chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Amylase normal, Blood test normal, Blood triglycerides normal, Blood urea nitrogen/creatinine ratio
Clinical narrative: 12/19/21 Developed acute pancreatitis. Severe abdomen pain (pain worse than labor), could not lay down or eat, liquid diet for several weeks, lost 30 pounds, lasted well into March 2022.  33 y/o breastfeeding mom, no alcohol or medication, no gallbladder issues and otherwise idiosyncratic acute pancreatitis 12/23/21 Went to ER because pain so bad, left without being seen 12/27/21 Telemed visit 12/28/21 CT Scan at urgent care visit confirming pancreatitis
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding, C-reactive protein normal, Computerised tomogram abdomen abnormal, Feeding disorder, Full blood count normal
Clinical narrative: 12/19/21 Developed acute pancreatitis. Severe abdomen pain (pain worse than labor), could not lay down or eat, liquid diet for several weeks, lost 30 pounds, lasted well into March 2022.  33 y/o breastfeeding mom, no alcohol or medication, no gallbladder issues and otherwise idiosyncratic acute pancreatitis 12/23/21 Went to ER because pain so bad, left without being seen 12/27/21 Telemed visit 12/28/21 CT Scan at urgent care visit confirming pancreatitis
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lipase increased, Magnetic resonance imaging abdominal abnormal, Metabolic function test normal, Pancreatitis acute, Scan with contrast abnormal
Clinical narrative: 12/19/21 Developed acute pancreatitis. Severe abdomen pain (pain worse than labor), could not lay down or eat, liquid diet for several weeks, lost 30 pounds, lasted well into March 2022.  33 y/o breastfeeding mom, no alcohol or medication, no gallbladder issues and otherwise idiosyncratic acute pancreatitis 12/23/21 Went to ER because pain so bad, left without being seen 12/27/21 Telemed visit 12/28/21 CT Scan at urgent care visit confirming pancreatitis
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound biliary tract normal, Weight decreased
Clinical narrative: 12/19/21 Developed acute pancreatitis. Severe abdomen pain (pain worse than labor), could not lay down or eat, liquid diet for several weeks, lost 30 pounds, lasted well into March 2022.  33 y/o breastfeeding mom, no alcohol or medication, no gallbladder issues and otherwise idiosyncratic acute pancreatitis 12/23/21 Went to ER because pain so bad, left without being seen 12/27/21 Telemed visit 12/28/21 CT Scan at urgent care visit confirming pancreatitis
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Exfoliative rash, Perioral dermatitis, Rash erythematous, Rash pruritic
Clinical narrative: I got the bivalent vaccine and flu shot on Monday at 2:15 p.m. On Wednesday morning,  I woke up with a red, itchy, scaly rash around my mouth.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT HAD A LARGE, RED, SWOLLEN AREA ON HIS ARM COVERING MOST OF HIS BICEPT. TOWARD HIS ELBOW THE LESION WAS PURPLE. THE REACTION OCCURRED OVERNIGHT AND WORSENED THROUGHOUT THE DAY WHILE HE WAS AT WORK. HE STATED IT DIDN'T ITCH BUT IT WAS VERY PAINFUL. HE WENT TO URGENT CARE AT 6PM AND HAD THE REACTION ASSESSED. HE WAS TOLD TO PUT ICE ON THE AREA TONIGHT AND IF IT WASN'T BETTER TOMORROW TO START CEPHALEXIN 500 MG TWICE DAILY FOR 7 DAYS. HE IS ALSO ON BENADRYL AND TAKING A PROBIOTIC DUE TO A HISTORY OF C. DIFF FROM ANTIBIOTIC TREAMENT.
Age: 1.08
Sex: M
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: No adverse reactions No treatment required due to no reaction. No adverse out come noted at this time.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: 26 patients were given a booster for COVID that was not Pfizer/Moderna Bivalent booster. We did not have vaccines available to administer until 10/12/22.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Inappropriate schedule of product administration
Clinical narrative: Telogen Effluvium; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIFFUSE ALOPECIA (non-serious), outcome "unknown", described as "Telogen Effluvium".  Additional information: Reporter stated that his hair had been falling out since he got the Covid vaccine. He knew that many others were having the same problem. Dermatologist diagnosed as Telogen Effluvium. Reporter was asking for any comments and any treatments. He further stated that he will never get another Covid vaccine or booster again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diffuse alopecia
Clinical narrative: Telogen Effluvium; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIFFUSE ALOPECIA (non-serious), outcome "unknown", described as "Telogen Effluvium".  Additional information: Reporter stated that his hair had been falling out since he got the Covid vaccine. He knew that many others were having the same problem. Dermatologist diagnosed as Telogen Effluvium. Reporter was asking for any comments and any treatments. He further stated that he will never get another Covid vaccine or booster again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Caught with COVID in the beginning of July 2022; Arm was sore / My arm hurt pretty bad / It was really sore, more than all the other shots; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Caught with COVID in the beginning of July 2022) and PAIN IN EXTREMITY (Arm was sore / My arm hurt pretty bad / It was really sore, more than all the other shots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065421A, 012F21A, 040A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm was sore / My arm hurt pretty bad / It was really sore, more than all the other shots). In July 2022, the patient experienced COVID-19 (Caught with COVID in the beginning of July 2022). At the time of the report, COVID-19 (Caught with COVID in the beginning of July 2022) and PAIN IN EXTREMITY (Arm was sore / My arm hurt pretty bad / It was really sore, more than all the other shots) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2022-657162 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pain in extremity
Clinical narrative: Caught with COVID in the beginning of July 2022; Arm was sore / My arm hurt pretty bad / It was really sore, more than all the other shots; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Caught with COVID in the beginning of July 2022) and PAIN IN EXTREMITY (Arm was sore / My arm hurt pretty bad / It was really sore, more than all the other shots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065421A, 012F21A, 040A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm was sore / My arm hurt pretty bad / It was really sore, more than all the other shots). In July 2022, the patient experienced COVID-19 (Caught with COVID in the beginning of July 2022). At the time of the report, COVID-19 (Caught with COVID in the beginning of July 2022) and PAIN IN EXTREMITY (Arm was sore / My arm hurt pretty bad / It was really sore, more than all the other shots) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2022-657162 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Pericarditis
Clinical narrative: Pt reports she woke up with chest pain went to ED 9/20 and consulted by  doctors and discharged 9/22. with colchicine  and ibuprofen
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone normal, Brain natriuretic peptide normal, C-reactive protein normal, Cardiac stress test normal, Catheterisation cardiac normal
Clinical narrative: Pt reports she woke up with chest pain went to ED 9/20 and consulted by  doctors and discharged 9/22. with colchicine  and ibuprofen
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram thorax normal, Echocardiogram normal, Electrocardiogram normal, Fibrin D dimer normal
Clinical narrative: Pt reports she woke up with chest pain went to ED 9/20 and consulted by  doctors and discharged 9/22. with colchicine  and ibuprofen
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Lipase normal, Lipids normal, Metabolic function test normal, Red blood cell sedimentation rate normal
Clinical narrative: Pt reports she woke up with chest pain went to ED 9/20 and consulted by  doctors and discharged 9/22. with colchicine  and ibuprofen
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast normal, Thyroxine normal
Clinical narrative: Pt reports she woke up with chest pain went to ED 9/20 and consulted by  doctors and discharged 9/22. with colchicine  and ibuprofen
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling hot, Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: feeling tired; first dose administerd on 5-Mar-2021 and second dose on 4-Nov-2021/More than 28 days between primary series vaccinations; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feeling tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose administerd on 5-Mar-2021 and second dose on 4-Nov-2021/More than 28 days between primary series vaccinations) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Aortic valve replacement in 2017, Mitral valve repair in 2017 and Scar removal (scar tissue in colon removed) in 2018. Concomitant products included METOPROLOL and LOSARTAN for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced FATIGUE (feeling tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose administerd on 5-Mar-2021 and second dose on 4-Nov-2021/More than 28 days between primary series vaccinations). At the time of the report, FATIGUE (feeling tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose administerd on 5-Mar-2021 and second dose on 4-Nov-2021/More than 28 days between primary series vaccinations) outcome was unknown.            No treatment drug details was reported.   This case was linked to MOD-2022-657569 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: feeling tired; first dose administerd on 5-Mar-2021 and second dose on 4-Nov-2021/More than 28 days between primary series vaccinations; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feeling tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose administerd on 5-Mar-2021 and second dose on 4-Nov-2021/More than 28 days between primary series vaccinations) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Aortic valve replacement in 2017, Mitral valve repair in 2017 and Scar removal (scar tissue in colon removed) in 2018. Concomitant products included METOPROLOL and LOSARTAN for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced FATIGUE (feeling tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose administerd on 5-Mar-2021 and second dose on 4-Nov-2021/More than 28 days between primary series vaccinations). At the time of the report, FATIGUE (feeling tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose administerd on 5-Mar-2021 and second dose on 4-Nov-2021/More than 28 days between primary series vaccinations) outcome was unknown.            No treatment drug details was reported.   This case was linked to MOD-2022-657569 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Pruritus, Urticaria
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: hives & wheels specific to left arm inj area-also 1 wheel on rt arm the next day-Mild, Additional Details: She called Pfizer
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria, Pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: hives & wheels specific to left arm inj area-also 1 wheel on rt arm the next day-Mild, Additional Details: She called Pfizer
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Rash, Urticaria
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: hives & wheels specific to left arm inj area-also 1 wheel on rt arm the next day-Mild, Additional Details: She called Pfizer
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller is a office manager calling to report a temperautre excursion for VARIVAX. Caller reports that one dose of VARIVAX was administered to the patient on 19SEP2022; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender.  The patient's pertinent concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not provided.  On 19-SEP-2022, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number U030161 has been verified to be a valid lot number with expiration date on 28-SEP-2023, administered as prophylaxis (strength, dose, vaccination scheme, route of administration and anatomical location was not provided).  The varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature of 75-degree Fahrenheit, for an unknown time frame (product storage error). There was no previous temperature excursion, but It was reported that the excursion was still ongoing.  No additional adverse events were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Extra dose administered
Clinical narrative: no longer had the antibodies for varicella/still did not have the antibodies; booster shot/another booster shot; This spontaneous report was received from a consumer (patient's mother) and refers to an adult female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On an unknown date, when she was a child, the patient received her first and second doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported).  On an unknown date, as an adult, she discovered she no longer had the antibodies for varicella. This resulted in her receiving a first booster dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Extra dose administered).  On an unknown date, a few years later, it was discovered she still did not have the antibodies for varicella, which resulted in her receiving second booster dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Extra dose administered).  At the time of reporting, the outcome of the event no longer had the antibodies for varicella/still did not have the antibodies was unknown.  The causal relationship between no longer had the antibodies for varicella/still did not have the antibodies and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no AE; Caller is a pharmacist reporting an AE for VAQTA. Caller states an infant patient age 2 months 12 days inadvertently received pediatric VAQTA on 9/27/2022. Caller did not provide lot/exp at time of call. Caller states it was unknown at time of call i; Caller is a pharmacist reporting an AE for VAQTA. Caller states an infant patient age 2 months 12 days inadvertently received pediatric VAQTA on 9/27/2022. Caller did not provide lot/exp at time of call. Caller states it was unknown at time of call i; Information has been received from a pharmacist, referring to a 2 months-old and 12 days infant patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 27-SEP-2022, the patient was inadvertently vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml (lot number, expiration date and administration route was not provided) for prophylaxis.  The reporting pharmacist stated that it was unknown at time of call if the administration was related to a medication error, stating it was possibly mistaken for hepatitis b vaccine (manufacturer unknown). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Myocardial infarction
Clinical narrative: heart attack; Information has been received from a lawyer, regarding a case in litigation and concerning a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On an unspecified date in or around January 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the suspect vaccine, the pt suffered a heart attack. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the event of heart attack was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of heart attack was considered to be disabling.  Upon internal review, the event of heart attack was determined to be medically significant.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; ROTATEQ was administered after its labeled expiry date.; This spontaneous report was received from a registered nurse and refers to an 11-week-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 29-SEP-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 ml, lot number: 1742463 was found to be valid, expiration date: 20-SEP-2022 (expired product administered) administered orally for prophylaxis (strength was not provided). The reporter confirmed, that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had not undergone any temperature excursions. No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse reported that a patient received improperly stored vaccine; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 03-OCT-2022, the patient was vaccinated with an improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1879866, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and upon internal validation established as 30-OCT-2023) (dose, anatomical location, route of administration, lot# and expiration date were not reported) for prophylaxis. The vaccine was stored at a temperature of 55.8 Fahrenheit degrees (F) for 44 hours (Product storage error). The vaccine did not have previous temperature excursions.  No additional adverse events were reported.; Sender's Comments:  US-009507513-2210USA000978:
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No other adverse events reported; PROQUAD was administered to a 16 year old in error on 31Aug2022; patient should have received MMR and Varicella vaccines; This spontaneous report was received from a registered nurse concerning a 16-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 31-AUG-2022, the patient was vaccinated in error with one dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) administered as prophylaxis, lot number W019631 with expiration date 19-DEC-2023 (route of administration was not provided) (Inappropriate age at vaccine administration). The nurse reported that the medical assistant that administered Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) did not know it was not indicated for patients less than 12 months of age or 13 years and older, the patient should have received Measles, Mumps, Rubella (MMR) and varicella vaccines (Wrong product administered). No other adverse events were reported (No adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Caller reports that an expired VAQTA was administered.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 04-OCT-2022, the patient was administered with an expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #1792241, expiration date: 01-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided) (Expired vaccine used). No additional AE reported.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Arrhythmia, Emotional distress, Gastrointestinal disorder, Nervous system disorder
Clinical narrative: He developed arrythmia and his "heart will act up"; he has had "gastrointestinal issues" and "difficulties with using the bathroom."; he has had "a lot of suffering"; The effects have "taken a toll on his mental health" and resulted in "neurological conditions."; This spontaneous report has been received from a consumer referring a 23-year-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unspecified date, reported as "sometime 2017- 2018", the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for human papilloma virus prevention (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided).  On an unknown date, the patient experienced a lot of health issues. It was reported he developed arrhythmia and his "heart will act up" (arrhythmia). He has had gastrointestinal issues (gastrointestinal disorder) and difficulties with using the bathroom. Also, he has had a lot of suffering (emotional distress), where the effects have taken a toll on his mental health and resulted in neurological conditions (nervous system disorder). The outcome of the aforementioned events were not reported.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event arrhytmia was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse event (AE); HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a unknown age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 06-OCT-2022, the patient was vaccinated with a improperly storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) lot number W023868, expiration date: 24-JAN-2024 (upon internal review, had been verified to be a valid number) administered for prophylaxis (strength, dose, anatomical site of injection and route of administration were not provided). The vaccine underwent a temperature of 10.8 degrees Fahrenheit with a time frame of 1 hour, 39 minutes and 0 seconds. There was no previous temperature excursion.; Sender's Comments:  US-009507513-2210USA002259: US-009507513-2210USA002344:
Sex: M
Vaccine: HEPA
Symptoms: Hepatic enzyme increased
Clinical narrative: Voice message received on 09OCT2022, outside of normal business hours, from a Merck employee who reported an adverse event on behalf of a HCP who was the patient. Caller explained the HCP had elevated liver enzymes after he was admini; This spontaneous report has been received from the patient who was also a health care professional (HCP) via company representative, referring to himself a male patient of unknown age.The patient's medical history, current conditions, concomitant therapies, and previous drugs reactions or allergies were unknown.  On an unknown date, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, dose, vaccination scheme, lot #, expiry date, and route of administration were unknown).  On an unknown date, after the vaccine administration the patient developed elevated liver enzymes.  The outcome, as well as the causality assessment between the hepatic enzyme increased event and hepatitis a vaccine, inactivated (VAQTA) were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: have shingles now, had shot years ago/Suspected vaccination failure; shingles; pain is unbearable; 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 (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), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comments:  This case was received from Consumer via interactive digital media. The reporter stated that the patient had shingles at the time of reporting. The patient stated that when told you get the shot. The patient had the shot years ago but  still got them and the pain was unbearable. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Condition aggravated, Laboratory test, Scan abnormal
Clinical narrative: Loss of vision/95% of vision gone; Condition aggravated; This case was reported by a consumer and described the occurrence of loss of vision in a patient who received Herpes zoster (Shingles vaccine) (batch number P7N2H, expiry date 30th January 2023) for prophylaxis.   Concurrent medical conditions included swelling of retina (vision issues with a swollen retina in the right eye in July 2022), poor vision (limited vision in left eye due to explosion) and abnormal vision.   On 1st August 2022, the patient received Shingles vaccine. On 2nd August 2022, 1 days after receiving Shingles vaccine, the patient experienced loss of vision (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the outcome of the loss of vision and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the loss of vision and condition aggravated to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: The case was self reported by the patient. The patient received a dose of Shingles vaccine and had vision issues with a swollen retina in the right eye. The patient received shingles vaccine and woke up the next morning with 95 percent of vision gone and vision had not returned to date.  Retina Specialist was shocked when he did a retinal scan the end of August. It clearly shown the vision gone from clear with some dots in July to 95 percent dark on the next retinal scan the end of August 2022. The patient reported that he/she who had very limited vision in left eye due to explosion and now no vision in right eye.The reporter would appreciate a response as soon as possible.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness unilateral, Hearing aid user, Hypoacusis
Clinical narrative: Hearing loss in left ear; A lot in right ear (wear hearing aid); This case was reported by a consumer via interactive digital media and described the occurrence of hearing loss unilateral in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced hearing loss unilateral (serious criteria GSK medically significant) and hearing reduced. On an unknown date, the outcome of the hearing loss unilateral and hearing reduced were unknown.   It was unknown if the reporter considered the hearing loss unilateral and hearing reduced to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-Oct-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received Shingles shot and lost his/her hearing in left ear and alot in his/her right.  The patient had to wear a hearing aid in right. The follow-up could not be possible as no contact details were available. Additional Supportive Information: Hearing aid was not coded as treatment due to limitation of ICDS dictionary.
Sex: U
Vaccine: VARZOS
Symptoms: Gait inability, Herpes zoster, Nerve injury, Vaccination failure, Walking aid user
Clinical narrative: Suspected vaccination failure/had the shots and got shingles; shingles anyway; need to use walker now; Right leg,  now have nerve damage; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2022, unknown after receiving Shingles vaccine, the patient experienced nerve damage. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and unable to walk. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the nerve damage and unable to walk were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage and unable to walk to be related to Shingles vaccine.     Additional Information: GSK receipt date: 7-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shots and got shingles anyway in right leg and now had nerve damage in that leg.  The patient need to use a walker now.  The patient stated that no fun.  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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: me too, but I still got shingles/Suspected vaccination failure; shingles/ Still got shingles; 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 (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: 1-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The reporter denied to follow-up. The patient stated he/she too, but still got shingles. 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. Suspect was coded as per narrative information.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blood glucose increased, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Glucose level, mostly high; Suspected vaccination failure/second dose MAR-2019, shingles in July 2021; shingles, 4 outbreaks; second dose MAR-2019, shingles in July 2021; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes (was diabetic since 2017 and on medication to control them).   In March 2019, the patient received the 2nd dose of Shingrix. In July 2018, the patient received the 1st dose of Shingrix. In March 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced glucose increased. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles, glucose increased and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and glucose increased to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 9-Oct-2022 and 11-Oct-2022 Reporter's comment: The patient was currently 68 years old. The patient had a pharma background and had detailed his/her medical history. The patient wanted to talk to clinician about Shingrix vaccination. The patient received both doses Shingrix vaccine and the approximately 8 to 9 months between doses. The patient contracted a mild case of shingles and apparently joined the 10 percent club as Shringrix was advertised as 90 percent effective.  The patient was treated with Valacyclovir. The patient reported that however over the next 14 months, he/she had 3 additional outbreaks of shingles for a total of 4. During the period of outbreak the patient's glucose level were all over the map mostly high. The patient really would like to talk to an expert on Shingrix to get their perspective from any clinical data that was available. The reporter consented to follow-up. Additional supportive information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2022AMR145825, reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2022AMR145825:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure/Got the vaccine last year, now I have shingles; Shingles/ Now i have shingles; It is miserable; It is painful; 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. In October 2022, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling miserable and pain. On an unknown date, the outcome of the vaccination failure, feeling miserable and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, feeling miserable and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccine last year, but now had shingles. The patient stated that it was miserable and painful. The patient wishes that the vaccine was 100 percent effective, but it's not. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. As the reporter was describing shingles as it was miserable and painful therefore onset date for both event was captured as October 2022 same as shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got the vaccine and had shingles/Suspected vaccination failure; Had shingles again; Such pain; 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.   The patient's past medical history included shingles.   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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccine and had the shingles again, such pain. The reporter denied to follow-up. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Was vaccinated and still got shingles; Still got shingles; 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 (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: 9-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was vaccinated and still got shingles. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got the shot, 6 months later got shingles; Got shingles; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months 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: 12-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot and six months later he/she got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure/Is the 3rd time (shingles) since I got the shingles vaccine; Is the 3rd time (shingles) since got the shingles vaccine; Worst pain ever; 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 (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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient never had shingles until he/she got the shingles vaccine worst pain ever this was the third time since he/she got the shingles vaccine. 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.