chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure to SARS-CoV-2, Hypersensitivity, Inappropriate schedule of product administration, Injection site hypoaesthesia
Clinical narrative: this patient was exposed to COVID-19 on an unspecified date.; After that first dose, the patient experienced "superficial numbness in her left arm" (where the dose was administered); She is "very sensitive to vaccines."; Patient received her first dose of GARDASIL 9 at age 25 years / The patient is now currently 39 years old and received her 2nd dose; This spontaneous report was received from a pharmacist regarding a 25-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date (reported as "at age 25 years"), 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) (dosage regimen, strength, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis. On an unknown date (reported as "after that first dose"), the patient experienced superficial numbness in her left arm (where the dose was administered) (Injection site hypoaesthesia). On an unspecified date, she was exposed to Coronavirus disease 2019 (COVID-19) (Exposure to COVID-19). In approximately June 2022 (reported as "approximately 2 months ago"), 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) (dosage regimen, strength, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis (Inappropriate schedule of product administration). Therefore, the patient stated that "she was very sensitive to vaccines" (Hypersensitivity). She was treated for the events. At the time of reporting, the patient was not recovered from the event of injection site hypoaesthesia. However, the outcome of the events exposure to COVID-19 and hypersensitivity was not provided.  The causal relationship between hypersensitivity and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was related. However, the causal relationship between exposure to COVID-19, injection site hypoaesthesia, and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse event; a dose of PROQUAD was administered intramuscularly to the patient.; This spontaneous report was received from a medical assistant and refers to a 14-year-old female patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 27-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (also reported as Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R) conflicting information) at a dose of 0.5 mililiter, lot number U016976 who had been verified to be a valid number, expiration date: 24-NOV-2022, for prophylaxis (strength, frequency and anatomical location were not provided). On the same date, it was reported that the vaccine was administered intramuscularly instead of subcutaneous (incorrect route of product administration).   It was reported that the event was noted and informed to the provider and the patient. It was reported that the immunogenicity was achieved, also that there was no ill consequence and that no more future interventions were necessary for the patient (no adverse event).
Age: 0.17
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Caller said at this time the patient had not other issues at time of call AE letter was refused.; GARDASIL 9 was administered to a 2 month old.; This spontaneous report was received from an other healthcare professional and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-AUG-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age).  There were no adverse events reported (no adverse event).
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/ No PQC/. Patient did not have any side effects; a patient that was administered ROTATEQ that had been improperly stored. Patient did not have any side effects; This spontaneous report was received from a nurse and refers to a 3-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. There was no information regarding the patient's drug reactions or allergies.  On an unknown date, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml, administered orally, lot #W004501, expiration date: 20-APR-2023, (strength, and dose number were not provided) for prophylaxis.   For rotavirus vaccine, live, oral, pentavalent (ROTATEQ) the temperature excursion was reported as 34.4 Fahrenheit degree (F) for 20 minutes. The previous temperature excursions was not occurred. Patient did not have any side effects. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported vaccine administered after temperature excursions; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies, and concurrent conditions were not provided.  On 16-AUG-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, a dose of 0.5ml, administered subcutaneously, lot # W017567, expiration date 29-NOV-2023 (dose number, strength and anatomical location were not provided) for prophylaxis (product storage error). The administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) underwent temperature excursion on 10.9 Fahrenheit degrees for 1 hour and 30 minutes. There were no previous temperature excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA000437:02237204 US-009507513-2209USA000235:02237237 US-009507513-2209USA000255:02237256 US-009507513-2209USA000438:02237157 US-009507513-2209USA000361:02237219 US-009507513-2209USA000179:02237190 US-009507513-2209USA000374:02237270 US-009507513-2209USA000350:02237201
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller reported vaccine administered after temperature excursions.; This spontaneous report was received from a medical assistant regarding to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot #U015678, expiration date: 18-MAY-2023, administered subcutaneously (SQ), (strength was not provided) as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 10.9 degrees Fahrenheit (F) for 1 hour and 25 minutes without previous excursions.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2209USA000437: US-009507513-2209USA000438: US-009507513-2209USA000179: US-009507513-2209USA000350: US-009507513-2209USA000177: US-009507513-2209USA000361: US-009507513-2209USA000374:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported.; vaccine administered after temperature excursions; This spontaneous report has been received from a medical assistant concerning to patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX) in which the maximum temperature reached was 10.9 degrees Fahrenheit for a time frame of 5 hours and 30 minutes. No previous temperature excursions were reported.  On 18-AUG-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, administered subcutaneous (SQ), lot W012166, expiration date 12-APR-2024, (anatomical location was not provided) as prophylaxis (product storage error). No additional events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA000437: US-009507513-2209USA000235: US-009507513-2209USA000255: US-009507513-2209USA000438: US-009507513-2209USA000177: US-009507513-2208USA011663:02236682
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; improperly stored vaccine was administered on 08/26/22.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. There was no information regarding, the patients drug reactions and allergies.  On 26-AUG-2022, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), injection, lot# T029522, expiration date 13-MAR-2023, (strength, dose, dose number, route and site of vaccination were not provided) for prophylaxis (product storage error). No additional adverse events (AEs) (no adverse event).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), underwent the temperature excursion of -39.8 Fahrenheit degrees (F) for 3 hours and 27 minutes. Previous temperature excursion was not occurred.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was administered improperly stored PROQUAD on unknown, previous date; No additional AE reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies, and concurrent conditions were nor provided.  On an unknown date, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, lot # W017567, expiration date 29-NOV-2023 (dose, dose number, strength, route of administration, and anatomical location were nor provided) for prophylaxis (product storage error). On 19-AUG-2022, the administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) underwent temperature excursion of 7.7 Fahrenheit (F) degrees for 10 minutes. Previous temperature excursions included: 7.3 F degrees, from 6 F degrees to 14 F degrees for 10 minutes on 09-AUG-2022, 7.0 F degrees, from 6 F degrees to 14 F degrees for 9 minutes on 08-AUG-2022, 7.2 F degrees, from 6 F degrees to 14 F degrees for 9 minutes on 04-AUG-2022, and 7.5 F degrees, from 6 F degrees to 14 F degrees for 10 minutes on 03-AUG-2022. No additional adverse event was reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA000852:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Incorrect product storage; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On an unknown date in 2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W017567, expiration date of 29-NOV-2023, for prophylaxis (strength, dose and route of administration were not reported) (product storage error). No adverse effects were reported.     It was stated that the vaccine underwent a temperature excursion as following:  Temperature: 7.7°F (Fahrenheit) (Affected Product's Most Recent Temperature Excursion had occurred on 19-AUG-2022).  Time frame: 10 Minutes (Affected Product's Most Recent Temperature Excursion had occurred on 19-AUG-2022).  Previous temperature excursion reported as following: 03-AUG-2022: (6°F up to 14°F) (7.5°F) for 10 Minutes; 04-AUG-2022: (6°F up to 14°F) (7.2°F) for 9 Minutes; 08-AUG-2022: (6°F up to 14°F) (7.0°F) for 9 Minutes; 09-AUG-2022: (6°F up to 14°F) (7.3°F) for 10 Minutes.   Reporter was unable to further clarify.; Sender's Comments:  US-009507513-2209USA000716:02238205
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported that PROQUAD that underwent a temperature excursion was administered.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 19-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # W010061, has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [rHA] [PROQUAD], expiration date reported and upon internal validation established as 20-SEP-2023) (dose, anatomical location and route of administration were not reported). The vaccine was administered for prophylaxis after a temperature excursion (temperature of -14 Celsius degrees [°C] up to -10°C [-14.18C] for 0 hours 15 minutes and 0 seconds) (Product storage error). The vaccine did not have previous temperature excursions.  No adverse event was reported.  This is one of three cases reported by the same reporter.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Doses were administered on below dates: 08/01/2015, 08/04/2016, 08/17/2017, 08/30/2022; No additional AE reported; During that call, she mentioned that a patient received 4 doses of GARDASIL 9.; This spontaneous report has been received from a nurse concerning a 23-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 01-AUG-2015, 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) (dose, anatomical location, route of administration, lot# and expiration date were not reported). On 04-AUG-2016, 17-AUG-2017 and 30-AUG-2022 the patient was vaccinated with the second, third and fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, anatomical location, route of administration, lot# and expiration date were not reported) respectively (Inappropriate schedule of product administration) (Extra dose administered). All doses were given as prophylaxis.  The patient did not experienced any side effect.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Employee reporting adverse even pertaining to MMR II. Employee states that Provider reported that a woman in his practice received MMR II while pregnant or just becoming pregnant. Employee unable to provide full demographic informat; no additional adverse event; This spontaneous prospective report was received from a physician via company representative concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered as prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided), while pregnant or just becoming pregnant (Maternal exposure during pregnancy). No additional adverse events reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 29-AUG-2022, the patient was vaccinated with improperly stored 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, for prophylaxis (strength, and route of administration were not provided) lot # w004504, expiration date: 16-JUN-2023 or lot# W002562 which has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) expiration date reported as 12-OCT-2023, the same as internal validation (product storage error). Administrated vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at 11.3 Celsius degrees for 34 minutes, no previous temperature excursion were reported.  There were no adverse events reported (no adverse events).
Age: 4.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events were reported; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received the vaccine.  No additional AEs were reported, no fu; This spontaneous report was received from a healthcare worker and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-AUG-2022, the patient was vaccinated with an improperly stored (temperature: 11.3 Celsius degrees, time frame: 34 minutes, no previous temperature excursions) hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, lot #W003118 with an expiration date: 13-JUL-2023 or lot #w015191 with an expiration date: 27-OCT-2023 (strength, exact dose, route of administration and vaccination site were not reported) administered for prophylaxis (product storage error). The patient received only one dose but the reporter did not specified which lot number was administered to the patient. No additional adverse events (AEs) were reported.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report has been received from an other health professional concerning a 11-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 24-AUG-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # w003118 and lot # w015191, has been verified to be a valid lot numbers for hepatitis a vaccine, inactivated [VAQTA], expiration dates reported and upon internal validation established as 13-JUL-2023 and 27-OCT-2023 respectively) (dose, anatomical location, and route of administration were not reported) for prophylaxis. The vaccine was improperly stored at a temperature of 11.3 Celsius (C) during 34 minutes (Product storage error). The vaccine did not have previous temperature excursions.  No adverse events were reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; A patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker referring to a 4-months-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 24-AUG-2022, the patient was vaccinated with one improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot numbers W004504 and  W002562 has been verified to be a valid lot numbers, with expiration dates reported and established as 16-JUN-2023 and 12-OCT-2023 respectively) (exact dose, strength, route of administration, anatomical injection site and vaccination scheme were not reported), administered for prophylaxis, that underwent a temperature excursion of 11.3 Celsius degrees for 34 minutes (product storage error). The reporter did not know which of the reported lot numbers received the patient. There was no previous temperature excursion. No additional adverse events were reported.
Age: 9.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker reported that a patient received improperly stored vaccine; This spontaneous report has been received from a health care worker concerning a 9-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 26-AUG-2022, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered as prophylaxis, lot number W003118 with expiration date 13-JUL-2023; lot number W015191 with expiration date 27-OCT-2023 (dosage frequency and route of administration were not reported) (Product storage error). No additional adverse events were reported (No adverse event). The mentioned vaccines underwent a temperature excursion of 11.3 degrees Celsius (C) for 34 minutes, with no previous temperature excursions.
Age: 1.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events were reported; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received the vaccine.; This spontaneous report was received from a health care worker regarding a 12-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 29-AUG-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA), lot #W003118, expiration date: 13-JUL-2023, lot #W015191, expiration date 27-OCT-2023 (the reporter did not specify which actual lot the patient received the vaccine) (dosage regimen, strength, dose description, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis (Product storage error). No adverse events were reported.   The improperly stored vaccine underwent a temperature excursion of 11.3 degrees Celsius (C) for 34 minutes without previous excursions.
Age: 2.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker reported that a patient received improperly stored vaccine. The patient received only one dose; This spontaneous report was received from a healthcare worker and refers to a 2-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-AUG-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection for prophylaxis (strength, frequency, route of administration and anatomical location were not reported) lot number W003118 with expiration date on 13-JUL-2023 or W015191 with expiration date on 27-JUL-2023 (incorrect product storage), however the reporter did not specify which actual lot received the patient.  The hepatitis a vaccine, inactivated (VAQTA) underwent a temperature excursion of 11.3 degrees Celsius (C) for a time frame of 34 minutes and there was no previous temperature excursion. No additional adverse events were reported.
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction, Incomplete course of vaccination, Milk allergy
Clinical narrative: Caller reported her daughter did not complete any of her "vaccine series" when she was younger due to a anaphylactic response to milk products.; her daughter did not complete any of her "vaccine series" when she was younger; This spontaneous report was received from a patient's mother regarding a female patient of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date (reported as "when she was younger"), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) administered as prophylaxis. It was stated that she did not complete any of her "vaccine series" (specific vaccines were not provided) (Incomplete course of vaccination) due to a anaphylactic response to milk products (Anaphylactic reaction). At the time of reporting, the outcome of anaphylactic reaction was not provided.  The causal relationship between anaphylactic reaction and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  Upon internal review the event of anaphylactic reaction was determined to be medically significant.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: post-herpetic neuralgia; Information has been received regarding a case in litigation from a lawyer, referring to an approximately 78 years old patient (pt) of unknown gender at the time of the report. No information was provided regarding the pt's medical history, concurrent conditions and concomitant medications.  On or about 20-MAY-2013, the pt was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, strength, route, lot number and expiration date were unknown) for the long-term prevention of shingles and zoster-related conditions at local pharmacy. Subsequently, pt was treated by providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: post-herpetic neuralgia. The pt claimed damages as a result of injury to themselves and economic losses. The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: multiple outbreaks of herpes zoster; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers, and was still under their care at the time of reporting. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The event was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event of herpes zoster to be disabling.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details; Office manager calling reports expired dose of MMR II was administered to a patient. Vaccine expired 9/4/2022 and was administered 9/6/2022. Product did not experience any temperature excursions through the date of administration. Because caller was; This spontaneous report has been received from an office manager, concerning a identified patient of unknown gender and age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies was unknown.  On 06-SEP-2022, the patient was vaccinated with sterile diluent (STERILE DILUENT) and an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (lot number reported as U007506 which was verified as invalid, expiration date reported as 04-SEP-2022) (strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (expired vaccine used). No adverse events (AE) reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse side effects have been reported from the patient; improperly stored dose of PROQUAD was administered to a patient on 8/16/2022; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-AUG-2022, the patient was vaccinated with improperly stored dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), recombinant human albumin (rHA), subcutaneous injection, 0.5 milliliter, lot #U019287, expiration date: 15-DEC-2022, administered subcutaneously for prophylaxis (strength was not provided) (Product storage error).  Administered doses of vaccines experienced the temperature excursion of -12.3 degrees Celsius for 1 hour. There was no previous temperature excursion.  There was no adverse event reported (No adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse side effects have been reported from the patient; improperly stored dose of MMR-II was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 31-AUG-2022, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), subcutaneous injection, 0.5 milliliter, lot #U022985, expiration date: 22-JUL-2023, administered subcutaneously for prophylaxis (strength was not provided) (Product storage error).  Administered dose of vaccine experienced the temperature excursion of -12.3 degrees Celsius for 1 hour. There was no previous temperature excursion.  There was no adverse event reported (No adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; expired dose of MMR II was administered to a patient on 07SEP202; This spontaneous report was received from an other health professional via company representative and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On 07-SEP-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #T016352, expiration date: 12-MAY-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No further information was provided. No additional adverse event or product quality complaint was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; professional in charge of vaccine storage calling for evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. Provided initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from professional and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.   On 6-SEP-2022, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1879864, expiration date: 19-OCT-2023, administered for prophylaxis (strength, dose, dose number and route of administration were not provided) (product storage error).  Administered dose of vaccine experienced the temperature excursion of above 46 degrees Fahrenheit (62.8F) for 8 hours.  No adverse event was reported.; Sender's Comments:  US-009507513-2209USA002722:02242106 US-009507513-2209USA002532:02242106
Age: 0.58
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; patient whose date or birth is 1/16/2022 received PNEMOVAX 23 on 9/7/2022; This spontaneous report was received from a registered nurse and refers to a 7-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 07-SEP-2022, the patient was vaccinated  with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)(strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis (Product administered to patient of inappropriate age). No adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Professional in charge of vaccine storage calling for evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. Professional provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report has been received from a professional, concerning an identified patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 05-SEP-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) Lot# 1879864 experienced a temperature excursion above 46 Fahrenheit (F) (62.8F) for a timeframe of 8 hours 0 minutes and 0 seconds; no other temperature excursions. If a digital data logger was involved was not reported (product storage error).   Consequently, on 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis (lot number 1879864 confirmed to be valid, expiration date reported and stablished as 19-OCT-2023) (strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA003021:Case number: 02242077 S-009507513-2209USA002510:Case number: 02242136 US-009507513-2209USA002566:Case number: 02242139 US-009507513-2209USA002779:Case number: 02242131 US-009507513-2209USA002481:Case number: 02242135 US-009507513-2209USA002570:Case number: 02242096 US-009507513-2209USA002722:Case number: 02242097 US-009507513-2209USA002574:Case number: 02242099 US-009507513-2209USA002469:Case number: 02242101 US-009507513-2209USA002573:Case number: 02242103 US-009507513-2209USA002606:Case number: 02242106 US-009507513-2209USA002532:Case number: 02242109 US-009507513-2209USA002746:Case number: 02242132
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Professional in charge of vaccine storage calling for valuation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. Professional provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report has been received from a healthcare business professional, concerning an identified patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 05-SEP-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) Lot# W011278   experienced a temperature excursion above 46 Fahrenheit (F) (62.8F); no other temperature excursions. If a digital data logger was involved was not reported (product storage error).   Consequently, on 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis (lot number W011278 confirmed to be valid, expiration date reported and stablished as 01-NOV-2023) (strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA002722:Case number: 02242132 US-009507513-2209USA003021:Case number: 02242077 US-009507513-2209USA002510:Case number: 02242136 US-009507513-2209USA002566:Case number: 02242139 US-009507513-2209USA002779:Case number: 02242131 US-009507513-2209USA002481:Case number: 02242135 US-009507513-2209USA002745:Case number: 02242092 US-009507513-2209USA002570:Case number: 02242096 US-009507513-2209USA002722:Case number: 02242097 US-009507513-2209USA002574:Case number: 02242099 US-009507513-2209USA002469:Case number: 02242101 US-009507513-2209USA002573:Case number: 02242103 US-009507513-2209USA002606:Case number: 02242106 US-009507513-2209USA002532:Case number: 02242109
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE details available; Products were administered to multiple patients.; This spontaneous report was received from a reporter and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-SEP-2022, a temperature excursion to rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (valid lot #W011278, expiration date: 01-NOV-2023) occurred. On 06-SEP-2022, the patient was vaccinated with improperly storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (valid lot #W011278, expiration date: 01-NOV-2023) (strength, anatomical location and route of administration were not provided). Temperature excursion was at 46 Fahrenheit (F) (62.8 F) for 8 hours. No previous temperature excursion occurred. No additional information or adverse event was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2209USA002722: US-009507513-2209USA003021: US-009507513-2209USA003055: US-009507513-2209USA002557: US-009507513-2209USA002540: US-009507513-2209USA002566: US-009507513-2209USA002746: US-009507513-2209USA002481: US-009507513-2209USA002745: US-009507513-2209USA002570: US-009507513-2209USA002574: US-009507513-2209USA002469: US-009507513-2209USA002559: US-009507513-2209USA002573: US-009507513-2209USA002606: US-009507513-2209USA002532:
Age: 15.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE; patient was inadvertently administered VARIVAX and MMRII via intramuscular route as opposed to recommended subcutaneous route; This spontaneous report was received from physician and refers to a 15-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-SEP-2022, the patient was vaccinated with dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #T032318, expiration date: 22-SEP-2022, administered intramuscularly for prophylaxis (strength was not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #U014656, expiration date: 07-MAY-2023, administered intramuscularly for prophylaxis (strength was not provided) (incorrect route of product administration).  No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, Medication dilution, No adverse event
Clinical narrative: No additional adverse events reported; expired MMR-II was in advertently administered to twins; This spontaneous report has been received from a medical assistant, concerning a twin patient of an unknown gender and age. The patient's medical history, drug reactions or allergies, concurrent conditions, and concomitant medications were not provided.   On 07-SEP-2022, patient was inadvertently vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) (dose, formulation, strength, route of administration, vaccination scheme, and anatomical site of vaccination were not reported, lot number T029549 which had been verified to be valid, expiration date reported as 01-SEP-2022 but validated as 10-SEP-2022, conflicting information), as prophylaxis (Expired product administered). In addition, a sterile diluent (lot Number U001953, which has been verified to be valid, expiration date reported and validated as 18-JAN-2023) was used to reconstitute the vaccine (medication dilution). No additional adverse events were provided.; Sender's Comments:  US-009507513-2209USA003388:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers to a child of unknown gender. The patient's concurrent conditions, medical history, allergies or concomitant therapies were not reported.  On 12-JUL-2022, 60 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002782 with expiration date 24-JUL-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 60 patients vaccinated with vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002782  with expiration date 24-JUL-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers to a child of unknown gender. The patient's concurrent conditions, medical history, allergies or concomitant therapies were not reported.  On 12-JUL-2022, 60 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002782 with expiration date 24-JUL-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 60 patients vaccinated with vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002782  with expiration date 24-JUL-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs were reported.; Nurse reported that a patient received PROQUAD via intramuscular route instead of subcutaneous route on 9/8/2022.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and previous drug reactions or allergies were not reported. The patient's concomitant medications included sterile diluent.  On 08-SEP-2022, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection (lot number U031562 was verified to be a valid number, expiration date reported and established as 06-APR-2023), administered via intramuscular instead of subcutaneous for prophylaxis (exact dose, strength, anatomical injection site, and vaccination scheme were not provided) (incorrect route of product administration). No additional adverse events were reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE; Caller is a nurse who reports that PROQUAD and VARIVAX may have been given after a temperature excursion that occurred in April 2022. Vaccines were then sent back to the agency so she does not have time/temperature data and does not know whether any vac; This spontaneous report was received from a registered nurse and refers to a 4-year-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 14-APR-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #U019289, expiration date: 15-DEC-2022, administered subcutaneously in the right deltoid for prophylaxis (product storage error), it was mentioned that there was not previous temperature excursion. No additional adverse event was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA009203: US-009507513-2209USA003333: US-009507513-2209USA003334: