB eliminated the use of steroids and was placed on anticoagulant and heart med to stabilize my rhythm. 06/2023 Started Cellcept (Autoimmune Suppressant) 08/2023 MRI showed slight increase and doctors told me that this was Autoimmune Encephalitis and it is a progressive! 10/2023 Started taking LDN At the present I'm still only able to function at 25% of my old normal and have identified that I can no longer tolerant: gluten, alcohol, refined sugars, lactose, temp swings, large events (store, car racing, Football, Concerts, Bars, Restaurants) due to Sensory Integration Disorder, moderate exercise, nor hunting. I'm trapped inside my house on my recliner about 75% of the daylight so my body can rest.
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| 2861775 | 0.25 | M | NY | 09/26/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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given before 6months
given before 6months
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| 2861776 | 71 | F | CA | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
u8830da |
Blood test, Computerised tomogram, Contusion, Prothrombin time, X-ray limb
Blood test, Computerised tomogram, Contusion, Prothrombin time, X-ray limb
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pt came to the pharmacy and showed us a large bruise on her left arm on 9/25/25 claiming that this ...
pt came to the pharmacy and showed us a large bruise on her left arm on 9/25/25 claiming that this occurred after she received the flu shot on 8/31/25.
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| 2861777 | 69 | M | CA | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
U8859AA |
Vomiting
Vomiting
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Patient reported saturated oxygen dropped to 89- blood pressure was measured at 280/128, he was vomi...
Patient reported saturated oxygen dropped to 89- blood pressure was measured at 280/128, he was vomiting every hour for 10-12 hours
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| 2861778 | 66 | F | CA | 09/26/2025 |
UNK |
UNKNOWN MANUFACTURER |
407247 |
Pruritus, Swelling face, Urticaria
Pruritus, Swelling face, Urticaria
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She had facial swelling, hives, and itching.
She had facial swelling, hives, and itching.
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| 2861785 | 18 | M | MN | 09/26/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052669 U8832BA |
Malaise, Pallor; Malaise, Pallor
Malaise, Pallor; Malaise, Pallor
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Patient experienced a loss of color in face following vaccination. He didn't feel well enough ...
Patient experienced a loss of color in face following vaccination. He didn't feel well enough to stand at first. We let him sit for 5 minutes in the vaccination room, and he was able to walk out on his own power. Patient refused 911 call.
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| 2861786 | 54 | F | MN | 09/26/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
U8832AA Z006889 |
Injection site rash, Injection site warmth, Rash erythematous; Injection site ra...
Injection site rash, Injection site warmth, Rash erythematous; Injection site rash, Injection site warmth, Rash erythematous
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Patient received Capvaxive and Flublok both in the right arm on 9/20/25. On 9/26/25, she noticed a b...
Patient received Capvaxive and Flublok both in the right arm on 9/20/25. On 9/26/25, she noticed a bright red rash about 5 inches by 5 inches on her arm where her shots were given. The rash is warm to the touch but she denied pain, itching, or swelling.
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| 2861787 | 2 | M | WA | 09/26/2025 |
FLU3 |
SEQIRUS, INC. |
AX4142A |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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Patient was given the Afluria prefilled syringe of 0.5ml. After the clinic was over and we were bill...
Patient was given the Afluria prefilled syringe of 0.5ml. After the clinic was over and we were billing the vaccines we noticed that the prefilled syringes are only approved for 3 years and up and after further investigation the patient should have received only 0.25 ml from a multidose vial and not the 0.5 ml from the prefilled syringe. Patient in essence received a double dose of the flu vaccine. I called and spoke with the patient's father and made him aware of the situation. Patient is doing great, no adverse events or symptoms came from the incident.
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| 2861788 | 2 | F | WA | 09/26/2025 |
FLU3 |
SEQIRUS, INC. |
AX4142A |
Incorrect dose administered
Incorrect dose administered
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Patient was given the Afluria prefilled syringe of 0.5ml. After the clinic was over and we were bill...
Patient was given the Afluria prefilled syringe of 0.5ml. After the clinic was over and we were billing the vaccines we noticed that the prefilled syringes are only approved for 3 years and up and after further investigation the patient should have received only 0.25 ml from a multidose vial and not the 0.5 ml from the prefilled syringe. Patient in essence received a double dose of the flu vaccine. Called and left a voicemail for the patient's parents to give me a call back to relay the incident and to check on how the child is doing.
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| 2861789 | 64 | F | CA | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
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Incorrect dose administered
Incorrect dose administered
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"I gave the high dose flu shot instead of the regular dose by accident"
"I gave the high dose flu shot instead of the regular dose by accident"
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| 2861790 | 83 | F | CO | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
U8800DA |
Unevaluable event
Unevaluable event
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Nurse provided patient Fluzone HD vaccination at Pharmacy around 4pm. Couple returned to pharmacy a...
Nurse provided patient Fluzone HD vaccination at Pharmacy around 4pm. Couple returned to pharmacy around 5pm with concerns about placement of vaccine. Pharmacist on duty, and nurse reviewed vaccination site on left deltoid and confirmed vaccination site was within two inches of acromion process. Patient did not have physical complaints during examination but was concerns of possible side effects such as bursitis. Pharmacist informed patient to keep the pharmacy team updated if she develops symptoms atypical from routine vaccinations occurring at deltoid (ie. injection site pain, malaise, etc.).
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| 2861791 | 67 | F | VA | 09/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
n77j2 |
Immediate post-injection reaction, Injection site pain, Pain in extremity
Immediate post-injection reaction, Injection site pain, Pain in extremity
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Patient came in September 25 2025 stated that her arm still hurt from the 2nd dose of Shingrix she w...
Patient came in September 25 2025 stated that her arm still hurt from the 2nd dose of Shingrix she was given on August 6 2025. She explained that at the time that the vaccine was given it felt like a "zinger". It was unexpected and immediately felt go down arm and forearm hurt. She explained that she still has a dull ache where injection was and down arm to the elbow. She is going to contact her primary md to ask if needs to be further evaulated.
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| 2861792 | 13 | M | WA | 09/26/2025 |
MMRV |
MERCK & CO. INC. |
Z003310 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Per PCP - No side effects or concerns with Pt history or current
Per PCP - No side effects or concerns with Pt history or current
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| 2861793 | 4 | F | CA | 09/26/2025 |
FLU3 HEPA MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
FH4YR 3255P Z005718 Z003767 |
No adverse event, Wrong patient; No adverse event, Wrong patient; No adverse eve...
No adverse event, Wrong patient; No adverse event, Wrong patient; No adverse event, Wrong patient; No adverse event, Wrong patient
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Medical Assistant administered vaccines to the wrong patient. No adverse reaction. Patient was evalu...
Medical Assistant administered vaccines to the wrong patient. No adverse reaction. Patient was evaluated on 9/26/25 with Dr. (name withheld). No further reaction documented in patient chart.
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| 2861794 | 71 | F | IA | 09/26/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA0587 UT8820CA |
Injected limb mobility decreased, Pain in extremity; Injected limb mobility decr...
Injected limb mobility decreased, Pain in extremity; Injected limb mobility decreased, Pain in extremity
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pain in the arm at a level 7, range of motion decreased in left arm
pain in the arm at a level 7, range of motion decreased in left arm
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| 2861795 | 73 | F | FL | 09/26/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Injection site bruising
Injection site bruising
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Square shallow "blood bruise" at injection site. Still present today 09/26/2025. No swell...
Square shallow "blood bruise" at injection site. Still present today 09/26/2025. No swelling or redness outside of the bruise boundaries. Patient reported no other symptoms.
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| 2861796 | 63 | F | OH | 09/26/2025 |
FLU3 TDAP |
SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
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Fatigue, Limb discomfort, Muscle fatigue, Musculoskeletal discomfort, Neck pain;...
Fatigue, Limb discomfort, Muscle fatigue, Musculoskeletal discomfort, Neck pain; Fatigue, Limb discomfort, Muscle fatigue, Musculoskeletal discomfort, Neck pain
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Approx. 1 week after receiving 2 vaccines, I experienced pain at back of neck that prevented me fro...
Approx. 1 week after receiving 2 vaccines, I experienced pain at back of neck that prevented me from laying on my back. Neck felt swollen. No difficulty swallowing/no difficulty breathing. No headache/no fever noted. Shoulders/Upper arms felt tired/heavy? Fatique. Neck pain lasted 3 nights/2 days. Shoulder tiredness/heaviness lasted about 10 days. (***ps, reference above listed vaccines -- I only know I had a TDP booster shot and a Flu shot. I am not sure of the exact name/manufacturer of the vaccine -- maybe the doctor's office has that information?)
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| 2861797 | 61 | M | IL | 09/26/2025 |
COVID19 |
PFIZER\BIONTECH |
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Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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None stated.
None stated.
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| 2861798 | 31 | F | IL | 09/26/2025 |
COVID19 FLU3 TDAP |
PFIZER\BIONTECH SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
my9550 u8823ca 37r35 |
Syncope; Syncope; Syncope
Syncope; Syncope; Syncope
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patient requested all three vaccines, before administering patient said she never had any issues wit...
patient requested all three vaccines, before administering patient said she never had any issues with vaccines in the past. After administering the vaccine patient seemed fine she got up and walked out of immunization room and around to pharmacy counter or receive her $20 coupon. There was another patient at the counter and she had to wait a minute, she then proceeded to faint. I walked around counter to attend to her. She was breathing and had a pulse. She aroused and responded to my questions in less then a minute. Because she hit her head on the floor the paramedics were called. Stayed with patient laying on the floor till paramedics arrived. Paramedicd sat her up and took her vitals. Paramedic transported her to hospital to be checked out
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| 2861799 | 31 | F | AZ | 09/26/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Y013565 Y013565 |
Arthralgia, Hypoaesthesia, Injection site pain, Local reaction, Lymphadenopathy;...
Arthralgia, Hypoaesthesia, Injection site pain, Local reaction, Lymphadenopathy; Oedema peripheral, Pain, Paraesthesia, Peripheral swelling
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Patient received three vaccines on 09/17/2025: two administered in the right deltoid (influenza vacc...
Patient received three vaccines on 09/17/2025: two administered in the right deltoid (influenza vaccine and Gardasil) and one in the left deltoid (hepatitis B). Patient presented today reporting localized side effects only in the right arm, where two vaccines were administered. Swelling in the right arm, underarm, and associated lymph nodes Tingling sensation at the tips of the fingers Pulsating sensation and intermittent numbness in the fingers Pain in the right shoulder Tenderness and pain upon touch at the right deltoid injection site Symptoms began one day after vaccination Patient reports that taking ibuprofen and applying an ice pack significantly reduces pain
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| 2861800 | 15 | M | MN | 09/26/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0196 EW0196 EW0196 EW0196 EW0196 EW0196 EW0196 EY0584 EY0584 EY0584 EY0584 EY0584 EY0584 EY0584 FJ5682 FJ5682 FJ5682 FJ5682 FJ5682 FJ5682 FJ5682 GL0446 GL0446 GL0446 GL0446 GL0446 GL0446 GL0446 |
Arteriogram carotid, Blood glucose, Blood magnesium, Blood thyroid stimulating h...
Arteriogram carotid, Blood glucose, Blood magnesium, Blood thyroid stimulating hormone, Borrelia test; COVID-19, Chest discomfort, Computerised tomogram head, Computerised tomogram spine, Computerised tomogram thorax; Differential white blood cell count, Drug screen, Dysarthria, Dyspnoea, Electrocardiogram; Fibrin D dimer, Full blood count, Haemoptysis, Hemiparesis, International normalised ratio; Lipids, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test, Platelet count; Prothrombin time, Scan with contrast, Syncope, Transient ischaemic attack, Troponin; Ultrasound Doppler, Vomiting; Arteriogram carotid, Blood glucose, Blood magnesium, Blood thyroid stimulating hormone, Borrelia test; COVID-19, Chest discomfort, Computerised tomogram head, Computerised tomogram spine, Computerised tomogram thorax; Differential white blood cell count, Drug screen, Dysarthria, Dyspnoea, Electrocardiogram; Fibrin D dimer, Full blood count, Haemoptysis, Hemiparesis, International normalised ratio; Lipids, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test, Platelet count; Prothrombin time, Scan with contrast, Syncope, Transient ischaemic attack, Troponin; Ultrasound Doppler, Vomiting; Arteriogram carotid, Blood glucose, Blood magnesium, Blood thyroid stimulating hormone, Borrelia test; COVID-19, Chest discomfort, Computerised tomogram head, Computerised tomogram spine, Computerised tomogram thorax; Differential white blood cell count, Drug screen, Dysarthria, Dyspnoea, Electrocardiogram; Fibrin D dimer, Full blood count, Haemoptysis, Hemiparesis, International normalised ratio; Lipids, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test, Platelet count; Prothrombin time, Scan with contrast, Syncope, Transient ischaemic attack, Troponin; Ultrasound Doppler, Vomiting; Arteriogram carotid, Blood glucose, Blood magnesium, Blood thyroid stimulating hormone, Borrelia test; COVID-19, Chest discomfort, Computerised tomogram head, Computerised tomogram spine, Computerised tomogram thorax; Differential white blood cell count, Drug screen, Dysarthria, Dyspnoea, Electrocardiogram; Fibrin D dimer, Full blood count, Haemoptysis, Hemiparesis, International normalised ratio; Lipids, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test, Platelet count; Prothrombin time, Scan with contrast, Syncope, Transient ischaemic attack, Troponin; Ultrasound Doppler, Vomiting
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received four doses of the Pfizer COVID-19 vaccine: two in 2021, one in 2022, and one in 2023. After...
received four doses of the Pfizer COVID-19 vaccine: two in 2021, one in 2022, and one in 2023. After each vaccination, I experienced chest tightness and vomiting that lasted for about a week. In late August of 2024, I contracted COVID-19. In early September 2024, I began coughing up blood and shortly after that, I suffered a transient ischemic attack (TIA). Since that time, I have continued to experience serious ongoing health issues including episodes of syncope (passing out), shortness of breath, right-sided weakness, and slurred speech following the fainting episodes. As of today, September 26, 2025, I am still dealing with these symptoms. I believe these health issues are connected to the Pfizer COVID-19 vaccinations.
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| 2861801 | 75 | F | NY | 09/26/2025 |
PNC21 |
MERCK & CO. INC. |
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Chest pain, Cough, Myalgia, Respiratory tract congestion
Chest pain, Cough, Myalgia, Respiratory tract congestion
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My chest started hurting, left side, 2 days after I received the shot. Now my right chest sometimes...
My chest started hurting, left side, 2 days after I received the shot. Now my right chest sometimes hurts as well. I feel congestion in my chest, causing me to cough intermittently. I have some muscular pain around my left armpit. The shot was given in my left arm.
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