chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting/ just threw up; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting/ just threw up) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced VOMITING (Vomiting/ just threw up). At the time of the report, VOMITING (Vomiting/ just threw up) outcome was unknown.            Relevant concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: non significant follow up appended
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Cough, Head discomfort, Lacrimation increased
Clinical narrative: head pressure; feet hands prick pins; itching; Tight cough; Feverish; Pain chest; ringing ears; weakness; Eyes watering; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain chest), TINNITUS (ringing ears), ASTHENIA (weakness), LACRIMATION INCREASED (Eyes watering) and HEAD DISCOMFORT (head pressure) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rash and Chest pain.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced CHEST PAIN (Pain chest), TINNITUS (ringing ears), ASTHENIA (weakness), LACRIMATION INCREASED (Eyes watering), PAIN (feet hands prick pins), PRURITUS (itching), COUGH (Tight cough) and PYREXIA (Feverish). On an unknown date, the patient experienced HEAD DISCOMFORT (head pressure). On 03-Sep-2021, CHEST PAIN (Pain chest), TINNITUS (ringing ears), ASTHENIA (weakness), LACRIMATION INCREASED (Eyes watering), PAIN (feet hands prick pins), PRURITUS (itching), COUGH (Tight cough) and PYREXIA (Feverish) had resolved. At the time of the report, HEAD DISCOMFORT (head pressure) had resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Patient's medical history included Nerves. The patient had ear dizzy.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia, Tinnitus
Clinical narrative: head pressure; feet hands prick pins; itching; Tight cough; Feverish; Pain chest; ringing ears; weakness; Eyes watering; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain chest), TINNITUS (ringing ears), ASTHENIA (weakness), LACRIMATION INCREASED (Eyes watering) and HEAD DISCOMFORT (head pressure) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rash and Chest pain.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced CHEST PAIN (Pain chest), TINNITUS (ringing ears), ASTHENIA (weakness), LACRIMATION INCREASED (Eyes watering), PAIN (feet hands prick pins), PRURITUS (itching), COUGH (Tight cough) and PYREXIA (Feverish). On an unknown date, the patient experienced HEAD DISCOMFORT (head pressure). On 03-Sep-2021, CHEST PAIN (Pain chest), TINNITUS (ringing ears), ASTHENIA (weakness), LACRIMATION INCREASED (Eyes watering), PAIN (feet hands prick pins), PRURITUS (itching), COUGH (Tight cough) and PYREXIA (Feverish) had resolved. At the time of the report, HEAD DISCOMFORT (head pressure) had resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Patient's medical history included Nerves. The patient had ear dizzy.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: ARDASIL 9 that experienced a temperature excursion was administered to a patient; No additional AE reported; This spontaneous report was received from a Medical Assistant, referring a patient of an unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 04-AUG-2021, the patient was vaccinated with an improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T029522 with expiration date on 13-APR-2022 (but upon internal validation established as 13-APR-2023), 0.5 milliliter dose (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis.    The vaccine administered was stored at temperature -4.8C for a time frame of 20 minutes. There was no previous temperature excursion. No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T029522; expirationdate: 13-MAR-2023; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: PPV
Symptoms: Muscle disorder
Clinical narrative: muscular issue / pneumonia vaccine, which gave her similar muscular issues; This spontaneous report as received from a currently 67-year-old female patient referring to herself via Pfizer. The patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.       On an unspecified date in the past, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route, anatomical location, lot # and expiration date were not provided).         On an unknown date, the patient experienced a muscular issue (muscle disorder) gave to her by pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). By the time of report, the outcome of muscle issue was unknown.     The reporter considered muscle issue to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: no adverse event; MMR II was improperly stored and administered; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug reactions/allergies were not reported.  Since 08-JUN-2021, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) was stored at 55 Fahrenheit (product storage error). The vaccine had no other previous temperature excursion. On 06-JUL-2021, the patient was vaccinated with this improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) for prophylaxis (strength, dose, and route of administration were not reported; lot number S037497 was verified to be valid lot number, expiration date was 20-NOV-2021). No additional adverse event was reported. The vaccine was stored at 55 Fahrenheit until 03-AUG-2021.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No further information.; had a dose of MMR and 1stof VARIVAX on 20Jul2016; This spontaneous report was received from an other, referring to a 12-month-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 20-JUL-2016, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status of rHA (recombinant Human albumin), 0.5 ml 1 time, strength, vaccination scheme, route of administration, anatomical site of vaccination were not provided, lot # L041456) and first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (0.5 ml 1 time, strength, vaccination scheme, route of administration, anatomical site of vaccination were not provided, lot # M006726, expiration date was not reported, but upon internal validation established as 08-FEB-2018) for prophylaxis (inappropriate schedule of product administration). On 07-JUL-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) albumin status of rHA (recombinant Human albumin), 0.5 ml 1 time, strength, vaccination scheme, route of administration, anatomical site of vaccination were not provided, lot # S013713, expiration date 01-NOV-2020) for prophylaxis. On 09-JUN-2021, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (0.5 ml 1 time, strength, vaccination scheme, route of administration, anatomical site of vaccination were not provided, lot # T025945, expiration date 20-JUL-2022) for prophylaxis. No other adverse event as a result of the vaccine administrations.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Medical Assistant was administered expired VARIVAX on 08/16/2021; This spontaneous report was received from a physician referring to a patient of unknown age and gender.  The patient concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported.  On 16-AUG-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration were not provided) (Lot # S024369, expiration date: 08-JUN-2021) for prophylaxis. It was reported that no temperature excursion for the expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) was confirmed by nurse at that time. No additional adverse event was reported. At the time of the report, the outcome of the event was not reported.  The causal relationship between the event and the expired suspect vaccine was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details provided; Improperly stored administered VARIVAX; Temperature/Time frame: (9.6 C) FOR 80 MINS; This spontaneous report as received from a nurse 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 varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: S032356, expiration date: 14-OCT-2021; dose and route of administration not provided). The vaccine was stored in temperature 9.6 degrees Celsius for 80 minutes. There was no previous temperature excursion.  No adverse event was reported.  This is one of the eleven reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA005918: US-009507513-2108USA005926: US-009507513-2108USA005939: US-009507513-2108USA006006: US-009507513-2108USA006030: US-009507513-2108USA006059: US-009507513-2108USA006112: US-009507513-2108USA006125: US-009507513-2108USA006146: US-009507513-2108USA006155:
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; patient was administered the first dose of ROTATEQ on 04-AUG-2021 and received the second dose today, 20-AUG-2021; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  The patient was administered the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number, expiration date and route of administration not provided) 2 mL on 04-AUG-2021 and received the second dose on 20-AUG-2021 (inappropriate schedule of vaccine administered). No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AE reported; M-M-R II administered after a temperature excursion; Temperature 9C; 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 19-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live 9 (rHA) (M-M-R II) (lot number: T003384, expiration date: 28-JAN-2022; dose and route of administration not provided). The vaccine was stored in temperature 9 degrees Celsius for 5 minutes. There was no previous temperature excursion.  No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No further information is available; A nurse is reporting that a patient received an expired PNEUMOV AX; This spontaneous report has been received from licensed practical nurse (LPN), concerning a patient of unknown age and gender. No information was provided regarding the patients' pertinent medical history, current conditions, concomitant medications and previous drug reactions or allergies.  On 23-AUG-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial, at a dose of 0.5 milliliter (ml) once administered intramuscularly (lot number S033790 has been verified to be valid, expiration date reported and validated as 02-AUG-2021) (anatomical location of administration were not reported) as prophylaxis. No further information was available (no adverse event).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This literature marketed report has been received from authors of a published article, titled as above, referring to a female patient of unknown age (age between 21-38 years). The patient's histologic diagnosis showed cervical intraepithelial neoplasm (CIN) 3 and human papillomavirus (HPV) genotype detected was type 16. Concomitant medication was unknown.  On an unknown date (reported as at 14 years old), the patient was vaccinated with the first quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. The patient only received 2 doses of vaccine (incomplete course of vaccination)  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from same literature.; Sender's Comments:  US-009507513-2109USA002363:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; lots that underwent temperature excursions were admnistered; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 03-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (lot # T016990, which was verified to be a valid lot number, expiration date reported as 11-NOV-2021), for prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion of 14 degrees Fahrenheit to 46 degrees Fahrenheit (24.8 degrees Fahrenheit) during a time frame of 30 minutes.   There were a previous temperature excursions n an unknown date: 6 to 14 degrees Fahrenheit (5.9 degrees Fahrenheit) during a time frame of 8 minutes, 6 to 14 degrees Fahrenheit (6.8 degrees Fahrenheit) during a time frame of 18 minutes and 6 to 14 degrees Fahrenheit (8.4 degrees Fahrenheit) during a time frame of 17 minutes.  No additional adverse events were reported.  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001125:AM US-009507513-2108USA001040:AL
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; lots that underwent temperature excursions were admnistered; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 03-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (lot # T016990, which was verified to be a valid lot number, expiration date reported as 11-NOV-2021), for prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion of 14 degrees Fahrenheit to 46 degrees Fahrenheit (24.8 degrees Fahrenheit) during a time frame of 30 minutes.   There were a previous temperature excursions n an unknown date: 6 to 14 degrees Fahrenheit (5.9 degrees Fahrenheit) during a time frame of 8 minutes, 6 to 14 degrees Fahrenheit (6.8 degrees Fahrenheit) during a time frame of 18 minutes and 6 to 14 degrees Fahrenheit (8.4 degrees Fahrenheit) during a time frame of 17 minutes.  No additional adverse events were reported.  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001125:AM US-009507513-2108USA001040:AL
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; lots that underwent temperature excursions were admnistered; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 17-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (lot # T016990, which was verified to be a valid lot number, expiration date reported as 11-NOV-2021), for prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion of 14 degrees Fahrenheit to 46 degrees Fahrenheit (24.8 degrees Fahrenheit) for a time frame of 30 minutes.   There were a previous temperature excursions n an unknown date: 6 to 14 degrees Fahrenheit (5.9 degrees Fahrenheit) during a time frame of 8 minutes, 6 to 14 degrees Fahrenheit (6.8 degrees Fahrenheit) during a time frame of 18 minutes and 6 to 14 degrees Fahrenheit (8.4 degrees Fahrenheit) during a time frame of 17 minutes.  No additional adverse events were reported.  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001125:AM US-009507513-2108USA001040:AL
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; lots that underwent temperature excursions were admnistered; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 19-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (lot # T016990, which was verified to be a valid lot number, expiration date reported as 11-NOV-2021), for prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion of 14 degrees Fahrenheit to 46 degrees Fahrenheit (24.8 degrees Fahrenheit) during a time frame of 30 minutes.   There were a previous temperature excursions n an unknown date: 6 to 14 degrees Fahrenheit (5.9 degrees Fahrenheit) during a time frame of 8 minutes, 6 to 14 degrees Fahrenheit (6.8 degrees Fahrenheit) during a time frame of 18 minutes and 6 to 14 degrees Fahrenheit (8.4 degrees Fahrenheit) during a time frame of 17 minutes.  No additional adverse events were reported.  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001125:AM US-009507513-2108USA001040:AL
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; administered following temperature excursion; This spontaneous report was received from an office manager and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On 23-AUG-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), rHA, lot # U009260 (lot # was determined as valid), expiration date was provided and also validated as 19-SEP-2022 (dose, strength, route of administration and anatomical location were not provided) for prophylaxis (improper storage of product in use). It was stated, that the vaccine before administration was stored at the temperature of -10.7 Celsius degree (C) for 192 hours. It was not provided, if data logger was involved. No additional adverse event (AE) reported (no adverse event). The reporter provided permission to follow-up regarding the report.  This is one of the two linked reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA007542:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered on 08/23/2021 following a temperature excursion; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.    On 23-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: U009260, expiration date: 19-SEP-2022; dose and route of administration not provided). The vaccine was stored in temperature -10.7 degrees Celsius for 192 hours 0 minutes and 0 seconds. There was no previous temperature excursion. No adverse event was reported.     This is one of the four cases from the same reporter.; Sender's Comments:  US-009507513-2108USA007463: US-009507513-2108USA007542: US-009507513-2109USA002267:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE's; Pneumovax was administered past its expiration date; This spontaneous report has been received from a clinic supervisor, concerning a patient of unknown age and gender. No information was provided regarding the patients' pertinent medical history, current conditions, concomitant medications and previous drug reactions or allergies.  On 26-AUG-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial (lot number T007383 has been verified to be valid, expiration date reported and validated as 23-AUG-2021) (dose, vaccination scheme, route and anatomical location of administration were not reported) as prophylaxis. No additional adverse events details (no adverse event).
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; an expired PEDVAX HIB dose was administered to one patient on today; This spontaneous report was received from a medical assistant referring to a patient of unknown age or gender.   No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, or drug reactions/allergies was provided.  On 30-AUG-2021, the patient was vaccinated with an expired dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number UJ351AAB is an invalid lot number for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB), and it does not match any Company product as confirmed by Lot Validation team) as 1 time dose for prophylaxis (administered dose, vaccination scheme, route of administration and anatomical location of vaccination were not reported; expiration date was reported as 09-AUG-2021) (expired product administered).  The reporter confirmed that Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) did not experience any temperature excursions. No additional adverse events (AEs) were reported.
Age: 46.0
Sex: F
Vaccine: HPV9
Symptoms: Anogenital warts, Product administered to patient of inappropriate age
Clinical narrative: now has something that looks like a genital wart /the possibility of getting human papillomavirus (HPV); she received the vaccine series after the age of 45; This spontaneous report as received from a consumer refers to a female patient, of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On an unknown date, the patient was vaccinated 3 months after turning 46 year old  with the vaccine series of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (doses, route of administration, lot number and expiration date were not reported). The patient called inquiring about the possibility of getting human papillomavirus (HPV) after taking the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  On an unknown date, she had something that looked like a genital wart that it had recently appeared.It was reported that the patient had not been diagnosed with genital wart at this time as she had not seen her physician yet for this. No treatment was given for the adverse event. She received the vaccine series after the age of 45-year-old and possible development of HPV after getting the vaccine.  The outcome of anogenital warts was reported as not recovered. Causality of the event of human papillomavirus (HPV) and genital wart was not reported,
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. The patient was vaccinated with zoster vaccine live (ZOSTAVAX) (vaccination date, strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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 of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event herpes zoster to be disability.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Scar
Clinical narrative: multiple outbreaks of herpes zoster; scarring; Information has been received from a lawyer referring to a male patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered multiple outbreaks of herpes zoster, resulting in scarring. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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 of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events multiple outbreaks of herpes zoster and scarring were considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events multiple outbreaks of herpes zoster and scarring to be disability.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Encephalitis, Herpes zoster
Clinical narrative: encephalitis; shingles; death; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 02-SEP-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around September 2012, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles and encephalitis. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 23-SEP-2018. As direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of patients conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of encephalitis and shingles was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of encephalitis was considered to be medically significant.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: all of its sequelae; shingles; Information was received from a lawyer regarding a case in litigation concerning a 88-year-old female patient (Conflicting information: Also reported that the patient was 79-years-old when she received the zoster vaccine live (ZOSTAVAX) vaccine).  No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. In January 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), administered at a Family Clinic (indication, strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). In February 2016, result of her receipt of zoster vaccine live (ZOSTAVA), the patient suffer shingles, including any and all of its sequelae (Ill-defined disorder). As a result of her receipt of vaccine live (ZOSTAVA), the patient, has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of events was not provided. Causality was related.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Accidental overdose, Dizziness, Extra dose administered, Fatigue, Headache
Clinical narrative: tingling and numbness in left arm and hand; tingling and numbness in left arm and hand; nausea; light headedness/dizziness; headaches; the patient was tired(experienced fatigue).; vomiting; she gave the patient another dose. This dose was the fourth dose of GARDASIL 9 that the patient had received; overdose; This spontaneous report was received from a consumer (the patient's mother) referring to her son, a 23-years-old male patient. His medical history and concurrent conditions were not reported. Drug reactions/allergies included insect stings. Concomitant therapies included influenza vaccine (FLU SHOTS).  On 05-JUN-2013, the patient was vaccinated with the first dose of human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 virus-like protein (vlp) vaccine (yeast) (GARDASIL 9) injection in the right arm (exact dose, route of administration, lot # and expiration date were not provided) as prevention of Human papillomavirus (HPV). On 09-SEP-2013 and 25-JAN-2014, the patient received the second and third dose of human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 virus-like protein (vlp) vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, vaccination site, lot # and expiration date were not provided) as prevention of HPV. The three doses were administered by the patient's Pediatrician.  On 03-SEP-2021, the patient went to see a doctor who treated adult patients for the first time. The new doctor misread the patient's medical history and thought that the patient had never received human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 virus-like protein (vlp) vaccine (yeast) (GARDASIL 9) before, so she gave the patient another dose (that was the fourth dose) (extra dose administered and accidental overdose), no exact dose, route of administration, vaccination site, lot # and expiration date were reported. On the same date, roughly four hours after the shot, due to the overdose, the patient began having adverse reactions that included nausea, light headedness and dizziness, vomiting, headaches, tingling and numbness in left arm and hand, and the patient was tired (experienced fatigue). No treatment for the events was given. At the time of the report, the patient was being checked into the emergency room, so he had not yet been admitted to the hospital or had any lab/diagnostics/studies performed. The Company is unable to retrieve the product because the vaccine was administered at a doctor's office and then thrown away. The outcome of the events was not recovered. No product quality complaint reported.  The causality assessment between human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 virus-like protein (vlp) vaccine (yeast) (GARDASIL 9) and nausea, light headedness and dizziness, vomiting, headaches, tingling and numbness in left arm and hand, and fatigue was related.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, Nausea, Paraesthesia, Vomiting
Clinical narrative: tingling and numbness in left arm and hand; tingling and numbness in left arm and hand; nausea; light headedness/dizziness; headaches; the patient was tired(experienced fatigue).; vomiting; she gave the patient another dose. This dose was the fourth dose of GARDASIL 9 that the patient had received; overdose; This spontaneous report was received from a consumer (the patient's mother) referring to her son, a 23-years-old male patient. His medical history and concurrent conditions were not reported. Drug reactions/allergies included insect stings. Concomitant therapies included influenza vaccine (FLU SHOTS).  On 05-JUN-2013, the patient was vaccinated with the first dose of human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 virus-like protein (vlp) vaccine (yeast) (GARDASIL 9) injection in the right arm (exact dose, route of administration, lot # and expiration date were not provided) as prevention of Human papillomavirus (HPV). On 09-SEP-2013 and 25-JAN-2014, the patient received the second and third dose of human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 virus-like protein (vlp) vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, vaccination site, lot # and expiration date were not provided) as prevention of HPV. The three doses were administered by the patient's Pediatrician.  On 03-SEP-2021, the patient went to see a doctor who treated adult patients for the first time. The new doctor misread the patient's medical history and thought that the patient had never received human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 virus-like protein (vlp) vaccine (yeast) (GARDASIL 9) before, so she gave the patient another dose (that was the fourth dose) (extra dose administered and accidental overdose), no exact dose, route of administration, vaccination site, lot # and expiration date were reported. On the same date, roughly four hours after the shot, due to the overdose, the patient began having adverse reactions that included nausea, light headedness and dizziness, vomiting, headaches, tingling and numbness in left arm and hand, and the patient was tired (experienced fatigue). No treatment for the events was given. At the time of the report, the patient was being checked into the emergency room, so he had not yet been admitted to the hospital or had any lab/diagnostics/studies performed. The Company is unable to retrieve the product because the vaccine was administered at a doctor's office and then thrown away. The outcome of the events was not recovered. No product quality complaint reported.  The causality assessment between human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 virus-like protein (vlp) vaccine (yeast) (GARDASIL 9) and nausea, light headedness and dizziness, vomiting, headaches, tingling and numbness in left arm and hand, and fatigue was related.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Vaccination site nodule
Clinical narrative: The site was tender; She developed a nodule at the vaccination site. The nodule continually got "bigger and worse"; This spontaneous report was received from a medical assistant, via company representative, referring to a 42-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions, or allergies were unknown by the reporter.  On 25-MAY-2021, the patient received her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in the left arm (administered dose, vaccination scheme, route of administration, lot number and expiration date were unknown by the reporter) as prophylaxis (reported as "vaccination"). Subsequently, on an unknown date in 2021, the patient developed a nodule at the vaccination site. The nodule continually got "bigger and worse". On 29-JUN-2021, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in her right arm (administered dose, vaccination scheme, route of administration, lot number and expiration date were unknown by the reporter) as prophylaxis. There wasn't a reaction to that injection site.   On 24-AUG-2021, the patient went to the physician's office, and the site was tender (vaccination site pain). The doctor prescribed sulfamethoxazole, trimethoprim (BACTRIM) as treatment. The outcome of the events was not reported.  The reporter did not provide a causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), vaccination site nodule and vaccination site pain.
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Abdominal pain upper, Acute hepatitis B, Alanine aminotransferase increased, Alpha-1 anti-trypsin normal
Clinical narrative: ACUTE HEPATITIS B; Therapy non-responder; Anti-HBs antibody negative;   Information has been received from the authors of a published literature article, regarding to a 32 year old male patient.   The patient's concurrent conditions was not reported. The patient's medical history included depression. Family history was notable for hemochromatosis in his father. He denied having unprofessional tattoos, IV drug use, heavy alcohol use, recent acetaminophen use, ingestion of non-commercial mushrooms or herbal supplements, but reported unprotected sexual intercourse with male partners.     On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), for prophylaxis (dose, route of administration, lot# and expiration date were not provided).         On an unknown date, the patient experienced hepatitis b, requiring hospitalization. On an unknown date, he was transferred to our hospital, for escalation of care, after presenting with 4-day history of nausea, vomiting, jaundice, body aches, abdominal pain, and worsening lethargy. Upon arrival, his lethargy resolved, but >jaundice and RUQ abdominal pain persisted. Initial labs showed elevated aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) of 3075/4895 IU, respectively; bilirubin of 16.3 mg/dL, INR greater than 2 and ferritin levels 17,000 ng/ml. Ceruloplasmin levels and alpha-1 antitrypsin clearance were within normal limits. Blood toxicology ruled out acetaminophen, alcohol, and salicylate toxicity. Evaluation for Hereditary Hemochromatosis showed a heterozygous H63D-mutation of HFE. However, Viral Hepatitis panel was positive for HBsAg, anti-HBc IgM, HBeAg, and negative for anti-HBs and a Viral Hep B DNA of 579000 copies. Hepatitis D Antigen and CMV evaluations were inconclusive. He improved over a few days with supportive care and n-acetylcysteine, until his transaminase levels dropped below 1000 (units not provided). No tenofovir or entecavir were required. He was then discharged with outpatient follow up. The outcome of acute hepatitis b was resolving. The outcome of therapy non-responder and hepatitis b surface antibody negative was unknown.     The reporter considered therapy non-responder, hepatitis b surface antibody negative and acute hepatitis b to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).     Upon internal review, Hepatitis b was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HEP
Symptoms: Aspartate aminotransferase increased, Blood bilirubin increased, Ceruloplasmin normal, Cytomegalovirus test, Gene mutation identification test positive
Clinical narrative: ACUTE HEPATITIS B; Therapy non-responder; Anti-HBs antibody negative;   Information has been received from the authors of a published literature article, regarding to a 32 year old male patient.   The patient's concurrent conditions was not reported. The patient's medical history included depression. Family history was notable for hemochromatosis in his father. He denied having unprofessional tattoos, IV drug use, heavy alcohol use, recent acetaminophen use, ingestion of non-commercial mushrooms or herbal supplements, but reported unprotected sexual intercourse with male partners.     On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), for prophylaxis (dose, route of administration, lot# and expiration date were not provided).         On an unknown date, the patient experienced hepatitis b, requiring hospitalization. On an unknown date, he was transferred to our hospital, for escalation of care, after presenting with 4-day history of nausea, vomiting, jaundice, body aches, abdominal pain, and worsening lethargy. Upon arrival, his lethargy resolved, but >jaundice and RUQ abdominal pain persisted. Initial labs showed elevated aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) of 3075/4895 IU, respectively; bilirubin of 16.3 mg/dL, INR greater than 2 and ferritin levels 17,000 ng/ml. Ceruloplasmin levels and alpha-1 antitrypsin clearance were within normal limits. Blood toxicology ruled out acetaminophen, alcohol, and salicylate toxicity. Evaluation for Hereditary Hemochromatosis showed a heterozygous H63D-mutation of HFE. However, Viral Hepatitis panel was positive for HBsAg, anti-HBc IgM, HBeAg, and negative for anti-HBs and a Viral Hep B DNA of 579000 copies. Hepatitis D Antigen and CMV evaluations were inconclusive. He improved over a few days with supportive care and n-acetylcysteine, until his transaminase levels dropped below 1000 (units not provided). No tenofovir or entecavir were required. He was then discharged with outpatient follow up. The outcome of acute hepatitis b was resolving. The outcome of therapy non-responder and hepatitis b surface antibody negative was unknown.     The reporter considered therapy non-responder, hepatitis b surface antibody negative and acute hepatitis b to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).     Upon internal review, Hepatitis b was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.