chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional AEs; inadvertently administered to a 19 year old female; inadvertently administered instead of the MMR II; This spontaneous report was received from a medical assistant referring to a 19 years old female patient. The patient's concomitant medication, pertinent medical history and drug reaction/allergies were not reported.  On 11-MAY-2021, the patient was inadvertently administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (strength and route were not reported, 0.5 ml injection, lot # T027114, expiration date 07-FEB-2022) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No additional adverse events and no further information were provided
Age: 11.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Cervical dysplasia, Loop electrosurgical excision procedure, Papilloma viral infection
Clinical narrative: High Risk HPV; cervical dysplasia; Interchange of Vaccine Products; GARDASIL-9 administrations: Dose 1: 30-JAN-2016; Dose 2: 29-DEC-2016; Dose 3: 03-JUL-2017; This spontaneous report was received from a physician (who was also the patient's parent) and refers to a 22-year-old female patient. No information regarding the patient's medical history, concurrent conditions was provided. She had penicillin allergy. Her concomitant medication included unspecified birth control.  On an unknown date in approximately 2005 (reported as 16 years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscularly (formulation, dose, anatomical location, lot # and expiration date were not reported) for prevention.  On 30-JAN-2016, 29-DEC-2016 and 03-JUL-2017, she was vaccinated with three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, once, vial, intramuscularly (anatomical location was not reported) for prevention. Lot numbers and expiration dates of this doses were: lot # L011846, expiration date reported as 17-JUN-2017, but upon internal validation process, it was established as 16-JUN-2017, lot # L011846, expiration date reported as 05-JUN-2019 and # L011846, expiration date reported as 29-JUL-2017, but upon internal validation process, it was established as 28-JUL-2017. It could not be determined which lot numbers were administered on what dates.  On an unknown date in January 2021 (reported as 4 months ago), the patient was diagnosed with high risk human papillomavirus (HPV) infection and moderate cervical dysplasia. She sought medical attention and had loop electrosurgical excision procedure (LEEP) performed as a treatment for the events. It was unknown if any laboratory diagnostics or studies were performed. At the reporting time, she did not recovered from the events.  The causality assessment between the events and the suspect vaccines was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse events; Expired dose administered; This spontaneous report was received from an other health professional and refers to a 34-year-old patient. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On 03-MAY-2021, the patient was vaccinated with expired hepatitis a vaccine, inactivated(VAQTA), 0.5 milliliter, non-valid lot # T01590 with expiration date 14-APR-2021, for prophylaxis. There was no previous temperature excursions. There was no additional adverse events reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE reported; The vaccine was administered 17 days after expiration; This report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On approximately 14-MAY-2021, also reported as 17 days after vaccine expiration, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot number R027946 with expiration date 27-APR-2021, 0.5 milliliter for prophylaxis (expired vaccine used).  No product quality complaint or adverse effects were reported.  At the reporting time, the patient's outcome was unknown. 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: R027946; expirationdate: 27-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additonal adverse event or product quality concern reported/ No addittional adverse events were experienced by the patient; an expired dose of VAQTA was admnistered on 24-MAY-2021; This spontaneous report was received from a register nurse via a company representative and refers to a 69 year old female patient.  The patient's pertinent medical history and drug reactions or allergies were unknown. There was no concomitant therapies.  The nurse reported that on 24-MAY-2021, one of the medical assistants vaccinated the patient with of an expired dose of hepatitis a vaccine, inactivated (VAQTA) second dose, lot # T014590 expiration date 15-APR-2021 for prophylaxis (dosage, route of administration and anatomical location were not reported). No additional adverse event were experienced by the patient. No prescription drug treatment was required. The patient did not required emergency room (ER) doctor visit. The vaccine has not had a temperature excursion (TE). The vaccine was evaluated and found to be supported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of PROQUAD was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 24-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S030210 with an expiration date on 25-MAR-2021) for prophylaxis.        Strength, dose, anatomical location, and route of administration were not reported. The suspect vaccine did not experience any prior temperature excursión.  No additional adverse events had been reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired vaccine used; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     On 24-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) (lot # S015428, expiration date 20-MAY-2021) for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No further information provided. No additional adverse events reported. No product quality complaints.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE/no additional information; PROQUAD that underwent a temperature excursion had been administered to the patient; This spontaneous report has been received from a healthcare business professional referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 25-MAY-2021, the patient was vaccinated with the improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) for prophylaxis (lot # T028298, expiration date 16-FEB-2022; strength, dose, and route were not reported), which underwent a temperature excursion at 6.96 Fahrenheit (F) for 15 min (product storage error). The temperature excursion was detected by a data logger. There was no previous temperature excursion. No additional adverse event or information was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA001672:
Age: 57.0
Sex: M
Vaccine: COVID19, HPV9
Symptoms: Inappropriate schedule of product administration, Oropharyngeal discomfort, Oropharyngeal pain, Product administered to patient of inappropriate age, SARS-CoV-2 test
Clinical narrative: his throat feels "uncomfortable; he developed a sore throat that same day; first dose of GARDASIL 9 on an unspecified date in March 2020, his second dose on an unspecified date in June 2020, and his third dose on 11/3/2020.; received the GARDASIL 9 vaccine at the age of 57; This spontaneous report as received from a 57-year-old male patient who reported on himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On an unknown date in March 2020, at the age of 57, 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) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) as Human papillomavirus (HPV) prevention (product administered to patient of inappropriate age). He received his second dose on an unspecified date in June 2020 and his third dose on 03-NOV-2020 (exact dose, route of administration, anatomical location, lot # and expiration date were not reported for any of the doses); both as HPV prevention (inappropriate schedule of product administration). The patient additionally received the COVID-19 vaccine (SARS-COV-2 VACCINE); the first dose was received on an unspecified date in December 2020 and the second dose on an unspecified date in January 2021 (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 22-MAY-2021, he engaged in intercourse with his girlfriend and he developed a sore throat that same day. The patient stated his throat felt "uncomfortable" and he wanted to receive a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unspecified date, he was tested for COVID-19 and the test results were negative. He wanted a "Merck Specialist" to call him back and tell him he can receive a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) GARDASIL 9. The outcome of the events was unknown.  The causality assessment between the events and the suspect vaccines was not provided.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE reported; expired dose of MMR II; This spontaneous report was received from the office manager referring to a 5-year-old patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported     On 26-MAY-2021 , the patient was vaccinated with a expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # S015427,expiry day 20-MAY-2021, 0.5 milliliter, intramuscular for prophylaxis; No other adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no other adverse events; temperature excursion; This spontaneous report was received from a physician referring to a 11 month old patient of unspecified gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.    On 20-MAY-2021, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature excursion that lasted 84 hours, at a temperature of 43.7 degrees Fahrenheit (product storage error); no previous temperature excursions had occurred. On 24-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot number T037957, expiration date 09-MAY-2022, 1 dosage form (dose/frequency reported as "1 time dose") as prophylaxis (strength, route of administration and anatomical location were not provided). Digital data logger was involved. No signs, symptoms or adverse events were reported.        The outcome of product storage error was unknown.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE reported.; the vaccine expired on 15-APR-2021 and was administered to a patient on 21-MAY-2021; the vaccine had a temperature excursion on 07-APR2021 and was administered to a patient on 21-MAY-2021; This spontaneous report was received from a consumer referring to themselves, a patient of unknown age and gender.  No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided.  On 21-MAY-2021, the patient was vaccinated with  hepatitis a vaccine, inactivated(VAQTA) lot # T014590, which has been verified to be a valid lot number, expiration date reported as 15-APR-2021 and upon internal validation established as the same (expired product administered) (dosage schedule, route and anatomical location were not reported) for prophylaxis. It was also reported that the vaccine had a temperature excursion on 07-APR-2021 (product storage error). There was no adverse effect reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no additional events; 1st dose of GARDASIL 9 series over one year and just returned for second dose; This spontaneous report as received from a pharmacist refers to a 24 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided.   In approximately 2020 (reported as about a year ago), the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series for prophylaxis. On 27-MAY-2021 the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (Inappropriate schedule of vaccine administered). No product quality complaint or additional adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product use in unapproved indication
Clinical narrative: No additional AE; Drug use for unapproved indication; This spontaneous report was received from an other reporter referring to a female patient of unknown age from an article found by the reporter's daughter who was a nurse. The patient's concomitant medication, pertinent medical history and drug allergies/reactions were unknown by reporter. The patient's concurrent conditions included check pain that occurred from the trigeminal neuralgia shocks.     In July 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, frequency, lot# and expiration date were not provided) for trigeminal neuralgia shocks (product use in unapproved indication). The patient's check pain that occurred from the trigeminal neuralgia shocks had resolved within a week and had no pains. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: A nurse reported PROQUAD was improperly stored and administered; This spontaneous report was received from a nurse referring to patient of an unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug allergies/reactions and concomitant medications were not provided.  On 01-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) (dosage regimen and route of administration were not provided), lot # T034823, expiration date 11-APR-2022, administered as prophylaxis.   On that day, the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature of -5.3 degree Celsius (C) for 1 hours and 42 minutes, with no previous temperature excursion. The call because a digital data logger.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; nurse with credentials L.V.N. administered a dose of GARDASIL 9 that expired 5/30/2021; This spontaneous report as received from a registered nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On 01-JUN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), dose reported as 1 dose, lot # R024259, expiration date: 30-MAY-2021 for prophylaxis (dose, and route of administration, were not reported) . It was reported that dose was properly stored.No additional adverse events reported. No product quality complaint.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no further AEs occurred from the concomitant administration; they gave PROQUAD and VARICELLA together to a patient; This spontaneous report was received from a medical assistant referring to a 1-year-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, one time, lot number T034613, expiraton date 10-APR-2021 (route of administration was not reported) for prophylaxis and varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, one time, lot number T031381, expiraton date 15-SEP-2022 (route of administration was not reported) for prophylaxis too (extra dose administered). Both vaccines were reconstitued with sterile diluent(STERILE DILUENT) 0.5 milliliters, lot number T020663 and U000171. No adverse event was reported.
Sex: F
Vaccine: PPV
Symptoms: Atypical pneumonia, Chest X-ray abnormal, Chest discomfort, Erythema, Oedema peripheral
Clinical narrative: pneumonia; arm swelled up; pocket fuid in her left arm; turned red; the injection, "the second" hurt a little more but not a big deal; This spontaneous report was received from a female patient via Pfizer (MFR# 2021616142) concerning   herself. Patient stated she was not a healthcare professional, but was a caregiver to some older people. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On an unspecified date, she was administered with the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot# and expiration date were not provided) for pneumonia prophylaxis and "ended up in the emergency room (ER) twice". the patient stated she states she had quite a reaction.   On an unspecified date approximately in 2018 (reported as "2 or 3 years ago") (conflictive information), she went to a health conference center and it was set up so people were 6 feet apart and masked. She talked to the "same doctor before" and the second time. They told her which station she would go to. She talked to the nurse, told her the reactions she had had in the past and the nurse asked her if she was allergic to any of the items, she had no idea as she had no idea what was in the vaccine so the nurse explained what they usually are in and asked again, this time she answered she was not allergic. After a while talking the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). She stated the injection, "the second" hurt a little more but not a big deal (vaccination site pain). A couple months later, she went to the doctor because her chest was tight, she worked all week. She had a chest x-ray, and the doctor said she had "waking" pneumonia.  She added that with the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) her arm swelled up (peripheral swelling) and she had a pocket of fluid in her left arm (oedema peripheral), it turned red (unspecified date). She went to the ER and they gave her unspecified medication. They sent her home and said if it gets worse, she had to come back. On "sunday morning", she got up and she did not believe it, it was worse than ever. She went back to the ER and said it was getting worse. She stated it was terrible. She stated she had it back right around 2017 or 2018 also, but she was not sure (conflictive information). She ended up telling the doctor she would never take that one again, never ever. The doctor said she would not have to.         At the time of the report, the outcome of pneumonia and vaccination site pain was unknown.  The causal relationship between the event and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon internal review, pneumonia was considered a medically significant event.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: pneumonia; arm swelled up; pocket fuid in her left arm; turned red; the injection, "the second" hurt a little more but not a big deal; This spontaneous report was received from a female patient via Pfizer (MFR# 2021616142) concerning   herself. Patient stated she was not a healthcare professional, but was a caregiver to some older people. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On an unspecified date, she was administered with the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot# and expiration date were not provided) for pneumonia prophylaxis and "ended up in the emergency room (ER) twice". the patient stated she states she had quite a reaction.   On an unspecified date approximately in 2018 (reported as "2 or 3 years ago") (conflictive information), she went to a health conference center and it was set up so people were 6 feet apart and masked. She talked to the "same doctor before" and the second time. They told her which station she would go to. She talked to the nurse, told her the reactions she had had in the past and the nurse asked her if she was allergic to any of the items, she had no idea as she had no idea what was in the vaccine so the nurse explained what they usually are in and asked again, this time she answered she was not allergic. After a while talking the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). She stated the injection, "the second" hurt a little more but not a big deal (vaccination site pain). A couple months later, she went to the doctor because her chest was tight, she worked all week. She had a chest x-ray, and the doctor said she had "waking" pneumonia.  She added that with the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) her arm swelled up (peripheral swelling) and she had a pocket of fluid in her left arm (oedema peripheral), it turned red (unspecified date). She went to the ER and they gave her unspecified medication. They sent her home and said if it gets worse, she had to come back. On "sunday morning", she got up and she did not believe it, it was worse than ever. She went back to the ER and said it was getting worse. She stated it was terrible. She stated she had it back right around 2017 or 2018 also, but she was not sure (conflictive information). She ended up telling the doctor she would never take that one again, never ever. The doctor said she would not have to.         At the time of the report, the outcome of pneumonia and vaccination site pain was unknown.  The causal relationship between the event and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon internal review, pneumonia was considered a medically significant event.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE/ PQC reported at this time; Caller reported VAQTA (lot T033304 exp 4/2/2022) and ROTATEQ (lot 1741376 exp 3/6/2022) were administered to patients.; This spontaneous report was received from a healthcare professional, referring to a 4-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported.  On 18-MAY-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number 1741376, expiration date 06-MAR-2022) as prophylaxis (product storage error). No adverse effect (AE)/product quality complaint (PQC) reported at this time.  The vaccine experienced a temperature excursion between 36 degrees Fahrenheit (F) to 46F (48.2F) for 0 hours, 15 minutes and 0 seconds. There was a previous temperature excursion between 36F to 46F (46.2F) for 0 hours, 15 minutes and 0 seconds, as recorded by a data logger.
Age: 1.92
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE/ PQC reported at this time.; VAQTA were administered with an imporperly temperature excursion; This spontaneous report was received from a health care professional referring to a 23 month old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-MAY-2021, the patient was vaccinated with an improperly stored temperature excursion dose of  hepatitis a vaccine, inactivated(VAQTA) prefilled syringe, lot #: T033304 , expiration date:02-APR-2022 (dose, and route of administration, were not reported)., for prophylaxis . The administered dose of the vaccine experienced a temperature excursion 36 to 47 degrees Fahrenheit  for 15 minutes, as recorded by a data logger. There was no adverse effect reported.No product quality complaint was involved.   This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T033304; expirationdate: 02-APR-2022; 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: M
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No PQC or additional AEs reported; 31 year old male patient received GARD ASIL 9 on following dates. # 5/27/2020 #2 7/17/2020 #3 10/6/2020. Dosing schedule not followed as in PI; This spontaneous report was received from an unspecified reporter referring to a 31-year-old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 27-MAY-2020, 17-JUL-2020 and 06-OCT-2020, the patient was vaccinated with three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration). One dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was reported as 0.5 ml, lot # 1659422, expiration date 04-SEP-2022.  No adverse event was 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: 1659422; expirationdate: 04-SEP-2022; 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: U
Vaccine: HEPA, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Incorrect product storage; This spontaneous report was received from a health care professional referring  to a 8-week-old patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.      On 11-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1741376, expiry date 06-MAR-2022 for prophylaxis (strength, dose, and frequency were not provided).  Other vaccines improperly stored were hepatitis a vaccine, inactivated (VAQTA)lot number 1741376, expiry date 06-MAR-2022, and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, strength, route of administration, lot number, indication and expiry date were not reported)      rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a temperature frame between 36 and 46 Fahrenheit degrees for 15 minutes, recorded y a digital data logger  (product storage error).  No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose 12 years ago; This spontaneous report as received from a physician refers to a 30 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided.   In approximately 2009 (reported as 12 years ago), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis. She did not complete the series (Inappropriate schedule of vaccine administered).
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Nerve injury, Physical disability
Clinical narrative: nerve damage; shingles; Information has been received from a lawyer and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. In or around June 2016, patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered shingles and nerve damage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, 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 company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Age: 1.75
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; the patient was administered an improperly stored VAQTA vaccine / temperature: 32.1 degree Fahrenheit; This spontaneous report was received from a certified medical assistant and refers to a 21 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 01-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # T023914, expiration date 31-MAR-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 32.1 degree Fahrenheit (F) for 4 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No adverse event (AE) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023914; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Interrupted vaccine schedule / The patient received her first dose of GARDASIL 9 on 20-FEB-2017 at the age of 17 years old and did not receive the second or third dose; No additional AE reported; This spontaneous report was received from a registered pharmacist and refers to a female patient, who was 21 years old at the time of the report. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On 20-FEB-2017, when she was 17 years old, the patient was vaccinated with her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. At the reporting time, she did not receive the second or third dose of the vaccine yet and the pharmacist was requesting information regarding interrupted vaccine schedules for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No adverse event (AE) was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Choking, Decreased appetite
Clinical narrative: Choking; Loss of consciousness; Ageusia; Anosmia; Decreased appetite; Drooling; Feeling abnormal; Fatigue; Pyrexia; Chills; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CHOKING (Choking) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 68-year-old male 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 High cholesterol. Concurrent medical conditions included Prostate cancer (Hormone shot taken 02-APR-2021 for prostate cancer) and Blood pressure high. Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CHOKING (Choking) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), AGEUSIA (Ageusia), ANOSMIA (Anosmia), DECREASED APPETITE (Decreased appetite), DROOLING (Drooling), FEELING ABNORMAL (Feeling abnormal), FATIGUE (Fatigue), PYREXIA (Pyrexia) and CHILLS (Chills). At the time of the report, CHOKING (Choking), LOSS OF CONSCIOUSNESS (Loss of consciousness), AGEUSIA (Ageusia), ANOSMIA (Anosmia), DECREASED APPETITE (Decreased appetite), DROOLING (Drooling), FEELING ABNORMAL (Feeling abnormal), FATIGUE (Fatigue), PYREXIA (Pyrexia) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Drooling, Fatigue, Feeling abnormal, Loss of consciousness, Pyrexia
Clinical narrative: Choking; Loss of consciousness; Ageusia; Anosmia; Decreased appetite; Drooling; Feeling abnormal; Fatigue; Pyrexia; Chills; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CHOKING (Choking) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 68-year-old male 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 High cholesterol. Concurrent medical conditions included Prostate cancer (Hormone shot taken 02-APR-2021 for prostate cancer) and Blood pressure high. Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CHOKING (Choking) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), AGEUSIA (Ageusia), ANOSMIA (Anosmia), DECREASED APPETITE (Decreased appetite), DROOLING (Drooling), FEELING ABNORMAL (Feeling abnormal), FATIGUE (Fatigue), PYREXIA (Pyrexia) and CHILLS (Chills). At the time of the report, CHOKING (Choking), LOSS OF CONSCIOUSNESS (Loss of consciousness), AGEUSIA (Ageusia), ANOSMIA (Anosmia), DECREASED APPETITE (Decreased appetite), DROOLING (Drooling), FEELING ABNORMAL (Feeling abnormal), FATIGUE (Fatigue), PYREXIA (Pyrexia) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Syncope; Unresponsive to stimuli; Asthenia; Confusional state; Diarrhoea; Dizziness; Hyperventilation; Hypotension; Injection site bruising; Lethargy; Headache; Pyrexia; Fatigue; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criterion medically significant), ASTHENIA (Asthenia), CONFUSIONAL STATE (Confusional state), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), HYPERVENTILATION (Hyperventilation), HYPOTENSION (Hypotension), INJECTION SITE BRUISING (Injection site bruising), LETHARGY (Lethargy), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue). At the time of the report, SYNCOPE (Syncope), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli), ASTHENIA (Asthenia), CONFUSIONAL STATE (Confusional state), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), HYPERVENTILATION (Hyperventilation), HYPOTENSION (Hypotension), INJECTION SITE BRUISING (Injection site bruising), LETHARGY (Lethargy), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient received vaccination at 10:45am and by 10:50am patient informed others she felt light headed. Nurse rushed to the patient with the Epi pen.  They observed patient head tilted backward and unresponsive. The patient started to response and become confused. Nurse didn't administer the Epi Pen.  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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperventilation, Hypotension, Injection site bruising, Lethargy
Clinical narrative: Syncope; Unresponsive to stimuli; Asthenia; Confusional state; Diarrhoea; Dizziness; Hyperventilation; Hypotension; Injection site bruising; Lethargy; Headache; Pyrexia; Fatigue; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criterion medically significant), ASTHENIA (Asthenia), CONFUSIONAL STATE (Confusional state), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), HYPERVENTILATION (Hyperventilation), HYPOTENSION (Hypotension), INJECTION SITE BRUISING (Injection site bruising), LETHARGY (Lethargy), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue). At the time of the report, SYNCOPE (Syncope), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli), ASTHENIA (Asthenia), CONFUSIONAL STATE (Confusional state), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), HYPERVENTILATION (Hyperventilation), HYPOTENSION (Hypotension), INJECTION SITE BRUISING (Injection site bruising), LETHARGY (Lethargy), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient received vaccination at 10:45am and by 10:50am patient informed others she felt light headed. Nurse rushed to the patient with the Epi pen.  They observed patient head tilted backward and unresponsive. The patient started to response and become confused. Nurse didn't administer the Epi Pen.  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.