| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2871089 | 52 | F | CO | 11/06/2025 |
RSV UNK |
GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER |
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Immediate post-injection reaction, Injection site pain, Injection site reaction,...
Immediate post-injection reaction, Injection site pain, Injection site reaction, Muscle spasms; Immediate post-injection reaction, Injection site pain, Injection site reaction, Muscle spasms
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The moment the pharmacist injected on my right arm, I felt extreme pain. The pain was excruciating a...
The moment the pharmacist injected on my right arm, I felt extreme pain. The pain was excruciating and unusual, causing an involuntary scream immediately. It felt like the needle hit a nerve or muscle or something, that caused great discomfort and agony. I felt some sort a spasm accompanied with that pain.
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| 2871091 | 68 | M | CA | 11/06/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052734 UT8804CA |
Deafness neurosensory, Sudden hearing loss; Deafness neurosensory, Sudden hearin...
Deafness neurosensory, Sudden hearing loss; Deafness neurosensory, Sudden hearing loss
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About 15 days (Oct 22) after receiving both the flu and covid vaccines (Oct 7) in same arm, I woke u...
About 15 days (Oct 22) after receiving both the flu and covid vaccines (Oct 7) in same arm, I woke up from a. nap with total deafness in left ear. The very next morning I went to Urgent Care and they referred me to an Audio Lab and a ENT doctor all within 6 hours. I had an MRI done on October 24th which came out with no medical issues with brain. It was determined that I have Sudden Sensorineural Hearing Loss (hearing loss in left ear). I have received 3 steroid injections to left ear, a prednisone prescription for inflammation, and I am receiving FDA approved Hyperbaric Oxygen Therapy sessions. I still have deafness in left ear. Right ears is ok. It should be said that the Audio Lab Doctor confirmed these conclusions .
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| 2871101 | 11/06/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Blindness
Blindness
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Vision loss from the vaccine; This serious case was reported by a consumer via interactive digital ...
Vision loss from the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of loss of vision in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced loss of vision (Verbatim: Vision loss from the vaccine) (serious criteria GSK medically significant). The outcome of the loss of vision was not reported. The reporter considered the loss of vision to be related to Shingles vaccine. The company considered the loss of vision to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 03-NOV-2025 This case was reported by a patient via interactive digital media. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Blindness, unknown time after receiving a dose of Shingles vaccine in a subject. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2871132 | 1 | F | WV | 11/06/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2H2S9 |
Expired product administered
Expired product administered
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Expired dose given; This non-serious case was reported by a physician via call center representativ...
Expired dose given; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 2H2S9, expiry date 11-JUN-2025) for prophylaxis. On 29-OCT-2025, the patient received the 1st dose of FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used 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 MD called to inform about an expired vaccine that was given to a child, it was FluLaval.. Also, reporter mentioned that it was the 1st dose of the patient.
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| 2871141 | F | 11/06/2025 |
FLUX |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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flu shot almost killed me; This serious case was reported by a consumer via interactive digital medi...
flu shot almost killed me; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced near death experience (Verbatim: flu shot almost killed me) (serious criteria GSK medically significant). The outcome of the near death experience was unknown. The reporter considered the near death experience to be related to Flu vaccine. The company considered the near death experience to be unrelated to Flu vaccine. Additional Information: GSK receipt date:26-OCT-2025 This case was reported by a patient via interactive digital media. Consumer reported that a flu shot almost killed her, don't think she will be getting another vaccination. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Near death experience, on an unknown time after receiving Flu vaccine, in an adult female patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.
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| 2871142 | 11/06/2025 |
COVID19 |
MODERNA |
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Troponin, Troponin increased
Troponin, Troponin increased
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elevated troponin; This spontaneous case was reported by a consumer and describes the occurrence of ...
elevated troponin; This spontaneous case was reported by a consumer and describes the occurrence of TROPONIN INCREASED (elevated troponin) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TROPONIN INCREASED (elevated troponin). At the time of the report, TROPONIN INCREASED (elevated troponin) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Troponin: elevated. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. This case contains information for the 1st of 3 patients described by the reporter. Concomitant medications were not reported. It was reported that the data came from a randomized, placebo-controlled phase 4 trial in which researchers measured troponin levels a marker of heart injury. It was reported that after vaccination only three participants showed elevated troponin after receiving the shot, and Pfeiffer was dismissed those as being caused by "physical activity." Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790703, US-MODERNATX, INC.-MOD-2025-790704 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790703:different patient US-MODERNATX, INC.-MOD-2025-790704:different patient
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| 2871143 | 11/06/2025 |
COVID19 |
MODERNA |
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Troponin, Troponin increased
Troponin, Troponin increased
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elevated troponin; This spontaneous case was reported by a non-health professional and describes the...
elevated troponin; This spontaneous case was reported by a non-health professional and describes the occurrence of TROPONIN INCREASED (elevated troponin) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TROPONIN INCREASED (elevated troponin). At the time of the report, TROPONIN INCREASED (elevated troponin) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Troponin: elevated troponin. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. This case contains information for the 2nd out of 3 patients as described by the reporter. Concomitant medications were not reported. It was reported that the data came from a randomized, placebo-controlled phase 4 trial in which researchers measured troponin levels as a marker of heart injury after vaccination. It was reported that after vaccination, only three participants showed elevated troponin after receiving the shot, and that symptom was dismissed as being caused by "physical activity." Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790702 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790702:different patient
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| 2871144 | 11/06/2025 |
COVID19 |
MODERNA |
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Troponin, Troponin increased
Troponin, Troponin increased
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Elevated troponin; This spontaneous case was reported by a consumer and describes the occurrence of ...
Elevated troponin; This spontaneous case was reported by a consumer and describes the occurrence of TROPONIN INCREASED (Elevated troponin) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TROPONIN INCREASED (Elevated troponin). At the time of the report, TROPONIN INCREASED (Elevated troponin) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Troponin: Showed elevated troponin. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. This case contains information for the 3rd of 3 patients described by the reporter. Concomitant medications were not reported. It was reported that the data came from a randomized, placebo-controlled phase 4 trial in which researchers measured troponin levels a marker of heart injury. It was reported that after vaccination only three participants showed elevated troponin after receiving the shot, and Pfeiffer was dismissed those as being caused by "physical activity." Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790702 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790702:Same reporter with different patient (Patient 3 of 3)
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| 2871145 | M | 11/06/2025 |
COVID19 |
MODERNA |
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Vaccination site pain
Vaccination site pain
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Minor sore arm at the injection site; This spontaneous case was reported by a consumer and describes...
Minor sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minor sore arm at the injection site) in a male patient of an unknown age who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Minor sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Minor sore arm at the injection site) outcome was unknown. Concomitant medications were not reported. It was reported that patient would personally like to thank MODERNA for mNexspike vaccine. It was reported that patient had experienced no reaction at all except for a minor sore arm at the injection site. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. This case was linked to MOD-2025-790767 (Patient Link).
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| 2871146 | F | 11/06/2025 |
COVID19 |
MODERNA |
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Malaise, Pyrexia
Malaise, Pyrexia
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feel sort of rotten; run a fever; This spontaneous case was reported by a consumer and describes the...
feel sort of rotten; run a fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel sort of rotten) and PYREXIA (run a fever) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feel sort of rotten) and PYREXIA (run a fever). At the time of the report, MALAISE (feel sort of rotten) and PYREXIA (run a fever) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Patient had no relevant medical history (vaccines within the past 4 weeks, medical conditions). Patient had flu shot last year 07-Oct-2024 (Fluzone HD) 65+. No concomitant medication was reported. Typically, patient had Moderna vaccine for COVID all along. Typically, patient had run a fever and feel sort of rotten for a day or two, and that was all within what patient expected. No treatment information was reported. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2025-790714 (Patient Link).
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| 2871147 | 66 | F | OR | 11/06/2025 |
COVID19 |
MODERNA |
80777040060 |
Erythema, Eyelid rash, Pruritus, Rash, Urticaria
Erythema, Eyelid rash, Pruritus, Rash, Urticaria
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small rash on my left eyelid; hives; They are quite itchy and red.; They are quite itchy and red.; i...
small rash on my left eyelid; hives; They are quite itchy and red.; They are quite itchy and red.; itchy patches/a patch the size of a quarter on my right shoulder at my neck; This spontaneous case was reported by a consumer and describes the occurrence of EYELID RASH (small rash on my left eyelid), URTICARIA (hives), PRURITUS (They are quite itchy and red.), ERYTHEMA (They are quite itchy and red.) and RASH (itchy patches/a patch the size of a quarter on my right shoulder at my neck) in a 66-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 80777040060) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 80777040060) for COVID-19 prophylaxis. On 21-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 24-Oct-2025, the patient experienced EYELID RASH (small rash on my left eyelid), URTICARIA (hives), PRURITUS (They are quite itchy and red.), ERYTHEMA (They are quite itchy and red.) and RASH (itchy patches/a patch the size of a quarter on my right shoulder at my neck). The patient was treated with Fexofenadine hydrochloride (Allegra) on 24-Oct-2025 for Rash, at a dose of 24 hour dose; Fexofenadine hydrochloride (Allegra) ongoing from October 2025 for Rash, at a dose of 12 hour dose and Triamcinolone acetonide (topical) ongoing from 24-Oct-2025 for Itching, at a dose of approximately every three hours. At the time of the report, EYELID RASH (small rash on my left eyelid), URTICARIA (hives), PRURITUS (They are quite itchy and red.), ERYTHEMA (They are quite itchy and red.) and RASH (itchy patches/a patch the size of a quarter on my right shoulder at my neck) had not resolved. The patient had no medical history, concomitant disease or risk factor. No concomitant medication was reported. The patient received the Moderna Covid vaccine on 21-Oct-2025. On 24-Oct-2025, the patient developed a small rash on the left eyelid and a patch the size of a quarter on the right shoulder at the neck. The patient had hives and itchy patches, mainly on the left side of the body, the side of the injection. If that matters, they were on the neck, on the chest, a large hard patch under the chin and around the lips and in the left ear. They had not changed but seemed to be getting a little worse, meaning patients were getting more of them. They were quite itchy and red. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. Once the patient realized it was a rash as it spread to the corner of that left eye, they then got the quarter-sized patch on the right shoulder. The patient put herself on a 12-hour dose of Allegra. The patient also applied a topical cream spelled TRIAMCINOLONE ACETONIDE 0.1%. The patient applied the cream approximately every three hours to relieve itching. The patient took Allegra every 12 hours as 24 hours did not help. The patient also used ice on the rash areas that were painful or itchy so that patient did not scratch. The patient had been taking both from 24-Oct-2025 until the current date, which was 27-Oct-2025. It had not made much difference. It only relieved some itching.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
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| 2871148 | 68 | F | 11/06/2025 |
COVID19 |
MODERNA |
3032164 |
Rash, Rash pruritic
Rash, Rash pruritic
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rash all over body/it was on chest, on back, and on both arms, and not as much on the legs, but on t...
rash all over body/it was on chest, on back, and on both arms, and not as much on the legs, but on the legs as well; itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over body/it was on chest, on back, and on both arms, and not as much on the legs, but on the legs as well) and RASH PRURITIC (itchy rash) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032164) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3032164) for COVID-19 prophylaxis. No Medical History information was reported. On 31-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In November 2023, the patient experienced RASH (rash all over body/it was on chest, on back, and on both arms, and not as much on the legs, but on the legs as well) and RASH PRURITIC (itchy rash). In November 2023, RASH (rash all over body/it was on chest, on back, and on both arms, and not as much on the legs, but on the legs as well) and RASH PRURITIC (itchy rash) had resolved. No concomitant medications were provided. Patient had no relevant medical history (vaccines within the past 4 weeks, medical conditions). The patient received a Moderna COVID vaccine 2 years ago in 2023. Typically, the patient had Moderna vaccine for COVID all along. But this last time, the patient had developed a rash all over body and it lasted for about 2 weeks. It was a lot. The patient had called the doctor. The patient had a telehealth visit about it and everything. It was advised just never to take the vaccine again. The patient had one doctor who told never take another mRNA vaccine, which seemed entirely wrong and then the patient had a doctor recently told either the Moderna or the Pfizer vaccine for COVID, but that means basically patient had no choice because nobody around here carries anything else. The patient had a concern that patient might have a bigger reaction the next time. The patient about to get a flu shot and had a flu shot last year and did not have anything more than just a little grumbling from that. The product was Fluzone HD 65+administered on 07-Oct-2024. The patient had developed rash instead; she had a telehealth visit with another provider. The patient asked about Moderna's most recent Spikevax and a new one that's for seniors (mNEXSPIKE). The rash for at least, not now, it was 2 years ago now. I did not have it now, but it started maybe the day after the injection. It was itchy. It was on chest, on back, and on both arms, and not as much on the legs, but on the legs as well and the patient was told by two healthcare providers that they thought it was an allergic reaction and that if patient was to get the vaccine again, the reaction might be a lot worse. No treatment medication was provided. This case was linked to MOD-2025-790821 (Patient Link).
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| 2871149 | 83 | F | 11/06/2025 |
COVID19 RSV |
MODERNA MODERNA |
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Discomfort, Fatigue, Myalgia, Pain in extremity; Discomfort, Fatigue, Myalgia, P...
Discomfort, Fatigue, Myalgia, Pain in extremity; Discomfort, Fatigue, Myalgia, Pain in extremity
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arm pain; discomfort; some body aches; tiredness/real tired; This spontaneous case was reported by a...
arm pain; discomfort; some body aches; tiredness/real tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), DISCOMFORT (discomfort), MYALGIA (some body aches) and FATIGUE (tiredness/real tired) in an 83-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The suspect products included Pre-filled Syringe injection for COVID-19 prophylaxis, mRNA-1345 (mRESVIA) for Respiratory syncytial virus infection prophylaxis and Pre-filled Syringe injection for Respiratory syncytial virus infection prophylaxis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (2-3 Pfizer COVID-19 vaccine doses); for COVID-19 prophylaxis: SPIKEVAX NOS (5 Moderna COVID-19 vaccine doses). Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE and SPIKEVAX NOS. On 20-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 01-Jul-2025, the patient received dose of mRNA-1345 (mRESVIA) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose and Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced PAIN IN EXTREMITY (arm pain), DISCOMFORT (discomfort), MYALGIA (some body aches) and FATIGUE (tiredness/real tired). The patient was treated with Paracetamol (Tylenol) in 2025 for Discomfort, at an unspecified dose and frequency. In 2025, PAIN IN EXTREMITY (arm pain), DISCOMFORT (discomfort), MYALGIA (some body aches) and FATIGUE (tiredness/real tired) had resolved. The action taken with mRNA-1345 (mRESVIA) (Unknown) was unknown. Patient had no other vaccines within the past 4 weeks prior to the Moderna Spikevax, and patient had no medical conditions. The patient had 5 Moderna COVID-19 vaccine doses and 2-3 Pfizer COVID-19 vaccine doses in the past but had no further details. No concomitant medication was reported. The patient felt like she was overloaded with the COVID-19 vaccines, and she was spooked out and uncomfortable by having so many COVID shots. It looked like she was supposed to take another freaking shot. The patient was administered on 20-Jun-2025 in the left arm, where she had experienced significant arm pain, along with somebody aches and tiredness, and she was not prepared for this reaction. However, it was not as severe as the reaction to the RSV shot. She felt the discomfort was expected and suggested that the severity might depend on the person administering the shot or the injection site. It was worse than some previous shots, but referring to it as a little worse, but it was not terrible or horrible. She continued on that the pain from the reaction did not discourage her but referred it as gook and was referring to the vaccine. The patient received the RSV vaccine 10 days to 2 weeks after getting the Moderna Spikevax on 20-Jun-2025. Later confirmed that the RSV vaccine was administered on 01-Jul-2025. She experienced a more severe reaction to the RSV vaccine but noted that she did not remember all the details clearly. However, she had the same reactions with Spikevax for RSV but worse and mentioned she was exhausted. The patient did not remember exactly the details as it was too long ago but remembered it was way more severe than she had ever expected with RSV and hoped that Moderna would come out of a once in a lifetime COVID-19 vaccine like the RSV vaccine. It was unknown if the patient experienced any additional symptoms/events. Her experience of discomfort that lasted for two or three days which resolved on its own with the help of a couple of Tylenol, but she started taking after the first or second day.
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| 2871151 | 53 | F | 11/06/2025 |
FLUX FLUX PNC20 PNC20 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH |
5R4CY 5R4CY MG7418 MG7418 |
Chills, Decreased appetite, Fatigue, Headache, Injection site erythema; Injectio...
Chills, Decreased appetite, Fatigue, Headache, Injection site erythema; Injection site pain, Injection site pruritus, Nausea, Pain in extremity, Peripheral swelling; Chills, Decreased appetite, Fatigue, Headache, Injection site erythema; Injection site pain, Injection site pruritus, Nausea, Pain in extremity, Peripheral swelling
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red arm; pain, itching in the injection area; pain, itching in the injection area; arm has a red pat...
red arm; pain, itching in the injection area; pain, itching in the injection area; arm has a red path where the liquid went through; Tiredness; loss of appetite; chills; headache; swelling of the arm; severe pain in the arm; This is a spontaneous report received from a Consumer or other non HCP. A 53-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Oct2025 at 09:30 as dose 1, single (Lot number: MG7418) at the age of 53 years, in left arm for immunisation, Device Lot Number: MG7418; influenza vaccine (INFLUENZA VACCINE), on 28Oct2025 as dose 1, single (Lot number: 5R4CY), in right arm for immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing). Concomitant medication(s) included: METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID], start date: 03Oct2025, stop date: 26Oct2025. The following information was reported: FATIGUE (non-serious) with onset 28Oct2025 at 14:30, outcome "recovering", described as "Tiredness"; CHILLS (non-serious) with onset 28Oct2025 at 14:30, outcome "recovering"; HEADACHE (non-serious) with onset 28Oct2025 at 14:30, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 28Oct2025 at 14:30, outcome "recovering", described as "loss of appetite"; PAIN IN EXTREMITY (non-serious) with onset 28Oct2025 at 14:30, outcome "recovering", described as "severe pain in the arm"; PERIPHERAL SWELLING (non-serious) with onset 28Oct2025 at 14:30, outcome "recovering", described as "swelling of the arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 30Oct2025, outcome "recovering", described as "arm has a red path where the liquid went through"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 30Oct2025, outcome "recovering" and all described as "pain, itching in the injection area"; ERYTHEMA (non-serious) with onset 30Oct2025, outcome "recovering", described as "red arm". Therapeutic measures were taken as a result of fatigue, decreased appetite, chills, headache, peripheral swelling, pain in extremity, erythema, vaccination site pain, vaccination site pruritus, vaccination site erythema. Additional information: Reported event in the Evening: Tiredness and loss of appetite. At night: chills, headache, swelling of the arm, severe pain in the arm. In the morning: chills, headaches, nausea, tiredness, red arm, severe pain in the arm, loss of appetite. After 48 hours: red arm, pain, itching in the injection area, headache. Arm has a red path where the liquid went through. Treatment received for the adverse event: Tylenol, Advil, compress. No follow-up attempts are possible.
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| 2871152 | 64 | F | CA | 11/06/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
NA4452 NA4452 |
Brain fog, Fatigue, Vaccination site erythema, Vaccination site pain, Vaccinatio...
Brain fog, Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus; Vaccination site swelling
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Redness, swell, itching, and pain in area below and to the front of the arm from the injectioan site...
Redness, swell, itching, and pain in area below and to the front of the arm from the injectioan site.; Redness, swell, itching, and pain in area below and to the front of the arm from the injectioan site.; Redness, swell, itching, and pain in area below and to the front of the arm from the injectioan site.; Redness, swell, itching, and pain in area below and to the front of the arm from the injectioan site.; Brain fog; Great fatigue/extreme fatigue/fatigue unique/extreme tiredness; This is a spontaneous report received from a Consumer or other non HCP. A 64-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 23Oct2025 as dose 1, single (Lot number: NA4452) at the age of 64 years for covid-19 immunisation. The patient also took a Sanofi Pasteur product with lot number: UT8826LA, on 23Oct2025, on left arm. The patient's relevant medical history included: "Dry eye" (unspecified if ongoing); "arthritis of knees and back" (unspecified if ongoing); "arthritis of knees and back" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BRAIN FOG (non-serious) with onset 24Oct2025 at 02:30, outcome "recovering"; FATIGUE (non-serious) with onset 24Oct2025 at 02:30, outcome "recovering", described as "Great fatigue/extreme fatigue/fatigue unique/extreme tiredness"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 24Oct2025 at 02:30, outcome "recovering" and all described as "Redness, swell, itching, and pain in area below and to the front of the arm from the injectioan site.". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pruritus, vaccination site pain, brain fog, fatigue. Additional information: Reported events of redness, swell, itching, and pain in area below and to the front of the arm from the injection site. Developed <12 hours after injection, increased on second day, still have pain and itching at this site 9 days after injection and must limit use of arm. Great fatigue for more than two days. Brain fog, extreme fatigue first 24 hours (have had after every Covid vaccine dose). Second day continued fatigue unique, continued extreme tiredness for 3 more days (total 5 days). Treatment received for the adverse events included antihistimine (Allegra), and hydrocortisone.
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| 2871153 | 40 | F | 11/06/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4452 |
Migraine, Nausea, Neck pain, Vaccination site pain
Migraine, Nausea, Neck pain, Vaccination site pain
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Neck pain; Migraine headache; Mild nausea; Pain in the left arm at the injection site; arm pain; Thi...
Neck pain; Migraine headache; Mild nausea; Pain in the left arm at the injection site; arm pain; This is a spontaneous report received from a consumer. A 40-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 31Oct2025 at 15:30 as dose 1, single (Lot number: NA4452) at the age of 40 years, in left arm for covid-19 immunisation, Device Lot Number: NA4452. The patient's relevant medical history included: "Postural orthostatic tachycardia" (unspecified if ongoing); "Hypotension" (unspecified if ongoing). Concomitant medication(s) included: ELDERBERRY [SAMBUCUS NIGRA]. The patient also took other concomitant therapy. Past drug history included: Percocet, reaction(s): "Allergy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Nov2025 at 03:00, outcome "recovered" (02Nov2025), described as "Pain in the left arm at the injection site; arm pain"; NAUSEA (non-serious) with onset 01Nov2025 at 05:30, outcome "recovered" (01Nov2025 at 06:30), described as "Mild nausea"; MIGRAINE (non-serious) with onset 01Nov2025 at 06:30, outcome "recovered" (01Nov2025 at 18:30), described as "Migraine headache"; NECK PAIN (non-serious) with onset 01Nov2025 at 06:30, outcome "recovered" (01Nov2025 at 18:30). Therapeutic measures were not taken as a result of vaccination site pain, nausea, neck pain, migraine. Additional Information: Other concomitant medications included which included unspecified Women's Multi-Vitamin and OSTEVA (as reported). Around 12 hours post-vaccine, pain in the left arm at the injection site. Arm pain lasted about 24 hours and stopped approximately 36 hours post-injection. 14 hours post vaccine, mild nausea started which lasted about 1 hour. 15 hours post-vaccine, neck pain and migraine headache started. Neck pain and headache lasted about 12 hours. No follow-up attempts are possible.
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| 2871154 | 11/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Headache, Influenza, Myalgia, Somnolence
Headache, Influenza, Myalgia, Somnolence
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flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or ot...
flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790487 (Moderna). A 69-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; HEADACHE (non-serious), outcome "unknown"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepiness". Additional information: The reporter stated that patient has received 6 doses of the Pfizer COVID vaccine and had a reaction every time. The reporter states that patient would be sick for a day or two and it felt like the flu with muscle aches, headache, sleepiness and everything. The reporter states that patient is not looking forward to getting the vaccine, but on the flip side has never had COVID. The reporter states that even had COVID in the same house so feels like it works. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2871155 | 11/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Headache, Influenza, Myalgia, Somnolence
Headache, Influenza, Myalgia, Somnolence
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flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or ot...
flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790487 (Moderna). A 69-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 3, single (Batch/Lot number: unknown) intramuscular 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, reaction(s): "Headache", "Flu", "Muscle ache", "Sleepiness"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Headache", "Flu", "Muscle ache", "Sleepiness". The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; HEADACHE (non-serious), outcome "unknown"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepiness". Additional information: The reporter stated that patient has received 6 doses of the Pfizer COVID vaccine and had a reaction every time. The reporter states that patient would be sick for a day or two and it felt like the flu with muscle aches, headache, sleepiness and everything. The reporter states that patient is not looking forward to getting the vaccine, but on the flip side has never had COVID. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2871156 | M | 11/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Diarrhoea
Diarrhoea
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Diarrhea; This is a spontaneous report received from a Consumer or other non HCP. A male patient re...
Diarrhea; 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: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea". Additional information: Reporter stated that he wanted to get the side effects of the Pfizer COVID-19 Vaccine. Reporter had been reading about it and mentioned that a friend of reporter took it and he got diarrhea. Reporter asked if that was true or not. Reporter had heard that diarrhea was a side effect and wanted to confirm if it was true. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2871157 | 74 | F | NY | 11/06/2025 |
COVID19 COVID19 PNC20 PNC20 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH |
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Erythema, Limb discomfort, Middle insomnia, Vaccination site erythema, Vaccinati...
Erythema, Limb discomfort, Middle insomnia, Vaccination site erythema, Vaccination site pain; Vaccination site pruritus, Vaccination site warmth; Erythema, Limb discomfort, Middle insomnia, Vaccination site erythema, Vaccination site pain; Vaccination site pruritus, Vaccination site warmth
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it was hot; It was extremely painful, keeping me awake at night; Its been uncomfortable for the whol...
it was hot; It was extremely painful, keeping me awake at night; Its been uncomfortable for the whole week raising my arm and trying to use it; arm got very red and itchy; arm got very red and itchy; It was extremely painful, keeping me awake at night; redness continued to move down my arm to my elbow for whole week; This is a spontaneous report received from a Consumer or other non HCP. A 74-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Oct2025 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in right arm for immunisation; COVID-19 vaccine (COVID-19 VACCINE), on 28Oct2025 as dose number unknown, single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "borderline diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 05Aug2015; SIMVASTATIN, start date: 20Aug2015. The following information was reported: MIDDLE INSOMNIA (non-serious) with onset 28Oct2025 at 15:30, outcome "recovering", VACCINATION SITE PAIN (non-serious) with onset 28Oct2025 at 15:30, outcome "recovered" and all described as "It was extremely painful, keeping me awake at night"; LIMB DISCOMFORT (non-serious) with onset 28Oct2025 at 15:30, outcome "recovering", described as "Its been uncomfortable for the whole week raising my arm and trying to use it"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 28Oct2025 at 15:30, outcome "recovering" and all described as "arm got very red and itchy"; VACCINATION SITE WARMTH (non-serious) with onset 28Oct2025 at 15:30, outcome "recovering", described as "it was hot"; ERYTHEMA (non-serious) with onset 28Oct2025 at 15:30, outcome "recovering", described as "redness continued to move down my arm to my elbow for whole week". Therapeutic measures were not taken as a result of vaccination site warmth, middle insomnia, limb discomfort, vaccination site erythema, vaccination site pain, erythema. Therapeutic measures were taken as a result of vaccination site pruritus. Additional information: When patient got flu vaccine today the pharmacist administering it recommended she should contact because her experience with Prevnar 20 last week was not something she had seen or heard of from any of her patients. Patients arm got very red and itchy and the redness continued to move down her arm to her elbow for the whole week since she received it. It was extremely painful, keeping her awake at night, it was hot and itchy. she was right handed and the person administering the vaccine did not ask about an arm preference. It was been uncomfortable for the whole week raising her arm and trying to use it. This was the 7th day since she received it and the redness was subsiding, the pain was gone but she was still using some Benadryl anti-itch gel for the itching which was much improved but still bothersome. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2871159 | 63 | M | VA | 11/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pruritus, Urticaria
Pruritus, Urticaria
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Hives; itching scalp; This is a spontaneous report received from a Consumer or other non HCP. A 63-...
Hives; itching scalp; This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Oct2025 at 11:45 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing); "Iodine allergy" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 24Sep2025 as dose number unknown, single; LOSARTIN, start date: 01Aug2023. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 10Oct2025 at 14:00, outcome "not recovered", described as "Hives"; PRURITUS (non-serious) with onset 10Oct2025 at 14:00, outcome "not recovered", described as "itching scalp". Therapeutic measures were taken as a result of urticaria, pruritus. Additional information: The patient did not receive any other vaccines on the same date. Doctor told him to take Zyrtec for hives daily. 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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| 2871160 | 11/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Food poisoning, Rhinorrhoea, SARS-CoV-2 test, Sneezing
COVID-19, Food poisoning, Rhinorrhoea, SARS-CoV-2 test, Sneezing
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was ill with food poisoning; runny nose; sneezing; tested positive for COVID-19; This is a spontaneo...
was ill with food poisoning; runny nose; sneezing; tested positive for COVID-19; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-782369 (Moderna). A patient (age and gender not provided) 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: COVID-19 (non-serious) with onset 13Jan2025, outcome "recovered" (20Jan2025), described as "tested positive for COVID-19"; FOOD POISONING (non-serious), outcome "unknown", described as "was ill with food poisoning"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; SNEEZING (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: On 15Dec2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On an unknown date, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On 13Jan2025, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (tested positive for COVID-19). On an unknown date, the patient experienced FOOD POISONING (was ill with food poisoning). In January 2025, COVID-19 (tested positive for COVID-19) had resolved. At the time of the report, FOOD POISONING (was ill with food poisoning) outcome was unknown. The patient was originally set to received the new COVID vaccine for the 2024-2025 season in Dec2024, but due to food poisoning, appointment was postponed to Jan2025. On 13Jan2025, tested positive for COVID-19 and missed the rescheduled vaccination. had severe cold-like symptoms, including a runny nose and sneezing, but denied having a cough. Although suspected it wasn't COVID, daughter encouraged to get tested. Ultimately, tested negative on 20Jan2025, with no further information available. The patient was inquiring about the availability of the new Moderna COVID-19 booster in Dorset, as could not find it stocked in the local pharmacies. The reporter expressed difficulty in finding a provider offering Moderna's vaccine, noting that local pharmacies were stocking Pfizer. The patient was spending time in another state and had a mixture of Pfizer and Moderna vaccines previously. could not get a booster last year due to contracting COVID-19 and preferred Moderna for future vaccinations. The patient was inquiring about the availability of the new Moderna COVID-19 booster in Dorset, as could not find it stocked in the local pharmacies. The patient expressed difficulty in finding a provider offering Moderna's vaccine, noting that local pharmacies were stocking Pfizer. The patient was spending time in another state and had a mixture of Pfizer and Moderna vaccines previously. The patient could not get a booster last year due to contracting COVID-19 and preferred Moderna for future vaccinations. The reported that they had a were a mixture because, initially in the UK, they did not have access to either Pfizer or Moderna. However, since then, The patient had received a combination of both Pfizer and Moderna vaccines. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported.
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| 2871161 | 73 | F | OR | 11/06/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FF3350 FF3350 FF3350 |
Blindness unilateral, Blood cholesterol, Blood cholesterol increased, Blood pres...
Blindness unilateral, Blood cholesterol, Blood cholesterol increased, Blood pressure measurement, Condition aggravated; Diabetes mellitus, Fall, Headache, Hypertension, Memory impairment; Thinking abnormal
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Eye went blind; Fallen 6 times; High cholesterol; It raised up diabetes; It raised up diabetes; High...
Eye went blind; Fallen 6 times; High cholesterol; It raised up diabetes; It raised up diabetes; High blood pressure; Cannot think straight; Headaches; Cannot remember where she is; This is a spontaneous report received from a consumer. A 73-year-old female patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Lot number: FF3350) at the age of 73 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient was not allergic to any previous vaccination, medications, food or other products. There are no other diagnosed illnesses, medical history, or chronic health conditions to report. Concomitant medication(s) included: LISINOPRIL taken for blood pressure management; METFORMIN taken for diabetes mellitus; GLIMEPIRIDE; HYDROCHLOROTHIAZIDE taken for blood pressure management. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EW0176; right arm), administration date: 30Apr2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2; Lot Number: EW0176; right arm), administration date: 23May2021, when the patient was 73-year-old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The following information was reported: MEMORY IMPAIRMENT (hospitalization, disability, life threatening) with onset 09Oct2021, outcome "not recovered", described as "Cannot remember where she is"; THINKING ABNORMAL (hospitalization, disability, life threatening) with onset 09Oct2021, outcome "not recovered", described as "Cannot think straight"; BLINDNESS UNILATERAL (hospitalization, disability, life threatening) with onset 09Oct2021, outcome "not recovered", described as "Eye went blind"; FALL (hospitalization, disability, life threatening) with onset 09Oct2021, outcome "not recovered", described as "Fallen 6 times"; HEADACHE (hospitalization, disability, life threatening) with onset 09Oct2021, outcome "not recovered", described as "Headaches"; HYPERTENSION (hospitalization, disability, life threatening) with onset 09Oct2021, outcome "not recovered", described as "High blood pressure"; BLOOD CHOLESTEROL INCREASED (hospitalization, disability, life threatening) with onset 09Oct2021, outcome "not recovered", described as "High cholesterol"; DIABETES MELLITUS (hospitalization, disability, life threatening), CONDITION AGGRAVATED (hospitalization, disability, life threatening) all with onset 09Oct2021, outcome "not recovered" and all described as "It raised up diabetes". On 09Oct2021 (after the third vaccination), the patient experienced high blood pressure and cholesterol, it raised up diabetes, eye went blind, has fallen 6 times, cannot think straight anymore, headaches, and cannot remember where she is. The events resulted in hospitalization for 5 days, life threating illness (immediate risk of death from the event), disability or permanent damage, and visit to the emergency room. It was unknown if the patient received treatment for the adverse events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500154287 Same patient and product; different dose and event;US-PFIZER INC-202500151734 Same patient and product; different dose and event;
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| 2871162 | 11/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Atrial fibrillation
Atrial fibrillation
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atrial fibrillation; This is a spontaneous report received from a Consumer or other non HCP, Program...
atrial fibrillation; 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown". The patient contracted an atrial fibrillation from taking the Pfizer COVID vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2871163 | 11/06/2025 |
COVID19 COVID19 FLUX |
MODERNA PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site warm...
Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site warmth; Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site warmth; Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
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red and warm to the touch; warm to the touch; sore arm where the shot was given; feels tired; This i...
red and warm to the touch; warm to the touch; sore arm where the shot was given; feels tired; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790756 (Moderna). 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; elasomeran (SPIKEVAX), for immunisation; influenza vaccine (INFLUENZA), for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered", described as "red and warm to the touch"; VACCINATION SITE WARMTH (non-serious), outcome "recovered", described as "warm to the touch"; FATIGUE (non-serious), outcome "recovered", described as "feels tired"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "sore arm where the shot was given". Additional information: On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form, dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. The patient had received COVID shots twice a year since they had been offered, received Pfizer at the beginning but then switched to Moderna since thinks had a better response from the Moderna product. The patient definitely felt the effects of the vaccine and if this was what the vaccination was like, really did not want COVID. The patient had noticeable effects every single time received a COVID vaccination, and it didn't 'slam ' but it woke up immune system and, like it said, 'pay attention', which means it was really working. The patient experienced a sore arm where the shot was given, and it was red and warm to the touch. Did not experience a fever, but felt tired, but was still fully functionable. experienced these effects for the first 48 hours and considered these to be "normal side effects" experience wasn't any different to than every other COVID shot had, nor was it different from every other flu shot ever had. It's nothing extreme; was not passing out or having extreme reactions No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2871166 | 11/06/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
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Chest X-ray, Pneumonia
Chest X-ray, Pneumonia
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PNEUMONIA; Initial information received on 24-Oct-2025 regarding a solicited valid serious case rec...
PNEUMONIA; Initial information received on 24-Oct-2025 regarding a solicited valid serious case received from a physician, in the scope of company sponsored study. Study Title. This case involves Adult and unknown gender subject who experienced pneumonia, during the study participation. The subject's past medical history included Drug hypersensitivity from 2000 to 16-Oct-2025 and Nephrolithiasis on 02-Sep-2025. At the time of the event, the subject had ongoing Drug hypersensitivity since 1988, Obesity since 2005, Obstructive sleep apnoea syndrome since 2010, Asthma, Hypertension, Benign prostatic hyperplasia and Hyperlipidaemia all since 2012, Bundle branch block left since 2015, Chronic obstructive pulmonary disease since 2016, Atrial fibrillation and Hypertonic bladder both since 2020. The subject's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included valsartan and furosemide both for hypertension; atorvastatin for hyperlipidaemia; tamsulosin for benign prostatic hyperplasia; vibegron for hypertonic bladder; varenicline for smoking cessation therapy; and albuterol [salbutamol] for chronic obstructive pulmonary disease. On 16-Oct-2025, the screening/visit 1 was performed. On an unknown date, the subject received a dose of suspect investigational NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE, Solution for injection in pre-filled syringe at an unknown dose via unknown route as prophylactic vaccination. On 19-Oct-2025, unknown latency following the administration of NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE, the subject had shortness of breath, chest pain and dry cough. The subject went to emergency room (ER) and was admitted. Chest x-ray was done (result not provided). The subject was diagnosed with pneumonia. The maximum intensity of the event was severe. The event was assessed as a medically attended adverse event (MAAE) but not assessed as an Adverse Event of Special Interest (AESI). Healthcare provider was contacted for the event. Action taken was not applicable with SARS-COV-2 (OMICRON JN.1) RECOMBINANT SPIKE PROTEIN. The subject received unspecified intravenous (IV) antibiotics as corrective treatment for the event (pneumonia). On 22-Oct-2025, the subject was discharged with oral antibiotics. At time of reporting, the outcome was Recovering / Resolving for the event pneumonia. The event did not cause discontinuation of the subject from the study. Pneumonia was considered to be not related to NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE by the reporter and not reportable by the company based on company causality assessment. Rationale for final investigator causality: Possible bacterial in nature Relationship between Pneumonia and the study procedure was not related by the reporter and not reportable by the company based on company causality assessment.
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| 2871168 | 15 | M | 11/06/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Rash, Rash erythematous
Rash, Rash erythematous
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small red dots on his chest/belly; Initial information received on 28-Oct-2025 regarding an unsolici...
small red dots on his chest/belly; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional). This case involves a 15 years old male patient who experienced small red dots on his chest/belly after receiving Influenza Trivalent Recombinant Vaccine [FLUBLOK TIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Oct-2025, the patient received an unknown dose of suspect Influenza Trivalent Recombinant Vaccine (lot number, strength, expiry date and formulation-unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence. On 26-Oct-2025 the patient developed a non-serious small red dots on his chest/belly (erythema) (latency-1 day). Action taken was not applicable. The patient was treated with Diphenhydramine Hydrochloride (Benadryl) At time of reporting, the outcome was Unknown for the event.
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| 2871170 | 51 | F | 11/06/2025 |
UNK |
UNKNOWN MANUFACTURER |
U8790AA |
Exposure via skin contact, Needle issue, No adverse event
Exposure via skin contact, Needle issue, No adverse event
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administering the vaccine, the needle snapped and the product trickled down my arm with no reported ...
administering the vaccine, the needle snapped and the product trickled down my arm with no reported adverse event; administering the vaccine, the needle snapped and the product trickled down my arm with no reported adverse event; Initial information received on 30-Oct-2025 (with live follow up attached on same day) regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 51 years old female patient who received the influenza trivalent recombinant vaccine [flublok TIV], the needle snapped and the product trickled down my arm with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Sep-2025, the patient received 0.5 ml of suspect influenza trivalent recombinant vaccine Solution for injection (Unknown strength) with lot U8790AA and expiry date 30-APR-2026 via intramuscular route in the right arm for Prophylactic vaccination (immunization), the needle snapped and the product trickled down my arm with no reported adverse event (accidental exposure to product) (exposure via skin contact) (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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| 2871171 | 65 | CA | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
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No adverse event, Underdose
No adverse event, Underdose
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accidently gave a regular dose to a 65-year-old patient instead of the HD with no reported ae; Initi...
accidently gave a regular dose to a 65-year-old patient instead of the HD with no reported ae; Initial information received on 27-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old and unknown gender patient who accidentally administered regular Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] Instead Of The Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient accidentally received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Prophylactic vaccination [Immunisation] instead of the [Fluzone HD] with no reported adverse event (wrong product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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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| 2871172 | 71 | M | SC | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8415KA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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patient received an expired dose of the 2024-2025 fluzone vaccine with no reported adverse event; In...
patient received an expired dose of the 2024-2025 fluzone vaccine with no reported adverse event; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 71 year old male patient who received an expired dose of the 2024-2025 Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Oct-2025, the patient received an expired 0.5mL dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (Once), Strength Standard, lot UT8415KA and expiry date 30-Jun-2025 via intramuscular route in the right deltoid for immunisation, with no reported adverse event (expired product 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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| 2871177 | F | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
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No adverse event, Wrong product administered
No adverse event, Wrong product administered
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patient was upset getting FLUBLOK instead of the FLUZONE HD with no reported adverse event; Initial ...
patient was upset getting FLUBLOK instead of the FLUZONE HD with no reported adverse event; Initial information received on 29-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient who was administered with Influenza Trivalent Recombinant Vaccine [Flublok] instead of the Influenza Vaccine Trivalent [Fluzone Hd] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization instead of the fluzone hd with no reported adverse event (wrong product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, reporter stated that healthcare organization previously had Fluzone, but this season they are only carrying Flublok. One of the doctors reporter work with keeps calling Flublok the high dose vaccine. Even though it has more kick to it than the regular flu vaccine that we have (Flulaval), it still is a little bit less than Fluzone High Dose. Reporter have been doing research and the numbers for each one respectively regarding strength is 15, 45, and 60. Reporter is aware that Flublok and Fluzone are a part of a trio of the recommended ones for 65 and above, but feel like it would be more accurate to call the Flublok a high dose or elevated dose. (Just not high dose). It feel like telling a patient that it is High Dose is like giving them an orange and calling it a tangerine. 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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| 2871178 | 0.42 | F | IN | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792LA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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5 & 1/2 month old was administered Fluzone in the right thigh with no reported adverse event; In...
5 & 1/2 month old was administered Fluzone in the right thigh with no reported adverse event; Initial information received on 29-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 and ๏ฟฝ months old female patient who was administered with Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] in the right thigh 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 Nirsevimab (Beyfortus [Nirsevimab]). On 14-Oct-2025, the 5 and ๏ฟฝ months old female patient received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot UT8792LA and expiry date-30-Jun-2026) via unknown route in the right thigh for Immunization (product administered to patient of inappropriate age) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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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| 2871180 | 58 | F | NY | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
U8847CA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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inadvertently administering fluzone hd to an adult patient, with no reported adverse event; Initial ...
inadvertently administering fluzone hd to an adult patient, with no reported adverse event; Initial information received on 30-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 58 years old female patient who was inadvertently administered to Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] to an adult patient, 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 Elasomeran (Spikevax) for Product used for unknown indication. On 28-Oct-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8847CA, expiry date 30-Jun-2026, frequency once and strength high dose) via intramuscular route in the left deltoid for Immunisation and inadvertently administering fluzone hd to an adult patient, with no reported adverse event (product administered to patient of inappropriate age) (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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| 2871181 | 69 | M | LA | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
U8874CA |
Device leakage, No adverse event
Device leakage, No adverse event
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Instead of delivering the dose, the vaccine leaked from the needle hub onto the patient's arm w...
Instead of delivering the dose, the vaccine leaked from the needle hub onto the patient's arm with no reported adverse event; Instead of delivering the dose, the vaccine leaked from the needle hub onto the patient's arm with no reported adverse event; Initial information received on 30-Oct-2025 regarding an unsolicited valid non-serious case received from a Other Health Care Professional. This case involves a 69 years old male patient and the nurse was administering influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] instead of delivering the dose, the vaccine leaked from the needle hub onto the patient's arm with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Oct-2025, the nurse was administering influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- unknown, expiry date- 30-JUN-2026 and lot U8874CA) via unknown route in an unknown administration site for Influenza (Influenza immunisation) instead of delivering the dose, the vaccine leaked from the needle hub onto the patient's arm with no reported adverse event (accidental exposure to product) (exposure via skin contact) (latency- same day). It was reported that, "the leakage occur when administering the dose. The needle hub appears to be intact but here are dents around it. Caller was asked to callback to provide a few more information. Previous case was about FLUZONE HD. Caller noted that the area where the needle meets the tip, the top part, seemed to be chipped . Caller asked the nurse if the product was dropped but the nurse said that it was not. Product was taken out of the box and it leaked down on the patient's arm. Caller was requesting for a replacement." 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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| 2871182 | 84 | M | WI | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
|
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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84 years old patient received 2 doses of fluzone hd with no reported adverse event; Initial informat...
84 years old patient received 2 doses of fluzone hd with no reported adverse event; Initial information received on 31-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 84 years old male patient who received 2 doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2025, the patient received dose 1 of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe dose 0.5 ml frequency once via intramuscular route (batch and expiry date unknown) in the left deltoid for influenza (Influenza immunization). On 31-Oct-2025 he also received dose 2 of same vaccine dose 0.5 ml frequency once with lot U8855CA expiry date-30-Jun-2026 via intramuscular route in the left deltoid for influenza (Influenza immunization) with no reported adverse event (extra dose administered) (latency same day). 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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| 2871185 | F | PA | 11/06/2025 |
UNK |
UNKNOWN MANUFACTURER |
No batch number |
Tinnitus
Tinnitus
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Tinnitus every single day; This spontaneous case, initially received on 21-Oct-2025 (including addit...
Tinnitus every single day; This spontaneous case, initially received on 21-Oct-2025 (including additional information received 22-Oct-2025), was reported by a non health professional and concerns a female patient. Concomitant Medications: Unknown, Medical History: Unknown Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for Active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, route of administration: not reported, Anatomical location: Not reported, Lot number: No batch number available and would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, 14 days after the vaccine was administered, the patient experienced Tinnitus every single day (outcome: Not Reported). Patient took Flucelvax and 14 days later, she started experiencing tinnitus every single day. The patient did not had tinnitus in the past. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter (Consumer) did not provided the seriousness assessment and considered the event Tinnitus every single day as related to the administration of Flucelvax (TIV).; Reporter's Comments: Due to the spontaneous nature of the case, the event Tinnitus is considered related for reporting purposes.
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| 2871186 | 59 | F | NM | 11/06/2025 |
COVID19 |
MODERNA |
3052087 |
Pruritus, Rash
Pruritus, Rash
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patient developed rash,itching
patient developed rash,itching
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| 2871187 | 39 | M | AZ | 11/06/2025 |
COVID19 IPV |
MODERNA SANOFI PASTEUR |
3053238 Y1D49P1 |
Underdose; Underdose
Underdose; Underdose
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Pateint inadverdantly given a 6m-11y Modera instead of adult dose.
Pateint inadverdantly given a 6m-11y Modera instead of adult dose.
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| 2871189 | 75 | F | CO | 11/06/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052733 u8874aa |
Concussion, Dizziness, Head injury, Loss of consciousness; Concussion, Dizziness...
Concussion, Dizziness, Head injury, Loss of consciousness; Concussion, Dizziness, Head injury, Loss of consciousness
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Upon receiving the doses, pt appeared more sensitive to the immunizations than the typical patient. ...
Upon receiving the doses, pt appeared more sensitive to the immunizations than the typical patient. She reported the following morning that she felt dizzy, eventually passed out, hit her head on a door frame, and ended up going to the hospital with a concussion.
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| 2871191 | 56 | M | CO | 11/06/2025 |
COVID19 |
MODERNA |
3052576 |
Immunisation reaction, No adverse event
Immunisation reaction, No adverse event
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Gave 6mo to 11yr old dose of 0.25mL to adult who should have received the 0.50mL. No adverse symptom...
Gave 6mo to 11yr old dose of 0.25mL to adult who should have received the 0.50mL. No adverse symptoms just wrong dose amount
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| 2871207 | 75 | F | FL | 11/06/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Erythema, Pain, Rash, Swelling
Erythema, Pain, Rash, Swelling
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Patient got soreness, redness and swelling , as well as rash a day or two of the vaccine.
Patient got soreness, redness and swelling , as well as rash a day or two of the vaccine.
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| 2871208 | 9 | M | PA | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2545 |
Syncope
Syncope
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Pt received vaccine and then was checking out in store and fainted. Pt did not report any injuries a...
Pt received vaccine and then was checking out in store and fainted. Pt did not report any injuries and was monitored by rph and given orange juice at the request of the parent. Pt was feeling better and left prior to paramedics arriving.
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| 2871211 | 18 | M | VA | 11/06/2025 |
FLU3 |
SEQIRUS, INC. |
409411 |
Loss of consciousness, Muscular weakness, Syncope
Loss of consciousness, Muscular weakness, Syncope
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Patient fainted within 10-15 seconds after receiving flu vaccine. Immediately patient was placed fla...
Patient fainted within 10-15 seconds after receiving flu vaccine. Immediately patient was placed flat on his back on the floor with his legs raised on chair. During this time patient had lost consciousness. After 10-20 seconds, patient regained consciousness but remained in the same position. During this time, patient was able to respond and communicate, and he was able to answer personal identifying questions. Patient requested and was provided bottle of water and ice-pack after he complained of feeling hot. After about 10 minutes, patient sat down on a chair. He complained that his legs felt a little weak. He was encouraged to remain seated during which time he was actively looking on his phone and talking to his mother and brother. Eventually, after 20-30 minutes from the start of incident, patient was able to walk out of the pharmacy. We followed up with patient?s mom on 11/06/2025 and confirmed patient is doing okay. Patient is known to pharmacy and according to his mother he has a history of passing out after receiving a vaccine. While patient did not pass out the two times we administered flu vaccine to him in previous years (2023 and 2024), he did faint this time around.
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| 2871212 | 81 | F | CA | 11/06/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH SEQIRUS, INC. SEQIRUS, INC. |
NA0739 NA0739 407269 407269 |
Asthenia, Cough, Fatigue, Lacrimation increased, Night sweats; Respiratory tract...
Asthenia, Cough, Fatigue, Lacrimation increased, Night sweats; Respiratory tract congestion, Skin warm; Asthenia, Cough, Fatigue, Lacrimation increased, Night sweats; Respiratory tract congestion, Skin warm
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5in x 6in red patch, very tired, watery eyes, cough, congestion, very exhausted walking even to kitc...
5in x 6in red patch, very tired, watery eyes, cough, congestion, very exhausted walking even to kitchen, night sweats, hot face. She went to her doctor and is treated for symptoms, they have lasted a week or so per patient. She is still weak. She is being monitored by her doctor.
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| 2871213 | 55 | F | TX | 11/06/2025 |
FLU3 VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
u8864ca 5a727 |
Injection site erythema; Injection site erythema
Injection site erythema; Injection site erythema
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Patient reported to pharmacy on 11/06/25 close to 5pm and complained of redness near injection site ...
Patient reported to pharmacy on 11/06/25 close to 5pm and complained of redness near injection site that upon visible inspection was located on the right lateral side of arm below site of injection for the shingles vaccine, Shingrix. There was mild swelling and redness that began on Wednesday 11/05/25 (four days after vaccination) according to patient. She also reported a radiating pain down the right forearm. No reported airway issues, fever, angioedema or radiating pain through shoulder into other parts of the body. I recommended oral benadryl 25mg (1-2 tablets every 6 hours) and an ice pack. I plan on following up with patient on 11/07/25 to make sure symptoms resolve.
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| 2871214 | 71 | F | 11/06/2025 |
COVID19 |
PFIZER\BIONTECH |
na0589 |
Lymphoedema, Pain in extremity
Lymphoedema, Pain in extremity
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Patient stated she developed pain on her left foot (top part) as later stated as lymphedema per pati...
Patient stated she developed pain on her left foot (top part) as later stated as lymphedema per patient provider.Patient requested lot number from pharmacy and also reported it. patient has recovered as of yesterday
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| 2871215 | 12 | M | MO | 11/06/2025 |
COVID19 COVID19 FLU3 FLU3 |
MODERNA MODERNA SANOFI PASTEUR SANOFI PASTEUR |
3051995 3051995 u8864ca u8864ca |
Dizziness, Head injury, Hyperhidrosis, Nausea, Syncope; Visual impairment, Vomit...
Dizziness, Head injury, Hyperhidrosis, Nausea, Syncope; Visual impairment, Vomiting; Dizziness, Head injury, Hyperhidrosis, Nausea, Syncope; Visual impairment, Vomiting
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Patient received 2 immunizations and felt dizzy and his vision was affected briefly afterward and fa...
Patient received 2 immunizations and felt dizzy and his vision was affected briefly afterward and fainted and lightly bumped his head on the wall next to the chair. he didnt fall out of the chair and his dad held him as he fainted. didnt leave a mark on his head. He never fully lost conciousness. He was sweating and sat in the chair for about 10 minutes and the dizziness passed. the dad said this kind of thing has happened before but he had never fully passed out. just nausea/vomiting and dizziness.
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| 2871216 | 46 | F | WI | 11/06/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
99H9A |
Eye swelling, Lip swelling, Swelling face, Swelling of eyelid
Eye swelling, Lip swelling, Swelling face, Swelling of eyelid
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whites of eyes swollen, eyes swollen shut, facial swelling, upper lip swelling--patient has had simi...
whites of eyes swollen, eyes swollen shut, facial swelling, upper lip swelling--patient has had similar symptoms to her allergies/allergens in the past. She has received flu vaccines in the past without reactions.
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| 2871217 | 13 | F | IL | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
U8823DA |
Presyncope, Skin laceration, Syncope, Wound closure
Presyncope, Skin laceration, Syncope, Wound closure
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Patient had a vasovagal reaction five minutes after receiving the vaccine and fainted.
Patient had a vasovagal reaction five minutes after receiving the vaccine and fainted.
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| 2871218 | 64 | M | FL | 11/06/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
U8832DA Z007870 |
Erythema, Pain in extremity, Pruritus; Erythema, Pain in extremity, Pruritus
Erythema, Pain in extremity, Pruritus; Erythema, Pain in extremity, Pruritus
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Patient felt itchy and pain 10/28/25. On 10/29/25 it was still itchy, red and painful. Nov 1, it wa...
Patient felt itchy and pain 10/28/25. On 10/29/25 it was still itchy, red and painful. Nov 1, it was more painful, still red and has spread to the back of the arm.
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