| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2818037 | 23 | F | TX | 12/26/2024 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Lymphadenopathy, Ultrasound scan abnormal; Biopsy, Blood test, Body temperature,...
Lymphadenopathy, Ultrasound scan abnormal; Biopsy, Blood test, Body temperature, Fatigue, Feeling abnormal; Inguinal mass, Lymphadenopathy, Ultrasound scan, Ultrasound testes
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A few hours after getting the vaccine the pt developed a 3 inch large lump on her left groin in her ...
A few hours after getting the vaccine the pt developed a 3 inch large lump on her left groin in her lymph gland. She was taken to urgent care. She was sent directly to the ER Hospital. She was given an ultrsound. She was diagnosed with swollen lymph node and released to follow up with PCP. PCP thinks she may need to have it surgically removed but will see her again before referring her to a surgeon. Family is concerned about the pt having to go under anesthesia for surgery because of her history of seizures and medical issues.
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| 2833122 | 03/25/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster
Herpes zoster
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got the shingles; This non-serious case was reported by a consumer via interactive digital media and...
got the shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got the shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a reporter via interactive digital media. The reporter knew of several people (patients) who got the Shingles shot and within the week got the shingles.
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| 2833123 | 03/25/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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Sick; This non-serious case was reported by a consumer via interactive digital media and described t...
Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not resolved. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAR-2025 The patient said sorry if he/she came across as too gruff, he/she sick right now. The patient said if they know there were alternative cures for cancer. Research the Tippins protocol. Patient would never get any big pharma therapies personally. His/her own choice as done so much research on big pharma. He/she done deep dives on statins, most vaccines, and, of course, all the medications that take. His/her rheumatologist has farmed over to a psoriatic arthritis because would not take any of their fancy infusion therapies that have fetal cell lines in them. Mostly keep him/herself healthy by diet and taking ivermectin prophylaxis when in a crowd.; Sender's Comments: US-GSK-US2025AMR035772:Same reporter
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| 2833124 | 03/25/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster
Herpes zoster
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3 days after vaccine, pateint broke out with shingles; This non-serious case was reported by a consu...
3 days after vaccine, pateint broke out with shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: 3 days after vaccine, pateint broke out with shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine at the hospital the patient worked at and 3 days later broke out with shingles.
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| 2833125 | 03/25/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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suspected vaccination failure; vaccine did not work for me; This serious case was reported by a cons...
suspected vaccination failure; vaccine did not work for me; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: vaccine did not work for me). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-MAR-2025 This case was reported by a patient via interactive digital media. The reporter stated that the vaccine did not work for him/her, but they said that the small pox vaccine helps. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2833126 | F | 03/25/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Product contamination, Respiratory syncytial virus infection, Vaccination failur...
Product contamination, Respiratory syncytial virus infection, Vaccination failure
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Suspected Vaccination failure; Going thru it now/Respiratory syncytial virus infection; it was conta...
Suspected Vaccination failure; Going thru it now/Respiratory syncytial virus infection; it was contaminated; Got vaccine, but it was contaminated; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: Going thru it now/Respiratory syncytial virus infection), product contamination (Verbatim: it was contaminated) and poor quality vaccine administered (Verbatim: Got vaccine, but it was contaminated). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was not resolved and the outcome of the product contamination and poor quality vaccine administered were not applicable. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 18-MAR-2025 This case was reported by a patient via interactive digital media. The patient received the RSV vaccine and was going through it (Respiratory syncytial virus infection) now. The patient received the contaminated vaccine and got letter 2 days before he/she got it. The patient reported it to be awful and requested to get vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for Respiratory syncytial virus infection and laboratory confirmation regarding Respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.
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| 2833127 | 03/25/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster
Herpes zoster
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Had them on neck and face; This non-serious case was reported by a consumer via interactive digital ...
Had them on neck and face; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced herpes zoster (Verbatim: Had them on neck and face). The outcome of the herpes zoster was not reported. It was unknown if the reporter considered the herpes zoster to be related to Shingles vaccine. It was unknown if the company considered the herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported to have a high pain tolerance but told would rather have three more kids than have shingles again. The patient reported it was the most painful thing he/she have ever had. The patient had shingles on face and neck and that was after having the first shingle vaccine. The patient stated would better believed she/he will get the vaccine that is out now.
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| 2833128 | M | MI | 03/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Unevaluable event
Unevaluable event
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Dialysis after first dose of Shingrix; This non-serious case was reported by a pharmacist via call c...
Dialysis after first dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of dialysis in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 31-OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced dialysis (Verbatim: Dialysis after first dose of Shingrix). The outcome of the dialysis was unknown. It was unknown if the reporter considered the dialysis to be related to Shingrix. It was unknown if the company considered the dialysis to be related to Shingrix. Additional Information: GSK Receipt Date: 17-MAR-2025 Pharmacist called to report about a patient who received the Shingrix and before getting the second dose, The pharmacist stated, He was not a dialysis patient and he is undergoing dialysis patient with three times a week . The pharmacist enquired if there was any contraindication for getting the vaccine. Patient was undergoing dialysis and Health Care Professional was looking if it was safe to complete the schedule of Shingrix.
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| 2833129 | F | 03/25/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
X527B |
Expired product administered
Expired product administered
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administration of an expired dose of Engerix-B; This non-serious case was reported by a other health...
administration of an expired dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HBV (Engerix B) (batch number X527B, expiry date 17-MAR-2025) for prophylaxis. On 18-MAR-2025, the patient received Engerix B. On 18-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administration of an expired dose of Engerix-B). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 19-MAR-2025 The healthcare professional called in to request data about the administration of an expired dose of Engerix-B. They stated the dose expired on March 17th, 2025, and was administered on March 18th, 2025, which led to expired vaccine used. They asked and doubled down on their wish to remain anonymous, but did consent to receive follow-up. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2833130 | 03/25/2025 |
COVID19 |
MODERNA |
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Nervous system disorder
Nervous system disorder
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Severe Neurological Reaction; This spontaneous case was reported by a non-health professional and de...
Severe Neurological Reaction; This spontaneous case was reported by a non-health professional and describes the occurrence of NERVOUS SYSTEM DISORDER (Severe Neurological Reaction) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (Severe Neurological Reaction) (seriousness criterion medically significant). At the time of the report, NERVOUS SYSTEM DISORDER (Severe Neurological Reaction) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No Concomitant medications provided by the reporter. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2023-732177 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2023-732177:S-R
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| 2833131 | M | 03/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Allergy to vaccine, Graves' disease
Allergy to vaccine, Graves' disease
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Grave's disease; they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine; This ...
Grave's disease; they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 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: Bnt162b2 (DOSE 1, single), for COVID-19 immunization, reaction(s): "allergy to ingredient in COVID-19 vaccine"; Bnt162b2 (DOSE 2, single), for COVID-19 immunization, reaction(s): "allergy to ingredient in COVID-19 vaccine". The following information was reported: GRAVES' DISEASE (medically significant), outcome "unknown", described as "Grave's disease"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine". Clinical course: The patient received 3 doses. The patient had an allergy to ingredient in COVID-19 vaccine, clarified a PEG, 3350 or something, allergy, an allergy to Miralax. Said the ingredient in Miralax was also in the vaccine. The patient was after 3rd dose and had Grave's disease, confirmed spelling with caller, hyperthyroid. The patient was given medicine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2833132 | F | NJ | 03/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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she has Covid; she has Covid; This is a spontaneous report and received from Consumer or other non H...
she has Covid; she has Covid; This is a spontaneous report and received from Consumer or other non HCPs, Program ID. A 42-year-old female 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 included: "COVID-19" (not ongoing), notes: has taken Paxlovid 2 years ago; within five days cured. The patient's concomitant medications were not reported. Past drug history included: Paxlovid, start date: 2023, stop date: 2023, for COVID-19 immunization. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has Covid". Clinical course: Reporter states that the patient had COVID and has taken Paxlovid 2 years ago. Patient is 42 years old but has a mind at the fourth-grade level. During an inbound call for financial assistance, patient's father stated that he was calling for his daughter who is developmentally disabled. Patient was prescribed with Paxlovid. Later in the call patient's mother stated, "...she has Covid, and we have to get that medicine, and we have Covid too." The patient's mother stated she never had trouble getting medication for her but "since they gave her # (unspecified) all the sudden they won't pay for it." Later in the call, patient's mother stated, "We had, we had it in the past, we had Covid, couple years ago and we all got Paxlovid then...it was great, within five days we were cured, you know..." When asked if this was the second time getting Covid, patient's mother said "Yes" and when asked if this was the second time getting Paxlovid, patient's mother said "Yes, yes". When asked how long did the patient have Covid, patient's mother responded, "...It was about two years ago", Later In the call, patient's mother stated, "You know, I just want you to know a part from my daughter being mentally disabled, she is physically very healthy, she has no medical, physical yes she has no Physical problems whatsoever, it's just mentally". Towards the end of the call, patient's mother stated, "She had all the vaccinations too, she had all the Pfizer uh, Pfizer ones, she was fully vaccinated..."
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| 2833133 | M | FL | 03/25/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood creatinine, Brain natriuretic peptide, COVID-19, Drug ineffective, Echocar...
Blood creatinine, Brain natriuretic peptide, COVID-19, Drug ineffective, Echocardiogram; Ejection fraction, Electrocardiogram, Liver function test, SARS-CoV-2 test, Troponin
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COVID-19 infection was confirmed by PCR testing; COVID-19 infection was confirmed by PCR testing; Th...
COVID-19 infection was confirmed by PCR testing; COVID-19 infection was confirmed by PCR testing; This is a literature report for the following literature source(s). A 77-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in 2021 as dose unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CKD" (ongoing); "paroxysmal atrial fibrillation" (ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (death, medically significant), DRUG INEFFECTIVE (death, medically significant), outcome "fatal" and all described as "COVID-19 infection was confirmed by PCR testing". Clinical course: We present a case of COVID-19 induced myocarditis leading to hemodynamic instability and end-organ dysfunction. A 77-year-old male with a history of CKD, paroxysmal atrial fibrillation, and COPD was transferred to our hospital for a higher level of care due to worsening cardiogenic shock. He was cold and wet (Forrester class IV) with a High Sensitivity troponin of 331 and a BNP level of 21,503. EKG showed atrial fibrillation with RVR but no evidence of acute ischemic changes. A TTE was done which revealed an EF of 30-35% and diffuse hypokinesis with regional variation, a significant reduction from an EF of 50-55% just 4 weeks prior. The patient exhibited end-organ dysfunction, as evidenced by deranged liver function tests and a rise in creatinine from a baseline of 2 to 4.6, indicating congestive hepatopathy and cardiorenal syndrome respectively. The patient's hemodynamics necessitated milrinone and norepinephrine infusions and efforts to wean them off were unsuccessful due to repeated failed fluid bolus challenges. Considering the patient's clinical picture, there was a strong suspicion of viral-induced cardiomyopathy, and a COVID-19 infection was confirmed by PCR testing; his last COVID-19 booster dose was in 2021. The patient was promptly started on remdesivir and IV steroids. Unfortunately, the patient's condition continued to deteriorate, and he succumbed to his illness. Discussion: A myriad of cardiovascular manifestations have been implicated with COVID-19, including ACS, myocarditis, and heart failure. Although the exact underlying mechanisms for each of these conditions are unclear, a complex interplay between direct viral injury, systemic inflammation, and cytokine storm has been hypothesized. Our case illustrates the quick progression of heart failure into cardiogenic shock requiring pressor support, with subsequent rapid decompensation rendering CMR, cardiac catheterization, and biopsy timely impractical. It serves as a reminder to explore COVID-19 as a potential cause of biventricular failure in individuals with no evident reason and rapid clinical deterioration, particularly as early initiation of antiviral therapy could improve prognoses. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with COVID-19 Vaccine - Manufacturer Unknown can not be fully excluded. 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.; Reported Cause(s) of Death: COVID-19 infection; Myocarditis leading to cardiogenic shock; Myocarditis leading to cardiogenic shock
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| 2833135 | PA | 03/25/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK038AA |
No adverse event, Single component of a two-component product administered
No adverse event, Single component of a two-component product administered
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only PENTACEL's DTap-IPV component was administered with no reported AE; Initial information re...
only PENTACEL's DTap-IPV component was administered with no reported AE; Initial information received on 24-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age / gender patient who received only DTAP-IPV component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] 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 Hepatitis a vaccine (Hepa); and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) both for Immunisation. On 14-Mar-2025, the patient received 0.5 ml of dose 4 of DTAP-IPV component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength- standard, expiry date- 30-JUN-2025 and lot UK038AA) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (single component of a two-component product administered) (latency- same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2833144 | 65 | F | 03/25/2025 |
PPV PPV PPV PPV PPV VARZOS VARZOS VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK |
Ataxia, Autonomic nervous system imbalance, Back pain, Borrelia test negative, C...
Ataxia, Autonomic nervous system imbalance, Back pain, Borrelia test negative, CSF cell count increased; CSF protein normal, CSF white blood cell count negative, Endotracheal intubation, Gastrostomy, Guillain-Barre syndrome; Hypoaesthesia, Immunoglobulin therapy, Laboratory test normal, Muscle spasms, Muscular weakness; Paraesthesia, Plasmapheresis, Pneumonia streptococcal, Respiratory failure, Staphylococcal infection; Tracheostomy, Walking aid user; Ataxia, Autonomic nervous system imbalance, Back pain, Borrelia test negative, CSF cell count increased; CSF protein normal, CSF white blood cell count negative, Endotracheal intubation, Gastrostomy, Guillain-Barre syndrome; Hypoaesthesia, Immunoglobulin therapy, Laboratory test normal, Muscle spasms, Muscular weakness; Paraesthesia, Plasmapheresis, Pneumonia streptococcal, Respiratory failure, Staphylococcal infection; Tracheostomy, Walking aid user
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Guillain Barre syndrome; Hypoxic respiratory failure; strep pneumonia; MSSA; Patient was seen in whe...
Guillain Barre syndrome; Hypoxic respiratory failure; strep pneumonia; MSSA; Patient was seen in wheelchair today, but she was able to walk with a walker; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis. On 03-AUG-2024, the patient received Shingrix. On 01-JUL-2024, the patient received Pneumococcal vaccine. In AUG-2024, less than 2 weeks after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization, GSK medically significant and other: serious as per reporter), hypoxic respiratory failure (Verbatim: Hypoxic respiratory failure) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), pneumonia streptococcal (Verbatim: strep pneumonia) (serious criteria hospitalization and GSK medically significant) and methicillin-sensitive staphylococcus aureus infection (Verbatim: MSSA) (serious criteria hospitalization). On an unknown date, the patient experienced walker user (Verbatim: Patient was seen in wheelchair today, but she was able to walk with a walker). The patient was treated with immunoglobulins nos (Immunoglobulin I.V). The outcome of the guillain barre syndrome was resolving and the outcome of the hypoxic respiratory failure was resolved and the outcome of the pneumonia streptococcal, methicillin-sensitive staphylococcus aureus infection and walker user were not reported. It was unknown if the reporter considered the guillain barre syndrome, hypoxic respiratory failure, pneumonia streptococcal, methicillin-sensitive staphylococcus aureus infection and walker user to be related to Shingrix. It was unknown if the company considered the guillain barre syndrome, hypoxic respiratory failure, pneumonia streptococcal, methicillin-sensitive staphylococcus aureus infection and walker user to be related to Shingrix. Additional Information: GSK Receipt Date: 12-MAR-2025 The patient received Pneumonia vaccine on 01-JUL-2024 in the office and Shingrix on 03-AUG-2024 at the pharmacy. No other products were received by the patient. The patient was in hospital for GBS (guillain barre syndrome) and diagnosed on 12-AUG-2024. Guillain-Barre syndrome-patient called the on-call physician on Sunday August 11th, 2024, for new onset of numbness and tingling in her hands and feet. At that time had no other symptoms. The patient was told to call and schedule a visit the next day on 12th August 2024. Patient was seen the next day in at that time had severe ataxia as well as upper and lower extremity weakness and paresthesia. She was sent to emergency room. She was then transferred to emergency room. She had 4 doses of IVIG then she had 5 doses of plasmapheresis. Patient had received Pneumonia vaccine and followed by Shingles vaccine about 2 weeks prior. Also, she had a recent tick bite. Lumbar puncture showed no white cells and protein and 150. Lyme was negative. She then developed hypoxic respiratory failure requiring endotracheal intubation on 14-AUG-2024. She was transferred to hospital on August 19th until August 31st, 2024. Patient's hospital course was complicated by MSSA (Methicillin-Sensitive Staphylococcus Aureus) and strep pneumonia, autonomic dysfunction and labile blood pressures. She was unable to be weaned from the ventilator and underwent trach (Tracheostomy) or PEG (Percutaneous Endoscopic Gastrostomy) tube on 25-AUG-2024. She was then sent to hospital and for weaning. Patient was finally weaned on 25th-SEP-2024. PEG tube was shortly thereafter discontinued. She was then admitted to hospital on 3rd October 2024 till 4th November 2024 for aggressive physical therapy. She was then sent to subacute rehab for which she stayed from 4th November 2024 until 27th November 2024. She was then discharged to home with home health care as well as occupational therapy and physical therapy. Patient was seen in wheelchair today, but she was able to walk with a walker. She continued have paresthesia's in the hands in the feet she occasionally has back pain and spasms. She denied any dysphagia or dyspnea. Denied any difficulty swallowing. Less than a month, after received Shingrix, the patient experienced pneumonia streptococcal and methicillin-sensitive staphylococcus aureus infection. Between 1 and 2 months, after received Pneumococcal vaccine, the patient experienced guillain barre syndrome, hypoxic respiratory failure, pneumonia streptococcal and methicillin-sensitive staphylococcus aureus infection. It was unknown if the company considered the guillain barre syndrome, hypoxic respiratory failure, pneumonia streptococcal, methicillin-sensitive staphylococcus aureus infection and walker user to be related to Pneumococcal vaccine.; Sender's Comments: Guillain-Barre syndrome is a listed event which is considered related to a GSK vaccine Shingrix Respiratory failure, Pneumonia streptococcal and Staphylococcal infection are unlisted events which are considered unrelated to GSK vaccine Shingrix
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| 2833145 | F | 03/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Allergic reaction to excipient, Arthralgia, Erythema, Pain in extremity, Swellin...
Allergic reaction to excipient, Arthralgia, Erythema, Pain in extremity, Swelling
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an allergy to ingredient in COVID-19 vaccine, clarified a PEG, or something; an allergic reaction (s...
an allergy to ingredient in COVID-19 vaccine, clarified a PEG, or something; an allergic reaction (swelling, redness) as well as pain in both arms and legs; an allergic reaction (swelling, redness) as well as pain in both arms and legs; an allergic reaction (swelling, redness) as well as pain in both arms and legs; pain from left arm to leg, right arm to leg, shoulder; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female 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. Past drug history included: Miralax, reaction(s): "allergy". The following information was reported: ALLERGIC REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "an allergy to ingredient in COVID-19 vaccine, clarified a PEG, or something"; SWELLING (non-serious), ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "an allergic reaction (swelling, redness) as well as pain in both arms and legs"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain from left arm to leg, right arm to leg, shoulder". The events "an allergy to ingredient in covid-19 vaccine, clarified a peg, or something", "an allergic reaction (swelling, redness) as well as pain in both arms and legs" and "pain from left arm to leg, right arm to leg, shoulder" required physician office visit. Therapeutic measures were not taken as a result of allergic reaction to excipient, swelling, erythema, pain in extremity, arthralgia. Additional information: The patient has an allergy to ingredient in COVID-19 vaccine, clarified a PEG, or something. She said the ingredient in Miralax is also in the vaccine. She has something that feels like pain from left arm to leg, right arm to leg, shoulder, sometimes swollen and red like an allergic reaction. The patient and her son both have allergy to Miralax. The patient saw endocrinologist, did not do anything, told caller to obverse. Family does not have any thyroid problems. The events occurred after got the vaccine, she thinks not the only one case, other people have. She wants to check therapies, wants suggestion from doctor, wants to know how to treat, what do people do since was because of vaccine. She wants to know what treatment can be given. Confirmed received the Pfizer COVID-19 vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500062913 same reporter/patient, different vaccine dose/event;
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| 2833146 | AL | 03/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Laboratory test
COVID-19, Drug ineffective, Laboratory test
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Covid after Pfizer Shots; Covid after Pfizer Shots; This is a spontaneous report received from a Con...
Covid after Pfizer Shots; Covid after Pfizer Shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 78-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid after Pfizer Shots". The patient underwent the following laboratory tests and procedures: did a test: Unknown results. Clinical course: During an inbound call for financial assistance, towards the end of the conversation, the caller expressed concern about contracting COVID-19 again despite having received all their shots and boosters. In the background, someone mentioned they had received Pfizer shots. The caller confirmed, stating that Pfizer was the vaccine they had taken. When asked to clarify if this was their first or second time contracting COVID-19 (though the question was not specified), the caller explained that they had a mild case two years ago, which only required testing due to coughing symptoms and did not necessitate any medication. However, this time, the illness affected them more severely.
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| 2833147 | F | 03/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Psoriasis
Psoriasis
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skin reaction the day following her own COVID vaccine in 2021 to a diagnosis of Psoriasis; This is a...
skin reaction the day following her own COVID vaccine in 2021 to a diagnosis of Psoriasis; This is a spontaneous report received from a Physician. 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 included: "Psoriasis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "skin reaction the day following her own COVID vaccine in 2021 to a diagnosis of Psoriasis". Additional information: The reporter stated that a physician I met with stated she attributes a skin reaction the day following her own COVID vaccine in 2021 to a diagnosis of Psoriasis. She stated her vaccine was a Pfizer vaccine. Of note, she stated her Rheumatologist describes that after COVID infections, patients with Rheumatic diseases can no longer be managed with monotherapy immune modulation due to severity of immune disease. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2833148 | F | FL | 03/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, SARS-CoV-2 test, Therapeutic response unexpected
COVID-19, Drug ineffective, SARS-CoV-2 test, Therapeutic response unexpected
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she live with constant pain/24 hours after the Pfizer vaccine she had absolutely no pain in her body...
she live with constant pain/24 hours after the Pfizer vaccine she had absolutely no pain in her body; She had a mild case of Covid/It's just like a little cold; She had a mild case of Covid/It's just like a little cold; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 80-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to a lot of things" (unspecified if ongoing); "constant pain" (ongoing); "heart attack", start date: 2023 (unspecified if ongoing), she had a heart attack last year (2023) and she had a specific group of medicines she take and then she went to get a new medicine on 08Aug2023 and on 09Aug2023 she was found lying on the Kitchen floor at 8 o'clock in the morning, obviously that's not a drug Pfizer give her again. She was only taking the ones that were prescribed after the heart attack. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Primary Immunization series complete, All Pfizer vaccine), for COVID-19 immunization, reaction(s): "after the Pfizer vaccine she had absolutely no pain in her body". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jan2024, outcome "unknown" and all described as "She had a mild case of Covid/It's just like a little cold"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "she live with constant pain/24 hours after the Pfizer vaccine she had absolutely no pain in her body". The event "she had a mild case of covid/it's just like a little cold" required emergency room visit. Clinical course: She had a mild case of Covid at the time and so she didn't take the medicine because of the listed side effects. She was horribly allergic to a lot of things and so she wasn't going to chance it and it was a very mild case cause She had had all the boosters and the vaccines. She was the only person she know that 24 hours next 24 hours after the Pfizer vaccine she had absolutely no pain in her body She was 80 years old now and she live with constant pain so for 24 hours after the shot she had no pain and the following week she had very little pain and that's happened every time she had taken the Pfizer vaccine or the boosters. She didn't know what's in the Pfizer thing, but it worked for her. 10Jan2024 was when she was diagnosed with the Covid, the day that she was diagnosed as positive. She went to the ER (emergency room) on 08Jan with COVID and was negative on the Tuesday (09Jan2024), then Wednesday the 10th (10Jan2024), she was positive, but it's a very mild case, It's just like a little cold. She got the Paxlovid but she ended up not using it because of side effects. She decided she was not doing any kind of drugs except for her normal regimen just cause she don't want to end up in the ER. She had a list of 20 do not give her medicines including Benadryl. She stay away as much as possible from drugs of any kin. She was on 3 blood thinners at this point so there were two of them that were blood thinners still. Many of these drugs come with a fear of that. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500035386 same patient/drug, different event/dose;
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| 2833149 | 39 | F | AL | 03/25/2025 |
HEP |
MERCK & CO. INC. |
y012507 |
No adverse event, Underdose
No adverse event, Underdose
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Patient received pediatric dose of Hep B instead of adult dose. Contacted patient for revaccination....
Patient received pediatric dose of Hep B instead of adult dose. Contacted patient for revaccination. No adverse events experienced.
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| 2833150 | 56 | F | 03/25/2025 |
HEP |
MERCK & CO. INC. |
y012507 |
No adverse event, Underdose
No adverse event, Underdose
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Patient received pediatric dose of Hep B. Contacted for revaccination. No adverse events
Patient received pediatric dose of Hep B. Contacted for revaccination. No adverse events
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| 2833151 | 51 | M | CA | 03/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7349L |
Chest pain, Dizziness, Electrocardiogram normal, Hypertension, Nervousness
Chest pain, Dizziness, Electrocardiogram normal, Hypertension, Nervousness
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After 5-10 minutes of shingles vaccine he felt sharp pain retrosternal and dizzy and lightheaded His...
After 5-10 minutes of shingles vaccine he felt sharp pain retrosternal and dizzy and lightheaded His blood pressure was high not low, chest pain resolved after short time He says that he was nervous because he has PTSD of more and most of the time needle causing flashback of war and he gets nervous attack 911 came EKG was done no problem His vital sign came back to normal He declined to go to the ER and signed AMA
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| 2833152 | 78 | F | NJ | 03/25/2025 |
RSV |
PFIZER\WYETH |
lg9828 |
Pain in extremity
Pain in extremity
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patient had soreness started in the arm and went away but not completely, she still feels sore somet...
patient had soreness started in the arm and went away but not completely, she still feels sore sometimes, not sure related to vaccine, she will contact her PCP, no lunmps or bumps or rashes
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| 2833153 | 19 | F | 03/25/2025 |
FLU3 HEP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
UT8496LA 32M5G |
Underdose; Underdose
Underdose; Underdose
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Patient was given a pediatric dose instead of adult dose
Patient was given a pediatric dose instead of adult dose
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| 2833154 | 19 | F | 03/25/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
32M5G |
Underdose
Underdose
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Pt was given a pediatric dose instead of an adult dose.
Pt was given a pediatric dose instead of an adult dose.
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| 2833170 | 57 | M | 03/25/2025 |
HEP |
MERCK & CO. INC. |
y012507 |
No adverse event, Underdose
No adverse event, Underdose
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Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse eve...
Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events.
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| 2833171 | 73 | M | WI | 03/25/2025 |
UNK UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
388487 388487 6024MF016A 6024MF016A |
Immediate post-injection reaction, Inflammation, Injected limb mobility decrease...
Immediate post-injection reaction, Inflammation, Injected limb mobility decreased, Pain, Pain in extremity; Product administered at inappropriate site; Immediate post-injection reaction, Inflammation, Injected limb mobility decreased, Pain, Pain in extremity; Product administered at inappropriate site
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Both Injections were placed in the left shoulder Bersa instead of the muscle tissue. This resulted i...
Both Injections were placed in the left shoulder Bersa instead of the muscle tissue. This resulted in immediate high level of pain. After pain continued for a couple of weeks medical attention was sought. It was determined that the injections in the Bursa had resulted in considerable inflammation. The inflammation caused a high degree of pain during movement of the arm and limited use of the arm. Several visits were made to the Bone and Joint Clinic where cortisone was injected along with prednisone being prescribed' Once the prednisone ran it course the pain returned. Every week that passed I kept hoping the arm would get better but it has not improved. I still have limited use of my arm.
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| 2833172 | 32 | M | 03/25/2025 |
HEP |
MERCK & CO. INC. |
y012507 |
No adverse event, Underdose
No adverse event, Underdose
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Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse eve...
Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events
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| 2833173 | 54 | M | 03/25/2025 |
HEP |
MERCK & CO. INC. |
y012507 |
No adverse event, Underdose
No adverse event, Underdose
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Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse eve...
Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events
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| 2833174 | 55 | F | 03/25/2025 |
HEP |
MERCK & CO. INC. |
y012507 |
No adverse event, Underdose
No adverse event, Underdose
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Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse eve...
Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events
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| 2833176 | 26 | F | 03/25/2025 |
HEP |
MERCK & CO. INC. |
y012507 |
No adverse event, Underdose
No adverse event, Underdose
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Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse eve...
Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events
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| 2833177 | 03/25/2025 |
HEP |
MERCK & CO. INC. |
y012507 |
No adverse event, Underdose
No adverse event, Underdose
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Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse eve...
Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events
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| 2833178 | 48 | F | 03/25/2025 |
HEP |
MERCK & CO. INC. |
y012507 |
No adverse event, Underdose
No adverse event, Underdose
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Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse eve...
Patient received pediatric dose of Hep B. Contacted for revaccination as recommended. No adverse events
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| 2833179 | 74 | M | CA | 03/25/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
3BH5K |
Gait inability, Limb discomfort
Gait inability, Limb discomfort
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Per patient, he couldn't walk on the morning the day after the vaccine. Per patient his leg fee...
Per patient, he couldn't walk on the morning the day after the vaccine. Per patient his leg feel really heavy.
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| 2833180 | 61 | F | AZ | 03/25/2025 |
RSV |
PFIZER\WYETH |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received two doses of abrysvo vaccine without any medical consequence or effect that was lif...
Patient received two doses of abrysvo vaccine without any medical consequence or effect that was life threatening or other medical concern leading to immediate medical attention or further medical review. ACIP (Advisory Committee on Immunization Practices (ACIP) guidelines did not specify harmful outcome related to duplicate dose of abrysvo.
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| 2833181 | 22 | F | PA | 03/25/2025 |
COVID19 |
MODERNA |
8080803 |
Headache, Injection site mass, Injection site pain, Nausea, Pain
Headache, Injection site mass, Injection site pain, Nausea, Pain
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Body aches/pain, nausea, headache, hard bump at injection site and pain surrounding it. These sympto...
Body aches/pain, nausea, headache, hard bump at injection site and pain surrounding it. These symptoms lasted multiple days.
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| 2833182 | 65 | M | FL | 03/25/2025 |
PPV VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
MSDX014729 SKBE3XT9 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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PATIENT RECEIVED A REDUDANT/DUPLICATE PPSV23 WHEN PNEUMONIA SERIES COMPLETED TWO YEARS PRIOR. PATIEN...
PATIENT RECEIVED A REDUDANT/DUPLICATE PPSV23 WHEN PNEUMONIA SERIES COMPLETED TWO YEARS PRIOR. PATIENT ALSO RECEIVED A FOURTH DOSE IN A 2-DOSE SERIES SHINGRIX (THE FIRST SERIES COMPLETED IN 2018) AND THE SECOND ROUND OF DOSES GIVEN 2/9/24 AND 7/24/24, RESPECTIVELY.
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| 2833183 | 73 | F | FL | 03/25/2025 |
COVID19 |
PFIZER\BIONTECH |
lt536 |
Decreased appetite, Erythema, Fatigue, Swelling face
Decreased appetite, Erythema, Fatigue, Swelling face
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patient woke up with red swollen face, loss of appetite, and tiredness. Patient has taken Benadryl a...
patient woke up with red swollen face, loss of appetite, and tiredness. Patient has taken Benadryl and will follow up if no improvement in a few days. Patient will seek medical attention if any signs of anaphylaxis.
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| 2833184 | 75 | M | 03/25/2025 |
PNC20 |
PFIZER\WYETH |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received a duplicate vaccine. Patient received original pcv20 vaccine on 03/11/2023, and dup...
Patient received a duplicate vaccine. Patient received original pcv20 vaccine on 03/11/2023, and duplicate vaccination on 03/24/2025. Patient reports no adverse effects from duplicate vaccine.
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| 2833185 | 61 | M | CO | 03/25/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
yo11819 g79dh |
Arthralgia, Mobility decreased, Myalgia, Pain in extremity, Toothache; Arthralgi...
Arthralgia, Mobility decreased, Myalgia, Pain in extremity, Toothache; Arthralgia, Mobility decreased, Myalgia, Pain in extremity, Toothache
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Patient received Shingrix and Capvaxive in the left deltoid on the same day. Had shoulder, then elb...
Patient received Shingrix and Capvaxive in the left deltoid on the same day. Had shoulder, then elbow, then finger pain that lasted approximately 10 days before completely resolving. Experienced joint pain and muscle aches making it difficult to move fingers. No redness or itching reported at injection sites. Also started to experience teeth pain about a week later and was unsure if it was related to vaccine. Received follow up care and was prescribed antibiotic and steroid 1/16/25. RPH requests clarification about CDC recommendation that Shingrix can be administered concomitantly with other vaccines at "different anatomical sites" --does this mean that 2 vaccines on the same day must go in different arms altogether if receiving Shingrix, or is the same arm but injection sites 1 inch apart okay?
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| 2833186 | 65 | M | FL | 03/25/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
SKBGE3S7 |
Extra dose administered
Extra dose administered
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RECEIVED A DUPLICATE/REDUDANT RSV VACCINE (FIRST VACCINE 11/17/2023)
RECEIVED A DUPLICATE/REDUDANT RSV VACCINE (FIRST VACCINE 11/17/2023)
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| 2833187 | 5 | M | MA | 03/25/2025 |
COVID19 |
MODERNA |
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Expired product administered, No adverse event
Expired product administered, No adverse event
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the BUD was beyond 60s out of the freezer. no reported issues with patient.
the BUD was beyond 60s out of the freezer. no reported issues with patient.
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| 2833188 | 60 | M | FL | 03/25/2025 |
FLU3 |
SEQIRUS, INC. |
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Extra dose administered
Extra dose administered
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RECEIVED A DUPLICATE/REDUDANT FLU SHOT IN THE SAME FLU SEASON 2018-2019 (FIRST FLU QUAD PF 8/21/2018...
RECEIVED A DUPLICATE/REDUDANT FLU SHOT IN THE SAME FLU SEASON 2018-2019 (FIRST FLU QUAD PF 8/21/2018)
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| 2833189 | 10 | M | MA | 03/25/2025 |
COVID19 |
MODERNA |
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Expired product administered, No adverse event
Expired product administered, No adverse event
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BUD on vaccine out of the freezer was beyond 60 days. no reported issues from parents.
BUD on vaccine out of the freezer was beyond 60 days. no reported issues from parents.
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| 2833190 | 6 | M | MA | 03/25/2025 |
COVID19 |
MODERNA |
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Expired product administered, No adverse event
Expired product administered, No adverse event
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the vaccine was BUD of 60 days. no reported patient issues.
the vaccine was BUD of 60 days. no reported patient issues.
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| 2833191 | 58 | M | WA | 03/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
H97H2 |
Cardiac discomfort
Cardiac discomfort
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PATIENT HAD TO CALL 911 AT HOME 2 HOURS AFTER GETTING THE VACCINE AS HE FELT HE WAS HAVING A HEART A...
PATIENT HAD TO CALL 911 AT HOME 2 HOURS AFTER GETTING THE VACCINE AS HE FELT HE WAS HAVING A HEART ATTACK. HE WAS RUSHED TO THE HOSPITAL AND AS OF TODAY, 3/25/25, PER WIFE, HE WILL UNDERGO HEART SURGERY. OUTCOME NOT YET KNOWN.
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| 2833203 | 52 | F | OR | 03/25/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Vomiting; Vomiting
Vomiting; Vomiting
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Pt received shingles vaccine #1 and #2 and both times she developed severe vomiting that lasted 8 ho...
Pt received shingles vaccine #1 and #2 and both times she developed severe vomiting that lasted 8 hours
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| 2833204 | 0.17 | F | KS | 03/25/2025 |
DTAPHEPBIP HIBV PNC20 RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH |
D252F TC3N5 HN5978 HM0167 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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RSV (ABRYSVO) indicated for adults over 60 yrs of age and pregnant women 32-36 weeks was administere...
RSV (ABRYSVO) indicated for adults over 60 yrs of age and pregnant women 32-36 weeks was administered to 2 month old. No treatment required- informed patient's mother baby monitored.
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| 2832740 | 1 | F | WI | 03/24/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y017206 Y015101 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Nurse calling to report the inadvertent administration of PROQUAD and VARIVAX to 15 month old patien...
Nurse calling to report the inadvertent administration of PROQUAD and VARIVAX to 15 month old patient on the same day. No symptoms reported as of now and no additional details provided. This agent is filing a full AE, as the patient and parents hav; Nurse calling to report the inadvertent administration of PROQUAD and VARIVAX to 15 month old patient on the same day. No symptoms reported as of now and no additional details provided. This agent is filing a full AE, as the patient and parents hav; No symptoms reported as of now and no additional details provided.; Information has been received from Business Partner/CRO on 20-Feb-2025. This spontaneous report was received from a/an Nurse and refers to a(n) 1-year-old female patient. The patient's medical history included Patient had the Flu recently. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-Feb-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017206, expiration date: 13-Apr-2026). On 20-Feb-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y015101, expiration date: 06-Sep-2026). On 20-Feb-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for the treatment of Prophylaxis. The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), for the treatment of prophylaxis. On 20-Feb-2025, the patient experienced Nurse calling to report the inadvertent administration of PROQUAD and VARIVAX to 15 month old patient on the same day. No symptoms reported as of now and no additional details provided. This agent is filing a full AE, as the patient and parents hav. On 20-Feb-2025, the patient experienced Nurse calling to report the inadvertent administration of PROQUAD and VARIVAX to 15 month old patient on the same day. No symptoms reported as of now and no additional details provided. This agent is filing a full AE, as the patient and parents hav. On 20-Feb-2025, the patient experienced No symptoms reported as of now and no additional details provided.. At the reporting time, the outcome of Nurse calling to report the inadvertent administration of PROQUAD and VARIVAX to 15 month old patient on the same day. No symptoms reported as of now and no additional details provided. This agent is filing a full AE, as the patient and parents hav, Nurse calling to report the inadvertent administration of PROQUAD and VARIVAX to 15 month old patient on the same day. No symptoms reported as of now and no additional details provided. This agent is filing a full AE, as the patient and parents hav and No symptoms reported as of now and no additional details provided. was unknown. The action taken with sterile diluent. nMeasles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable.
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