| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2864399 | 10/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; I have shingles right now; This serious case was reported by a consum...
Suspected vaccination failure; I have shingles right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have shingles right now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 01-OCT-2025 This case was reported by a patient via interactive digital media. Patient had shingles right now and stated that he/she would pick up prescription when better. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix, in a patient. 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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| 2864400 | 10/08/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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suspected vaccination failure; got shingles; This serious case was reported by a consumer via intera...
suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 01-OCT-2025 This case was reported by the patient via interactive digital media. The patient got the two shots and then a few years later, he/she got shingles. The patient thought it was a milder case than it would have been if patient had not gotten the shots first. This case was considered as suspected vaccination failure as details of laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, several years after receiving 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine, in a 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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| 2864401 | FL | 10/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Rash
Rash
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rash; This non-serious case was reported by a nurse via sales rep and described the occurrence of ra...
rash; This non-serious case was reported by a nurse via sales rep and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: rash). The outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK Receipt Date: 22-SEP-2025 The reporter reported that a patient who experienced rash after Shingrix shot. No further information has been provided. The batch number was not provided upon follow- up with the reporter.
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| 2864402 | 50 | F | UT | 10/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5A4H7 |
Product preparation issue
Product preparation issue
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Shingrix adjuvant alone administration; Shingrix adjuvant alone administration; This non-serious cas...
Shingrix adjuvant alone administration; Shingrix adjuvant alone administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 5A4H7, expiry date 23-OCT-2026) for prophylaxis. On 09-SEP-2025, the patient received Shingrix. On 09-SEP-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix adjuvant alone administration) and inappropriate dose of vaccine administered (Verbatim: Shingrix adjuvant alone administration). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 22-SEP-2025 The reporter reported that wanted to know how to proceed after administering only the adjuvant portion of Shingrix.
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| 2864403 | 58 | F | KY | 10/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Late second dose/ First dose of Shingrix was given on 2021 and 2nd dose given on 25-SEP-2025; This n...
Late second dose/ First dose of Shingrix was given on 2021 and 2nd dose given on 25-SEP-2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in 2021). On 25-SEP-2025, the patient received the 2nd dose of Shingrix. On 25-SEP-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose/ First dose of Shingrix was given on 2021 and 2nd dose given on 25-SEP-2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 25-SEP-2025 Pharmacist reported that he/she called patient before, about a year, a year and a half, he had not started over but now it had been four years. So, the reporter wanted to know do the patient need to re-start from scratch and receive two vaccines or do they still need one to finish. The batch number was not provided upon follow- up with the reporter.
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| 2864404 | M | MO | 10/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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did not come back for the 2nd Shingrix dose; This non-serious case was reported by a other health p...
did not come back for the 2nd Shingrix dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax (received in 2017) and Shingrix (received 1st dose on 26-JUL-2018). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: did not come back for the 2nd Shingrix dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 26-SEP-2025 The pharmacy student called and informed that of their patient received in 2017 one dose of Zostavax, then on 26-JUL-2018 the same patient received one dose of Shingrix. Since then, the patient did not came back for the 2nd Shingrix dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
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| 2864405 | CO | 10/08/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Expired product administered
Expired product administered
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Boostrix - Expired dose; This non-serious case was reported by a other health professional via call ...
Boostrix - Expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 24-SEP-2023) for prophylaxis. On 25-SEP-2023, the patient received Boostrix. On 25-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix - Expired dose). 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: 29-SEP-2025 The patient received Boostrix vaccine, which was expired, which led to expired vaccine used. The vaccine remained in stable temperature per manufacturer recommendations until administration. The reporter asked was this still a viable administration.
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| 2864406 | 70 | F | FL | 10/08/2025 |
COVID19 |
MODERNA |
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Immunisation reaction, Pain in extremity
Immunisation reaction, Pain in extremity
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Sore arm; Minor side effects/other small things; This spontaneous case was reported by a consumer an...
Sore arm; Minor side effects/other small things; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and IMMUNISATION REACTION (Minor side effects/other small things) in an 8-decade-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and IMMUNISATION REACTION (Minor side effects/other small things). At the time of the report, PAIN IN EXTREMITY (Sore arm) and IMMUNISATION REACTION (Minor side effects/other small things) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient was in her 70s. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789812, US-MODERNATX, INC.-MOD-2025-789815 (E2B Linked Report). This case was linked to MOD-2025-789817 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2025: Live follow up received that contains non-significant information includes reference numbers were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789812:Husband case (Moderna COVID-19 Vaccine) US-MODERNATX, INC.-MOD-2025-789815:Husband case (SPIKEVAX NOS)
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| 2864407 | F | 10/08/2025 |
COVID19 |
MODERNA |
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Decreased appetite, Fatigue, Headache, Illness, Immunisation reaction
Decreased appetite, Fatigue, Headache, Illness, Immunisation reaction
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still under the weather; no appetite; had every side effects that are possible; Fatigue; still have ...
still under the weather; no appetite; had every side effects that are possible; Fatigue; still have a headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (still under the weather), DECREASED APPETITE (no appetite), IMMUNISATION REACTION (had every side effects that are possible), FATIGUE (Fatigue) and HEADACHE (still have a headache) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Concurrent medical conditions included Asthma. On 30-Sep-2025, the patient received eighth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form. In 2025, the patient experienced ILLNESS (still under the weather), DECREASED APPETITE (no appetite), IMMUNISATION REACTION (had every side effects that are possible), FATIGUE (Fatigue) and HEADACHE (still have a headache). At the time of the report, ILLNESS (still under the weather), DECREASED APPETITE (no appetite), IMMUNISATION REACTION (had every side effects that are possible), FATIGUE (Fatigue) and HEADACHE (still have a headache) had not resolved. No concomitant medication was reported. The patient received shot on 30-Sep-2025 and was still under the weather. She had every side effect that were possible. The patient still had a headache, no appetite and fatigue. The patient had 8 injections (over the years), and everyone was the same. The patient had decided that she was done, she cannot tolerate this vaccine. She had wasted over a month of her life for this vaccine. Unless there was a way to receive a lesser dosage. No treatment medication was reported. This case was linked to MOD-2025-789476 (Patient Link).
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| 2864408 | F | 10/08/2025 |
COVID19 |
MODERNA |
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Fatigue, Malaise, Pain, Pyrexia
Fatigue, Malaise, Pain, Pyrexia
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aches; make her quite sick each time; fever; extreme exhaustion; This spontaneous case was reported ...
aches; make her quite sick each time; fever; extreme exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), MALAISE (make her quite sick each time), PYREXIA (fever) and FATIGUE (extreme exhaustion) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Evolocumab (Repatha) injection for an unknown indication. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and Evolocumab (Repatha) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (aches), MALAISE (make her quite sick each time), PYREXIA (fever) and FATIGUE (extreme exhaustion). At the time of the report, PAIN (aches), MALAISE (make her quite sick each time), PYREXIA (fever) and FATIGUE (extreme exhaustion) outcome was unknown. Patient had no relevant medical conditions. No concomitant medication was reported. The patient was a senior over 65 and had always got the Moderna COVID vaccines and not the Pfizer. It usually made her quite sick each time (she had a vaccine) but she realized it was an unnecessary evil. She did not want COVID. The symptoms she normally experienced were fever, aches and extreme exhaustion. This happened after each COVID vaccine, and she had probably had at least 6 of them. She took Repatha (also an injection) and she would be taking it in the same morning; she would be getting the COVID vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not provided. This case was linked to MOD-2025-789920 (Patient Link). Reporter did not allow further contact
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| 2864409 | 71 | F | NC | 10/08/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Eructation, Hiccups; Eructation, Hiccups
Eructation, Hiccups; Eructation, Hiccups
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I hiccup all the time; belch - burping; This spontaneous case was reported by a consumer and describ...
I hiccup all the time; belch - burping; This spontaneous case was reported by a consumer and describes the occurrence of HICCUPS (I hiccup all the time) and ERUCTATION (belch - burping) in a 71-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced HICCUPS (I hiccup all the time) and ERUCTATION (belch - burping). At the time of the report, HICCUPS (I hiccup all the time) and ERUCTATION (belch - burping) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications provided by the reporter. It was reported that patient received total of 6 Moderna Covid vaccines since 2021, but exact dates were not available at the time of the reporting. The Patient received last dose as Spikevax vaccination on Nov-2024. It was reported that the Patient had noticing hiccupping and belching more frequently since the patient had Moderna Covid vaccines. The patient used to have hiccups all the time and the patient also experienced belch-burping. The symptoms lasted for the patient for the year, but they continued after a year. The patient did not notice when the symptoms started, the patient informed him that it had been years. The patient used to wait for two weeks in between flu shot and our COVID shot. No treatment medications provided by the reporter. This case was linked to MOD-2025-789935, MOD-2025-789940 (Patient Link).
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| 2864411 | 75 | F | 10/08/2025 |
COVID19 |
MODERNA |
6704983 |
Discomfort, Groin pain, Headache, Illness, Pain in extremity
Discomfort, Groin pain, Headache, Illness, Pain in extremity
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severe pain in her inner thigh; severe headache; feel so ill; fell so uncomfortable; experiencing pa...
severe pain in her inner thigh; severe headache; feel so ill; fell so uncomfortable; experiencing pain in the groin, specifically in the inner portion of her thigh; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feel so ill), PAIN IN EXTREMITY (severe pain in her inner thigh), DISCOMFORT (fell so uncomfortable), GROIN PAIN (experiencing pain in the groin, specifically in the inner portion of her thigh) and HEADACHE (severe headache) in a 75-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 6704983) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Dose 1) in 2019; for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 3) and Moderna COVID-19 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse effect with COVID-19 VACCINE, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. On 27-Sep-2025, the patient received fourth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced ILLNESS (feel so ill), DISCOMFORT (fell so uncomfortable) and GROIN PAIN (experiencing pain in the groin, specifically in the inner portion of her thigh). On 27-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced PAIN IN EXTREMITY (severe pain in her inner thigh) and HEADACHE (severe headache). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, ILLNESS (feel so ill), PAIN IN EXTREMITY (severe pain in her inner thigh), DISCOMFORT (fell so uncomfortable) and GROIN PAIN (experiencing pain in the groin, specifically in the inner portion of her thigh) had not resolved and HEADACHE (severe headache) was resolving. No concomitant medication was reported. It was stated that patient received the Moderna vaccine, which was her usual choice for the COVID-19 vaccine, on 27-Sep-2025. It was added that in the past, she had never any reactions or adverse effects, but this time, since the 27th, she had experienced a severe headache. Now, main concern was severe pain in her inner thigh, which she did not have before. It was mentioned that she had never any kind of problem like this before, and it all started after she received the vaccine, and it did not go away. She had been taking Tylenol, but it just did not go away. It was stated that she had received several COVID-19 vaccines, usually choosing Moderna. It was believed patient might have had at least three, and this was her fourth vaccine. It was then asked why she was having an adverse reaction to the Spikevax 2025-2026 when patient has been receiving the COVID-19 vaccine since 2019 without any adverse effects. It was inquired about what was in this vaccine that was causing her to feel so ill and uncomfortable. It was also asked how she could take away the pain in her thigh and whether it was one of the side effects, as the pain was so intense. It started with a severe headache, but now the headache was very minimal because she took Tylenol. However, the inner thigh pain, which started the day she got the vaccine, was bothering her the most, and it was just getting worse. It was also asked if Moderna vaccine could cause a blood clot. It was stated that she was 75 years old but very healthy. She had not been in the hospital in the last 10 years. It was then asked again if patient should be experiencing severe pain in her thigh, on the opposite side of where she received the injection. It was mentioned that she had the injection in her left deltoid and was now experiencing pain in the groin, specifically in the inner portion of her thigh, which was not there until she got the vaccine. It was stated that it felt almost like severe cramps, which was so painful that they made it difficult for her to go down the stairs. It was also asked how long this was supposed to last. Patient received the vaccine on 27-Sept-2025 and marked either 4 or 5 days since then. It was expressed the need to know why this was happening because patient always got any kind of vaccine that was protect her and had never experienced adverse effects like the ones she was having with Spikevax 2025-2026. hopes it would go away soon because she was very uncomfortable. It was unknown if the patient experienced any additional symptoms/events.
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| 2864412 | 73 | F | MD | 10/08/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
80777-0400-60 80777-0400-60 |
Decreased appetite, Flushing, Headache, Lethargy, Nausea; Retching, Swelling fac...
Decreased appetite, Flushing, Headache, Lethargy, Nausea; Retching, Swelling face, Vomiting
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dry heaves; red fevered face; puffy face; lethargic; no appetite; severe headaches; nausea; vomiting...
dry heaves; red fevered face; puffy face; lethargic; no appetite; severe headaches; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), FLUSHING (red fevered face), SWELLING FACE (puffy face), LETHARGY (lethargic) and DECREASED APPETITE (no appetite) in a 73-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 80777-0400-60) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 29-Sep-2025, the patient experienced RETCHING (dry heaves), FLUSHING (red fevered face), SWELLING FACE (puffy face), LETHARGY (lethargic), DECREASED APPETITE (no appetite), HEADACHE (severe headaches), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, RETCHING (dry heaves), FLUSHING (red fevered face), SWELLING FACE (puffy face), LETHARGY (lethargic), DECREASED APPETITE (no appetite), HEADACHE (severe headaches), NAUSEA (nausea) and VOMITING (vomiting) was resolving. The concomitant medication was not reported by the reporter. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
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| 2864413 | 90 | F | MN | 10/08/2025 |
COVID19 COVID19 FLUX FLUX |
MODERNA MODERNA UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Asthenia, Chills, Fatigue, Feeling hot, Influenza; Nasopharyngitis, Poor quality...
Asthenia, Chills, Fatigue, Feeling hot, Influenza; Nasopharyngitis, Poor quality sleep, Restlessness, Tremor; Asthenia, Chills, Fatigue, Feeling hot, Influenza; Nasopharyngitis, Poor quality sleep, Restlessness, Tremor
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tired; tremors/hand tremors; cold; flu; generally weak and had a weak voice/lacked energy; restless;...
tired; tremors/hand tremors; cold; flu; generally weak and had a weak voice/lacked energy; restless; poor sleep; warm; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremors/hand tremors), NASOPHARYNGITIS (cold), INFLUENZA (flu), ASTHENIA (generally weak and had a weak voice/lacked energy) and RESTLESSNESS (restless) in a 90-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On 02-Oct-2025, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 02-Oct-2025 at 11:00 AM, the patient received first dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 02-Oct-2025, the patient experienced TREMOR (tremors/hand tremors), NASOPHARYNGITIS (cold), INFLUENZA (flu), ASTHENIA (generally weak and had a weak voice/lacked energy), RESTLESSNESS (restless), POOR QUALITY SLEEP (poor sleep), FEELING HOT (warm) and CHILLS (chills). On 03-Oct-2025, the patient experienced FATIGUE (tired). At the time of the report, TREMOR (tremors/hand tremors), NASOPHARYNGITIS (cold), INFLUENZA (flu), ASTHENIA (generally weak and had a weak voice/lacked energy), RESTLESSNESS (restless), POOR QUALITY SLEEP (poor sleep), FEELING HOT (warm), CHILLS (chills) and FATIGUE (tired) had not resolved. No concomitant medications were provided. Patient had received the COVID-19 vaccine on 02-Oct-2025 at her local pharmacy, along with a flu shot. After the vaccination at 11 AM EST on 02-Oct-2025, she began experiencing chills and tremors around 4 PM EST. She also felt generally weak and had a weak voice. Despite having supper, she became warm, lacked energy, and had a restless night with poor sleep. By 8 AM EST on 03-Oct-2025, she experienced hand tremors and continued to feel very weak and tired, although she did not have a fever. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2025: Live follow-up received which contains significant information, patient details, suspect product information and events details were updated.
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| 2864414 | 70 | F | 10/08/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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Fatigue, Pain, Pain in extremity; Fatigue, Pain, Pain in extremity
Fatigue, Pain, Pain in extremity; Fatigue, Pain, Pain in extremity
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achy feeling in the body; soreness of the arm; tiredness; This spontaneous case was reported by a co...
achy feeling in the body; soreness of the arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy feeling in the body), PAIN IN EXTREMITY (soreness of the arm) and FATIGUE (tiredness) in an 8-decade-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy feeling in the body), PAIN IN EXTREMITY (soreness of the arm) and FATIGUE (tiredness). At the time of the report, PAIN (achy feeling in the body), PAIN IN EXTREMITY (soreness of the arm) and FATIGUE (tiredness) had resolved. No concomitant medication was reported. No medical conditions, no vaccines within the past 4 weeks prior to receiving her last COVID-19 vaccine. The patient probably had at least 2 or 3 shots with Moderna COVID-19 vaccine, but she had more Pfizer COVID-19 shots and received several Moderna COVID-19 shots. But the patient was unsure if it was the Pfizer or the Moderna COVID-19 vaccine she had a year ago. The patient wanted to know if the Spikevax vaccine would alter anything of their laboratory work on Monday as the patient would be receiving the said product on the day of reporting in the afternoon. The patient also asked if the mNEXSPIKE covered the same variant with Spikevax. The patient then followed up by asking if she would have a reaction to the said product if she did not have any major reaction with her previous Moderna COVID-19 vaccine. The patient had soreness of the arm as everybody does, a little achy feeling in the body, tiredness which usually went away after 2 days. The patient did not remember which Moderna COVID-19 vaccine or Pfizer COVID-19 vaccine she had to the said reactions. The patient described these reactions as slight, light and not bad. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter did not allow further contact
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| 2864415 | 68 | M | 10/08/2025 |
COVID19 |
MODERNA |
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Chills, Malaise, Pain
Chills, Malaise, Pain
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Achiness; felt crappy; chills; This spontaneous case was reported by a consumer and describes the oc...
Achiness; felt crappy; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), MALAISE (felt crappy) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced PAIN (Achiness), MALAISE (felt crappy) and CHILLS (chills). In 2024, PAIN (Achiness), MALAISE (felt crappy) and CHILLS (chills) had resolved. No concomitant medication was reported. Patient had chills, achiness and felt crappy 12 hours after the injection a year ago. That was probably the most severe one. These reactions passed after 2 hours. These reactions happened from the vaccines, and the reporter relates the reaction to the vaccines. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Causality was not provided. Reporter did not allow further contact
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| 2864416 | F | 10/08/2025 |
COVID19 |
MODERNA |
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Fatigue, Malaise, Pain, Pyrexia
Fatigue, Malaise, Pain, Pyrexia
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make her quite sick each time; aches; fever; extreme exhaustion; This spontaneous case was reported ...
make her quite sick each time; aches; fever; extreme exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (make her quite sick each time), PAIN (aches), PYREXIA (fever) and FATIGUE (extreme exhaustion) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Evolocumab (Repatha) injection for an unknown indication. On 31-Mar-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and Evolocumab (Repatha) (unknown route) at an unspecified dose. In 2025, the patient experienced MALAISE (make her quite sick each time), PAIN (aches), PYREXIA (fever) and FATIGUE (extreme exhaustion). At the time of the report, MALAISE (make her quite sick each time), PAIN (aches), PYREXIA (fever) and FATIGUE (extreme exhaustion) outcome was unknown. Patient had no relevant medical conditions. No concomitant medication was reported. The patient was a senior over 65 and had always got the Moderna COVID vaccines and not the Pfizer. It usually made her quite sick each time (she had a vaccine) but she realized it was an unnecessary evil. She did not want COVID. The symptoms she normally experienced were fever, aches and extreme exhaustion. This happened after each COVID vaccine, and she had probably had at least 6 of them. She took Repatha (also an injection) and she would be taking it in the same morning, she would be getting the COVID vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not provided. This case was linked to MOD-2025-789921 (Patient Link). Reporter did not allow further contact
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| 2864417 | 71 | F | NC | 10/08/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Eructation, Hiccups; Eructation, Hiccups
Eructation, Hiccups; Eructation, Hiccups
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belch - burping; I hiccup all the time; This spontaneous case was reported by a consumer and describ...
belch - burping; I hiccup all the time; This spontaneous case was reported by a consumer and describes the occurrence of ERUCTATION (belch - burping) and HICCUPS (I hiccup all the time) in a 71-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. Concurrent medical conditions included Heart disease, unspecified. In 2024, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. In November 2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ERUCTATION (belch - burping) and HICCUPS (I hiccup all the time). At the time of the report, ERUCTATION (belch - burping) and HICCUPS (I hiccup all the time) had not resolved. No concomitant medications provided by the reporter. It was reported that patient received total of 6 Moderna Covid vaccines since 2021, but exact dates were not available at the time of the reporting. The patient received last dose as Spikevax vaccination on Nov-2024. It was reported that the Patient had noticing hiccupping and belching more frequently since the patient had Moderna Covid vaccines. The patient used to have hiccups all the time and the patient also experienced belch-burping. It had been years, but it was after. The patient did not notice when the symptoms started, and it had been years. The patient used to wait for two weeks in between flu shot and our COVID shot. It was unknown if the patient experienced any additional symptoms/events. No treatment medications provided by the reporter. Reporter causality was not provided. This case was linked to MOD-2025-789940, MOD-2025-789957 (Patient Link).
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| 2864418 | 44 | F | MA | 10/08/2025 |
COVID19 |
MODERNA |
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Chills, Nausea, Poor quality sleep
Chills, Nausea, Poor quality sleep
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Poor sleep; Chills; Some nauseum; This spontaneous case was reported by a consumer and describes the...
Poor sleep; Chills; Some nauseum; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Poor sleep), CHILLS (Chills) and NAUSEA (Some nauseum) in a 44-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Influenza vaccine on 16-Sep-2025. Past adverse reactions to the above products included No adverse effect with Influenza vaccine. On 02-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 02-Oct-2025, the patient experienced POOR QUALITY SLEEP (Poor sleep), CHILLS (Chills) and NAUSEA (Some nauseum). The patient was treated with Ibuprofen (Advil) for Poor sleep, at an unspecified dose and frequency. On 03-Oct-2025, POOR QUALITY SLEEP (Poor sleep), CHILLS (Chills) and NAUSEA (Some nauseum) had resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. Patient did not have medical history, concomitant disease or risk factors. Patient did not experience any additional symptoms or events.
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| 2864419 | 10/08/2025 |
COVID19 |
MODERNA |
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Illness
Illness
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ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) ...
ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (ill). At the time of the report, ILLNESS (ill) had resolved. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was reported as unknown. No concomitant medication was reported. The first time, the patient was only ill for a week or so, the second time patient was ill in bed for many weeks. Patient fell behind on the studies. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. The reporter causality was not reported.
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| 2864421 | F | VA | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Weight
COVID-19, Drug ineffective, Weight
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took Pfizer Covid-19 vaccine and did get Covid; took Pfizer Covid-19 vaccine and did get Covid; This...
took Pfizer Covid-19 vaccine and did get Covid; took Pfizer Covid-19 vaccine and did get Covid; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "for stomach" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "heart issues" (unspecified if ongoing); "Allergic to penicillin" (unspecified if ongoing), notes: with anaphylaxis; "Allergic to sulfa medications" (unspecified if ongoing), notes: with anaphylaxis; "bronchitis" (unspecified if ongoing); "arthritic" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension; SIMVASTATIN taken for blood cholesterol increased; CETIRIZINE HCL taken for multiple allergies; FUROSEMIDE taken for fluid retention; OMEPRAZOLE/SODIUM BICARBONATE taken for gastrointestinal disorder; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for multiple allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "took Pfizer Covid-19 vaccine and did get Covid". The patient underwent the following laboratory tests and procedures: Weight: 230, notes: Approximately. Clinical course: The caller was patient, took Comirnaty vaccine, afterwards, did get Covid. Caller stated to transferring agent, she has some pretty bad muscle aches and headaches, wanted to share experience. Caller stated everything she has suffered, in her opinion, has been worse than what the vaccine the vaccine provided her, as in her ability to get Covid, to have it and not die from it like so many. Feels like much of what she suffered from, the vaccine and having Covid, has been relatively low, comparatively. Is still thankful. Was significantly affected, does not know if from the vaccination or from having had Covid. Got Covid after being vaccinated, she thinks, more than once. Thinks she had the vaccine a couple of times by then. Takes as precaution because she has autoimmune disease and her son suffers from autoimmune disease. Son had chemo for over 10 years, his autoimmunity is dangerously low right now. He goes through these treatments and caller has to be careful as well as she can be on a regular basis. That is why she called today, for assistance in getting this shot because she can no longer afford to get that and not doing them for free anymore. Has had some lingering, guesses they might even call it long Covid. She has studied up on it, trying to decipher if its one thing or another. Thinks this would have been first shot. Knows she had Covid within first year or year and a half, think was in 2021 or may have been as late as 2022. Second time she had Covid, was not able to test since she saved the test for her son. First time having Covid, after having the covid vaccine, was either 2021 or 2022. Is 62 now, guessing she was maybe 58 or 57. Weight: Approximately 230. Primary / Prescribing Healthcare Professional Info: Unknown, Was governmental, CDC, went like everybody did, did not have doctor to prescribe it to her. After that was enrolled in something with CDC for Covid and she was put at high risk because of her medical conditions, then, she would go to (withheld) or (withheld) to get shot. Did get Covid: Clarified, caller got Covid first time, after having a couple Covid vaccines. Was definitely more than once, was in 2021 or 2022. Then had Covid again, probably about a year later, was very similar to first time. Severity of it, was not as horrible but felt like it took forever to get over it. Finally, someone said it is maybe not matter of not being over it because she would probably not get anyone else sick. Is what they call long covid when having lingering effects. Did a little more research on that, would say what she had was maybe be described as long covid case. Clarified, she thinks she had significant effects first time having Covid that did sort of linger. Looking back on it, definitely had that the second time. Believes she only had covid twice, if that second time was in fact Covid, it was very similar. Had been well otherwise, all though she has diabetes, has heart issues. Is not a sickly person that is always sick with something. Because of her practices in handwashing and wearing masks out, which she still does, thinks was actually with all things she would normal get like she seasonal has terrible allergies, that would end up getting exacerbated and go into bronchitis and gets that once a year, almost faithfully, in the fall. Thankful to Pfizer because, between of her practices and having had the vaccines, has been more well overall as far as colds, flu, bronchitis. Has literally never had bronchitis since getting the first Covid shot. And she has learned to be more careful in public. Muscle aches and headaches: Clarified, she had muscle aches and headaches both times having Covid. The very first shot was very painful thereafter, it really bothered her. There was hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot. Each time she would get Covid shots, lump would go back and forth between her two arms. Clarified, she experienced in lumps in both arms, had shots in both arms. Clarified first one in left arm. Happened in right arm as well, was just terrible. Muscle aches and headaches: not recovered. In her mind she does not know what to zero in on for exact cause since she is 62 and is arthritic. Very specifically knows some of that muscle ache and pain was vaccine related because of how it came on, how it lingered. In general, it just took down her overall energy and stamina. Has not really gotten any better, thinks she just learned to just work through it. In general the muscle aches, are just so natural to her now and she can't really differentiate. She certainly has good days where she feels good. Also has to do with the weather which may make no sense but if there is terrible humidity, if there is a terrible humid day she can be in so much discomfort. And specifically where she got shots can be very tender. Rubbing arm right now, feels lumps still sore but not horrible. Is not anything that would keep her from doing what she needs to do, just makes it maybe a little less comfortable. Used to garden veraciously, does not do much anymore. If she even has half an afternoon of weeding the aftermath is pretty bad. Even if not immediate, the next day she literally has a down day, where she can't do very much but it is hard to tell exactly what that is from. Treatment: Really not able to take any NSAIDS so she would only rely on Tylenol and because she is diabetic, worries about kidneys so she does not take very much Tylenol. She would do more CBD, which is a derivative of hemp, she would rub that on there and it would sometimes be effective. Has tried another natural thing called Arnica. Results of those seem to be hit or miss. She is big on drinking water like when she is sick with anything in any kid of way she drinks as much good water as possible, that seems to help a bit. Being very purposeful about staying hydrated as best she can and just moving best as she can and stretching. Does not take any kind of prescribed medication for it, or anything like that. Lump: Started in arm where she initially had shot was in left arm. Then over time lump seems to have traveled a little bit in the same arm and then again later when she had a shot in her right arm. Now, has multiple lumps, in both arms. Specific date this started, unknown. Was when she got first shot, within a few days after that the lump was still there. Had called pharmacy, wondering if that was normal. Was told by pharmacist that it is a significant lump that the pharmacist would call the lump an injection injury. When she mentioned to her doctor, doctor said did not know what she was talking about. Clarified, she now has multiple lumps. Almost every time she has gotten a shot she would get a lump and has multiple lumps in both arms. Treatment: There is not really treatment because, when she asked if she should use hot or cold compress was told no. Said it would work itself out over time and told her to just take Tylenol, or Aspirin. Was afraid to massage too much and did not really rub it but would check to see if still there and if still as big and if it was moving. It did move some, she thinks, from where it was initially. Second Dose on: 03Apr2021; LOT: EW0151 in right arm. Third dose (booster) on: 14Oct2021; LOT: (Probably) FH8020, Fourth Dose on: 09Apr2022; LOT: FJ4991, Fifth Dose on 12Aug2022; LOT: FP7138. Sixth Dose: Does not know what was written but states it says either RAW or DAW then provides GHA703 or maybe OHA703 but thinks they should have been more clear in the writing on her vaccine card and then states she thinks it is a G but she is not sure. She thinks it was also given at the (withheld). Something over to the left written really tiny and thinks it VOORW or maybe it says VOOM or V00M or V00N and then states maybe the R is a V but she does not know. It is horrible writing and then below that says BLBAWA or who knows what is written there. Unable to clarify further as caller states it is all on the same line and the handwriting is horrible and she does not know about this one. There is nothing else written by sixth dose. Seventh Dose on 04Aug2023. She thinks it says Pfizer and then thinks it says (withheld); LOT: AK0928, she thinks that is the lot number). Eighth Dose: Pfizer thinks it says 23-24. Administered on 16Dec2023 LOT: Can't tell since writing is messed up and states the first character is either a H or # and then J7324 or J7224. She cannot tell or confirm what it states for lot number due to handwriting. When clarifying that caller had total of 8 Covid vaccines, she states she is not sure if that is all of them. That is all she has documented, not sure if she had more. Caller confirms she does not have any further details to provide for any other covid vaccine or any other lot numbers. She only has what is on her three vaccine cards as provided above. Concomitant Products/Medical Conditions: Is diabetic, takes Metformin. Has high blood pressure, takes medicine for that. Probably has had different medications over the years. Takes Amlodipine and Losartan. Can't tell how long she has been on the medications but longer than Covid has been around. Test results: Has not been able to go in to get labs done recently, other than regular finger sticks for diabetes, has those results. Has glucose serum and Hemoglobin A1C. Did the patient receive any other vaccines on the same date as the Pfizer vaccine? Would be almost impossible to remember but definitely does know it would not have been on the same day. Did see recently that Pfizer is suggesting that which is what prompted her call in the first place that it is being suggested to get Covid shot when getting flu shot and she was unable to do that. Is there reason for that? Is that more beneficial to get covid and flu shot together? Caller advised to refer, advised that, they have product specific information to provide. Caller declined when offered transfer. When clarifying that she has not had any other vaccines on same day, or within 4 weeks prior to covid vaccines, caller states, she does not think so. Is her own personal habit that she would not have done vaccines at same time because if she were to have bad reaction, she would not know if it was from one thing or the other. The AE not require a visit to the Emergency Room Physician's Office. Are you allergic to any previous vaccination, medications, food or other products? Has some allergies, not to vaccinations. Allergic to penicillin and sulfa medications both with anaphylaxis. Was so long ago, has stayed away from those medications successfully.
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| 2864422 | M | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pruritus, Psoriasis, Scratch
Pruritus, Psoriasis, Scratch
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psoriasis; scratches in one arm and leg; itches; This is a spontaneous report received from a Consum...
psoriasis; scratches in one arm and leg; itches; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2024, outcome "unknown", described as "itches"; PSORIASIS (non-serious) with onset 2024, outcome "unknown"; SCRATCH (non-serious) with onset 2024, outcome "unknown", described as "scratches in one arm and leg". Additional information: Reporter explained the Comirnaty vaccine one year ago, in Sep2024. He was now 73 years old and wanted to know if he should get the new vaccine or the last dose still provides protection against COVID infection. He explained that he had received a lot of Pfizer COVID vaccines. After 3 to 4 weeks from the last dose from Sep2024, he experienced psoriasis, itches and scratches in one arm and leg, although he said it wasn't too much. He wanted to know if he was still recommended to get the new vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2864423 | 48 | F | NJ | 10/08/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Cough, Fatigue, Headache, Pain; Cough, Fatigue, Headache, Pain
Cough, Fatigue, Headache, Pain; Cough, Fatigue, Headache, Pain
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Body aches; dry cough; fatigue; headache; This is a spontaneous report received from a Consumer or o...
Body aches; dry cough; fatigue; headache; This is a spontaneous report received from a Consumer or other non HCP. A 48-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 01Oct2025 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 01Oct2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 18Jul2025. The following information was reported: PAIN (non-serious) with onset 02Oct2025, outcome "recovered" (03Oct2025), described as "Body aches"; COUGH (non-serious) with onset 02Oct2025, outcome "recovered" (03Oct2025), described as "dry cough"; FATIGUE (non-serious) with onset 02Oct2025, outcome "recovered" (03Oct2025); HEADACHE (non-serious) with onset 02Oct2025, outcome "recovered" (03Oct2025). Therapeutic measures were not taken as a result of pain, cough, fatigue, headache. Additional information: Vaccine was administered at workplace clinic. The patient was not received any other vaccines within 4 weeks prior to the vaccine(s) for which was reporting. The patient was taking other medications within 2 weeks of the event starting. Reported events were body aches, fatigue, headache, dry cough. No allergies were reported. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2864424 | F | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood pressure measurement, COVID-19, Drug ineffective
Blood pressure measurement, COVID-19, Drug ineffective
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had a COVID-19 infection four and a half years ago; had a COVID-19 infection four and a half years a...
had a COVID-19 infection four and a half years ago; had a COVID-19 infection four and a half years ago; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 88-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing), notes: I'm diabetic. Caller described that she has been diabetic for "about 24 years. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "had a COVID-19 infection four and a half years ago". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 130/75-80. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient late eighties and she just wants to make sure. Her husband and she has taken 5 of the COVID-19 vaccines and have had no problem with them she did get a mild case of COVID and took PAXLOVID. it was a very mild case. husband and she have never had any reaction to the COVID-19 vaccine. She glad she took it; it helped her. She was diabetic. She made the right decision. Additionally, patient mentioned that she had a COVID-19 infection four and a half years ago and also mentioned that her husband does not have the health condition she has. Caller described that she has been diabetic for about 24 years and that her usual blood pressure is 130/75-80. The patient was 88 years of age, and her birthday was in January. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2864425 | F | ID | 10/08/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site erythema, Injection site pruritus, Injection site swelling, Injec...
Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
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reactions at the injection site / small hives; reactions at the injection site / redness; reactions ...
reactions at the injection site / small hives; reactions at the injection site / redness; reactions at the injection site / swelling; reactions at the injection site / itching; reactions at the injection site / warm to touch; This is a spontaneous report received from a Pharmacist and a Consumer or other non HCP from medical information team. A 67-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE URTICARIA (non-serious), outcome "unknown", described as "reactions at the injection site / small hives"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "reactions at the injection site / redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "reactions at the injection site / swelling"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "reactions at the injection site / itching"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "reactions at the injection site / warm to touch". Therapeutic measures were not taken as a result of vaccination site urticaria, vaccination site erythema, vaccination site swelling, vaccination site pruritus, vaccination site warmth. Additional information: Husband is calling on behalf of his wife who received Prevnar 20. Are dermatological reactions at the injection site (small hives, redness, swelling, itching, warm to touch) common or possibly related to something else. Reporter stated that the reaction occurred a week after injection and approximately 2-3 inches from the injection site. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2864426 | F | CT | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pain in extremity
Pain in extremity
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never had a problem other than a sore arm; This is a spontaneous report received from a Consumer or ...
never had a problem other than a sore arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "never had a problem other than a sore arm". Additional information: It was reported that, patient have had the Pfizer vaccine every 6 months since the vaccines came out and she have never had a problem other than a sore arm. Patient recently had the new covid vaccine on 13Sep2025. All her previous ones gave her no problem except for a sore arm. The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500119025 Same reporter and patient, different dose and event;
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| 2864427 | F | IL | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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Illness, Inappropriate schedule of product administration, Malaise
Illness, Inappropriate schedule of product administration, Malaise
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Sick; did not feel good after the second one; 14Sep2021 was when she got the first shot / second dos...
Sick; did not feel good after the second one; 14Sep2021 was when she got the first shot / second dose was given on 19Nov2021; This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old female patient received BNT162b2 (BNT162B2), on 19Nov2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depressed" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; LEXAPRO; LORAZEPAM. Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: 14Sep2021, for COVID-19 Immunization. The following information was reported: ILLNESS (hospitalization) with onset 2021, outcome "unknown", described as "Sick"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "14Sep2021 was when she got the first shot / second dose was given on 19Nov2021"; MALAISE (non-serious), outcome "unknown", described as "did not feel good after the second one". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300015030 same patient, different vaccine dose number/event;US-PFIZER INC-202500198227 same patient, different vaccine dose number/event;
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| 2864428 | F | AR | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
EL1284 |
Cardiac disorder, Cough, Illness, Menstrual disorder
Cardiac disorder, Cough, Illness, Menstrual disorder
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sick; bad menstrual bleeding problems; heart problems; cough; This is a spontaneous report received ...
sick; bad menstrual bleeding problems; heart problems; cough; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An adult female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EL1284) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "not recovered", described as "sick"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "bad menstrual bleeding problems"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems"; COUGH (non-serious), outcome "recovered". Additional information: The patient took the Pfizer Covid-19 vaccine and has been really sick every since she's taken the vaccine, for a few years. Caller stated that her daughter (patient) "gets sick a lot, and has been from the day she took the vaccine up until now." Caller stated that her daughter got so badly sick and that the daughter will get a cough that will last for a month or two. Caller stated that her daughter states "it feels like she's having heart problems." Caller stated that her daughter "has really bad menstrual bleeding problems, and she is sure there is more side effects she is experiencing that she is unaware of." Caller stated that she has seen "so many reports of menstrual problems." Caller stated that she was worried to death for her.
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| 2864429 | M | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
EK4176 |
Alopecia
Alopecia
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Losing hair; This is a spontaneous report received from a Consumer or other non HCP from medical inf...
Losing hair; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 21-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EK4176) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Losing hair".
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| 2864430 | 72 | M | NJ | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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Decreased appetite, Fatigue, Pain in extremity
Decreased appetite, Fatigue, Pain in extremity
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Arm soreness; fatigue; loss of appetite; This is a spontaneous report received from a Consumer or ot...
Arm soreness; fatigue; loss of appetite; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Oct2025 at 12:45 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Diabetes 2" (unspecified if ongoing); "high LDL" (unspecified if ongoing); "HBP" (unspecified if ongoing); "Vertigo" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC, start date: Mar2025. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Oct2025 at 16:30, outcome "recovering", described as "Arm soreness"; FATIGUE (non-serious) with onset 07Oct2025 at 16:30, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 07Oct2025 at 16:30, outcome "recovering", described as "loss of appetite". Therapeutic measures were not taken as a result of pain in extremity, fatigue, decreased appetite. Additional information:The patient did not receive any other vaccines on the same date as the vaccine (Comirnaty (2025-2026 Formula). The patient did not receive any other vaccines within 4 weeks prior to the vaccine (Comirnaty (2025-2026 Formula). The patient had no drug allergy.Events without hospitalization prolonged No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2864432 | AL | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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I am with COVID; I am with COVID; This is a spontaneous report received from a Consumer or other non...
I am with COVID; I am with COVID; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2025, outcome "unknown" and all described as "I am with COVID". Clinical course: The patient can't count the Pfizer COVID vaccinations he/she had since 2020 and yet here he/she was with COVID. It was not unexpected and it seemed that everybody gets it sometime, and he/she thought that perhaps this will be a light case given his/her faithful adherence to vaccination. The patient went to get Paxlovid but no generic alternative was available. The patient stated that it will cost him/her more than 400 dollars. The patient said that Pfizer should be ashamed for not getting the price down. He/She was querying if Pfizer was making a fortune off the patient's sickness. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2864433 | 10/08/2025 |
COVID19 COVID19 COVID19 |
MODERNA PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Pain in extremity, Prostate cancer; Pain in extremity, Prostate cancer; Pain in ...
Pain in extremity, Prostate cancer; Pain in extremity, Prostate cancer; Pain in extremity, Prostate cancer
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prostate cancer; a sore arm; This is a spontaneous report received from a Consumer or other non HCP....
prostate cancer; a sore arm; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789712 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) and in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing). The patient's family history included: "Cardiac disorder" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Shingrix, administration date: 2016, for Immunization, reaction(s): "No adverse event"; Influenza vaccine, for Immunization, reaction(s): "No adverse event". The following information was reported: PROSTATE CANCER (medically significant) with onset Mar2023, outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "a sore arm". Therapeutic measures were taken as a result of prostate cancer. Clinical course: The patient was received two doses of Pfizer in fall 2021 and after that the patient received Moderna COVID-19 vaccine every year afterwards. The patient had surgery for prostate cancer in Sep2024. It was reported that the patient experienced a sore arm for a day and that was it after an unspecific COVID vaccine. It was reported that the patient should get vaccines as often as has heart disease in family history and has personal issues including hypothyroidism. No treatment medications provided by the reporter. Case Comment/Sender Comment: Co-suspect Pfizer vaccine is a confounder for the events. Due to lack of biological plausibility, the causality of the event prostate cancer was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2864434 | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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caller mentioned they got a Covid vaccine two weeks ago but diagnosed with covid; caller mentioned t...
caller mentioned they got a Covid vaccine two weeks ago but diagnosed with covid; caller mentioned they got a Covid vaccine two weeks ago but diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Sep2025 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "caller mentioned they got a Covid vaccine two weeks ago but diagnosed with covid". The caller and their spouse, both recently diagnosed with COVID-19. The caller mentioned they got a Covid vaccine two weeks ago in Sep2025 but diagnosed with covid and prescribed Paxlovid medication. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2864435 | F | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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Illness
Illness
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sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female ...
sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female 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: ILLNESS (non-serious), outcome "unknown", described as "sick". Additional information:Covid vaccine from them made my mom sick. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2864436 | 10/08/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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Vaccination site erythema; Vaccination site erythema
Vaccination site erythema; Vaccination site erythema
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at worst got a little dime size redness around the injection site; This is a spontaneous report rece...
at worst got a little dime size redness around the injection site; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789840 (ModernaTX, Inc), MOD-2025-789824 (ModernaTX, Inc). An elderly patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "at worst got a little dime size redness around the injection site". Additional information: The patient received SPIKEVAX NOS for COVID-19 prophylaxis. Co-suspect product included Tozinameran (Pfizer BioNTech COVID-19 vaccine). It was reported that the patient never had a problem with Moderna vaccine or Pfizer vaccine. At worst got a little dime size redness around the injection site and sometimes used to get nothing. Batch/lot number is not provided, and it cannot be obtained.
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| 2864439 | OH | 10/08/2025 |
DTAP |
UNKNOWN MANUFACTURER |
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No adverse event, Product storage error
No adverse event, Product storage error
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Temperature excursion due to human error, Max/low temperature reached 56๏ฟฝF for 4 hours, 32.2๏ฟฝF f...
Temperature excursion due to human error, Max/low temperature reached 56๏ฟฝF for 4 hours, 32.2๏ฟฝF for 2.25 hours, 48.8๏ฟฝF for 0.75 hours with no reported adverse event; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received Diphtheria, Tetanus And Acellular Pertussis Vaccine that was exposed to max/low temperature reached 56๏ฟฝf for 4 hours, 32.2๏ฟฝf for 2.25 hours, 48.8๏ฟฝf for 0.75 hours and is recommended to get revaccinated 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 Diphtheria, Tetanus And Acellular Pertussis Vaccine produced by unknown manufacturer (lot number, formulation, strength and expiry date-unknown) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) that was exposed to max/low temperature reached 56๏ฟฝf for 4 hours, 32.2๏ฟฝf for 2.25 hours, 48.8๏ฟฝf for 0.75 hours and is recommended to get revaccinated with no reported adverse event (poor quality 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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| 2864444 | OH | 10/08/2025 |
DTAP |
UNKNOWN MANUFACTURER |
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No adverse event, Product storage error
No adverse event, Product storage error
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Patient was vaccinated post temperature excursion with max/low temperature reached 56 degree F for 4...
Patient was vaccinated post temperature excursion with max/low temperature reached 56 degree F for 4 hours, 32.2 degree F for 2.25 hours, 48.8 degree F for 0.75 hours with no adverse event; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves Adult and unknown gender patient received Diphtheria, Tetanus And Acellular Pertussis Vaccine that was exposed to max/low temperature reached 56 degree f for 4 hours, 32.2 degree f for 2.25 hours, 48.8 degree f for 0.75 hours with no 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 Diphtheria, Tetanus And Acellular Pertussis Vaccine produced by unknown manufacturer (lot number, strength, expiry date and formulation) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) that was exposed to max/low temperature reached 56 degree f for 4 hours, 32.2 degree f for 2.25 hours, 48.8 degree f for 0.75 hours with no adverse event (poor quality 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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| 2864449 | 40 | OH | 10/08/2025 |
DTAP |
UNKNOWN MANUFACTURER |
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No adverse event, Product storage error
No adverse event, Product storage error
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temperature excursion due to a new refrigerator as their old one had multiple excursions, however, i...
temperature excursion due to a new refrigerator as their old one had multiple excursions, however, in the new refrigerator, their Wi- Fi data loggers were not activated, and the USB data loggers were not engaged for 92.25 hours with no ae; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a from a other health professional. This case was linked with US-SA-2025SA202579 (master case). This case involves a 40 years old and unknown gender patient who received diphtheria, tetanus and acellular pertussis vaccine post temperature excursion due to a new refrigerator as their old one had multiple excursions, however, in the new refrigerator, their Wi- Fi data loggers were not activated, and the USB data loggers were not engaged for 92.25 hours with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Jul-2025, the patient received an unknown dose of diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunization) post temperature excursion due to a new refrigerator as their old one had multiple excursions, however, in the new refrigerator, their Wi- Fi data loggers were not activated, and the USB data loggers were not engaged for 92.25 hours with no adverse event (product storage error). Reportedly, Max/low temperature reached: 21May2025-26Jun2025: 56๏ฟฝF for 4 hours, 25Jun2025: 32.2๏ฟฝF for 2.25 hours, 11Jul2025: 48.8๏ฟฝF for 0.75 hours, 10- 14Jul2025: 87.5 hours: no temperature data - total hours 92.25 hours ? included 87.5 hours if it was a hot excursion. ? excluding the cold excursion on 25Jun2025. ? excluding 87.5 hours it would only be 4.75 hours cumulatively (hot excursion). There was no previous excursion. Human error was involved. The extended stability data did not cover the excursion. 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.; Sender's Comments: US-SA-2025SA202579:Master case
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| 2864450 | M | 10/08/2025 |
FLU3 |
SANOFI PASTEUR |
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Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
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whole arm is swollen, it was all swollen like a very bad reaction; had severe reaction in his arm, w...
whole arm is swollen, it was all swollen like a very bad reaction; had severe reaction in his arm, whole arm is hot and red; had severe reaction in his arm, whole arm is hot and red; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Healthcare Professional). This case involves a 4 years old male patient who had whole arm is swollen, it was all swollen like a very bad reaction and had severe reaction in his arm, whole arm is hot and red while receiving Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Sep-2025, the patient received a dose (0.5ml) of suspect Influenza USP Trival A-B Subvirion no Preservative Vaccine; Suspension for injection (lot number, strength, dose and expiry date not reported) via unknown route in the arm non (not otherwise specified) for Influenza. Information on the batch number was requested corresponding to the one at time of event occurrence. On 29-SEP-2025 the patient whole arm is swollen, it was all swollen like a very bad reaction (vaccination site swelling) and had severe reaction in his arm, whole arm is hot and red (vaccination site warmth) and (vaccination site erythema) (latency: same day) Action taken was not applicable. Received steroids as corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events.
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| 2864455 | CA | 10/08/2025 |
YF |
SANOFI PASTEUR |
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Dysbiosis, Streptococcal infection
Dysbiosis, Streptococcal infection
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develop dysbiosis; develop dysbiosis characterized with an overgrowth of streptococcus; Initial info...
develop dysbiosis; develop dysbiosis characterized with an overgrowth of streptococcus; Initial information received on 03-Oct-2025 regarding an unsolicited valid Non-serious case received from a pharmacist. This case involves Adult and unknown gender patient who had develop dysbiosis characterized with an overgrowth of streptococcus after receiving Yellow fever vaccine- [YF-VAX]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Yellow fever vaccine- Solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. On an unknown date the patient developed develop dysbiosis characterized with an overgrowth of streptococcus (dysbiosis) (streptococcal infection) (unknown latency). Reportedly, overgrowth of streptococcus needing to be treated with bacteriophages. Action taken: not applicable. It was not reported if the patient received a corrective treatment for both events. At time of reporting, the outcome was Unknown for both events
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| 2864456 | 77 | F | GA | 10/08/2025 |
FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8847BA U8847BA U8847BA |
Anxiety, Arthralgia, Decreased appetite, Disorientation, Fatigue; Headache, Lip ...
Anxiety, Arthralgia, Decreased appetite, Disorientation, Fatigue; Headache, Lip pruritus, Malaise, Nasal pruritus, Pyrexia; Wheezing
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feeling horrible and they still are not feeling well yet; extreme fatigue; joint pain, every joint i...
feeling horrible and they still are not feeling well yet; extreme fatigue; joint pain, every joint in the body hurts really bad; bad headache; low grade fever; lot of itching of the nose and lips; lot more wheezing more than they usually do with the lung; anxiety; felling disoriented; no appetite; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from patient. This case involves a 77 years old female patient who experienced feeling horrible and they still are not feeling well yet, lot more wheezing more than they usually do with the lung, extreme fatigue, anxiety, joint pain, every joint in the body hurts really bad, bad headache, low grade fever, felling disoriented, no appetite and lot of itching of the nose and lips after receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Interstitial lung disease. On 20-Aug-2025, the patient received 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (lot U8847BA and expiry 30-Jun-2026) via unknown route in the left arm for immunization (strength: standard). On an unknown date in 2025 the patient developed a non-serious lot more wheezing more than they usually do with the lung (wheezing), extreme fatigue (fatigue), anxiety, joint pain, every joint in the body hurts really bad (arthralgia), bad headache (headache), low grade fever (pyrexia), felling disoriented (disorientation), no appetite (decreased appetite) and lot of itching of the nose and lips (pruritus) (latency unknown). On 21-AUG-2025 the patient developed a non-serious feeling horrible and they still are not feeling well yet (malaise) (latency 1 day). Reportedly:- Patient have extreme fatigue described as all they could do was go back and forth from the bathroom and they could not hold a phone; that since the injection the caller has had anxiety, joint pain, every joint in the body hurts really bad, having a bad headache, having a low grade fever, felling disoriented, and having no appetite; that the consumer still does not have an appetite; that the consumer also having a lot of itching of the nose and lips; that her doctors did nothing for the events; that they saw their primary care doctor and was told to go to the Emergency Room; that while there, at the emergency room, they took blood and the results were okay; that the doctor has called to check up on them; that the doctor thinks the caller may be having a reaction to a different strain in the vaccine; that they did not really want the flu shot, this year, due to hearing what the health secretary was saying about products added in the vaccine; that the Pulmonologist reported that that consumer would be getting a newer FLUZONE HD that does not have this; that she has had flu shots every year and has never had an adverse action at all; that they did take the flu shot last year and ended up getting the flu; and that they do not know the brand or name of the flu vaccine they got last year. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all events At time of reporting, the outcome was Not Recovered / Not Resolved for the events (Malaise and no appetite ) and unknown for rest of the events
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| 2864458 | 61 | F | TX | 10/08/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
U8847AA |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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administered fluzone hd instead of fluzone np to a patient with no reported adverse event; Initial i...
administered fluzone hd instead of fluzone np to a patient with no reported adverse event; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 61 years old female patient who was administered influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] instead of 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 03-Oct-2025, the patient received a dose of 0.5 ml (dose 1) once of suspect influenza USP trival A-B high dose subvirion vaccine (Suspension for injection in pre-filled syringe) (lot: U8847AA; expiry date: 30-Jun-2026) via intramuscular route in the left upper arm for Immunisation instead of influenza USP trival A-B subvirion no preservative vaccine (Suspension for injection) with no reported adverse event (wrong product administered) (latency: same day). The patient had no other immunizations. 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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| 2864460 | MN | 10/08/2025 |
FLU3 |
SANOFI PASTEUR |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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getting 2 doses of flu vaccine with no reported adverse event; Initial information received on 03-Oc...
getting 2 doses of flu vaccine with no reported adverse event; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient 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 an unknown date, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for influenza. On an unknown date, the patient received an extra dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for influenza, with no reported adverse event (extra dose administered) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Reportedly, Nurse supervisor called to ask for possible side effects if a high dose flu vaccine was administered twice at one given time. Caller was not able to provide its brand name but said that the manufacturer was Sanofi and they were assuming that it was Fluzone HD. Caller cannot yet guarantee if a patient was administered or not but they still wanted to get information about possible side effects. 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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| 2864465 | 68 | F | NJ | 10/08/2025 |
UNK |
UNKNOWN MANUFACTURER |
388479 |
Dizziness, Heart rate increased, Increased bronchial secretion, Influenza like i...
Dizziness, Heart rate increased, Increased bronchial secretion, Influenza like illness, Malaise
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Full flu; Heartbeat issue/ heart was beating so fast; Gurgling sensation; Thought I was going to die...
Full flu; Heartbeat issue/ heart was beating so fast; Gurgling sensation; Thought I was going to die; Felt lightheaded; This spontaneous case, initially received on 29-Sep-2025, was reported by a non health professional and concerns an adult female patient. Historical vaccinations included Fluad (Reaction: No adverse reactions). Administration of company suspect drug: On 19-Sep-2024, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease., Dose regimen: not reported, Route of administration: not reported, Anatomical location: not reported, Lot number: 388479. No additional suspect drugs. Adverse reactions/events and outcomes: On 19-Sep-2024, same day of vaccination, the patient experienced Heartbeat issue/ heart was beating so fast (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Gurgling sensation (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Thought I was going to die (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Felt lightheaded (outcome: Recovered / Resolved, stop date: 20-Sep-2024). On an unknown date, the patient experienced Full flu (Medically Significant, outcome: Not Reported). Case was upgraded to serious upon company assessment of the reported event (Full flu) clinical significance. The consumer reported that on 2024 she thought she was going to die after she had the Fluad shot, that was how bad the reaction was, her heart was beating so fast, it was so lightheaded. The patient took Tylenol and it helped, but she felt like she had a full flu. Patient reported she had heartbeat issue and had gurgling sensation, she thought she was going to die. She felt lightheaded at the pharmacy, it happened almost immediately. The patient also reported that she took Tylenol at home but mentioned that she felt like she should have gone to the hospital, but she didn't because she had been too sick to drive and didn't want to call an ambulance. Fluad (TIV) action taken: Not Applicable Treatment medication: Tylenol Reporter's assessment: The primary reporter assessed the events Heartbeat issue/ heart was beating so fast, Gurgling sensation, Thought I was going to die, Felt lightheaded as non-serious and did not provide causality assessment. The primary reporter did not provide the seriousness and causality assessment of the event Full flu.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. Considering plausible temporal relationship (reported as almost happened immediately after vaccination for events heart rate increased, gurgling sensation, fear of death, dizziness and flu). For event Flu, the event occurred post vaccination (reported as immediately) before 21 days of vaccination (outside the window period of 21-180 days), hence not considered vaccination failure.
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| 2864479 | F | WV | 10/08/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
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Burning sensation, Chills, Feeling abnormal, Influenza like illness, Injection s...
Burning sensation, Chills, Feeling abnormal, Influenza like illness, Injection site pain; Pain, Product administered at inappropriate site
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This morning, she is pretty miserable; With chilling; and burning in her neck and body; Generalized ...
This morning, she is pretty miserable; With chilling; and burning in her neck and body; Generalized body ache and pain, similar to the flu; Generalized body ache and pain, similar to the flu; It was administered in her high upper right arm, and her arm has been sore ever since/Her arm pain has gotten progressively worse; she felt the medicine travelling thru her arm down to her elbow, the worst that she has ever felt it during a vaccination; This spontaneous report was received from a consumer or other non-health professional referring to herself a 54-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 30-Sep-2025, the patient was vaccinated with a dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) administered as prophylaxis (Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). On the same date (30-Sep-2025), the patient experienced the medicine travelling thru her arm down to her elbow, the worst that she has ever felt it during a vaccination (sensory disturbance) and it was stated that the vaccine was administered in her high upper right arm, and her arm has been sore ever since and her arm pain has gotten progressively worse (vaccination site pain). On 01-Oct-2025 (reported as this morning), it was reported that she was pretty miserable (feeling abnormal) and her arm pain was with chilling (chills) and burning in her neck and body (burning sensation); also, the patient experienced generalized body ache and pain, similar to the flu (pain) (influenza like illness). At the reporting time, the patient had not recovered from the event of vaccination site pain (reported as arm pain has gotten progressively worse). The outcome of the events of sensory disturbance, feeling abnormal, chills, burning sensation, pain and influenza like illness was unknown. The causal relationship between all the events with the suspect vaccine was not provided.
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| 2864480 | M | WV | 10/08/2025 |
PNC21 |
MERCK & CO. INC. |
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Pain in extremity
Pain in extremity
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Side effect reported is minor arm pain; This spontaneous report was received from a consumer (patien...
Side effect reported is minor arm pain; This spontaneous report was received from a consumer (patient's wife) and refers to a 54-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-SEP-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), administered for vaccination (strength, dosage, lot #, expiration date and anatomical site of administration were not reported), route of administration reported as "injection". On the same date (30-SEP-2025), the patient experienced minor arm pain (Mild). At the reporting time, the patient had not recovered from the event. No medical attention of treatment given for this adverse event. The causal relationship between the event of arm pain (Mild) and Pneumococcal 21-valent Conjugate Vaccine was not provided. This is one of 2 reports received from the same reporter.
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| 2864481 | M | 10/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Headache
Headache
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Headache; This non-serious case was reported by a physician via sales rep and described the occurren...
Headache; This non-serious case was reported by a physician via sales rep and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 19-SEP-2025, the patient received the 1st dose of Shingrix (left arm). On 20-SEP-2025, 1 days after receiving Shingrix, the patient experienced headache (Verbatim: Headache). On 22-SEP-2025, the outcome of the headache was resolved (duration 2 days). The reporter considered the headache to be related to Shingrix. The company considered the headache to be related to Shingrix. Additional Information: GSK Receipt Date: 22-SEP-2025 Reporter consent to contact was not provided. The batch number was not provided, and we are unable to contact the reporter.
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| 2864482 | 75 | F | MA | 10/08/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
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Back pain, Dizziness, Headache, Photophobia; Back pain, Dizziness, Headache, Pho...
Back pain, Dizziness, Headache, Photophobia; Back pain, Dizziness, Headache, Photophobia
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headache; lightheadedness; light sensitivity; lower back pain; This is a spontaneous report received...
headache; lightheadedness; light sensitivity; lower back pain; This is a spontaneous report received from a Pharmacist from medical information team. A 75-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Oct2025 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 75 years, in arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 05Oct2025 as unk unk, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Oct2025, outcome "unknown"; PHOTOPHOBIA (non-serious) with onset Oct2025, outcome "unknown", described as "light sensitivity"; DIZZINESS (non-serious) with onset Oct2025, outcome "unknown", described as "lightheadedness"; BACK PAIN (non-serious) with onset Oct2025, outcome "unknown", described as "lower back pain". Therapeutic measures were not taken as a result of headache, dizziness, photophobia, back pain. Additional information: patient who got the Comirnaty complains of headache, lightheadedness, light sensitivity and lower back pain. The patient was fine the first day and all symptoms started the next day. The patient declined any treatment. The patient sounds very uncomfortable and assumes patient is not doing well, patient had to go lay down. Caller stated something else but did not remember. Seriousness: It is not medically significant but significant enough since the patient called. Caller states the patient is a registered nurse. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2864485 | 87 | M | VA | 10/08/2025 |
FLU3 |
SANOFI PASTEUR |
U8764BB |
Injection site pain, Pain
Injection site pain, Pain
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injection site soreness after the injection; experiencing symptoms at the injection site described a...
injection site soreness after the injection; experiencing symptoms at the injection site described as not hurting, but a sensation of a "jumping" feeling when the injection site area is touched or if he moves his arm in a certain way, like the nerves are affected, but it is not actual pain; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 87 years old male patient who had injection site soreness after the injection and experiencing symptoms at the injection site described as not hurting, but a sensation of a jumping feeling when the injection site area is touched or if he moves his arm in a certain way, like the nerves are affected, but it is not actual pain after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received no concomitant vaccines. On 10-Sep-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8764BB, expiry date:30-Jun-2026, strength not reported via intramuscular route in the right deltoid for Immunization. On an unknown date In 2025 the patient had injection site soreness after the injection (vaccination site pain) and symptoms at the injection site described as not hurting, but a sensation of a jumping feeling when the injection site area is touched or if he moves his arm in a certain way, like the nerves are affected, but it is not actual pain (vaccination site paraesthesia) (unknown latency). Action taken was Not Applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for the vaccination site pain after the injection and was Not Recovered / Not Resolved for the event vaccination site paraesthesia.
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| 2864486 | 65 | F | NC | 10/08/2025 |
FLU3 |
SANOFI PASTEUR |
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Arthralgia, Chills, Headache, Myalgia, Vomiting
Arthralgia, Chills, Headache, Myalgia, Vomiting
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severe muscle pain; joint aches; severe chills; severe headache; vomiting; Initial information recei...
severe muscle pain; joint aches; severe chills; severe headache; vomiting; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional). This case involves a 65 years old female patient who had severe muscle pain, joint aches, severe chills, severe headache and vomiting after receiving Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone HD]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Oct-2025 at 05:00 hours, the patient received a dose of 0.5ml of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe standard strength, frequency-once (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for Immunization. Information on the batch number was requested corresponding to the one at time of event occurrence. On 02-Oct-2025 the patient developed a severe muscle pain (myalgia), joint aches (arthralgia), severe chills (chills), headache (headache) and vomiting (latency-few hours). Reportedly- She had been taking the flu shots for years and have never had a reaction to any flu shot but she seems to have a very strong reaction to this vaccine yesterday. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
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