| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2858479 | M | 09/12/2025 |
COVID19 |
MODERNA |
|
Illness
Illness
|
He was also "in bed" for a week and he was "really sick"; This spontaneous case ...
He was also "in bed" for a week and he was "really sick"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He was also "in bed" for a week and he was "really sick") in an adult male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (He was also "in bed" for a week and he was "really sick"). At the time of the report, ILLNESS (He was also "in bed" for a week and he was "really sick") outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication was not provided. It was reported that the patient was in bed for a week and no longer wished to receive the vaccine as a result of the experience. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789235 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789235:Master case
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| 2858480 | 67 | M | 09/12/2025 |
COVID19 |
MODERNA |
|
COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
|
Diagnosed with Covid/First symptons were flu like and started mild; This spontaneous case was report...
Diagnosed with Covid/First symptons were flu like and started mild; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid/First symptons were flu like and started mild) in a 67-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna's Covid 19 vaccines (Patient received all Moderna's Covid-19 vaccines twice a year: Spring/Fall.). Past adverse reactions to the above products included No adverse effect with Moderna's Covid 19 vaccines. In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 31-Dec-2024, the patient experienced COVID-19 (Diagnosed with Covid/First symptons were flu like and started mild). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) from 01-Jan-2025 to January 2025 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Diagnosed with Covid/First symptons were flu like and started mild) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2024, SARS-CoV-2 test: Positive. Concomitant medication use information was not provided by reporter. The reporter wanted to know where to get it and what the difference was between mNEXSPIKE and Spikevax, and which would be more effective for a patient who got Covid despite having had the Moderna Covid vaccine in September 2024. Up until the patient tested positive on 31-Dec-2024 at 67 years old, one week after being on vacation at the museum. The reporter assumed that this was where the patient got Covid because, while the patient was at that museum, although everyone was wearing a mask, it was filled with hundreds of children running all over the place. The first symptoms were flu-like and started mild. The patient was never hospitalized. The symptoms just persisted. The reporter called his HCP as soon as the patient was diagnosed with Covid, and the patient agreed on starting a treatment because the traveling was involved, so the patient had a specific 5-day treatment with Paxlovid on January 1st. The last vaccine taken was Pfizer in April 2025. It was unknown if the patient experienced any additional symptoms/events. Reporter did not allow further contact
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| 2858481 | 68 | F | 09/12/2025 |
COVID19 |
MODERNA |
|
COVID-19, Cardiac disorder, Craniofacial fracture, Loss of consciousness, Pyrexi...
COVID-19, Cardiac disorder, Craniofacial fracture, Loss of consciousness, Pyrexia
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kept passing out; broke my nose; cardiac effect; had COVID/States the fatigue was pretty severe; typ...
kept passing out; broke my nose; cardiac effect; had COVID/States the fatigue was pretty severe; typical high fever or moderate fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (kept passing out) and CRANIOFACIAL FRACTURE (broke my nose) in a 68-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Zoledronic acid (Reclast) 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 Zoledronic acid (Reclast) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (kept passing out) (seriousness criterion medically significant), CRANIOFACIAL FRACTURE (broke my nose) (seriousness criterion medically significant), CARDIAC DISORDER (cardiac effect), COVID-19 (had COVID/States the fatigue was pretty severe) and PYREXIA (typical high fever or moderate fever). At the time of the report, LOSS OF CONSCIOUSNESS (kept passing out), CRANIOFACIAL FRACTURE (broke my nose), CARDIAC DISORDER (cardiac effect), COVID-19 (had COVID/States the fatigue was pretty severe) and PYREXIA (typical high fever or moderate fever) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient had lots of health issues but was also healthier than most people in some ways. She worked out all the time and could go further and longer on a treadmill than most people half her age and considered herself fit but had health challenges. It was reported that, the patient had received the Moderna COVID vaccine for the last couple of years. Never had any huge issues with the vaccine at all, she expected to get a fever. It was mentioned that even minor things would put her in the hospital. One time she had COVID, despite an antiviral, despite all the vaccines, she could not work full time for a month. Her fatigue was pretty severe, and she did not end up thankfully with pneumonia or anything which she was prone to but also had her pneumonia shots. It was reported that the only thing she usually got is the typical high fever or moderate fever, etc. It was reported that she had horrible effects, had Reclast and still did not understand it that had a cardiac effect and kept passing out and broke her nose, etc. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter's Comments: Causality for Craniofacial fracture was assessed as not related, due to vaccineοΏ½s mechanism of action. The benefit-risk relationship of product is not affected by this report.
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| 2858482 | M | 09/12/2025 |
COVID19 |
MODERNA |
|
Immune system disorder
Immune system disorder
|
immune system compromised; This spontaneous case was reported by a consumer and describes the occurr...
immune system compromised; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (immune system compromised) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 in 2024. On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (immune system compromised) (seriousness criterion hospitalization). At the time of the report, IMMUNE SYSTEM DISORDER (immune system compromised) outcome was unknown. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. Concomitant medication was not reported. Reporter causality was not reported. Reporter wants to know what vaccine they should choose to be administered to the immune compromise patient. Last year before the vaccination he got COVID and after vaccination he still get to the hospital since his immune system had been compromised. All questions related to this customer interaction had been fully addressed by the contact center team. It was unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine were unknown. Moderna was not authorized to communicate with the patient's / your healthcare provider. Treatment information was not reported.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
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| 2858485 | 69 | F | VA | 09/12/2025 |
COVID19 |
PFIZER\BIONTECH |
EM9810 |
Asthenia, Pain in extremity
Asthenia, Pain in extremity
|
sore arm; down with energy; This is a spontaneous report received from a Consumer or other non HCP f...
sore arm; down with energy; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 69-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EM9810) at the age of 69 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing), notes: she had MS for 30 years. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; ASTHENIA (non-serious), outcome "unknown", described as "down with energy". Additional information: It was reported that caller on the line calling about the Comirnaty previous formulation/Covid-19 vaccines and reported that she had MS for 30 years. She had 6 booster doses from Pfizer. She reported not having any problems and was doing well. She also reported that she had a flu shot type response with the Pfizer covid vaccines. She got her 7th booster dose from Moderna and the Moderna vaccine activated her MS and had to go on steroids due to complications. Her neurologist advised against getting another covid vaccine and that was 2 years ago. She is ambulant, but did not want to activate her MS and was wanting advice on whether or not to get the new vaccine. Her final booster was Moderna and it activated her MS. She did not have anything other than a response like she would have with a flu shot from the Pfizer covid vaccines and she was good with that. She was on a immunosuppressant at the time she had the Moderna vaccine. Caller said that she is not immunosuppressed, but is modulated. She clarified that she had a sore arm and down with energy a little bit for a day or so after receiving the Pfizer Covid-19 Vaccines. It was not a big deal and she does not see it as a negative at all.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500179079 same patient/SD/AE, different dose;US-PFIZER INC-202500179080 same patient/SD/AE, different dose;US-PFIZER INC-202500179081 same patient/SD/AE, different dose;US-PFIZER INC-202500179078 same patient/SD/AE, different dose;US-PFIZER INC-202500179048 same patient/SD/AE, different dose;
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| 2858486 | M | FL | 09/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
|
States he took 2 Pfizer to start and the booster and still got Covid; States he took 2 Pfizer to sta...
States he took 2 Pfizer to start and the booster and still got Covid; States he took 2 Pfizer to start and the booster and still got Covid; This is a spontaneous report received from a Consumer or other non HCP. An 80-year-old male patient received BNT162b2 (BNT162B2), 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), outcome "unknown" and all described as "States he took 2 Pfizer to start and the booster and still got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported as the patient took 2 Pfizer to start and the booster and still got Covid. When queried name of product caller states it was the recommended Pfizer and the booster after 1 year of the others. The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.
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| 2858487 | 09/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Pruritus
Pruritus
|
my arm to itch weeks after my covid vaccine; This is a spontaneous report received from a Consumer o...
my arm to itch weeks after my covid vaccine; 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: PRURITUS (non-serious), outcome "unknown", described as "my arm to itch weeks after my covid vaccine". Additional information:What could have caused my arm to itch weeks after my COVID vaccine. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2858491 | M | FL | 09/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
had COVID/We have gotten every single COVID vaccine plus the flu shot every year; had COVID/We have ...
had COVID/We have gotten every single COVID vaccine plus the flu shot every year; had COVID/We have gotten every single COVID vaccine plus the flu shot every year; This is a spontaneous report received from a Consumer or other non HCP. A 61-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "had COVID/We have gotten every single COVID vaccine plus the flu shot every year". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: During an inbound call for financial assistance, the patient's spouse, (withheld), stated, reporter calling on behalf of her husband, (withheld) her husband was 61 years old, recently she learned that after he was prescribed Paxlovid However, patient has been prescribed Paxlovid in the past when he's had COVID. He did not have any side effects from it. He did fine. He went to urgent care because he has COVID. He has underlying conditions; it was prescribed for him. He was had this prescribed before in the past times when he was had COVID. Later, she stated, they used to cover it. In the past, when he had COVID, they did pay for Paxlovid, and in the past, his policy covered both brand name and generic. Reporter think it was important for decision-makers to know, reporter husband was almost 62 years old, he was 61, and he works at a grocery store. The patient worked all through COVID. He should be able to get this, and he had it before, during the earlier years of COVID, and we had no problem. Reporter sated, her husband was just hospitalized in Jun. Even though we are fortunate enough to have a primary care physician who knows my entire history, and reporter believe was going to give us, she think it was very likely they're going to give us a prescription, reporter husband caught COVID prior to us being able to get to that appointment. They're making it so difficult for people to help themselves. And he has had-we have had-all of the previous vaccines. We have gotten every single COVID vaccine plus the flu shot every year; he's had the flu shot this year, also. For the last 27 years, we've gotten the flu shot. When providing the phone number to the program for further assistance, reporter stated, the patient was hospitalized in Jun for something else.
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| 2858492 | M | CA | 09/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
|
this is the 3rd time patient had COVID; this is the 3rd time patient had COVID; this is the 3rd time...
this is the 3rd time patient had COVID; this is the 3rd time patient had COVID; this is the 3rd time patient had COVID; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1,single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown, manufacturer unknown), for COVID 19 IMMUNIZATION; Moderna (dose number unknown), for COVID 19 IMMUNIZATION; Flu, for Immunization. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 08Sep2025, outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "this is the 3rd time patient had COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Sep2025) COVID. Clinical course: Patient took a test last night and found out he have COVID. And reaffirmed it with his doctor today. Because the test was a couple of years old, just to make sure it was conclusive. And they gave a prescription. This is the 3rd time patient had COVID. He just muscle his way through it, that's all. He was not too worried about it. Every time he get it, its a little less. Well, he had four vaccinations too, so his antibodies are built up really good. He probably went through the worst of it last night. He couldn't sleep at all and had a cough. She had a cough for 2 days. Pretty good cough, no sore throat. So, it just is what it is. But you know a couple of them might have been, two of them might have been Moderna, and the other two. Patient mentioned she have had no side effects. Maybe, just kind of like a flu shot. 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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| 2858493 | F | 09/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Immune system disorder
Immune system disorder
|
immune reaction; This is a spontaneous report received from a Consumer or other non HCP. A female p...
immune reaction; This is a spontaneous report received from a Consumer or other non HCP. 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: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune reaction". Additional information: Patient stated that when she had her shot in the past there was immune reaction and wanted to make sure to do it accordingly this year. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2858494 | F | CA | 09/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Influenza
Influenza
|
flu; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old female p...
flu; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu". 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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| 2858495 | F | NH | 09/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Immune system disorder
Immune system disorder
|
It attacked my immune system; This is a spontaneous report received from a Consumer or other non HCP...
It attacked my immune system; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 (BNT162B2), in 2021 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: IMMUNE SYSTEM DISORDER (non-serious), 45 min after the suspect product(s) administration, outcome "unknown", described as "It attacked my immune system". Additional information: patient reported her life was ruined. Patient received covid shot in 2021, within 45 minutes, had a terrible reaction and stated her life is over. It attached her immune system. Patient thought it was going to be her time to enjoy life taking care of her husband and daughter with life ending health issues. Suffering was terrible. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2858496 | NY | 09/12/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Therapeutic response unexpected
Therapeutic response unexpected
|
Had a positive experience from the Covid vaccine. The patient has not had one Rheumatoid arthritis f...
Had a positive experience from the Covid vaccine. The patient has not had one Rheumatoid arthritis flare up since taking it 3-4 years ago; 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 included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Had a positive experience from the Covid vaccine. The patient has not had one Rheumatoid arthritis flare up since taking it 3-4 years ago". Additional information: It was reported that the patient had a positive experience from the Covid vaccine! The patient had not had one Rheumatoid arthritis flare up since taking it 3-4 years ago. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2858497 | 34 | F | PA | 09/12/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792LA |
Exposure during pregnancy, No adverse event
Exposure during pregnancy, No adverse event
|
taking fluzone during pregnancy with no reported adverse event; Initial information received on 04-S...
taking fluzone during pregnancy with no reported adverse event; Initial information received on 04-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 34 years old female pregnant patient who was exposed to Influenza USP Trival A-B Subvirion No preservative Vaccine [Fluzone] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date is 02-May-2026. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy. On 09-Apr-2025, the pregnant patient received a dose 1 of suspect Influenza USP Trival A-B Subvirion No preservative Vaccine Suspension for injection (strength, expiry date: unknown and lot UT8792LA) via intramuscular route in unknown administration site as prophylactic vaccination (immunization) with no reported adverse event (exposure during pregnancy) (latency: same day). Action taken: not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.
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| 2858498 | 32 | F | PA | 09/12/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792LA |
Exposure during pregnancy, No adverse event
Exposure during pregnancy, No adverse event
|
fluzone administered while mother was pregnant with no reported adverse event; Initial information r...
fluzone administered while mother was pregnant with no reported adverse event; Initial information received on 08-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 32 years old female patient who was exposed to vaccine influenza USP trival A-B subvirion NO preservative vaccine [fluzone] in context of fluzone administered while mother was pregnant with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported fluzone administered while mother was pregnant with no reported adverse event occurred at 7 weeks of pregnancy and the patient was exposed to INfLUENZA USP trival A-B subvirion NO preservative vaccine at 7 weeks of pregnancy, during first pregnancy trimester for influenza USP trival A-B subvirion NO preservative vaccine. The date of last menstrual period was reported as 01-Aug-2025. The estimated due date is 01-May-2026. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 08-Sep-2025, the pregnant patient received a Dose 1 of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection (Unknown strength and expiry date) with lot UT8792LA via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (exposure during pregnancy) (latency same day) There were no information Relevant prenatal testing after exposure. Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.
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| 2858499 | 5 | F | GA | 09/12/2025 |
DTAP |
SANOFI PASTEUR |
3CA03C3 |
No adverse event, Product storage error
No adverse event, Product storage error
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received Daptacel post excursion with no reported adverse event; received 1 ml of Daptacel post excu...
received Daptacel post excursion with no reported adverse event; received 1 ml of Daptacel post excursion with no reported adverse event; Initial information received on 09-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old female patient who received 1 ml of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included polio vaccine INACT 3V (VERO) (Ipol Polio Vaccine) for Immunisation. On 22-Jul-2025, the patient received 1 ml of dose 1 of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] Suspension for injection with standard strength (expiry date- 30-SEP-2025 and lot 3CA03C3) via intramuscular route in the left arm for Immunization post excursion with no reported adverse event (poor quality product administered) (latency- same day). Reportedly, Reason: Fridge malfunction. Max/low temperature reached: negative 2.4 C. Duration: 13 hours and 30 minutes. There was no previous excursion. Human error was not involved. The extended stability data did not cover the excursion. 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-2025SA270817:cluster case
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| 2858500 | 2 | M | IA | 09/12/2025 |
DTPPVHBHPB PNC20 |
MSP VACCINE COMPANY PFIZER\WYETH |
U8314AA LX2496 |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
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Incorrect immunizations administered to patient. No adverse reactions noted.
Incorrect immunizations administered to patient. No adverse reactions noted.
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| 2858501 | 16 | M | GA | 09/12/2025 |
MNQ |
SANOFI PASTEUR |
u8256ba |
Inappropriate schedule of product administration, Rash
Inappropriate schedule of product administration, Rash
|
Rash all over the body and also dose was given not 8 weeks apart, done at the 7 week
Rash all over the body and also dose was given not 8 weeks apart, done at the 7 week
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| 2858502 | 80 | NJ | 09/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
GJ952 |
Extra dose administered
Extra dose administered
|
Patient completed Shingrix series 2023. She came 7/10/25- asked Shingrix not realizing she already h...
Patient completed Shingrix series 2023. She came 7/10/25- asked Shingrix not realizing she already had the vaccine. I immunized the patient on 7/10/25. I follow up with patient. Patient did not have any adverse event.
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| 2858503 | 65 | F | WA | 09/12/2025 |
PNC21 RSV |
MERCK & CO. INC. PFIZER\WYETH |
Y019158 LN5489 |
Erythema, Nausea, Pyrexia, Swelling, Vomiting; Erythema, Nausea, Pyrexia, Swelli...
Erythema, Nausea, Pyrexia, Swelling, Vomiting; Erythema, Nausea, Pyrexia, Swelling, Vomiting
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fever, redness, swelling starting about 24 hrs after injection. Nausea/vomiting about 36 hours after...
fever, redness, swelling starting about 24 hrs after injection. Nausea/vomiting about 36 hours after injection, redness now from site to elbow 7 days post injection.
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| 2858504 | 55 | M | MD | 09/12/2025 |
FLU3 |
SANOFI PASTEUR |
UT8763EA |
Incorrect dose administered
Incorrect dose administered
|
55 year old was given Fluzone HD
55 year old was given Fluzone HD
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| 2858505 | 53 | F | MD | 09/12/2025 |
FLU3 |
SANOFI PASTEUR |
UT8763EA |
Incorrect dose administered
Incorrect dose administered
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53 year old was given Fluzone HD
53 year old was given Fluzone HD
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| 2858520 | 62 | F | NJ | 09/12/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2503 |
Dizziness
Dizziness
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patient states extreme dizziness and light headedness
patient states extreme dizziness and light headedness
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| 2858521 | 8 | M | CA | 09/12/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
7F299 |
Urticaria
Urticaria
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Welts/hives all over body but worse on back
Welts/hives all over body but worse on back
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| 2858522 | 66 | F | WI | 09/12/2025 |
COVID19 |
MODERNA |
3051997 |
COVID-19, Chest discomfort, Cough, Oropharyngeal pain, SARS-CoV-2 test positive
COVID-19, Chest discomfort, Cough, Oropharyngeal pain, SARS-CoV-2 test positive
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Paxlovid prescription called in on 9/12/25 Patient received MNEXSPIKE 2025-2026 on 9/9/2025 Lot: 3...
Paxlovid prescription called in on 9/12/25 Patient received MNEXSPIKE 2025-2026 on 9/9/2025 Lot: 3051997 Exp Date: 06/19/2026 NDC: 80777-0400-60 Received around 10:30 am Patient stated that she noticed after receiving the vaccine (didn't state an approximate time) - at least 30-60 mins afterwards. Patient was starting to feel achy and sore throat that got worse throughout the day with the worst being at night. Patient thought it was a side effect of the vaccine. The next morning (9/10/25) patient 'felt it in her chest' and had a cough. She tested positive for COVID19 on 9/12/2025. Patient received Fluzone HD on 9/4/2025 Lot: U8800AA Exp Date: 06/30/2026 NDC: 49281-0125-65 Received around 15:30 Patient went to urgent care on 9/12/25 she said that the nurse there told her she was the 3rd person who got COVID19 after the receiving the vaccine. Patient was prescribed Paxlovid 300/100
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| 2858523 | 1 | M | CA | 09/12/2025 |
DTAPIPVHIB HEPA MMRV PNC20 |
SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH |
UK332AA Z005472 Z009078 LX2498 |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
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Patient had redness and swelling on right thigh where Prevnar20 and Pentacel were administered. Adm...
Patient had redness and swelling on right thigh where Prevnar20 and Pentacel were administered. Administered 2.5mL of 12.5mg/5mL of Benadryl PO x1 in office
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| 2858524 | 82 | F | FL | 09/12/2025 |
FLU3 |
SANOFI PASTEUR |
|
Chills, Pyrexia, Tremor
Chills, Pyrexia, Tremor
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I have always taken the flu vaccine as well as all Covid vaccines. Never have I ever had a bad exper...
I have always taken the flu vaccine as well as all Covid vaccines. Never have I ever had a bad experience until this year's flu vaccine. I had severe chills, shaking uncontrollably and then fever. It took me a day and a half to even feel like moving. I then had a severe headache, almost as bad as a migraine. That lasted more than a day. I am a retired pharmacist so I knew what to do. All I took was Excedrine Migraine which helped. I did report it to pharmacist who gave it to me, he didn't seem concerned and said no one else reported a problem.
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| 2858525 | 13 | F | ID | 09/12/2025 |
MNQ |
SANOFI PASTEUR |
U8574AA |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient received Meningococcal ACWY vaccine by mistake. She was not due to have the booster until 2...
Patient received Meningococcal ACWY vaccine by mistake. She was not due to have the booster until 2028. Both herself and her sister were receiving vaccines, and her sister, was supposed to get the Meningococcal vaccine, not pt. Father was present and informed of the error. He was given verbal education and written documentation as to what adverse reactions may occur. They were advised to contact the clinic for any adverse reactions. They were also informed a report would be filed with the vaccine program for the inadvertent vaccine administration.
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| 2858526 | 69 | F | CA | 09/12/2025 |
FLU3 |
SANOFI PASTEUR |
U8830AA |
Unevaluable event
Unevaluable event
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NONE
NONE
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| 2858527 | 18 | M | NJ | 09/12/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
022J211A 022J211A |
Cardiac stress test abnormal, Echocardiogram, Electrocardiogram abnormal, Heart ...
Cardiac stress test abnormal, Echocardiogram, Electrocardiogram abnormal, Heart rate irregular, Palpitations; Sleep disorder, Ultrasound scan abnormal
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Irregular heartbeat and palpitations. Cardiologist said it is present but benign pattern. Heart ultr...
Irregular heartbeat and palpitations. Cardiologist said it is present but benign pattern. Heart ultrasound, EKG and stress-test done and all confirmed an irregular heartbeat. Sometimes hard to sleep at night because I feel it. No family heart history. Doctor says it is benign but now I have to check on it every year
More
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β | |||||
| 2858528 | 72 | M | UT | 09/12/2025 |
FLU3 |
SEQIRUS, INC. |
4C7255 |
Back pain
Back pain
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Patient right at the time of receiving the vaccine experienced a sharp pain in the lower back. Pati...
Patient right at the time of receiving the vaccine experienced a sharp pain in the lower back. Patient had to sit down for a bit of time. Patient said the pain lasted for fifteen minutes. The pharmacist, called the patient at 6:10 and the patient happily reported that the pain was completely gone and returned to normal activity.
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| 2858529 | 25 | M | GA | 09/12/2025 |
HEPA HPV9 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
Z5434 Y009051 |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
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2ND DOSE GIVEN AT INCORRECT INTERVAL. BOTH WERE GIVEN 2 WEEKS LATER INSTEAD OF AT RECOMMEDED INTERV...
2ND DOSE GIVEN AT INCORRECT INTERVAL. BOTH WERE GIVEN 2 WEEKS LATER INSTEAD OF AT RECOMMEDED INTERVALS. PATIENT DID NOT HAVE ANY ADVERSE REACTIONS.
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| 2858530 | 58 | F | MI | 09/12/2025 |
FLU3 PNC21 VARZOS |
SEQIRUS, INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
|
Cellulitis, Erythema, Infection, Skin warm; Cellulitis, Erythema, Infection, Ski...
Cellulitis, Erythema, Infection, Skin warm; Cellulitis, Erythema, Infection, Skin warm; Cellulitis, Erythema, Infection, Skin warm
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Redness, warm to the touch, cellulitis or some form of infection presented to the urgent care
Redness, warm to the touch, cellulitis or some form of infection presented to the urgent care
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| 2858531 | 41 | F | MN | 09/12/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
|
Amenorrhoea, Asthenia, Dizziness, Fatigue, Full blood count; Haemoglobin, Heavy ...
Amenorrhoea, Asthenia, Dizziness, Fatigue, Full blood count; Haemoglobin, Heavy menstrual bleeding, Metabolic function test, Serum ferritin decreased, Stress at work
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Received two doses of HPV series first dose was 5/6/25, second was 6/15/25. In June I didn't g...
Received two doses of HPV series first dose was 5/6/25, second was 6/15/25. In June I didn't get a period. I was under a lot of stress that month though. The next two months, my period lasted very long, over two weeks. In August I felt very weak and tired. Being a RN, I asked my Dr to check my iron levels. My ferratin was low. She put me on iron. Then on 9/3/25 during my period, I had an episode of very heavy bleeding, going through tampons every 15-30 mins. I wasn't home at the time. I went home but felt like I was going to pass out. I went to ER. Luckily I didn't need blood because I was already on iron. My Hg and Ferratin did drop though a week later when my Dr re-checked it. My gyno when I asked her said this could be due to my age called menarge but this only started after I got the HPV vaccine, I'm not in menopause yet, I just had my hormones checked, they are normal.
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| 2858532 | 67 | F | MI | 09/12/2025 |
FLU3 PNC20 RSV |
SEQIRUS, INC. PFIZER\WYETH PFIZER\WYETH |
407242 LX2498 LN5464 |
Injection site erythema, Injection site warmth; Injection site erythema, Injecti...
Injection site erythema, Injection site warmth; Injection site erythema, Injection site warmth; Injection site erythema, Injection site warmth
More
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Patient came into the pharmacy on 9/12/25 and reported that her arms were red at the injection site...
Patient came into the pharmacy on 9/12/25 and reported that her arms were red at the injection site and warm to the touch. Injection site looks like it was midway between the shoulder and elbow. She also stated that it looks better as of 9/12/25 than previous days.
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| 2858533 | 36 | F | GA | 09/12/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Palpitations
Palpitations
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Heart Racing after Influenza vaccine
Heart Racing after Influenza vaccine
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| 2858534 | 6 | M | NY | 09/12/2025 |
DTAPIPV DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Asthenia, Confusional state, Delirium, Erythema, Fatigue; Pain, Pruritus, Pyrexi...
Asthenia, Confusional state, Delirium, Erythema, Fatigue; Pain, Pruritus, Pyrexia, Swelling, Vomiting
More
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Vomiting, fever, fatigue, confusion, delirium, redness, swelling, raised swelling, pain, itching, we...
Vomiting, fever, fatigue, confusion, delirium, redness, swelling, raised swelling, pain, itching, weakness
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| 2858535 | 74 | F | CA | 09/12/2025 |
FLU3 |
SEQIRUS, INC. |
407258 |
Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
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Patient filled out consent form for Pneumococcal vaccine and COVID vaccine; however, the pneumonia v...
Patient filled out consent form for Pneumococcal vaccine and COVID vaccine; however, the pneumonia vaccine was typed up for FLU vaccine. After administration of the FLU vaccine, the patient expressed that she did not come for the FLU vaccine (she had already received it at her doctor's office yesterday), she wanted the pneumonia vaccine.
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| 2858536 | 68 | F | NV | 09/12/2025 |
FLU3 |
SANOFI PASTEUR |
|
Chest discomfort, Dyspnoea
Chest discomfort, Dyspnoea
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PT said she felt tightness of chest and difficult breathing 2 days after immunization. She then wen...
PT said she felt tightness of chest and difficult breathing 2 days after immunization. She then went to quick care and get steroid and is feeling better now
More
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| 2858537 | 88 | F | 09/12/2025 |
PNC21 |
MERCK & CO. INC. |
Z002626 |
Erythema, Peripheral swelling, Pruritus
Erythema, Peripheral swelling, Pruritus
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Patient had capvaxive shot administered on 9/6/25. She called 9/12/25 to see if there was anything e...
Patient had capvaxive shot administered on 9/6/25. She called 9/12/25 to see if there was anything else she could use to help with her "the pink swollen spot" on her arm. She said it had started out as swollen and itchy but she had been putting cool compresses on it and they itchiness is now gone and it is just swollen and pink.
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| 2858538 | 30 | F | WA | 09/12/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
MY9550 U8832DA |
Immediate post-injection reaction, Syncope; Immediate post-injection reaction, S...
Immediate post-injection reaction, Syncope; Immediate post-injection reaction, Syncope
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A patient had an appointment for both a flu and a COVID-19 vaccine. The patient mentioned that she g...
A patient had an appointment for both a flu and a COVID-19 vaccine. The patient mentioned that she gets nervous with needles. The flu vaccine was administered first, and the patient was fine. Immediately after the COVID-19 vaccine was administered, the patient fainted. The pharmacist and a technician held the patient and helped her lie down on the floor. The patient woke up right away. The pharmacist asked, "Do you remember I gave you both the flu and COVID-19 vaccines?" The patient responded, "Yes, I do." The pharmacist then asked, "Do you remember fainting right after the COVID-19 vaccine?" The patient again replied, "Yes, I do." The pharmacist offered, "Do you want some water?" The patient said, "Yes, please. I have candies in my bag." The pharmacist checked the patient's bag and pulled out the candies. The technician brought a bottle of water. The patient was able to communicate clearly, so the pharmacist and technician helped her sit on a chair. The pharmacist asked the patient to wait in the vaccination room for at least 20-30 minutes until a new vaccination patient arrived. The pharmacist performed a final check on the patient, and she was fully recovered before leaving the pharmacy.
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| 2858539 | 61 | F | WA | 09/12/2025 |
FLU3 |
SANOFI PASTEUR |
UT8763HA |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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On 09/12/2025 at 4:00 PM, a patient under 65 years old came in for a flu vaccine. The vaccine was pr...
On 09/12/2025 at 4:00 PM, a patient under 65 years old came in for a flu vaccine. The vaccine was processed in the system as Flublok, but the patient was administered Fluzone High-Dose in error. The patient was contacted immediately after the error was identified and was informed of the issue. The patient acknowledged the situation and reported no immediate adverse reaction
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| 2858540 | 51 | M | NC | 09/12/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Formication
Formication
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Continuous Sensation of bugs crawling all over skin
Continuous Sensation of bugs crawling all over skin
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| 2858006 | IL | 09/11/2025 |
HEPA HEPA |
MERCK & CO. INC. MERCK & CO. INC. |
Y014446 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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No additional AE; HCP calling to report 2nd dose of VAQTA administered earlier than recommended for ...
No additional AE; HCP calling to report 2nd dose of VAQTA administered earlier than recommended for a 11-year-old patient; This spontaneous report was received from other health professional, concerning to a 11-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 09-Jun-2025, the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA), 1 dosage form total, (lot # and expiration date were not reported). On 19-Aug-2025, with the second dose of Hepatitis A Vaccine, Inactivated (VAQTA), (lot #Y014446 has been verified to be valid for this product as a pre-filled syringe, expiration date reported and confirmed as 01-Feb-2026), 0.5 mL, total. Both as prophylaxis. On 19-Aug-2025, since the second dose of VAQTA was administered earlier than recommended for a 11-year-old patient (Inappropriate schedule of product administration). No additional adverse event (No adverse event).
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| 2858007 | M | MD | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective, Laboratory test
COVID-19, Drug ineffective, Laboratory test
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Had the vaccination (COVID-19 Vaccine) before, having COVID; Had the vaccination (COVID-19 Vaccine) ...
Had the vaccination (COVID-19 Vaccine) before, having COVID; Had the vaccination (COVID-19 Vaccine) before, having COVID; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Diabetes" (unspecified if ongoing), notes: Diabetes consumer stated, "I take some type of diabetes medicine.". Concomitant medication(s) included: AMLODIPINE taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Sep2025, outcome "not recovered" and all described as "Had the vaccination (COVID-19 Vaccine) before, having COVID". The patient underwent the following laboratory tests and procedures: Test: (Aug2025) Unknown Results, notes: Consumer stated, "Not within two weeks but within last month or so, I just got a test and went and saw my doctor. Clinical course: Transferring agent stated, "I have patient on the other line who reported having COVID while also having, have had the vaccination (COVID-19 Vaccine) before, and would be taking the Paxlovid". Consumer stated that he do not know the name of the vaccine. He really did not know. Patient mean, he took it at the redacted, they did not mailed in. Reason for taking the vaccine, consumer stated that was supposed to diminish the chance of getting COVID or at least, if do get it, not going to die". Consumer stated that he received a COVID vaccine but patient did not know, who did it". Consumer stated that still not sure. Patient mean, if Pfizer the one that gave it to the (redacted) or other COVID shots too, patient did not know. Patient thought that was only Pfizer, patient did not know. When probed to clarify that consumer was not sure if the COVID-19 vaccine was Pfizer or not, consumer stated, he was not that intellectual that to try to scrutinize who was gave the vaccine. Patient just knew, he needed the vaccine. Now that he was said that, he know, Pfizer was one of the companies, but patient did not know if the pharmacy gives out that one or not". COVID-19 Vaccine Indication: Consumer stated that to reduce the chance of getting that or if he get that. To survive that. Anatomical location of administration of vaccine: Consumer stated that he don't know. Patient mean, they used to give one in each arm for different things, but most probably on the upper arm. Patient don't know where. Route of administration: Consumer stated that the muscle on the arm". Consumer stated he got COVID on the 4th (clarified as 04Sep2025). Treatment: Consumer stated that he just went to the doctor on 07Sep2025 and then they told patient to have the Paxlovid or whatever that was.. Patient have redacted which means he don't have money for that. Patient could get certain supplements, but that supplement was not covered". Other vaccine on same date with Pfizer vaccine: Consumer stated that he had but patient don't know that record, but the pharmacist has the record (Unspecified Vaccine)". Reason for taking the vaccine, consumer stated that he was supposed to diminish the chance of getting COVID or at least, if get it, not going to die". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2858008 | F | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dizziness
Dizziness
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dizzy; This is a spontaneous report received from a Consumer or other non HCP from medical informati...
dizzy; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: DIZZINESS (hospitalization) with onset 2023, outcome "not recovered", described as "dizzy". The event "dizzy" required emergency room visit. Clinical course: The patient got the Pfizer COVID vaccine in 2023 and got dizzy and had been dizzy ever since. She had been to the hospital, emergency rooms and her doctor and no one knows why she was dizzy. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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β | |||||||
| 2858009 | M | 09/11/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Arthralgia, Pain in extremity
Arthralgia, Pain in extremity
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shoulder started getting sore; felt sore/prior experience with previous administration; This is a sp...
shoulder started getting sore; felt sore/prior experience with previous administration; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization, reaction(s): "arm and shoulder started getting sore", "arm and shoulder started getting sore"; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization, reaction(s): "arm and shoulder started getting sore", "arm and shoulder started getting sore". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder started getting sore"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "felt sore/prior experience with previous administration". Additional information: Patient's arm and shoulder started getting sore as it has on previous occasions. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2858010 | 37 | MI | 09/11/2025 |
FLU3 |
SANOFI PASTEUR |
|
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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fluzone hd off label used in adult pt of 37 year old pt with no reported adverse event; Initial info...
fluzone hd off label used in adult pt of 37 year old pt with no reported adverse event; Initial information received on 08-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 37 years old adult patient with an unknown gender who was received with Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] as off label use at younger age group 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 (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Influenza as off label use at younger age group with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly, Pharmacist wanted to know if the dose must be repeated 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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| 2858028 | 70 | M | CA | 09/11/2025 |
COVID19 |
MODERNA |
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Asthenia, Fatigue, Frustration tolerance decreased, Loss of personal independenc...
Asthenia, Fatigue, Frustration tolerance decreased, Loss of personal independence in daily activities
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About few weeks after the 2nd dose, I started feeling an almost complete lack of energy. My normal e...
About few weeks after the 2nd dose, I started feeling an almost complete lack of energy. My normal energy level has never come back. I use to be able to do things like cut the lawn without feeling tired. Now I can barely muster up enough energy to do things like yard maintenance. I can?t even wash our cars anymore without feeling exhausted soon after starting. Besides this issue, I have no health issues whatsoever that would cause the loss of energy. Frustrating.
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| 2858033 | 68 | M | 09/11/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Atrial fibrillation, Cardiac stress test abnormal, Central venous catheterisatio...
Atrial fibrillation, Cardiac stress test abnormal, Central venous catheterisation, Chest tube insertion, Coronary artery bypass; Coronary artery disease, Coronary artery occlusion, Electrocardiogram QT prolonged
More
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Atrial Fibrillation; severe three vessel coronary artery disease; This 68-year-old male subject was ...
Atrial Fibrillation; severe three vessel coronary artery disease; This 68-year-old male subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 20-SEP-2022, for prophylaxis. Concomitant products included carvedilol and amlodipine. On 05-MAY-2023, 227 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 triple vessel disease (Verbatim: severe three vessel coronary artery disease). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation) on 23-MAY-2023 with serious criteria of hospitalization. The subject was treated with amiodarone and metoprolol. The action taken with RSVPreF3 vs Placebo was no change. The outcome of triple vessel disease was resolved on 18-MAY-2023. The outcome(s) of the additional event(s) included atrial fibrillation (resolved on 24-MAY-2023). Relevant Tests: On 05-MAY-2023; stress test showed left lower anterior descending coronary artery ligation. On an unknown date in 2023; Coronary Artery Bypass Graft x3. Diagnostic results (reference ranges are provided in parenthesis if available): Electrocardiogram-In MAY-2023 QTc was prolonged and in MAY-2023 QTc was improved. The investigator considered that there was no reasonable possibility that the triple vessel disease and atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the triple vessel disease and atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2023095341 GSK receipt date: 19-MAY-2023. Subject was seen by his cardiologist on 05 MAY 2023 for a stress test. He was scheduled for a heart catherization procedure on 15 MAY 2023. Subject's wife notified the site that he would be having bypass surgery on 18 MAY 2023. She contacted site to report that he had triple bypass surgery. Site would request hospital records upon subjects discharge and update accordingly. Site would also get updates from the subject's wife for any changes in condition. Subject was admitted to hospital on 5/18/23 and discharged home on 5/25/23. Still awaiting the hospital records. After numerous requests, hospital records were received on 11 JUL 2023. Event term was updated. During review of this event the subject was noted to have gone into atrial fibrillation on post op 5 while he was being prepared for discharge. Additional event had been noted for the atrial fibrillation. Spoke to subjects wife today 13 JUL 2023. She reported he was continuing to do well. We discussed medications noted in the hospital records. Site did not have 2 amlodipine 5 mg QD and carvedilol 3.125 mg BID captured in source/EDC. Questioned about diagnosis of hypertension. She indicated that he has had it since being diagnosed with hyperlipidemia. Med history and con med page updated. Reviewed ongoing post operative medications. He stopped the pain meds and muscle relaxer on 30 MAY 2023. Doctor stopped the potassium chloride and changed the dose of atorvastatin to 80 mg daily and metoprolol 12.5mg BID. Deleting Atrial Fibrillation as additional SAE(serious adverse event) and adding to this SAE(serious adverse event). Both events were in same hospitalization. Received and reviewed hospital medical records that were received on 11 JUL 2023. During review the subject was noted to have experience atrial fibrillation on post op day 5 (s/p coronary artery bypass graft x3). He was ready for discharge and had just had his chest tube removed we he went into atrial fibrillation. PICC line was placed and bolus of amiodarone was give and drip was started. On post op day 6 he converted back to normal sinus rhythm however his QTc was prolonged. Amiodarone was stopped and he was monitored for another day. Post op day 7 he remained hemodynamically stable in normal sinus rhythm and repeat ECG QTc was improved. He was discharged home with home health services. Admitted on 18 MAY 2023 and Discharged on 25 MAY 2023. Follow-up information received on 25-May-2023. Summary of changes: Narrative updated. Follow-up information received on 12-JUN-2023. Summary of changes: Hospitalization details and narrative updated. Follow-up information received on 10-JUL-2023. Summary of changes: Event term updated from coronary artery block to severe three vessel coronary artery disease. Follow-up information received on 11-JUL-2023 and 13-JUL-2023. Summary of changes: Relevant test and narrative updated. Follow-up information received on 14-JUL-2023. Summary of changes: Concomitant medications were updated. Follow-up information received on 30-OCT-2023. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). On 30/Oct/2023 case US2023095341 was identified as duplicate case of US2023071797. All the future correspondence will be added US2023071797. Summary of changes: Additional event Atrial fibrillation was added. General narrative comment updated. Metoprolol changed from concomitant to treatment medication. Upon internal review case was updated on 30-MAY-2024. Summary of changes: AESI statement was updated for AE atrial fibrillation. Start date for treatment drug metoprolol was updated from 23-JUN-2023 to 19-MAY-2023. Frequency of metoprolol was updated from BID to once daily. Treatment drug amiodarone was added. Narrative updated. Follow up information received on 12-Jun-2024. Summary of changes: Dosage regimen of metoprolol (start date: 22-Jun-2023) was deleted. Lab data and narrative updated. Follow up information received on 04-JUL-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial fibrillation and Coronary artery disease, 227 days after receiving the 2nd dose of RSVPreF3, in a 68-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility for the event Coronary artery disease and alternate etiology (h/o hypertension, hyperlipidemia) based on medical history. US-GSK-US2023095341:
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