chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus test, Fibromyalgia, Full blood count, HIV antibody, HIV antigen
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic encephalopathy, Hepatitis A antibody, Hepatitis B DNA assay, Hepatitis B core antibody, Hepatitis B surface antibody
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis C RNA, Hepatitis viral test, Hyperbilirubinaemia, Hypertransaminasaemia, Hypervolaemia
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoglycaemia, Intensive care, International normalised ratio increased, Laboratory test, Leukopenia
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Liver function test increased, Magnetic resonance imaging abdominal, Magnetic resonance imaging head, Metabolic function test
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Microscopy, Migraine, Ocular icterus, Pain, Prothrombin time prolonged
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon, SARS-CoV-2 test, Septic shock, Serum ferritin, Sjogren's syndrome
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Smooth muscle antibody, Tinnitus, Treponema test, Tumour marker test, Urine analysis
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Viral test
Clinical narrative: Went to ER-04/03/2021-Acute Liver Failure, Elevated INR, Hypoglycemia, Increased Ammonia Level-378, Septic Shock, Hepatic Encephalopathy, Acute Kidney Injury (HCC), Volume Overload, Anemia, Scleral Icterus, Elevated LFTs, Transaminitis, Bandemia, Coagulation, Tinnitus and Hyperbilirubinemia. Transferred on 04/03/2021 to alternate location. Transferred from alternate hospital on  04/04/2021 to 2nd ICU-released 04/12/2021.  Ongoing health issues continue after receiving the Pfizer Covid Vaccine injection-Debilitating Tinnitus, Sjogren's, Fibromyalgia, Migraines, Raynaud's, Leukopenia, Anemia, Positive ANA, Chronic Pain.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Gastritis, Injection site pruritus, Injection site swelling, Injection site vesicles, Skin reaction
Clinical narrative: Gastritis starting within hours and still occurring 12/20/22 The injection site started itching and swelling with blistering on December 2, two weeks after the injection. It is still itching and swollen with blisters, 12/20/22
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac arrest, Death, Resuscitation, Ventricular fibrillation
Clinical narrative: One day after Pfizer COVID bivalent booster, patient experienced a sudden, fatal cardiac arrest while exercising at the gym. Resuscitation efforts were unsuccessful. His 3 prior COVID vaccines were Moderna.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot inner  left leg 3 inches above ankle; blood clot cylindrical in shape  1 inch long 1/2 inch diameter
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Chills, headache, diarrhea,  nausea, fatigue, started that night and lasted thru the next day.  I took no medication.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Feeling abnormal, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: About 6 hours after receiving my dose, I went to bed and noticed elevated heart palpitations, as if experiencing anxiety or stress, and a sensation of such in the heart area. This continued intermittently for the past two days. The morning after I received the dose I had a hive, near the vaccination site, on the back of my arm shoulder, near the lymph nodes area by the armpit. There was redness surrounding the hive. There was an itchy feeling in the arm starting the night of and continuing in the morning. The hive went away in a few hours but there is still a small bump or puncture in the area where it was. I felt "knocked out" the first night's sleep and fatigue before going to bed. I felt arm soreness in the morning but it was mild and went away after the first day. By evening I no longer noticed any arm soreness.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Palpitations, Pruritus
Clinical narrative: About 6 hours after receiving my dose, I went to bed and noticed elevated heart palpitations, as if experiencing anxiety or stress, and a sensation of such in the heart area. This continued intermittently for the past two days. The morning after I received the dose I had a hive, near the vaccination site, on the back of my arm shoulder, near the lymph nodes area by the armpit. There was redness surrounding the hive. There was an itchy feeling in the arm starting the night of and continuing in the morning. The hive went away in a few hours but there is still a small bump or puncture in the area where it was. I felt "knocked out" the first night's sleep and fatigue before going to bed. I felt arm soreness in the morning but it was mild and went away after the first day. By evening I no longer noticed any arm soreness.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; she accidently administered both VARIVAX and PROQUAD to a patient instead of VARIVAX and MMRII.; This spontaneous report was received from a medical assistant and refers to an unknown age and gender patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 21-NOV-2022, it was reported that a patient was accidently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 0.5 milliliter (ml)/once, lot #W023866, expiration date: 24-JAN-2024 (strength, anatomical site injection were not provided), and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml/once, both vaccines administered subcutaneously for prophylaxis (strength, anatomical site injection, lot #, and expiry date were not provided); instead of varicella virus vaccine live (oka/merck) (VARIVAX) and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). (wrong product administered). No adverse event was reported.
Age: 44.0
Sex: U
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Medical assistant student calling with question about adult vaccination with MMR II and VARIVAX states an adult patient was recently vaccinated with MMR II. Because there is no adult dosing schedule in the MMR II prescribing information, AE is being; This spontaneous report was received from a medical assistant student and refers to a 44-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 16-NOV-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #U039908, expiration date: 16-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) reconstituted with a sterile diluent (Inappropriate age at vaccine administration).
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE details were provided and no additional AE's were reported; patients that were administered vaccines after they were involved in a TE.; This spontaneous report was received from a licensed practical nurse and referred to a 14-year-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.   On 08-NOV-2022 16:38, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter injection, 0.5 milliliter, lot # 1775827, expiration date: 27-JUN-2024, administered intramuscularly for prophylaxis in left deltoid after the vaccine was involved in a temperature excursion (Product storage error). The storage temperature of the with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was 11.4 degrees Celcius for a time frame of 1 hour 30 minutes. There was no previous temperature excursion. No additional adverse effect (AE) details were provided (no adverse event).    This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2212USA000032: US-009507513-2212USA000033: US-009507513-2212USA000034: US-009507513-2212USA000036: US-009507513-2212USA000037: US-009507513-2212USA000038: US-009507513-2212USA000031: US-009507513-2211USA004171:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE details were provided and no additional AE's were reported; patients that were administered vaccines after they were involved in a TE.; This spontaneous report was received from a licensed practical nurse and referred to a 12-year-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.   On 09-NOV-2022 10:36 AM, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter injection, lot #1775827, expiration date: 27-JUN-2024, administered intramuscularly for prophylaxis in right deltoid after the vaccine was involved in a temperature excursion (Product storage error). The storage temperature of the with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was 11.4 degrees Celcius for a time frame of 1 hour 30 minutes. There was no previous temperature excursion. No additional adverse effect (AE) details were provided (no adverse event).    This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2212USA000032: US-009507513-2212USA000033: US-009507513-2212USA000031: US-009507513-2212USA000034: US-009507513-2212USA000035: US-009507513-2212USA000037: US-009507513-2212USA000038: US-009507513-2211USA004171:
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site cyst
Clinical narrative: cyst develop at the injection site seven days after administering GARDASIL 9; This spontaneous report was received from a physician and refers to a 31-year-old female patient.  The patient's medical history included sicca syndrome. The patient's concurrent conditions and concomitant therapies were not reported.  On 25-OCT-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, use as directed to prevent human papilloma virus infection (prophylaxis), lot #W011264, expiration date: 05-SEP-2024, administered intramuscularly (strength was not provided).  On 01-NOV-2022 (also reported as seven days after vaccination), the patient experienced a cyst develop at the injection site (Vaccination site cyst). The cyst became golf ball sized. She sought for medical attention. At the time of the report, the size of the cyst had decreased to the size of a quarter. No treatment was given for the event. The patient had not recovered from the event. No additional information was available regarding the adverse experience.   The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding vaccination site cyst was not applicable.   The causal relationship between vaccination site cyst and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. The physician did not feel that the Sicca syndrome contributed to the cyst formation in any way. ; Sender's Comments:  US-009507513-2212USA000647:
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs; HCP called to report that MMR II with temp excursion on 22-NOV-2022 was administered on 23-NOV-2022; This spontaneous report was received from a physician and refers to a 12-month-old female patient.  The patient's birth weight was 3.048 kg, she had two siblings, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.   On 23-NOV-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, at dose 0.5ml, once (lot number W009107 was verified to be a valid number, expiration date reported and established as 04-DEC-2023, administered subcutaneously in the right thigh (vaccination scheme and strength were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, (lot number w018836 was verified to be a valid number, expiration date reported and established as 14-JUN-2024), administered subcutaneously in the left thigh (dose, vaccination scheme and strength were not provided); hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot  number w023937 was verified to be a valid number, expiration date reported and established as 06-DEC-2023), administered intramuscularly in the left thigh (dose, vaccination scheme and strength were not provided); and  influenza vaccine inact split 3v (FLULAVAL) (lot number 5m2h2, expiration date: 30-JUN-2023) administered intramuscularly in the right thigh (dose, vaccination scheme and strength were not provided), all the vaccines were administered for prophylaxis. The vaccines were administered at privade doctor's office/hospital with public funds by a health care professional. On 22-NOV-2022 (reported as night prior), the vaccines underwent a temperature excursion (product storage error). No additional adverse event were reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product dose omission issue, Product expiration date issue
Clinical narrative: Customer called and reported that the STERILE DILUENT for MMR-II was expired. A consumer missed a dose of MMR-II as a result.; Product expiration date issue; no adverse event; This spontaneous report was received from a pharmacist and referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  It was reported that the sterile diluent (strength, lot #, expiry date were not provided) for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was expired (product expiration date issue). On an unknown date, the patient missed a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose description, lot #, expiry date, and route of administration were not provided) as a result (product dose omission issue). No additional adverse event was reported (no adverse event).
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX that had undergone temperature excursion was administered to a patient; No additional AE reported.; This spontaneous report was received from medical assistant and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). Administered dose of vaccine experienced unknown temperature excursion.  There was no adverse event reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-DEC-2022, the patient was vaccinated with an expired dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #U010533, expiration date: 29-OCT-2022) administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional information was provided to further clarify any details. No additional adverse event (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Intercepted medication error, No adverse event, Product preparation issue
Clinical narrative: No adverse event; He reconstituted VARIVAX with expired STERILE DILUENT but did not administer the dose to the patient; caller states that he reconstituted VARIVAX with expired STERILE DILUENT; This spontaneous report was received from Pharmacist and refers to a patient of an unknown age or gender.  The patient's medical history, conditions and concomitant therapies were not reported.  On 05-DEC-2022, a varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U022320, expiration date: 15-JUL-2023 was reconstituted with an expired sterile diluent 0.5 milliliter, lot #T015779, expiration date: 02-DEC-2022 (Inappropriate preparation of medication). It was stated that after reconstituting the varicella virus vaccine live (oka/merck) (VARIVAX) the pharmacist realized that the sterile diluent  was expired and did not administer the dose to the patient (Intercepted medication error). No additional  adverse event was reported.
Age: 28.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; Pharmacist reported that adult patient received a pediatric dose of VAQTA; This spontaneous report was received from a pharmacist concerning a 28 years old adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-NOV-2022, the adult patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA), lot number w021491 with expiration date 14-DEC-2023, 0.5 millilitre (mL) dose, once for prophylaxis (strength, route of administration and anatomical location were not provided) (product administered to patient of inappropriate age). No adverse events (AEs) were reported(no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2212USA002459:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported.; an expired dose of PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from other healthcare professional (medical student) and referred to patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 05-DEC-2022, an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) 23 injection 0.5 ml once (valid lot#T032003 with expiration date 08-MAY-2022) was administered to a patient for prophylaxis (Expired vaccine used). There was no additional information provided to further clarify these details. No adverse effects were reported and no additional adverse event reported (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered to 1 patient following a temperature excursion; This spontaneous report was received from a consumer and referred to a patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 02-DEC-2022, the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (valid lot# W019630 with reported expiry date 19-DEC-2023)(strength, dose description, and route of administration were not provided) for prophylaxis after a temperature excursion with temperature 27.9 Fahrenheit (F) and time frame was 1 hour and 35 minutes (Incorrect product storage). There was no previous temperature excursion. There was no additional adverse event (No adverse event). And there was no additional information provided.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Nausea, Vomiting, Wrong product administered
Clinical narrative: vaccine exposure during pregnancy; wrong vaccine administered; product confusion; patient vomited "uncontrollably"; nausea; This spontaneous report was received from a consumer and refers to a 37-year-old female patient (reporter's wife). No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.   On an unknown date in November 2022, also reported as the week before Thanksgiving, the patient was supposed to be vaccinated with influenza vaccine (FLU [INFLUENZA VACCINE])(strength, dose, formulation, lot #, expiration date and route of administration were not provided) for prophylaxis, but accidentally received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered intramuscularly (strength, dose, lot # and expiration date were not provided) for prophylaxis (Product confusion, Wrong product administered). The patient was pregnant at the time of vaccination (Exposure during pregnancy).  On an unknown date in November 2022, also reported as for about 10 - 15 minutes after the vaccination, the patient vomited uncontrollably (Vomiting) and since then has been experiencing nausea (Nausea). It has been stated that the reporter is unsure if this is a side effect of pregnancy. The outcome of nausea and vomiting was reported as recovering.   The causal relationship between nausea and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. The causal relationship between patient vomiting "uncontrollably" and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Age: 12.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Medical assistant calling to report that a patient was inadvertently administered a 4th dose of GARDASIL9 on 06-DEC-2022; the second dose was given two years later; This spontaneous report was received from other health professional (medical assistant) and refers to a 14-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in 2020, at the age of 12, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (dose, frequency, lot #, expiration date, and route of administration were not provided).  There was an interruption in the dosing schedule between dose one and dose two and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, lot #, expiration date, and route of administration were not provided) was given two years later on 05-APR-2022 for prophylaxis (inappropriate schedule of product administration). The third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, lot #, expiration date, and route of administration were not provided) was administered on 01-NOV-2022 for prophylaxis. On 06-DEC-2022, the patient was inadvertently administered a 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Extra dose administered), 0.5 ml, lot # U029033 (lot number was verified to be valid lot number) expiration date 13-MAR-2024, (route of administration was not provided) for prophylaxis.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered after a temperature excursion to patient; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, once, lot #W023870, expiration date: 24-JAN-2024, administered for prophylaxis after a temperature excursion (strength, and route of administration were not provided) (Product storage error). It was reported that temperature and time frame were 5.9F for 13 Minutes and 33.4F for 1 Hour 54 Minutes. There were no previous temperature excursion. No further information provided. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; patient received improperly stored vaccine; 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 15-NOV-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, intramuscular injection, 1 dose, lot number W023937, expiration date: 06-DEC-2023, administered for prophylaxis (exact dose, strength, and route of administration were not provided). Before the administration the vaccine underwent temperature excursion (temperature: 47.8 Fahrenheit (F), time frame: 14 minutes, previous temperature excursion: 48 F for 10 minutes) (product storage error). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported.; Physician reported that a patient received an expired MMR II vaccine; This spontaneous report has been received from a physician and refers to a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. There was no information regarding the patient's medical history and concurrent conditions provided.  On 08-DEC-2022, the patient was vaccinated with one expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) subcutaneous injection, lot # T033815 confirmed to be valid with an expiration date 05-OCT-2022 (exact dose, dose number, route of administration, and anatomical location were not reported), for prophylaxis (expired product administered). No additional adverse events were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Healthcare provider states improperly stored vaccine involved in a temperature excursion  was administered to a patient. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): PEDVAX HIB W006595 10/10/2024 Temper; no additional adverse event; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender.   Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot number: W006595, expiration date: 10-OCT-2024; dose and route of administration not provided) (product storage error). The vaccine was stored in temperature 57.49 degrees Fahrenheit for 1 hour 45 minutes. No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Healthcare provider states improperly stored vaccine involved in a temperature excursion was administered to a patient on 28NOV2022. No additional AE reported. No PQC reported.     Names of vaccines involved (including lot/exp): MMR II U022316 7/15/; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and drug reactions/allergies were not reported.  On 28-NOV-2022, the patient was vaccinated with improperly stored mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) 1 dosage form (dosage reported as "1"), lot # U022315, expiration date 15-JUL-2023 (strength, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). Administered dose of suspect vaccine experienced temperature excursion of 57.49 Fahrenheit (F) for 1 hour and 45 minutes. There was no information about previous temperature excursion and if digital data logger was involved. No additional adverse event reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Healthcare provider states improperly stored vaccine involved in a temperature excursion was administered to a patient. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): PEDVAX HIB; No additional AE reported; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # W006595, expiration date 10-OCT-2024 (strength, dose, route and frequency were not reported) for prophylaxis.        The vaccine was stored at a temperature of 57.49 Fahrenheit degrees (F), during 1 hour and 45 minutes. No additional adverse event or product quality complaint was involved.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Conversion disorder, Gait disturbance, Inappropriate schedule of product administration, Orthostatic intolerance
Clinical narrative: on March 26, 2021 and April 11, 2022, the claimant was injured by Gardasil; orthostatic intolerance; functional neurological disorder; functional gait disorder; among other severe symptoms; Information has been received from a lawyer, regarding a case in litigation and concerning a 11-year-old female patient (pt). No information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On 26-MAR-2021 and 11-APR-2022, the pt was vaccinated respectively with first and second dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported for either of them) for prophylaxis (Inappropriate schedule of product administration). On these dates, the pt was "injured by quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) injections which caused her to develop orthostatic intolerance, functional neurological disorder, and functional gait disorder, among other severe symptoms". The outcome of the events was not provided.   The reporter considered the events of orthostatic intolerance, functional neurological disorder, functional gait disorder, and other severe symptoms to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: he received MMR vaccine at 18 months; with no issue; This spontaneous report was received from a consumer referring to her son, an 18-month-old male. The patient's concurrent conditions included egg allergy. There was no information about the patient's concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, lot #, expiry date, route of administration and administration site were not provided) for prophylaxis (product administered to patient of inappropriate age) with no issues (no adverse event). The reason for delaying the vaccination was mothers concern that the vaccines in general could "over-excite" the immune system and lead to side effects and her son might have side effects to the "pathogens" in the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine. The mother wanted to wait until her son was older and stronger.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA005215:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details were provided and no additional AE's were reported; patient was administered a dose of VARIVAX after it was involved in a temperature excursion.; This spontaneous report was received from  the office manager and refers to a patient of an not reported age or gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 14-DEC-2022, the patient was vaccinated with an improper stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliter, lot #W018825, expiration date: 14-JUN-2024, administered for prophylaxis (vaccination scheme and route of administration were not provided) following a temperature exception of 41 degree Fahrenheit for 7 hours and 30 minutes (product storage error), it was stated that no previous temperature excursion occurred and there was no additional adverse event reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; The HCP reports that a patient was administered a dose of PEDVAXHIB after it was involved in an excursion.; 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 06-DEC-2022, the patient was vaccinated with improperly storage dose Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular Injection, at a dose of o.5 milliliter (ml), for prophylaxis (lot number: T026066, which was determined to be valid, with an expiration date on 01-APR-2023) (strength dose, route of administration, vaccination scheme frequency, and anatomical site of injection were not reported) Administered doses were stored at a temperature of 101 degrees Celsius (C) during a time frame of 624 hours. There was no previous temperature excursion.  No additional adverse events were reported in the patient.
Age: 0.92
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional ae reported; 11 month old received a dose of MMR II and VARIVAX on the same visit; This spontaneous report was received from medical assistant and refers to an 11-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, approximately in November or December 2022, on the same visit, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, lot #, expiry date, route of administration and anatomical location were not provided for both) as prophylaxis. The patient would turn 1 year old in 10 days (inappropriate age at vaccine administration). No adverse effects and no additional adverse event (AE) were reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Heavy menstrual bleeding
Clinical narrative: heavier periods; Product origin unknown; This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient's medical history, concurrent condition, and concomitant therapy were not reported.   On an unknown date, the patient received human papillomavirus (HPV) vaccine administered (strength, dose, unit, lot number and expiry date not provided) for prophylaxis (Product origin unknown). On an unknown date, the patient had heavier periods due to the HPV vaccine. The outcome was not provided. The action taken was not applicable. The causality was considered as related.   This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; GARDASIL 9 was administered to a patient in error instead of a flu shot from an unknown manufacturer; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapies details were not reported.  On 15-DEC-2022, the patient was vaccinated in error with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W010661, expiration date: 19-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) instead of a flu shot vaccine of unknown manufacturer (Wrong product administered). No symptomatic side effect were reported. No additional adverse event or product quality complaint was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A HCP called and reported an AE where an adult patient received a dose of PROQUAD inadvertently on an unknown date.; No additional adverse event reported; This spontaneous report was received from a register nurse and refers to an adult patient of unknown age. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated inadvertently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose description, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse event was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shot 1 1/2 years ago, still got  Shingles/Suspected vaccination failure; Still got the shingles; Is incrediblypainful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   The reporter considered the vaccination failure, shingles and pain to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the Shingles shot one and half year ago from reporting. The patient developed shingles after being vaccinated with Shingles vaccine. The patient was two weeks in, and it was incredibly painful. The reporter thought that the events might had been related to the drug. The reporter did not consent to contact healthcare professional. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got the vaccine, still got shingles, vaccine doesn't prevent it; Shingles (horrible)/ still got shingles and they were horrible; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-Dec-2022 Reporter's comment: The case was received from the patient's children via interactive digital media. The patient got the vaccine and she still got shingles and they were horrible. The reporter stated that so the vaccine did not prevent them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Symptoms of A Fib before 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included atrial fibrillation (Patient had occasionally A Fib).   On 19th September 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation was unknown.   It was unknown if the reporter considered the atrial fibrillation to be related to Shingrix.     Linked case(s) involving the same patient:  US2022187987   Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's Comment: The patient was self-reported this case. The patient reported that he received Shingrix vaccine on the right arm. The patient stated that after received Shingrix vaccine he experienced the symptoms of A Fib before receiving the 2nd dose of Shingrix vaccine. The lot number and expiration date of the vaccine was unknown. The reporter did consent to follow up. Additional supportive information: for the tolerance of the 2nd dose, refer linked case US2022187987 reported by same reporter.; Sender's Comments:  US-GSK-US2022187987:same reporter - 2nd dose case