chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction, Pain, Pain in extremity
Clinical narrative: Reaction to covid-19; General body pain; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Reaction to covid-19), PAIN (General body pain) and PAIN IN EXTREMITY (Arm pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Previously administered products included for Allergy: Codeine. Past adverse reactions to the above products included Asthma with Codeine. Concurrent medical conditions included Psoriatic arthritis, Diabetic, Heart murmur, Cholesterol, Triglycerides, Insomnia, Anxiety and Clot blood. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Anxiety, MONTELUKAST SODIUM (SINGULAIR) for Asthma, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN COMPOUND [ACETYLSALICYLIC ACID;ASCORBIC ACID]) for Clot blood, CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) for Insomnia, METHOTREXATE for Rheumatoid arthritis, OMEGA-3-ACID ETHYL ESTER (LOVAZA) for Triglycerides, TROPOLONE, FOLIC ACID, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and LISINOPRIL for an unknown indication.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (Reaction to covid-19), PAIN (General body pain) and PAIN IN EXTREMITY (Arm pain). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and PARACETAMOL (PANADOL) at a dose of 1 dosage form. At the time of the report, IMMUNISATION REACTION (Reaction to covid-19), PAIN (General body pain) and PAIN IN EXTREMITY (Arm pain) had not resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The Humira dose was reported as 40 mg ,1 in 15 days. The drug indication for the concomitant medication Tropolene was reported as pressure, Wellbutrin was reported as Nerves, Lisinopril was reported as heart. The therapy duration for the concomitant medications Lipitor, Lovaza, Aspirin, Restoril, Folic Acid, Methotrexate, Wellbutrin,Prilosec, Lisinopril, Singulair was reported as over three years ago.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Asthenia, COVID-19, Immunisation reaction, Vertigo
Clinical narrative: COVID-19; Reaction to covid-19 vaccine; Weakness; Vertigo; Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), IMMUNISATION REACTION (Reaction to covid-19 vaccine), ASTHENIA (Weakness), VERTIGO (Vertigo) and ABDOMINAL PAIN (Abdominal pain) in an adult female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    The patient's past medical history included Herpes infection. Concurrent medical conditions included Hidradenitis suppurativa, Apnea, Upset stomach, Nasal allergy, Hypercholesterolemia and Blood pressure high. Concomitant products included SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for Blood pressure high, OMEGA-3-ACID ETHYL ESTER (LOVAZA) for Hypercholesterolemia, MONTELUKAST SODIUM (SINGULAIR) for Nasal allergy, OMEPRAZOLE for Upset stomach.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 10-Sep-2021, the patient experienced IMMUNISATION REACTION (Reaction to covid-19 vaccine), ASTHENIA (Weakness), VERTIGO (Vertigo) and ABDOMINAL PAIN (Abdominal pain). On an unknown date, the patient experienced COVID-19 (COVID-19). In September 2021, ASTHENIA (Weakness), VERTIGO (Vertigo) and ABDOMINAL PAIN (Abdominal pain) had resolved. At the time of the report, COVID-19 (COVID-19) and IMMUNISATION REACTION (Reaction to covid-19 vaccine) outcome was unknown.            Treatment medications were not reported. The reporter's causality for the events of weakness, reaction to covid-19 vaccine, vertigo and abdominal pain with humira 40mg/0.4ml (adalimumab) was no reasonable possibility. The reporter's causality for the event of COVID-19 was not provided for Humira. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up document included additional events of weakness and vertigo, event onset date updated.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Polymenorrhoea
Clinical narrative: FREQUENT MENSTRUATION; 1st vaccine on 30-May-2021 and 2nd dose on 21-Jul-2021; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (FREQUENT MENSTRUATION) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st vaccine on 30-May-2021 and 2nd dose on 21-Jul-2021) in a 21-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease and Disability NOS.   On 02-Aug-2016, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. On 30-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose every two weeks. On 21-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st vaccine on 30-May-2021 and 2nd dose on 21-Jul-2021). In November 2021, the patient experienced POLYMENORRHOEA (FREQUENT MENSTRUATION). At the time of the report, POLYMENORRHOEA (FREQUENT MENSTRUATION) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st vaccine on 30-May-2021 and 2nd dose on 21-Jul-2021) outcome was unknown. Not Provided          No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   as per reporter for event menstruation frequent was not related. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS IN RIGHT FOREARM; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (BLOOD CLOTS IN RIGHT FOREARM) in a 52-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Thrombosis leg, Venous insufficiency and Rheumatoid arthritis.   On 10-Jun-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. On 14-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In May 2021, the patient experienced THROMBOSIS (BLOOD CLOTS IN RIGHT FOREARM) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (BLOOD CLOTS IN RIGHT FOREARM) had not resolved. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosing remained unchanged.   Company comment: This is a spontaneous case concerning a 52-year-old female patient with thrombosis leg, venous insufficiency and Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Thrombosis in right forearm, on the same month after receiving the first dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per list. Patient´s medical conditions remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen. The reporter's causality for the event(s) of BLOOD CLOTS IN RIGHT FOREARM with Humira was no reasonable possibility. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments: Company comment: This is a spontaneous case concerning a 52-year-old female patient with thrombosis leg, venous insufficiency and Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Thrombosis in right forearm, on the same month after receiving the first dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per list. Patient´s medical conditions remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Tachycardia
Clinical narrative: covid dose 1: 8/28/2021: J&J , 0.5 mL, Lot# 205A21A, IM, Right deltoid covid dose 2: 12/28/2021: Moderna 100 mcg, Lot# 027H21B, IM, Left deltoid [flu vaccination: 9/3/2021 Fluarix PF; 0.5 mL, Lot B49F7, IM, Right deltoid] Please note that 'booster' dose of Moderna (recommended 50 mcg) was actually 100 mcg I went back to work that evening and developed chills and rigors. In the morning on 12/29/21, I had a severe headache and continued chills and extreme fatigue that would not relent. Of note, I was also tachycardic. I did not see a doc. My unnatural fatigue continues to current date.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphagia, Erythema, Flushing, Injection site rash, Lacrimation increased
Clinical narrative: approx 30 minutes after vaccine - runny nose, sneezing, water eyes approx 1 hour after vaccine - generalized itchiness, redness, flush approx 1 hour 30 mins - 2 hours after vaccine - rash around insertion site, rash on right arm, swelling in throat/mouth, difficulty swallowing took Benadryl over the counter called 24 hour nurse hotline, recommended ER visit ER visit given Benadryl, Epinephrine, Pepcid, Steroids Prescribed Benadryl, Pepcid and Steroids
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mouth swelling, Pharyngeal swelling, Pruritus, Rash, Rhinorrhoea
Clinical narrative: approx 30 minutes after vaccine - runny nose, sneezing, water eyes approx 1 hour after vaccine - generalized itchiness, redness, flush approx 1 hour 30 mins - 2 hours after vaccine - rash around insertion site, rash on right arm, swelling in throat/mouth, difficulty swallowing took Benadryl over the counter called 24 hour nurse hotline, recommended ER visit ER visit given Benadryl, Epinephrine, Pepcid, Steroids Prescribed Benadryl, Pepcid and Steroids
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sneezing
Clinical narrative: approx 30 minutes after vaccine - runny nose, sneezing, water eyes approx 1 hour after vaccine - generalized itchiness, redness, flush approx 1 hour 30 mins - 2 hours after vaccine - rash around insertion site, rash on right arm, swelling in throat/mouth, difficulty swallowing took Benadryl over the counter called 24 hour nurse hotline, recommended ER visit ER visit given Benadryl, Epinephrine, Pepcid, Steroids Prescribed Benadryl, Pepcid and Steroids
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Low grade fever, chills, achy, injection site painful
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient requested Moderna Bivalent Booster but received the Moderna Monovalent vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Panic reaction, Throat tightness
Clinical narrative: Approx. 45 minutes after receiving 1st shot of Novavax, I began to feel a tightening in my throat as if mucus or phlegm was stuck in my throat, but when I tried to clear my  throat no mucus or phlegm came up.  I started to feel alittle panicky so I took 2 Benadryl, 25 mg liquid capsules.  After approx. 20 minutes had passed, the throat tightening eased.  I had received the 1st Moderna shot last Aug-2021 and had a severe reaction.  I had to be taken to the emergency room with trouble breathing.  I cannot take Mrna vaccines, or J&J, and have been waiting so long for the Novavax vaccine.  I want to receive the 2nd Novavax shot, but am afraid I might have a more severe reaction of throat tightening.  I am going to contact my doctor to ask what I should do.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose-1-21-AUG-2021 Dose-2-01-SEP-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1-21-AUG-2021 Dose-2-01-SEP-2021) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Psoriasis.    No Medical History information was reported.   On 27-Jan-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1-21-AUG-2021 Dose-2-01-SEP-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1-21-AUG-2021 Dose-2-01-SEP-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant and treatment medication was provided Two days after vaccine process of clearing skin from plaques stopped and remained plaques on upper back and buttocks that had not gone away. Knees were clear. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-624327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2022: Live-non-significant follow up. Updated narrative
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anaphylactic reaction, Asthenia, Chest discomfort, Dizziness, Erythema
Clinical narrative: Anaphylactic allergic reaction- Chest tightness right away, throat tightness, ambu bag with oxygen, tingling, weak, light headed, flushed red and then pale, monitored, Benadryl, Pepcid, and Zyrtec. Assessed by MD on site.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Flushing, Pallor, Paraesthesia, Throat tightness
Clinical narrative: Anaphylactic allergic reaction- Chest tightness right away, throat tightness, ambu bag with oxygen, tingling, weak, light headed, flushed red and then pale, monitored, Benadryl, Pepcid, and Zyrtec. Assessed by MD on site.
Age: 31.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Unevaluable event
Clinical narrative: DID NOT GET A WHEAL THE FIRST TIME IN ARM SO HAD TO USE OTHER ARM TO PRODUCE A WHEAL WHILE INJECTING ID.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Severe right forehead and right top of head headache.
Age: 0.33
Sex: M
Vaccine: MNQ
Symptoms: Infant irritability, Wrong product administered
Clinical narrative: On 8/26/2022 patient was due for Pentacel, PCV13, and Rotavirus vaccinations. Vaccination orders were verbally conveyed to medical assistant as well as indicated on patient information sheets per office protocol. Vaccinations logged into patient's chart by medical assistant as Pentacel, PCV13, and Rotavirus on day of visit. Patient received Pentacel and PCV13 as ordered. However,, 8/29/22, it was reported to this physician by the office manager that diluting agent for Rotavirus was in error combined with MenQuadfi vaccine. Diluting agent mixed with MenQuadfi subsequently provided to patient PO.  Parents report ~3 days of fussiness s/p vaccinations. Return to baseline health after these ~3 days of fussiness.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laryngitis, SARS-CoV-2 test
Clinical narrative: sort of laryngitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunisation; Bnt162b2 (Dose: 2), for COVID-19 immunisation; Bnt162b2 (Dose: 3), for COVID-19 immunisation; Bnt162b2 (Dose: 4), for COVID-19 immunisation. The following information was reported: LARYNGITIS (non-serious) with onset 11Sep2022, outcome "unknown", described as "sort of laryngitis". The event "sort of laryngitis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient without any recent medical history, received the fifth dose of Pfizer/ BioNTech booster against the omicron variant on 09Sep2022, at a facility. Two days after, the patient noticed develop a "sort of laryngitis." None of the previous doses resulted in this type or any type of reaction. After three Covid tests to make sure it was not COVID she went to see the doctor who told her that other patients were having "similar reactions" after the last booster against the omicron variant. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events reported. No product quality complaints reported. No further details provided.; Medical Assistant reporting that Patient received an extra dose of GARDASIL 9. Medical Assistant reports that Patient was on 2 dose series of GARDASIL 9 and Patient received a 3rd dose.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 18-AUG-2022, the patient who was on 2 dose series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) received an extra dose of the vaccine 0.5 mL (strength and route were not provided; lot#: 1780878, expiration date: 02-DEC-2023) for prophylaxis (extra dose administered). No additional adverse events were reported, and no further details were provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reported PNEUMOVAX 23 (PFS) was administered after a temperature excursion to a patient.; This spontaneous report has been received from a medical assistant (healthcare professional (HCP)) regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 06-JUL-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U003306, expiration date: 15-OCT-2022, administered once for prophylaxis (dose, route of administration and anatomical location were not provided) after temperature excursion of 62 Fahrenheit (F) for 5 hours 12 minutes (which occurred on 12-APR-2022) (product storage error). There was no previous temperature excursion. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of four reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA010789: US-009507513-2208USA010861: US-009507513-2209USA000730:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reported PNEUMOVAX 23 was administered after a temperature excursion to a patient.; This spontaneous report has been received from a medical assistant (healthcare professional (HCP)) regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 20-JUL-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U003306, expiration date: 15-OCT-2022, administered once for prophylaxis (strength, dose, route of administration and anatomical location were not provided) after temperature excursion of 62 Fahrenheit (F) for 5 hours 12 minutes on 12-APR-2022 (product storage error). There was no previous temperature excursion. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of four reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA010789: US-009507513-2209USA000715: US-009507513-2208USA010861:
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report was received from health care worker and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-AUG-2022, the patient was vacicnated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # W003118 with expiration date: 13-JUL-2023 or lot # W015191 with expiration date: 27-OCT-2023 - exact lot # not specified) administered for prophylaxis (strength, and route of administration were not provided). The vaccine was stored at 11.3 degrees Celsius (C) for 34 minutes. There was no previous temperature excursion and no additional adverse events (AEs) were reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report has been received from a health care worker concerning a 2-month-old patient of unknown gender.  The patient's concurrent conditions, medical history, previous drug reactions, allergiesand concomitant therapies were not reported.  On 18-AUG-2022,, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, one dose orally administered as prophylaxis (lot number W004504 which has been verified to be valid, expiration date reported and validated as 16-JUN-2023) and (lot number W002562 which has been verified to be valid, expiration date reported and validated as 12-OCT-2023) (strength and vaccination scheme were not reported). The reporter clarify that the patient received only one dose but did not specify which actual lot was administered. The administered dose of the vaccine was stored at a temperature of 11.3 degrees Celsius (C), during a time frame of 34 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: neck tingling; shingles rash; This spontaneous report was received from a physician and refers to an 88-year-old female patient. The patient's medical history included neuropathy peripheral. The patient's concurrent conditions and concomitant therapies were not reported.  On an unknown dates (reported as years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and on an unspecified dates, with varicella zoster vaccine rge (cho) (SHINGRIX), administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided). The course with varicella zoster vaccine rge (cho) (SHINGRIX)was completed on an unspecified day in June 2022 (reported as 3 months ago).  On 23-AUG-2022, the patient developed shingles rash, and had to be started on valacyclovir. The patient also had neck tingling along with shingles rash,but the physician believed that was might be related to neuropathy. At the time of reporting, the outcome of the events shingles rash and neck tingling were not reported.   The causal relationship between the events and suspected therapies were not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit . No further information provided. No add; This spontaneous report was received from a nurse and refers to a child of unknown gender. The patient's concurrent conditions, medical history, allergies or concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002783 with expiration date 24-JUL-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002783  with expiration date 24-JUL-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers to a child of unknown gender. The patient's concurrent conditions, medical history, allergies or concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002783 with expiration date 24-JUL-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002783  with expiration date 24-JUL-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers to a child of unknown gender. The patient's concurrent conditions, medical history, allergies or concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002783 with expiration date 24-JUL-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002783  with expiration date 24-JUL-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Sex: M
Vaccine: PPV
Symptoms: COVID-19 pneumonia
Clinical narrative: her father who ise 93 years of age received the Penumovax 23 and then developed a COVID pneumonia; This spontaneous report was received from the patient's daughter and refers to a 93-year-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), administered for prophylaxis (strength, dose, route of administration, anatomical location, lot #, and expiry date were not provided).  On an unknown date, the patient experienced COVID pneumonia. It was unknown if the patient received treatment. At the time of reporting, the outcome of the event was not known.   The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.   Upon internal review, the event of COVID-19 pneumonia was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient did not have any other adverse events; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 16-SEP-2022, varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot #W011626, expiration date: 06-APR-2024, was administered for prophylaxis (strength, and route of administration were not provided), after a temperature excursion in -10.4 degrees Celsius (C) for 30 hours (product storage error). The patient did not have any other adverse events (no adverse event). No previous temperature excursion.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA007227:
Age: 1.25
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events were reported.; Field employee called to report an AE in behalf of a nurse.   The nurse told the field employee that a 15 month old patient suppose to receive only PROQUAD but the patient received PROQUAD and then received VARIVAX on the same day, 9/15/2022.  No add; This spontaneous report was received from a registered nurse referring to a 15-month-old, patient of unknown gender, whose medical history, concurrent conditions, and concomitant therapies were not provided.  On 15-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (exact dose, vaccination scheme frequency, route of administration, anatomical location, lot number and expiration date were not provided); it was administered together on the same date with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, for prophylaxis (exact dose, vaccination scheme frequency, route of administration, anatomical location, lot number, and expiration date were not provided) (overdose). No further information provided.  No additional adverse events were reported.
Age: 0.75
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Additional AEs; Caller reported GARDASIL 9 was administered to a 9 month old.  No other information provided.  No Additional AEs or PQC reported.; This spontaneous report was received from a nurse and refers to a 9-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-SEP-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 0.5 ml, lot number 1780878, expiration date: 02-DEC-2023, administered intramuscularly for prophylaxis (exact dose, and strength were not provided) (product administered to patient of inappropriate age).  No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Healthcare provider reports administration of an expired dose of MMR II; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-APR-2022, the patient was vaccinated with an 1 expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, recombinant human albumin (rHA), lot #T013724, expiration date: 21-APR-2022, administered for prophylaxis (strength, exact dose and route of administration were not provided) (Expired product administered).  It was reported that the vaccine was stored within the recommended storage range until date of administration and was not involved in a temperature excursion. No additional adverse event was reported.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events reported.; Administration of PROQUAD to an 18 year old Patient.; This spontaneous report was received from physician and regarding to an 18-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 22-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (Rha) (PROQUAD) injection, at a dose 0.5 milliliter (ml), administered for prophylaxis (lot number W016358 which has been verified to be valid, expiration date reported and validated as 16-NOV-2023) (strength, route of administration, and anatomical site of injection were not reported).Also, it was reported that the patient received the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (Rha) (PROQUAD) when had 18-years-old (product administered to patient of inappropriate age).  No additional adverse events were reported in the patient.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; A medical assistant reported that a dose of improperly stored PROQUAD was administered to a patient.    ?; This spontaneous report has been received from a medical assistant, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 21-SEP-2022, the patient was vaccinated with improperly storage dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA)(PROQUAD) injection, administered as prophylaxis (lot number W012729 which has been verified to be valid, expiration date reported and validated as 16-OCT-2023) (strength, dose, route of administration, and anatomical site of injection were not reported).   Administered doses were stored at a temperature of 55.5 degrees Fahrenheit (F) (also reported as above 46F for 1 hour) during a time frame of 10 hours. There was no previous temperature excursion. No additional adverse events were reported in the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Vaccination failure
Clinical narrative: Got the jab then had shingles / received the vaccine, then had shingles/Suspected vaccination failure; Horrible shingles, died while battling a horrible bout of shingles / suffered from shingles then passed away; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria death and GSK medically significant) and shingles (serious criteria death). On an unknown date, the outcome of the vaccination failure and shingles were fatal. The reported cause of death was shingles and vaccination failure.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 18-SEP-2022 Reporter's comment: This case was reported by a patient via interactive digital media.  The patient had a very health friend and never got shingles. The patient got the jab of shingles then suffered horrible shingles for years then passed away. The patient was died while battling horrible bout of shingles. The reporter stated that, the vaccine could lead to you getting shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.; Reported Cause(s) of Death: Shingles; Vaccination failure
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: 4th dose administered 3 weeks after 3rd; 4th dose administered 3 weeks after 3rd as 4th dose Dtap series and early IPV; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included PEDIARIX.   On an unknown date, the patient received the 4th dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown.   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: 13-SEP-2022 Reporter's Comment: The reporter reported that the patient received 4th dose of Pediarix vaccine after 3 weeks of received 3rd dose of Pediarix vaccine. The reporter stated that as a 4th dose of Dtap series it should be Infanrix vaccine and the patient received an extra dose of Hepatitis B and it was early. Additional supportive information: The patient received extra dose of Pediarix in error, which led to extra dose administered. The reporter reported that, patient administered Pediarix instead of Infanrix , which led to wrong vaccine administered. The reporter did consent to follow up.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric Engerix b administered to adult; Pediatric Engerix b instead adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   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: 13-SEP-2022 Reporter's comment: Pharmacist reported that the patient was administrated with the pediatric dose of Engerix B instead of the adult dose. No adverse event was reported. No patient's identifiers, lot number and expiration date were provided. The reporter consented to follow-up. Additional Supportive Information: The adult patient received pediatric dose of Engerix B, which led to underdose and adult use of child product. This case had been linked with case US2022132051, reported by the same reporter.; Sender's Comments:  US-GSK-US2022132051:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Face broke out in shingles from the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that his sister received Shingles vaccine she was not wanting it, but her doctor talked her into it. The reporter stated that 4 days after received Shingles vaccine the patient experienced right side of her face broke out in shingles from the vaccine. The reporter stated she definitely not get the vaccine. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles right after got the shot; This 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 patients received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that he had Shingles twice once he was 16 years old and when he was much older. The reporter stated that he not wants to receive shot because he knows people that received Shingles vaccine and right after they experienced Shingles. Additional supportive information: This case had been linked with US2022AMR132562 and US2022AMR132560 reported by same reporter or different patient. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR132562:Same reporter US-GSK-US2022AMR132560:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Crying, Malaise, Pain
Clinical narrative: hurt like hell, rolled around on bed for 3 days; rolled around on bed for 3 days and cried; rolled around on bed for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mom had shingles, it was awful).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, malaise and crying. On an unknown date, the outcome of the pain and crying were unknown and the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the pain, malaise and crying to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient had first Shingle shots hurt like hell, the second one almost nothing.  The patient was rolled around on the bed for 3 days and cried and the patient stated he/she would still get it again.  Additional Supportive Information: This case was linked with US2022AMR132568, reported by same reporter. Follow-up would not possible as no contact details were available; Sender's Comments:  US-GSK-US2022AMR132568:Same reporter