| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2798221 | 16 | M | FL | 10/11/2024 |
HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
X025115 X025115 X025115 X025115 X025115 X025115 X025115 X025115 |
Blood pressure decreased, Heart rate decreased, Hyperhidrosis, Immediate post-in...
Blood pressure decreased, Heart rate decreased, Hyperhidrosis, Immediate post-injection reaction, Pallor; Syncope; Blindness, Blood pressure decreased, Chest discomfort, Dizziness, Fatigue; Feeling cold, Heart rate decreased, Hyperhidrosis, Loss of consciousness, Pallor; Palpitations, Tremor, Vision blurred; Blindness, Blood pressure decreased, Chest discomfort, Dizziness, Fatigue; Feeling cold, Heart rate decreased, Hyperhidrosis, Loss of consciousness, Pallor; Palpitations, Tremor, Vision blurred
More
|
Patient received third dose of gardasil today while seated on an exam table. Before even removing ne...
Patient received third dose of gardasil today while seated on an exam table. Before even removing needle patient began sweating, turned pale, and fainted. Patient was then laid down on exam table and his legs were raised. Patients BP lowered to 88/44 and HR decreased to 46 and RR 18. After lying down for 3 minutes patient regained consciousness and felt better and wanted to sit up on his own. Patient was then given some water and pediasure and has tolerated it fine with no symptoms. Patient remains in office for an hour resting also per request of his nervous mother. Patient now has BP 105/76 HR 77 RR 18 and o2 sat 98%I After 5 minutes of resting lying down patient stated he felt better.
More
|
||||||
| 2823077 | 78 | F | 01/27/2025 |
COVID19 |
MODERNA |
|
Hypoaesthesia, Musculoskeletal stiffness
Hypoaesthesia, Musculoskeletal stiffness
|
While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down r...
While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down right out of her hand; Occasionally experienced numbness of her arms; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MUSCULOSKELETAL STIFFNESS (While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down right out of her hand) and HYPOAESTHESIA (Occasionally experienced numbness of her arms) in a 78-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Patient had been receiving Spikevax vaccine, and there had been no problem previously. In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced MUSCULOSKELETAL STIFFNESS (While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down right out of her hand) and HYPOAESTHESIA (Occasionally experienced numbness of her arms). At the time of the report, MUSCULOSKELETAL STIFFNESS (While eating with chopsticks, she suddenly felt stiff in her hands and the chopsticks dropped down right out of her hand) and HYPOAESTHESIA (Occasionally experienced numbness of her arms) had not resolved. Concomitant medication use information was not provided by reporter. The reaction had been going on for months. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter.
More
|
|||||||
| 2823078 | 90 | F | MD | 01/27/2025 |
COVID19 |
MODERNA |
|
Back pain
Back pain
|
severe back pain (middle to upper); This spontaneous case was reported by a patient family member or...
severe back pain (middle to upper); This spontaneous case was reported by a patient family member or friend and describes the occurrence of BACK PAIN (severe back pain (middle to upper)) in a 90-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In January 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In January 2025, the patient experienced BACK PAIN (severe back pain (middle to upper)). The patient was treated with Diclofenac sodium (Voltaren) at an unspecified dose and frequency. At the time of the report, BACK PAIN (severe back pain (middle to upper)) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown. Patient did not receive vaccines within the past 4 weeks. No concomitant medication was reported. The patient did not experience any additional symptoms or events. This case was linked to US-MODERNATX, INC.-MOD-2025-781607 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781607:Invalid case
More
|
||||||
| 2823079 | 52 | F | NJ | 01/27/2025 |
COVID19 |
MODERNA |
|
COVID-19
COVID-19
|
she had COVID attack last year; This spontaneous case was reported by a non-health professional and ...
she had COVID attack last year; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (she had COVID attack last year) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. In June 2024, the patient experienced COVID-19 (she had COVID attack last year). At the time of the report, COVID-19 (she had COVID attack last year) had resolved. No concomitant medication was reported. The patient also mentioned that she had to take the vaccination before travelling to avoid getting sick or COVID. She mentioned that she had COVID attack last year in late June as she did not take the Booster shot. No treatment information was reported. Reporter did not allow further contact
More
|
||||||
| 2823080 | 75 | M | NY | 01/27/2025 |
COVID19 |
MODERNA |
|
Fatigue, Oral mucosal eruption, Oral mucosal erythema, Oropharyngeal pain
Fatigue, Oral mucosal eruption, Oral mucosal erythema, Oropharyngeal pain
|
sore throat; fatigue; redness which had been climbing up my throat into my mouth; it looks more like...
sore throat; fatigue; redness which had been climbing up my throat into my mouth; it looks more like a little bit more like a rash almost (the redness in my throat converted to a rash appearance).; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ORAL MUCOSAL ERYTHEMA (redness which had been climbing up my throat into my mouth), ORAL MUCOSAL ERUPTION (it looks more like a little bit more like a rash almost (the redness in my throat converted to a rash appearance).) and FATIGUE (fatigue) in a 75-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 in July 2024. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Patient received 6 shots since 2019) in September 2023. Past adverse reactions to the above products included No adverse effect with COVID-19 Vaccine. On 05-Jan-2025, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 06-Jan-2025, the patient experienced OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue). In January 2025, the patient experienced ORAL MUCOSAL ERYTHEMA (redness which had been climbing up my throat into my mouth) and ORAL MUCOSAL ERUPTION (it looks more like a little bit more like a rash almost (the redness in my throat converted to a rash appearance).). At the time of the report, OROPHARYNGEAL PAIN (sore throat), ORAL MUCOSAL ERYTHEMA (redness which had been climbing up my throat into my mouth), ORAL MUCOSAL ERUPTION (it looks more like a little bit more like a rash almost (the redness in my throat converted to a rash appearance).) and FATIGUE (fatigue) had not resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Patient got the 1st two shots when they first came out. Then got the boosters. Then had over 4 boosters since. Patient did not receive vaccines within the past 4 weeks, and no medical conditions has reported. No concomitant medication was reported. On January 6th, at the end of the day, patient developed a sore throat and fatigue. It lasted longer than patient would have thought. Patient went to primary care doctor, and he gave me a swab for the throat to rule out Strep, it was not the strep. He said it could be a passing sore throat, which they could get, although it's already been at that point 10 or 11 days. Or could be possibly associated with the vaccine. Patient waited another 6 days and the redness which had been climbing up the throat into mouth, his wife looked in and it looked more like a little bit like a rash almost (the redness in throat converted to a rash appearance). Patient made an appointment for Friday to see doctor again. Patient was concerned about, something that will spread or that was a rash. It was not like typical of a viral sore throat because it just didn't go away, and it was not progressing and getting worse. It was just changing in nature. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-781696 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781696:Female case
More
|
||||||
| 2823081 | M | 01/27/2025 |
COVID19 |
MODERNA |
3043501 |
Alopecia
Alopecia
|
I started losing hair; This spontaneous case was reported by a patient and describes the occurrence ...
I started losing hair; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (I started losing hair) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043501) for COVID-19 prophylaxis. No Medical History information was reported. On 04-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In November 2024, the patient experienced ALOPECIA (I started losing hair). At the time of the report, ALOPECIA (I started losing hair) outcome was unknown. No concomitant medication was reported. Within 2 weeks after receiving vaccine patient started losing hair and it didn't seem to be letting up. There was no change in his medicine, diet, or water intake. He did read that this was a rare side effect, and it should be improved in 3 to 6 months. No treatment medication was reported. Reporter did not allow further contact
More
|
||||||||
| 2823082 | U | NY | 01/27/2025 |
PNC13 RSV |
PFIZER\WYETH PFIZER\WYETH |
|
Palpitations; Palpitations
Palpitations; Palpitations
|
intermittent palpitations; This is a spontaneous report received from a Pharmacist. A patient (age ...
intermittent palpitations; This is a spontaneous report received from a Pharmacist. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 14Jan2025 as dose 1, single (Batch/Lot number: unknown) for immunisation; pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 14Jan2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset 15Jan2025, outcome "unknown", described as "intermittent palpitations". Additional information: It was reported via email that last Tuesday (14Jan2025), they administered Abrysvo and Prevnar (reporter confirmed the email only listed as Prevnar, unable to clarify which Prevnar) to the patient and the patient came in today, 20Jan2025, to let know the following day after getting the vaccine (15Jan2025), the patient had intermittent palpitations after receiving the vaccine. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
More
|
|||||||
| 2823083 | 75 | F | WI | 01/27/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
|
COVID-19, Vaccination failure; Aldolase, Blood cholesterol, C-reactive protein, ...
COVID-19, Vaccination failure; Aldolase, Blood cholesterol, C-reactive protein, Insomnia, Investigation; Muscle enzyme, Pain, Pain assessment, Pelvic girdle pain; COVID-19, Vaccination failure; Aldolase, Blood cholesterol, C-reactive protein, Insomnia, Investigation; Muscle enzyme, Pain, Pain assessment, Pelvic girdle pain
More
|
COVID-19; COVID-19; This is a spontaneous report received from a Physician. A 76-year-old female pa...
COVID-19; COVID-19; This is a spontaneous report received from a Physician. A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jul2024 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "aortic dissection", start date: 23Dec2015 (unspecified if ongoing), notes: was medical emergency, genetic, probably thirty people in family would have had it, is a disabling feature of patient; "memory issues", start date: Mar2016 (unspecified if ongoing), notes: became more progressive, right now patient is stable; "head scan", start date: Sep2015 (unspecified if ongoing), notes: helped with diagnosis of memory issues. There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 2), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER)), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 4 (BOOSTER)), for Covid-19 immunization; Moderna bvln bstr (DOSE 5 (BOOSTER)), for Covid-19 immunization; Spikevax 12 plus (DOSE 6 (BOOSTER)), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "COVID-19". The clinical course was reported as follows: It was reported that the patient had gotten COVID three times, and twice patient had to be hospitalized, confirmed admitted into hospital, either for two nights or for four nights. Third time patient had to be in the emergency room about seven hours, and then patient seemed fine. The reporter could take patient home or leave her there, thought with patient's memory issues, the patient was probably better at home, but he stated should had left her there. Whenever patient got, was more problematic than when other people were getting it, so had gone ahead and given patient next booster. The patient's husband thought patient had had eight doses now (got other dose in either Sep2024 or Oct2024). The patient shifted over to Pfizer because patient's first doses were Moderna. The patient got Comirnaty 12 plus on 03Jul2024, the reporter thought the dose patient got of Comirnaty 12 plus must have been Pfizer, but unable to confirm.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.
More
|
✓ | |||||
| 2823084 | M | NJ | 01/27/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Cerebrovascular accident, Dizziness, Gait disturbance, Investigation, Vertigo; V...
Cerebrovascular accident, Dizziness, Gait disturbance, Investigation, Vertigo; Vision blurred
More
|
severe vertigo; dizzy; couldn't walk; couldn't see, vision was really blurry; Rear occipit...
severe vertigo; dizzy; couldn't walk; couldn't see, vision was really blurry; Rear occipital stroke; This is a spontaneous report received from an Other HCP. A 33-year-old male 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: CEREBROVASCULAR ACCIDENT (disability, medically significant) with onset 25Mar2023, outcome "recovering", described as "Rear occipital stroke"; VISION BLURRED (non-serious) with onset Jun2023, outcome "recovering", described as "couldn't see, vision was really blurry"; GAIT DISTURBANCE (non-serious) with onset Jun2023, outcome "recovering", described as "couldn't walk"; DIZZINESS (non-serious) with onset Jun2023, outcome "recovering", described as "dizzy"; VERTIGO (non-serious) with onset Jun2023, outcome "recovering", described as "severe vertigo". The patient underwent the following laboratory tests and procedures: numerous tests and studies: Unknown results. Clinical course: Patient initially suffered two cryptogenic strokes back in April, caller then checked and clarified and confirmed the two strokes were rear occipital strokes. First stroke occurred 25Mar2023, second stroke occurred 05Jun2023. Called to report, has gone through numerous tests and studies, doctors cannot figure out what caused. With first stroke, fainted, lost consciousness, was out for over a minute. With second stroke had severe vertigo, became dizzy, was dizzy for about three weeks nonstop, couldn't walk, was in bed two and a half weeks, couldn't see, vision was really blurry, wasn't stable, couldn't focus on anything for about a month. Would say disabling as well, hard to say whether life threatening, hard to say if life threatening, any time you have a stroke is life threatening. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The association between the event rear occipital stroke with BNT162b2 NOS can not be fully excluded based on the limited information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
More
|
✓ | ||||||
| 2823085 | F | 01/27/2025 |
COVID19 |
PFIZER\BIONTECH |
4F483A |
Headache
Headache
|
had a reaction with Dupixent and the second COVID vaccine / headaches; This is a spontaneous report ...
had a reaction with Dupixent and the second COVID vaccine / headaches; This is a spontaneous report received from a Consumer or other non HCP from License Party. An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Lot number: 4F483A, Expiration Date: 31Aug2026) for covid-19 immunisation; dupilumab (DUPIXENT), as 300 mg qow (every other week; strength: 3000mg/2ml)) subcutaneous for dermatitis atopic. The patient's relevant medical history included: "Arthritis" (ongoing); "Osteoporosis" (ongoing); "D.farinae mite extract" (unspecified if ongoing); "illness" (unspecified if ongoing). Concomitant medication(s) included: PROLIA; METHOTREXATE; ATORVASTATIN CALCIUM; PAXLOVID taken for covid-19 treatment; ALBUTEROL SULFATE HFA; KETOCONAZOLE; INCRUSE ELLIPTA; METOPROLOL SUCCINATE; METHYLPREDNISOLONE. Past drug history included: Bupropion hcl, reaction(s): "Drug allergies: Bupropion"; Wellbutrin sr, reaction(s): "allergic to Wellbutrin SR". Vaccination history included: Covid-19 vaccine (dose 1; unknown manufacturer), for covid-19 immunization. The following information was reported: HEADACHE (hospitalization), outcome "unknown", described as "had a reaction with Dupixent and the second COVID vaccine / headaches". The action taken for dupilumab was unknown. Clinical course: On an unknown date, the patient started taking dupilumab solution for injection at a dose of 300 mg QOW (every other week) subcutaneously with strength of 3000mg/2ml delivered via prefilled pen for dermatitis atopic. On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur. Reportedly, patient had a reaction with DUPIXENT and the second covid vaccine that put her in the hospital (adverse drug reaction; onset and latency: unknown). She had an injection of methylprednisone yesterday and she was aware that there's drug interactions between that and the Prolia. She was also prescribed methotrexate and it's concerned about drug interaction as well. Patient Prolia therapy stated she did not want to take anymore. Stated she was not fully informed by her doctor of the side effects of the Prolia also concerned with drug interactions she has read online about. Stated the Prolia caused joint pain, and she already had arthritis. Also believed there is a contraindication to using Prolia with a methylprednisone injection she received last week and her methotrexate. Upon follow-up, patient reported arthritis and headaches (headache; onset date and latency: unknown) (batch number: 4F483A and expiry date on 31Aug2026) no additional details. SUSPECT PRODUCT is under agreement with BIONTECH SE.
More
|
✓ | |||||||
| 2823086 | U | 01/27/2025 |
FLU3 |
SANOFI PASTEUR |
|
Feeling abnormal
Feeling abnormal
|
feeling so bad; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serio...
feeling so bad; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a Consumer/ Non-Healthcare Professional. This case involves an unknown age / gender patient who was feeling so bad after receiving influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone High Dose]. 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 influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization). Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date the patient feeling so bad (feeling abnormal) (unknown latency) following the administration of influenza USP TRIVAL A-B high dose subvirion vaccine. Reportedly, no additional information or specific symptoms were shared. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event.
More
|
||||||||
| 2823087 | 8 | M | PA | 01/27/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK044AA |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
inappropriate use due to inadvertently administering pentacel rather than tenivac with no reported a...
inappropriate use due to inadvertently administering pentacel rather than tenivac with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a Other health professional. This case involves, a 8 years old male patient who received inappropriate use due to inadvertently administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] rather than Tenivac with no reported adverse event. The patient's past medical treatment included Pediarix on 11-May-2017 with at 10 months of age. The patient's past medical history, vaccination(s) and family history were not provided. On 20-Nov-2024, the patient who received inappropriate use due to inadvertently administered 0.5 ml dose (once) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UK044AA, expiry date: 31-Aug-2025) (unknown strength) via intramuscular route in the right deltoid for immunization rather than Tenivac with no reported adverse event (wrong product administered) (latency-same day). Reportedly, Nurse practitioner stated that patient to receive Tenivac as part of his catch-up immunization schedule on 05-Nov-2024, but he was inadvertently administered Pentacel instead. His vaccine schedule was as follows:11-May-2017, at 10 months of age; 05-Sep-2024, at 8 years of age and 20-Nov-2024 - Pentacel (DTaPIPV-Hib) instead of Tenivac (Td). 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.
More
|
||||||
| 2823088 | U | VA | 01/27/2025 |
HIBV |
SANOFI PASTEUR |
|
No adverse event, Product preparation error
No adverse event, Product preparation error
|
ActHib was administered with sterile water instead of saline with no reported adverse event; Initial...
ActHib was administered with sterile water instead of saline with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age/gender patient to whom HIB (PRP/T) VACCINE [ACT-HIB] was administered with sterile water instead of saline 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 a dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (dose, strength, lot, expiry and route: unknown) with sterile water instead of saline with no reported adverse event (product preparation error) (latency same day) in unknown administration site for immunization. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. 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.
More
|
|||||||
| 2823089 | U | FL | 01/27/2025 |
TDAP |
SANOFI PASTEUR |
3CA17C1 |
No adverse event, Product preparation error
No adverse event, Product preparation error
|
Adacel was mixed with 0.5 ml of sterile diluent and administered to a patient in error with no repor...
Adacel was mixed with 0.5 ml of sterile diluent and administered to a patient in error with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient to whom had administered Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] was mixed with 0.5 ml of sterile diluent and administered to a patient in error 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 a unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: unknown, expiry date: 01-Feb-2026, lot 3CA17C1) via unknown route in unknown administration site as immunization and was mixed with 0.5 ml of sterile diluent and administered to a patient in error with no reported adverse event (product preparation error) (same day latency). 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.
More
|
|||||||
| 2823106 | U | 01/27/2025 |
MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
|
Febrile convulsion; Febrile convulsion
Febrile convulsion; Febrile convulsion
|
One febrile seizure was reported 14 days after dose 4 of PCV20; the seizure was considered not relat...
One febrile seizure was reported 14 days after dose 4 of PCV20; the seizure was considered not related to PCV20, but possibly related to the measles, mumps, and rubella or varicella vaccine; Literature Report: This literature marketed report has been received from the authors of the published article and refers to an infant of unspecified gender and age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On unspecified date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) formulation as default: injection, or varicella virus vaccine live (Oka/Merck) (VARIVAX) formulation as default: injection (strength, dose, frequency, route of administration, vaccination scheme, site of vaccination, lot #, and expiration date were not provided) as a prophylaxis. On unspecified date, the patient experienced a febrile seizure. At the reporting time, the outcome of the event was not provided. The causal relationship between suspect vaccine with the event was considered as related (possibly related). A copy of the published article is attached as further documentation of the patient's experience. Lot # is being requested and will be submitted if received.
More
|
||||||||
| 2823107 | U | IL | 01/27/2025 |
MMRV |
MERCK & CO. INC. |
Y013574 |
No adverse event, Product storage error
No adverse event, Product storage error
|
no adverse event; HCP reports that PROQUAD was inadvertently administered after suffering from a Tem...
no adverse event; HCP reports that PROQUAD was inadvertently administered after suffering from a Temperaturre excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided. On 18-DEC-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection, for prophylaxis, 0.5 milliliter per series, lot number Y013574 which has been verified t be valid, expiration date not reported but upon internal review established as 03-FEB-2026 (strength, route of administration and anatomical location not reported); and sterile diluent (MERCK STERILE DILUENT) solution for injection (strength, indication, dose, lot number, expiration date, route of administration and anatomical site not provided). On the same date, the reported stated that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection was inadvertently administered after suffering from a temperature excursion, the product reached -11.6 degree celcius but previous excursions could not be confirmed, the product was out of range for 3 hours 5 minutes and 0 seconds but previous excursions could not be confirmed (Improper storage of product in use). No symptomatic adverse events were reported.
More
|
|||||||
| 2823108 | F | PA | 01/27/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
|
Injection site erythema, Injection site inflammation, Injection site pain, Injec...
Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling; Injection site warmth
More
|
the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; ...
the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; swelling at the injection site; This is a spontaneous report received from a Nurse from medical information team. A 27-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 16Jan2025 as dose 1, single (Batch/Lot number: unknown), in right arm for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 18Jan2025, outcome "not recovered", described as "swelling at the injection site"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 18Jan2025, outcome "not recovered" and all described as "the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy". Therapeutic measures were taken as a result of vaccination site warmth, vaccination site erythema, vaccination site inflammation, vaccination site pain, vaccination site pruritus, vaccination site swelling. Additional information: Patient was treated with Benadryl but didn't help. Patient was asking for advise. Patient was advised by the reporter to use cold compresses, continuous Benadryl as needed or she could switch to Zyrtec.
More
|
|||||||
| 2823110 | 88 | F | NY | 01/27/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Ageusia, Anosmia, Condition aggravated, Weight decreased
Ageusia, Anosmia, Condition aggravated, Weight decreased
|
Lost taste; Lost smell; Lost a lot of weight/ it was worse now; Lost a lot of weight/ it was worse n...
Lost taste; Lost smell; Lost a lot of weight/ it was worse now; Lost a lot of weight/ it was worse now; This is a spontaneous report received from a Consumer or other non HCP. An 88-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 88 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes; "lost a lot of weight" (unspecified if ongoing), notes: beginning past 2, 3 years. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; JANUVIA [SITAGLIPTIN PHOSPHATE] taken for diabetes mellitus. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), administration date: Apr2021, when the patient was 85 years old, for covid-19 immunization. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "Lost taste"; ANOSMIA (non-serious), outcome "unknown", described as "Lost smell"; WEIGHT DECREASED (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "Lost a lot of weight/ it was worse now". Additional Information: The patient thought she had adverse events from the Pfizer vaccine. The patient had had it from the beginning like past 2, 3 years, she had been going there with this, in updates and follow up. The first one was in Apr2021 and the last one was on 29Oct2024. The patient did not know the time of vaccination, she thought it was noon 11, 12 or 1 o'clock, she was not sure. The patient could not tell the specific day, it gradually happened over time, and it was worse now, she had lost a lot of weight. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
More
|
||||||
| 2823111 | F | MI | 01/27/2025 |
COVID19 COVID19 FLUX FLUX |
PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Allergy to vaccine, COVID-19, Chills, Drug ineffective, Headache; Illness, Myalg...
Allergy to vaccine, COVID-19, Chills, Drug ineffective, Headache; Illness, Myalgia, Pain, Pyrexia, Radiotherapy; Allergy to vaccine, COVID-19, Chills, Drug ineffective, Headache; Illness, Myalgia, Pain, Pyrexia, Radiotherapy
More
|
did get COVID even after having a vaccine; did get COVID even after having a vaccine; allergic to Co...
did get COVID even after having a vaccine; did get COVID even after having a vaccine; allergic to Covid vaccine; sick; fever; chills; ached; Muscles aches all over my body; headache; The initial case was missing the following minimum criteria: unspecified suspect drug. Upon receipt of follow-up information on 15Jan2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 75-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "cancer", start date: 2019 (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Surgery" (unspecified if ongoing); "radiation therapy" (unspecified if ongoing). Concomitant medication(s) included: XANAX; WELLBUTRIN. Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 1, SINGLE; left arm), administration date: Oct2022, for COVID-19 Immunization, reaction(s): "chills", "bad headache", "sick", "muscles aches all over my body", "ached", "fever". The following information was reported: MYALGIA (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome "recovered", described as "Muscles aches all over my body"; PAIN (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome "recovered", described as "ached"; CHILLS (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome "recovered"; PYREXIA (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome "recovered"; ILLNESS (non-serious) with onset Oct2023, 6 hrs after the suspect product(s) administration, outcome "recovered", described as "sick"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "did get COVID even after having a vaccine"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic to Covid vaccine". The patient underwent the following laboratory tests and procedures: Radiotherapy: (Aug2024) Unknown results. Therapeutic measures were taken as a result of illness, pyrexia, chills, pain, myalgia, headache. Clinical course: The patient reported that she had a reaction to the Pfizer COVID-19 vaccine in Oct2022 and 2023. She said, she got those and got really sick, and she said that she ran a fever, chills and she ached, and this occurred 4 to 6 hours after the vaccine, and real bad headache. Both times and they were all Pfizer. Treated herself with Tylenol. The patient also mentioned that she had cancer in 2019 and then had surgery for it and then in 2024 she had radiation therapy in Aug. The patient would like to get another Covid vaccine, but now is afraid of them. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
More
|
|||||||
| 2823113 | U | 01/27/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Arterial occlusive disease, Cardiac disorder, Suicide threat
Arterial occlusive disease, Cardiac disorder, Suicide threat
|
I will need to get assisted suicide.; clogged arteries in my penis; heart issues; This is a spontane...
I will need to get assisted suicide.; clogged arteries in my penis; heart issues; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 OMI XBB.1.5), 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: SUICIDE THREAT (medically significant), outcome "unknown", described as "I will need to get assisted suicide."; ARTERIAL OCCLUSIVE DISEASE (non-serious), outcome "unknown", described as "clogged arteries in my penis"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart issues". Clinical course: The patient reported that :You guys caused clogged arteries in my penis. He has been to every single hospital and been to research hospitals and now has heart issues and clogged veins in his penis from the Vaccine. The patient also stated" At just 19 years old you ruined my life. I am 22 now. I will need to get assisted suicide" The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
More
|
||||||||
| 2823114 | 70 | F | OK | 01/27/2025 |
FLU4 |
SANOFI PASTEUR |
U8161CA |
Anaphylactic reaction, Angioedema, Limb injury, Peripheral swelling
Anaphylactic reaction, Angioedema, Limb injury, Peripheral swelling
|
Angioedema; anaphylaxis; bumped her arm; Initial information received on 20-Jan-2025 regarding an un...
Angioedema; anaphylaxis; bumped her arm; Initial information received on 20-Jan-2025 regarding an unsolicited valid serious case received from a consumer/non-health care professional. This case involves a 70 years old female patient who had angioedema, anaphylaxis and bumped her arm after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. Ona n unknown date in November 2024, the patient received a unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine lot U8161CA via intramuscular route in the left arm for Immunization (strength, formulation, expiry date was unknown). On an unknown date the patient developed angioedema, anaphylaxis (anaphylactic reaction) and bumped her arm (peripheral swelling) (unknown latency) following the administration of Influenza Quadrival A-B High Dose Hv Vaccine. Reportedly "She is not sure if she got the flu vaccine at that location in the past. ." Action taken was not applicable for all the events. It was not reported if the patient received a corrective treatment for the events (Angioedema, bumped her arm, anaphylaxis). At time of reporting, the outcome was Unknown for the events. Seriousness Criteria : Medically significant for the events angioedema and anaphylactic reaction.; Sender's Comments: Sanofi Company Comment dated 23-Jan-2025 : This case involves a 70-year-old female patient who had angioedema, anaphylaxis after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
More
|
||||||
| 2823115 | 0.33 | U | KY | 01/27/2025 |
FLU3 |
SANOFI PASTEUR |
|
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
FLUZONE NP was administered to a 4-month old patient with no reported adverse event; Initial informa...
FLUZONE NP was administered to a 4-month old patient with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves, a 4 months old and unknown gender patient was administered 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 an unknown date, the patient received a dose of suspect patient was administered Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (unknown strength, dosage, expiry date, batch number and route) via unknown administration site for Influenza with no reported adverse event (off label use) (latency- same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Caller stated the patient was accidentally given a flu shot and wasn't supposed to receive it until 6 months old.
More
|
||||||
| 2823116 | 64 | F | SC | 01/27/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Pain in extremity
Pain in extremity
|
Patient received 2 doses instead of 1, we did not know she had already received the vaccine. First o...
Patient received 2 doses instead of 1, we did not know she had already received the vaccine. First one given on 02/22/24 and second one given 01/23/25. Patient has had no complaints other than a sore arm.
More
|
||||||
| 2823117 | 90 | F | CT | 01/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
GK2AZ |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient received a thjrd dose of Shingrix that was not necessary. No adverse reactions noted
Patient received a thjrd dose of Shingrix that was not necessary. No adverse reactions noted
|
||||||
| 2823118 | 0.25 | F | WI | 01/27/2025 |
DTAPHEPBIP HIBV PNC13 RV1 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
|
Crying, Decreased appetite, Injection site rash, Pyrexia; Crying, Decreased appe...
Crying, Decreased appetite, Injection site rash, Pyrexia; Crying, Decreased appetite, Injection site rash, Pyrexia; Crying, Decreased appetite, Injection site rash, Pyrexia; Crying, Decreased appetite, Injection site rash, Pyrexia
More
|
She has been crying non stop for over 3 hours, is developing a rash on her left thigh by the injecti...
She has been crying non stop for over 3 hours, is developing a rash on her left thigh by the injection site, has not been taking her bottle, she has a fever of 101
More
|
||||||
| 2823130 | 53 | F | WI | 01/27/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
|
Axillary pain, Injection site pain, Pain
Axillary pain, Injection site pain, Pain
|
1/27/25 Employee contacted Employee Health to report she has had a constant dull Lt upper arm and ar...
1/27/25 Employee contacted Employee Health to report she has had a constant dull Lt upper arm and arm pit pain since her flu shot which was given on 12/23/24. She reports it becomes more intense when she lifts her arm. The employee was referred to be evaluated.
More
|
||||||
| 2823131 | 66 | F | CA | 01/27/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
52z52 52z52 |
Feeling hot, Injection site bruising, Injection site erythema, Lethargy, Pain; P...
Feeling hot, Injection site bruising, Injection site erythema, Lethargy, Pain; Peripheral swelling, Tenderness
More
|
patient had the vaccine on 01-07-25, noticed the reaction started on 01-09-25. patient experienced...
patient had the vaccine on 01-07-25, noticed the reaction started on 01-09-25. patient experienced swollen arm, stinging, felt hot, sensitive to the touch, lethargic, injection site had red ring , about 5 days later, noticed bruising (size of large chicken egg) , patient iced the injection site, felt a little better , 20 days later, site still has signs of bruise mark, with redness, but not much swelling, no more lethargy, still sensitive to touch
More
|
||||||
| 2823132 | 58 | M | IA | 01/27/2025 |
COVID19 UNK |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
|
Vitreous detachment; Vitreous detachment
Vitreous detachment; Vitreous detachment
|
Posterior Vitrious Detachment (PVD)
Posterior Vitrious Detachment (PVD)
|
||||||
| 2823133 | 35 | M | CA | 01/27/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
5RE93 |
Wrong product administered
Wrong product administered
|
Administered fluarix. A couple hours later, patient came back stating wanted COVID vaccine
Administered fluarix. A couple hours later, patient came back stating wanted COVID vaccine
|
||||||
| 2823134 | 57 | M | VA | 01/27/2025 |
COVID19 |
MODERNA |
014C21A |
Echocardiogram normal, Male reproductive tract disorder, Palpitations, Sperm con...
Echocardiogram normal, Male reproductive tract disorder, Palpitations, Sperm concentration zero, Spermatozoa progressive motility decreased
More
|
Sometime between June of 2021, and early 2022, Moderna vaccination resulted in permanent damage to m...
Sometime between June of 2021, and early 2022, Moderna vaccination resulted in permanent damage to my reproductive system. Tests done in 2022 and 2023 have shown that there are no sperm cells seen in the samples. Before vaccination, semen tests (done in 2015 and June 2021) have shown normal amount of motile sperm cells. The detailed timeline of semen tests performed is shown on the next page. There were no other events or problems (no health problems, no injuries) that would explain that sperm cells stopped generating in my reproductive system, pointing to vaccination as the reason of the problem. (See next page) Timeline of tests done for semen analysis before and after vaccination: Oct 20, 2023 � Lab test of semen � no sperm cells seen Feb 17, 2023 - test of semen � no sperm cells seen Feb 10, 2023 � test of semen � no sperm cells seen During 2022 � self-tests with microscope, seen gradual decrease of moving sperm cell numbers, and moving cells seen not on every try Dec 12, 2021 � Moderna 60H21A mRNA booster June 29, 2021 � Lab test of semen and count � normal results and good motility (12x10^6) May 16, 2021 � Moderna 014C21A mRNA vaccination Apr 18, 2021 � Moderna 046B21A mRNA vaccination Jan 2015 � Lab test of semen and count � normal results and good motility (14x10^6) Another troubling fact is that my wife, who received the same Moderna vaccinations, have lost ability to remember any new information sometime in summer of 2021, and after that her brain degeneration was developing exponentially. Please see report VAERS ID: 2822907, E-Report Number: 1050478 for wife's case. In addition to this permanent damage to reproductive system, I have also started to notice, since August 2021, heart palpitations. I never had any problems with heart before. I have followed with cardiologist. Ultrasound tests haven't shown any specific issues in the heart. After about two years, palpitations were gone. However, reproductive system was damaged permanently, as confirmed by periodic tests done in 2024 and 2025. Seeing that two people who received same vaccinations had damaging impacts, one can conclude that either a) it is possible that these specific batches of vaccines are in particular damaging; or b) patient and I were both damaged by vaccine because we came from a very similar ethnic group. Hope science research on these questions will be launched, helping people in the future.
More
|
✓ | |||||
| 2823135 | 5 | M | CA | 01/27/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
5RE93 |
Wrong product administered
Wrong product administered
|
Father came into pickup line asking clerk about vaccines for him and son. I overheard and thought I ...
Father came into pickup line asking clerk about vaccines for him and son. I overheard and thought I heard flu vaccines. I processed and administered. A couple hours later, father came and said wanted COVID vaccine
More
|
||||||
| 2823136 | 64 | F | GA | 01/27/2025 |
YF |
SANOFI PASTEUR |
|
Dizziness, Nausea, Vomiting
Dizziness, Nausea, Vomiting
|
nausea, vomiting, short bouts of dizziness Symptoms improved within 15 hours. No medication needed....
nausea, vomiting, short bouts of dizziness Symptoms improved within 15 hours. No medication needed. Could this have just been a stomach virus? No one else around me has been sick with stomach virus.
More
|
||||||
| 2823137 | 25 | M | FL | 01/27/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9429J 9429J |
Abdominal pain upper, Asthenia, Cold sweat, Dizziness, Feeling hot; Hyperhidrosi...
Abdominal pain upper, Asthenia, Cold sweat, Dizziness, Feeling hot; Hyperhidrosis, Loss of consciousness, Nausea
More
|
Received TDAP vaccine IM to the left deltoid muscle. Venipuncture for labs was then performed. Lab d...
Received TDAP vaccine IM to the left deltoid muscle. Venipuncture for labs was then performed. Lab draw was completed and he complained of feeling hot. His skin then became clammy and he appeared to black out for approx 1 second. He immediately regained consciousness. He was diaphoretic. He was placed in supine position on exam table. He remained alert. Blood pressure was 91/54. BP was 129/90 prior to TDAP dose. He then c/o feeling dizzy, lightheaded, nauseous and reported a stomach ache. He was allowed to rest and provided a gatorade to hydrate himself. After approximately 25 minutes of monitoring he reported feeling better but felt drained with residual nausea. Repeat BP 136/91.
More
|
||||||
| 2823138 | 45 | F | AZ | 01/27/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Rash macular, Urticaria
Rash macular, Urticaria
|
Body hives, red splotches on arms, thighs, stomach , shoulders, back
Body hives, red splotches on arms, thighs, stomach , shoulders, back
|
||||||
| 2823139 | 26 | M | KS | 01/27/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Cardiovascular symptom, Catheterisation cardiac, Echocardiogram, Magnetic resona...
Cardiovascular symptom, Catheterisation cardiac, Echocardiogram, Magnetic resonance imaging, Myocarditis; X-ray
More
|
Myocarditis, typical heart attack symptoms. Hospital 3 days end result us unknow cause of myocarditi...
Myocarditis, typical heart attack symptoms. Hospital 3 days end result us unknow cause of myocarditis
More
|
✓ | |||||
| 2822858 | 53 | F | CA | 01/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site reaction, Rash, Rash pruritic
Injection site reaction, Rash, Rash pruritic
|
Painful and itchy rash around the injection site
Painful and itchy rash around the injection site
|
||||||
| 2822859 | 63 | F | GA | 01/26/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
59K92 |
Extra dose administered
Extra dose administered
|
2nd Dose on Arexvy administered on 1/25/25; previous dose administered on 12/19/2023
2nd Dose on Arexvy administered on 1/25/25; previous dose administered on 12/19/2023
|
||||||
| 2822860 | 5 | F | SC | 01/26/2025 |
FLU3 |
SANOFI PASTEUR |
UT8415LA |
Influenza, Influenza virus test positive
Influenza, Influenza virus test positive
|
PATIENT CONTRACTED THE FLU STRAIN A ON 1/16/25 LASTED 5 DAYS.
PATIENT CONTRACTED THE FLU STRAIN A ON 1/16/25 LASTED 5 DAYS.
|
||||||
| 2822861 | 67 | F | PA | 01/26/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
354M3 354M3 |
Arthralgia, Joint range of motion decreased, Mobility decreased, Musculoskeletal...
Arthralgia, Joint range of motion decreased, Mobility decreased, Musculoskeletal stiffness, Pain; Pain in extremity, Pyrexia, X-ray
More
|
Stiffness and light pain in left shoulder and upper arm began on the evening of Jan 22., On the morn...
Stiffness and light pain in left shoulder and upper arm began on the evening of Jan 22., On the morning of Jan. 23 pain was severe causing extremely limited range of motion. Could not raise arm at all without pain, could not, reach out, or put on a jacket. In the late afternoon of Jan 23, I also developed a fever that lasted a few hours.
More
|
||||||
| 2822862 | 9 | F | FL | 01/26/2025 |
IPV |
SANOFI PASTEUR |
y013712 |
Urticaria
Urticaria
|
diffuse urticaria starting the next morning without any systemic symptoms. Improved with antihistami...
diffuse urticaria starting the next morning without any systemic symptoms. Improved with antihistamines
More
|
||||||
| 2822863 | 75 | M | GA | 01/26/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5HWX4X0CSH |
Extra dose administered
Extra dose administered
|
Patient requested an RSV vaccine and was administered vaccine without issue. The next day it was dis...
Patient requested an RSV vaccine and was administered vaccine without issue. The next day it was discovered by Pharmacy's internal clinical team that she had already received this vaccine in December 2023. We have attempted to reach out to patient to notify them but have been unsuccessful at this point in time.
More
|
||||||
| 2822864 | 31 | F | FL | 01/26/2025 |
VARCEL |
MERCK & CO. INC. |
X006979 |
Herpes zoster, Magnetic resonance imaging head, Malaise
Herpes zoster, Magnetic resonance imaging head, Malaise
|
Unknown if this would be #1 or dose #2. I am attending a school who made me get vaccines based on ne...
Unknown if this would be #1 or dose #2. I am attending a school who made me get vaccines based on negative titers of records that did not meet their specific standards. I got the varicella vaccine on 07/12/24 and was officially diagnosed on 1/23/25-though I had already felt ill for about a week and gone to the ER one other time before this visit.. I was diagnosed with shingles , never having chicken pox. I read up on (technically a doctor I work for read to me) some case studies of people getting shingles from the chicken pox vaccine. This was the worst couple weeks of my life, and now I will have thousands of dollars to pay in ER bills all because I got a vaccine
More
|
✓ | |||||
| 2822865 | 32 | F | FL | 01/26/2025 |
RSV |
PFIZER\WYETH |
hm9854 |
Exposure during pregnancy, Urticaria, Vision blurred
Exposure during pregnancy, Urticaria, Vision blurred
|
female pregnant 34 weeks' gestation called pharmacy approximately 20- 40 mins after vaccination...
female pregnant 34 weeks' gestation called pharmacy approximately 20- 40 mins after vaccination stating she was experiencing hive like welts in face and neck and chest. Patient said welts slowly subsided later that day with the right side of the face subsiding slower than the rest of the areas. stated she also experienced some blurred vision. She was advised to seek medical guidance from the prescribing OB. She states she was not able to get a hold of them during the weekend, but she feels better and has follow up appointment this week, she will call Monday to try and be seen earlier and discuss side effects with OB
More
|
||||||
| 2822866 | 82 | F | FL | 01/26/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
patient received duplicate vaccines. Received one dose in 12/23 and accidentally received another do...
patient received duplicate vaccines. Received one dose in 12/23 and accidentally received another dose on 1/24/25. no reaction was found, Spoke to patient and she is fine but wanted to report this
More
|
||||||
| 2822867 | 67 | F | TN | 01/26/2025 |
PNC20 |
PFIZER\WYETH |
lg5575 |
Extra dose administered
Extra dose administered
|
No problems. Patient specifically asked for Prevnar 20 vaccine and repeated again before administrat...
No problems. Patient specifically asked for Prevnar 20 vaccine and repeated again before administration that she wanted Prevnar 20. This was a 2nd dose of Prevnar20.
More
|
||||||
| 2822868 | M | PA | 01/26/2025 |
FLU3 |
SANOFI PASTEUR |
|
Periarthritis
Periarthritis
|
left "frozen shoulder"
left "frozen shoulder"
|
|||||||
| 2822869 | 67 | F | GA | 01/26/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y013009 X72D2 |
Injection site pain, Injection site rash, Injection site swelling; Injection sit...
Injection site pain, Injection site rash, Injection site swelling; Injection site pain, Injection site rash, Injection site swelling
More
|
Patient reported sweeling at injection site, pain and rash which was spreading
Patient reported sweeling at injection site, pain and rash which was spreading
|
||||||
| 2822870 | 77 | M | IL | 01/26/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
KB2YT KB2YT |
Blood pressure decreased, Endotracheal intubation, Intensive care, Mechanical ve...
Blood pressure decreased, Endotracheal intubation, Intensive care, Mechanical ventilation, Musculoskeletal stiffness; Pyrexia, Septic shock, Tremor, Unresponsive to stimuli
More
|
Patent had 104 degree Fahrenheit fever and his hands were shaking. Then he developed severe muscle s...
Patent had 104 degree Fahrenheit fever and his hands were shaking. Then he developed severe muscle stiffness . We called 911 and transferred him to Emergency Room at Hospital. He went to septic shock and became unresponsive. His blood pressure went town to 78/45 and was intubated and on ventilator for 36 hours.
More
|
✓ | |||||
| 2822871 | 63 | F | GA | 01/26/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
PATIENT RECEIVED ONE DOSE OF AREXVY BACK IN 02/2024 BUT PATIENT MADE ANOTHER APPOINTMENT FOR AREXVY ...
PATIENT RECEIVED ONE DOSE OF AREXVY BACK IN 02/2024 BUT PATIENT MADE ANOTHER APPOINTMENT FOR AREXVY VACCINE WITHOUT KNOWING THAT SHE'S RECEIVED IT. SHE RECEIVED SECOND DOSE OF AREXVY ON 01/25/25. PATIENT IS NOT EXPERIENCING ANY ADR CURRENTLY, BUT PATIENT NOTIFIED AND EDUCATED.
More
|
||||||
| 2822872 | 78 | F | IL | 01/26/2025 |
COVID19 VARZOS |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
lm2211 n77j2 |
Rash, Rash macular, Rash pruritic; Rash, Rash macular, Rash pruritic
Rash, Rash macular, Rash pruritic; Rash, Rash macular, Rash pruritic
|
Patient describes red itchy spots the up and down her left and right arm. says they resembles a rash...
Patient describes red itchy spots the up and down her left and right arm. says they resembles a rash. recommended to follow up with ER or PCP if not resolving within 24 hrs. no other symptoms but symptoms mimic shingles.
More
|