chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Pharmacist called to report that a patient received an expired VARIVAX on 6/8/2022.; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history or drug reactions/allergies was not provided.  On 08-JUN-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # T010308, expiration date 24-MAR-2022, serial Number 102648664469 (dose, strength, route of administration, and anatomical location were not provided) administered for prophylaxis (expired product administered). No additional adverse events were reported. No further information provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: No additional AE details provided.; Medical assistant calling reported he inadvertently administered PROQUAD and VARIVAX concomitantly to a patient.; This spontaneous report has been received from a medical assistant concerning to a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. The medical history, drug reactions or allergies and concurrent conditions were not reported.  On 14-JUN-2022, the patient was administered inadvertently a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # W004030, expiration date 02-AUG-2023 (dose, route of administration and anatomical location were not provided) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039949, expiration date 16-DEC-2023 (dose, route of administration and anatomical location were not provided) (accidental overdose). No additional events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reports vaccine was administered after experiencing temperature excursion/ Names of vaccines involved (including lot/exp) VARIVAX  Lot: U02505 / Exp date: 8/13/2022/ Temperature -11.6C/T ime frame  0 hour 30 minutes; No additional AE details; This spontaneous report has been received from an unspecified reporter referring to a patient (gender not provided) who was 1-year-old at the time of reporting.   The patient's concomitant medications included sterile diluent. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not provided.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) administered for prophylaxis, that underwent a temperature excursion of -11.6 Celsius grades in 30 minutes (product storage error); lot number U02505 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX); expiration date on 13-AUG-2023 (strength, dose, frequency, and route of administration were not reported). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: To report AE for improperly stored vaccines. / Temperature: 6°F up to 14°F (-14°C up to-10°C) -11.6 Time frame: 30 minutes; No additional AE information; This spontaneous report was received from other non-professional referring to a patient whom age, gender, race, and age group were not provided.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #U022727 with expiration date: 16-JAN-2023, administered for prophylaxis (strength, anatomical location, dose, frequency and route of administration were not provided). On an unknown date, was reported AE for improperly stored vaccines. / temperature: 6°F up to 14°F (-14°C up to-10°C) -11.6 time frame: 30 minutes (Product storage error). No additional AE information. (No adverse event)
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reports vaccine was administered after experiencing temperature excursion. Temperature -11.6C . Time frame  0 hour 30 minutes; No additional AE; This spontaneous report was received on 14-JUN-2022, from a consumer regarding to an infant patient of an unknown age and gender.  The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not provided. Concomitant medication included sterile diluent.  On an unknown date the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection,lot number: U02505, which was an invalid lot number for varicella virus vaccine live (oka/merck)(VARIVAX), expiration date reported as: 13-AUG-2023 (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported), administered as prophylaxis.   It was stated that on an unspecified date, the suspect vaccine varicella virus vaccine live (oka/merck) (VARIVAX) injection was improperly stored; therefore, it experience a temperature excursion of minus (-) 11.6  degree Celsius (C) for 0 hours, 30 minutes and 0 seconds. There was no previous temperature excursion, and no additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reports vaccine was administered after experiencing temperature excursion //Names of vaccines involved (including lot/exp) VARIVAX  Lot: U02505 / Exp date: 8/13/2023        ?    Temperature -11.6C        ?    Time frame  0 hour 30 minutes; No additional AE details.; This spontaneous report was received from a consumer and concerning to a patient (gender not provided) who was 1-year-old at the time of reporting.  The patient's medical history, current conditions, drug allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously for prophylaxis. Lot number [U02505] is an invalid lot number for (oka/merck) (VARIVAX) expiration date reported as 13-AUG-2022 (strength, and route of administration were not provided) (Product storage error).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature of -11.6C  for the time frame of 0 hour and 30 minutes. There was no previous temperature excursion.  No additional adverse effects reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Caller reported expired dose of MMR II administered.; This spontaneous report was received from a physician assistant concerning a patient of unknown age and gender. The subject's medical history, historical drugs, concurrent conditions, known allergies, and concomitant medications were not provided  On 15-JUN-2022, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live rHA (recombinant human albumin) (M-M-R-II) 0.5 milliliter (ml) administered subcutaneously (SQ) as prophylaxis (strength, frequency and anatomical site of application were not reported); lot # T013003 had been verified to be valid with an expiration date reported and established as 15-APR-2022 (Expired product administered).  No other information or additional adverse events (AEs) were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored administered vaccine.; No additional AE reported; This spontaneous report was received from unspecified reporter, referring to currently 5 year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (lot #U022727 has been verified to be valid, expiration date: 16-JAN-2023) for prophylaxis (strength, dose regimen, and route of administration were not provided).   Additonally, it was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) underwent a temperature excursion of -14 degree Celsius (°C) up to -10 °C (average temperature: -11,6 °C) for 30 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored administered vaccine; No additional AE reported; This spontaneous report was received from other referring to a patient of unknown age and gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, 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) subcutaneous injection, administered with lot #U022727 and expiration date: 16-JAN-2023, subcutaneously for prophylaxis (dose, vaccination scheme frequency, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius (C) up to -10 C (-11.6) for 30 minutes. It was stated that there was no previous temperature excursion. There were no adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: vaccine was administered after experiencing temperature excursion/Temperature -11.6C during 30 minutes; No additional adverse event details; This spontaneous report was received from other unspecified reporter concerning to an approximately 1 year old patient of unknown gender and race. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), with lot number U02505 (expiration date: 13-AUG-2023) that was an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) administered for prophylaxis (dose, frequency, strength and route of administration were not provided) that underwent through a temperature excursion of about -11.6 degrees Celsius (C) during 30 minutes (Product storage error). No further information was provided.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, Product storage error
Clinical narrative: No additional AE information provided; Office manager calling to report an AE. Caller states that PROQUAD LOT T030944 exp. 3/9/2022 was administered to a patient today, 6/16/2022. Caller confirms that the product was stored appropriately and did not have any temperature excursions.  HPC t; This spontaneous report was received from an administrator and refers to a 5-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 16-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, at a dose of 0.5 ml, lot number T030944 was found to be valid, expiration date: 09-MAR-2022 (strength, route of administration and vaccination site were not reported) for prophylaxis (expired product administered). The reporter confirmed that the product was stored appropriately and did not have any temperature excursions. No additional adverse events were reported.
Age: 1.08
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs were reported; patient received MMR II and VARIVAX shorter than recommended interval. The patient received MMR II on 10/16/2021 and VARIVAX on 11/11/2021.; This spontaneous report was received from a registered nurse and refers to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-OCT-2021, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, recombinant human albumin (rHA), lot # t022310, expiration date: 30-JUN-2022, for prophylaxis (strength, and route of administration were not provided). On 11-NOV-2021, the patient was vaccinated with 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot # u002394, expiration date: 22-JAN-2023, for prophylaxis (strength, and route of administration were not provided) (inappropriate schedule of product administration). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC.; Caller reported VARIVAX administered after temperature excursion. Names of vaccines involved (including lot/exp) VARIVAX U022321  7/15/2023. Temperature 6F. Time frame 30 min; This spontaneous report has been received from an administrator referring a patient of an unknown age and gender.   The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided.   On 22-APR-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) at dose 0.5 ml, subcutaneously, lot number U022321, expiration date on 15-JUL-2023 for prophylaxis (strength and frequency were not reported) that underwent a temperature excursion of 6 Fahrenheit degrees for 30 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further adverse events; Nurse reporting administered dose of expired DILUENT.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 15-JUN-2022, the patient was vaccinated with one dose of varicella virus vaccine live (VARIVAX) as prophylaxis (strength, frequency, route of administration, and anatomical injection site were not reported; lot number U025791 with an expiration date of 19-AUG-2023). The vaccine was reconstituted with one dose of an expired sterile diluent (lot number S026378 with an expiration date of 15-MAY-2022) (expired product administered). No further adverse events.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, Product preparation issue
Clinical narrative: No further adverse events/no product quality complaints.; Caller is nurse reporting administered dose of expired DILUENT. Caller reports no history of prior excursions on products. No additional details provided.; Caller is nurse reporting administered dose of expired DILUENT. Caller reports no history of prior excursions on products. No additional details provided. No further adverse events/no product quality complaints.; This spontaneous report was received from a nurse concerning a patient of an unknown age and gender. The information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 15-JUN-2022, the patient started was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U002399, expiration date 22-JAN-2023) which was reconstituted with a sterile diluent (MERCK STERILE DILUENT) (lot # S026378, expiration date 15-MAY-2022) (route of administration, anatomical location were not reported) for prophylaxis (product preparation issue and expired product administered).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; The nurse stated that a patient received an expired PROQUAD on 06/16/2022; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 16-JUN-2022, the patient was vaccinated with the expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type was recombinant Human albumin) subcutaneous injection, 1 dosage form for prophylaxis (lot #T034828, expiration date: 11-APR-2022, strength and route of administration were not provided) (expired product administered). The sterile diluent (manufacturer unknown) that was reconstituted with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot#T036815, expiration date 29-MAR-2023) was not expired. No additional adverse events were reported (not adverse event).
Sex: F
Vaccine: PNC15, PPV
Symptoms: Hypersensitivity, Ill-defined disorder, Pain
Clinical narrative: had an allergic reaction to it; now she is having constant pain; "it's hard"; This spontaneous report was received from the 80-year-old female patient, who refers to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) [not reported, if it was pneumococcal vaccine, polyvalent (23-valent) or pneumococcal 15v conj vaccine (crm197)] (dose number, strength, lot #, expiry date, and route of administration and anatomical location were not provided) for prophylaxis.  On an unknown date, the patient experienced an allergic reaction to the vaccine, she had a constant pain, and reported, that "it is hard" (ill-defined disorder). The outcome of the events was unknown.   The reporter considered event of an allergic reaction to be related to the suspect therapy and the relatedness was unknown regarding to the other events.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: No additional adverse events were reported; Nurse called because GARDASIL dosing has been interrupted.   She reported that 35 year old patient received one GARDASIL quadrivalent when she was a teenager and now she received one dose of GARDASIL 9 on 6/16/2022.; Nurse called because GARDASIL dosing has been interrupted. She reported that 35 year old patient received one GARDASIL quadrivalent when she was a teenager and now she received one dose of GARDASIL 9 on 6/16/2022; This spontaneous report has been from a licensed practical nurse (L.P.N.) concerning to a 35-year-old female patient.     The patient's medical history, concurrent and previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, while the patient was teenager, she was vaccinated with one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (dose, vaccine scheme, route and anatomical site of administration, lot number and expiration datewere not provided).  Then, on 16-JUN-2022 (reported as now) the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, vaccine scheme, route and anatomical site of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration and interchange of vaccine products). No additional adverse events were reported.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Caller stated a patient was prescribed RhoGAM but was administered GARDASIL 9 by mistake.; GARDASIL 9 administration occurred today and patient is pregnant.; Spontaneous prospective pregnancy report was received from a consumer referring a 23-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies. The patient became pregnant with last menstrual period (LMP) calculated as 05-DEC-2021 (and estimated date of delivery (EDD) of 11-SEP-2022, based on a pregnancy gestation reported as 27 weeks and 5 days, at the time of the report.  It was stated that the patient was prescribed anti-d immunoglobulin (RHOGAM) (strength, dose, frequency, route of administration, lot number, expiration date and indication were not reported) but on 17-JUN-2022 (reported as today), the patient was vaccinated with 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) by mistake for  prophylaxis (wrong vaccine administered) (strength, dose, frequency, route of administration, lot number, expiration date and indication were not reported). At the time of the report, the pregnancy outcome was pending, the fetal outcome was not provided, and the patient did not experience any additional adverse events (no adverse event).
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; HCP reported that PROQUAD was administered to a patient accidently via IM route instead of SC route.; This spontaneous report has been received from a licensed practical nurse referring to a 5-year-old patient. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were unknown by the reporter  On 17-JUN-2022, the patient was accidentally vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) 0.5 milliliter intramuscular (lot number U039955 has been verified to be a valid lot number, expiry date 14-JUN-2023) (strength, frequency, anatomical location, and vaccination scheme were not provided) instead of subcutaneously (incorrect route of product administration) for prophylaxis. No additional adverse event reported.      The outcome of the events was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 17-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, subcutaneous, lot number U022321, expiration date 15-JUL-2023 for prophylaxis (product storage error). No adverse event was reported.   The excursion was of 6 degrees Farhrenheit for 30 minutes. No previous temperature excursions were detected.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events reported; Caller reports improperly store vaccines were administered; This spontaneous report was received  from a medical assistant referring to a patient of unknown age and gender. The patient´s concurrent conditions, medical history and concomitant therapies were not reported.  On 15-JUN-2022, the patient was  avaccintaed with 1 dose of improperly stored   rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, , lot # 1 42084, expiration date: 05-OCT-2022,  for prophylaxis. (strength and dose  were not provided) (product storage error). The temperature was 41.17 farenheit degrees for 15 minutes and there was no previous temperature excursion. No other adverse event and no product quality complaints were reported.  This is one of several reports from the same reporter.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; patient received a second dose of PROQUAD approximately 8 weeks after the first dose.; The child was 5 years old at the time of the first administration; This spontaneous report has been received from a nurse, concerning a 5-year-old male patient. The patient's medical history, drug reactions or allergies, concurrent conditions, and concomitant therapies were not provided.   On 17-JUL-2018, at the age of 5-year-old, the patient was vaccinated (Inappropriate age at vaccine administration) with first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot #, and expiration date were not reported) as prophylaxis. On 12-SEP-2018 (approximately 8 weeks after the first dose), the patient received the second dose (Inappropriate schedule of product administration) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number R011217, which has been verified to be valid, expiration date reported and validated as 15-OCT-2019) as prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; Caller reports that doses of improperly stored vaccines were administered to patients.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 18-JUN-2022, the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, anatomical location, route of administration were not reported) (lot# U026792, has been verified to be a valid lot number for Hepatitis A Vaccine, Inactivated (VAQTA), expiration date reported as 28-OCT-2022) as prophylaxis. The vaccine dose was improperly stored at a temperature of 47.17 Fahrenheit degrees (°F) for 15 minutes (Product storage error); with no previous temperature excursion.  No other adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; ROTATEQ administered after temperature excursion.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history or drug reactions/allergies was not provided.  On an unspecified date, there was a temperature excursion reported for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) which was improperly stored at 49.8 Fahrenheit degrees, for 2 hours. There was no previous temperature excursion.  On 20-JUN-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #U006165, expiration date 18-OCT-2022, administered orally for prophylaxis (product storage error). No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Caller reports that doses of improperly stored vaccines were administered to patients.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent historical condition, concurrent condition, drug reactions/allergies or concomitant medication was not provided.    On 17-JUN-2022, the patient was vaccinated with improperly stored of  Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (1 dose, via oral, lot number 1742084, expiration date 05-OCT-2022) for prophylaxis (strength and frequency were not reported) that after temperature excursion to 47.17 Fahrenheit (F) for 15 minutes (product storage error). There was no previous temperature excursion. No other adverse events were reported (no adverse event).  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2206USA006116: US-009507513-2206USA006096: US-009507513-2206USA006061: US-009507513-2206USA006141: US-009507513-2206USA006019:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: herpes zoster; postherpetic neuralgia; 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. On an unknown date, the patient was inoculated 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), the patient suffered multiple outbreaks of herpes zoster, and postherpetic neuralgia. 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 the 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 herpes zoster and postherpetic neuralgia was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events herpes zoster and postherpetic neuralgia to be disability.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered. No further information was provided. No additional AE. No PQC.   ?    Names of vaccines involved (including lot/exp): M-M-R II LOT: T029550 EX; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 25-MAY-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1742467, expiration date: 05-OCT-2022, administered orally for prophylaxis (strength, dose, and anatomical location were not provided).  The vaccine was stored at the temperature that was reported as above 47 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported: above 47 degrees of Fahrenheit (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005639: US-009507513-2206USA005640: US-009507513-2206USA000873: US-009507513-2206USA006597: US-009507513-2206USA006598: US-009507513-2206USA006599: US-009507513-2206USA006600:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered. No further information was provided. No additional AE. No PQC.   ?    Names of vaccines involved (including lot/exp): M-M-R II LOT: T029550 EX; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 26-MAY-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1837116, expiration date: 24-MAR-2023, administered orally for prophylaxis (strength, dose, and anatomical location were not provided).  The vaccine was stored at the temperature that was reported as above 47 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported: above 47 degrees of Fahrenheit (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005639: US-009507513-2206USA005640: US-009507513-2206USA006596: US-009507513-2206USA000873: US-009507513-2206USA006598: US-009507513-2206USA006599: US-009507513-2206USA006600:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered. No further information was provided. No additional AE. No PQC.   ?    Names of vaccines involved (including lot/exp): M-M-R II LOT: T029550 EX; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1837116, expiration date: 24-MAR-2023, administered orally for prophylaxis (strength, dose, and anatomical location were not provided).  The vaccine was stored at the temperature that was reported as above 47 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported: above 47 degrees of Fahrenheit (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005639: US-009507513-2206USA005640: US-009507513-2206USA006596: US-009507513-2206USA006597: US-009507513-2206USA000873: US-009507513-2206USA006599: US-009507513-2206USA006600:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered. No further information was provided. No additional AE. No PQC.   ?    Names of vaccines involved (including lot/exp): M-M-R II LOT: T029550 EX; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1837116, expiration date: 24-MAR-2023, administered orally for prophylaxis (strength, dose, and anatomical location were not provided).  The vaccine was stored at the temperature that was reported as above 47 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported: above 47 degrees of Fahrenheit (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005639: US-009507513-2206USA005640: US-009507513-2206USA006596: US-009507513-2206USA006597: US-009507513-2206USA006598: US-009507513-2206USA000873: US-009507513-2206USA006600:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered. No further information was provided. No additional AE. No PQC.   ?    Names of vaccines involved (including lot/exp): M-M-R II LOT: T029550 EX; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 20-MAY-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #T029550, expiration date: 01-SEP-2022, administered for prophylaxis (strength, dose, route of administration, and anatomical location were not provided).  The vaccine was stored at the temperature that was reported as above 46 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported: above 46 degrees of Fahrenheit (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005639: US-009507513-2206USA005640: US-009507513-2206USA006596: US-009507513-2206USA006597: US-009507513-2206USA006598: US-009507513-2206USA006599: US-009507513-2206USA000873:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no additional AE reported; Caller was Medical Assistant. Caller reported AE for Patient.  Patient was administered expired MMRII; Expired / Administered Detail Summary is located within following space.  Caller did not wish to be contacted in the future regarding the event. No; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 20-JUN-2022, the patient was vaccinated with a expired measles, mumps, and rubella (recombinant human albumin (rHA)) (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot  number T020655, expiration date reported as 16-JUN-2022, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse event; VARIVAX was delivered on 07-JUN-2022 after the receive by date of 06-JUN-2022 and was administered to a patient; This spontaneous report was received from a medical technologist lab manager referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  The reporter explained varicella virus vaccine live (oka/merck)(VARIVAX) was delivered on 07-JUN-2022 after the receive by date of 06-JUN-2022 and was administered to a patient on 15-JUN-2022 (incorrect product storage), lot # W002599, expiration date on 24-JAN-2024 for prophylaxis (dose not reported). The temperature was unknown and also the timeframe. There was no previous temperature excursion. The reporter did not have any further clarifying details. No additional adverse event or product quality complaint were reported. No additional information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Aphasia, Cerebrovascular accident, Dysarthria, Hemiparesis
Clinical narrative: This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 21-JUN-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around 22-OCT-2014, 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 aphasia, slurring of speech and right sided weakness and was diagnosed with stoke (cerebrovascular accident). As a direct and proximate result of using Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. 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 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, 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 the event cerebrovascular accident was considered as not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review the event cerebrovascular accident was considered to be medically significant and disabling event.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Pharmacist reported that MMR II got administered to a patient via IM route instead of SC route.; patient age: 24 years old; This spontaneous report was received from a pharmacist referring to a 24-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medication, or drug reactions or allergies was reported.   On 20-JUN-2022, the patient was vaccinated with the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter (lot #, and expiration date were not provided) (Product administered to patient of inappropriate age), administered intramuscularly (IM) (Incorrect route of product administration) instead of subcutaneous (SC) route for prophylaxis. Information about treatment given for the event, and medical attention was unknown by the reporter.  No additional adverse event (AE) was reported. No product quality complaint (PQC) was reported. No further information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported; VARIVAX was delivered on 07JUN2022 after the receive by date of 06JUN2022 and was administered to the patient on 16-JUN-2022; This spontaneous report was received from a medical technologist lab manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported by the reporter.  Varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W002599, expiration date: 24-JAN-2024) was delivered on 07-JUN-2022 after the receive by date of 06-JUN-2022 (temperature and time frame were unknown) (Product storage error) and was administered to the patient on 16-JUN-2022 for prophylaxis (formulation, strength, dose and route of administration were not provided). There was no previous temperature excursion. No additional adverse event (AE) or product quality complaints (PQC) reported (No adverse event).
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: patient got one dose of 4-valent GARDASIL at age 18 and then did not complete the series. The patient now wants to complete the series at age 29.; No adverse event; This spontaneous report was received from a pharmacist and refers to a unknown gender 29-year-old patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date in 2011, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, dose and route of administration were not provided).  The reported stated that the patient got one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) at age of 18-year-old and then did not complete the series. The caller reported that the patient wanted to complete the series at the age of 29-year-old (reported as now) (inappropriate schedule of product administration). The caller did not provide any further information. No adverse event was reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Customer called and reported that a 9 month old baby received ROTATEQ. She reports that the baby received the 1st dose at 2 months old, the 2nd dose at 5 months old, and the 3rd dose at 9 months old. No additional AE reported. No PQC reported. No add; Customer called and reported that a 9 month old baby received ROTATEQ. She reports that the baby received the 1st dose at 2 months old, the 2nd dose at 5 months old, and the 3rd dose at 9 months old. No additional AE reported. No PQC reported. No add; Customer called and reported that a 9 month old baby received ROTATEQ. She reports that the baby received the 1st dose at 2 months old, the 2nd dose at 5 months old, and the 3rd dose at 9 months old. No additional AE reported. No PQC reported. No add; This spontaneous report was received from a nurse referring to a 5-month-old of unknown gender. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date in November 2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2ml, administered for prophylaxis (route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). On an unknown date in February 2022, at the age of 5 months, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2ml (route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported) (inappropriate schedule of vaccine administered). On 22-JUN-2022, at the age of 9 months old, the patient was vaccinated with the third and last reported dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2ml (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number W004501 with an expiration date of 20-APR-2023) (inappropriate schedule of vaccine administered). No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event, Product use issue
Clinical narrative: No adverse event; Patient was inadvertently administered to a patient via the intramuscular route as opposed; This spontaneous report has been received from a medical student and refers to a patient of an unknown age and gender.  The patient's medical history,concurrent conditions, concomitant therapies, and previous drugs reactions or allergies were not reported.  On 18-JUN-2022, the patient was  inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rhA) (M-M-R II)  at a dose of 0.5 milliliter, administered intramuscularly as prophylaxis lot number U029620 expiration date 22-SEP-2022 (strength and vaccination scheme were not provided) (product use issue). No additional adverse event was reported.