chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a currently 45-year-old female patient who was referring to herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JUL-2021, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (formulation, dose, site and route of administration, lot # and expiration date were not provided) for prophylaxis. On 22-DEC-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (formulation, dose, site and route of administration, lot # and expiration date were not provided) (inappropriate schedule of product administration). The caller reported a missed dose and she believed that she received the 2-dose regiment. No further information was provided, no additional adverse event / product quality complaint (AE/PQC) was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; Administration of improperly stored ROTATEQ; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 28-DEC-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (Lot# 1741817 and expiration date 30-JUL-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of 50.5 Fahrenheit for a period of 57 minutes. There was no previous temperature excursion. No additional adverse event reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; Administration of improperly stored ROTATEQ; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 22-DEC-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (Lot# 1741817 and expiration date 30-JUL-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of 50.5 Fahrenheit for a period of 57 minutes. There was no previous temperature excursion. No additional adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No adverse event; Medical assitant reports the administration of improperly stored VAQTA; This spontaneous report has been received from a medical assistant, concerning a patient of unknown gender and age.   The patient's concurrent conditions, medical history and concomitant medication were not reported.  On 23-DEC-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) (lot # T031202  has been verified to be valid, expiration date 14-JUN-2022) (anatomical location not provided) for prophylaxis. Temperature was 50.5 farenheit (F), time frame 57 minutes with no previous excursion. No additional adverse events reported.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a lawyer concerning a 48-year-old female patient. Her medical history included chickenpox. She was a smoker in the past. Her concomitant medications included influenza vaccine (FLU). The concurrent conditions were not reported. In November 1995, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) as prophylaxis (dose, dosage schedule, lot number, expiration date and route of administration were not reported) (inappropriate age at vaccine administration). No adverse reactions were reported. On 29-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) and experienced shingles (captured in MARRS 2109USA005241).; Sender's Comments:US-009507513-2109USA005241.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported.; Medical Assistant reports the administration of improperly stored VAQT A at 50.5 F; 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 medications were not reported.  On 27-DEC-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe (lot # T031202, expiration date 14-JUN-2022) 0.5 milliliter (frequency and route of administration were not reported) for prophylaxis (product storage error). The vaccine was stored at 50.5 degree Fahrenheit (F) for 57 minutes. No previous temperature excursions were reported. No additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported. No product quality complaints reported. No further details provided.; Medical Assistant reports the administration of improperly stored VAQTA.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 17-DEC-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T031202, expiration date 14-JUN-2022) 0.5 milliliter (anatomical location and route of administration were not reported) for prophylaxis (product storage error). The vaccine was stored at 50.5 degrees Fahrenheit (F) for 57 minutes. No previous temperature excursions were reported and it was not reported if a digital data logger was involved. No previous temperature excursion reported.  No additional adverse events were reported (no adverse event).
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: PNEUMOVAX23 Expired on 03-DEC-2021, was administered on 31-DEC-2021; This spontaneous report was received from a medical assistant regarding a 66-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On 31-DEC-2021, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml for prophylaxis, lot # T007790 with expiration date on 03-DEC-2021 (strength, dose number, anatomical location and route of administration were not reported). The dose was properly stored and temperature excursion did not ocurred.
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 16-SEP-2021, the temperature went out of range in the freezer where the vaccines were stored. The vaccine was taken to the hospital freezer with half an hour of temperature out of range. The freezer was replaced, and the vaccines were stored in the new freezer, 7 days after freezer temperature was controlled. On 22-OCT-2021, 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) (dose 1, subcutaneously in the right leg; lot number reported as 0002534 expiration date 24-JUL-2022) for prophylaxis. Lot number 0002534 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Lot number 0002534 does not match any Company product as confirmed by Lot Verification team.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a patient, refers to himself or herself of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were unknown. On an unknown date in 2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) as prophylaxis (dose, lot number, expiration date, route of administration and anatomical location were not reported). The patient mentioned that, anyone could get shingles, even after the vaccination (vaccination failure). On an unknown date, the patient experienced shingles (herpes zoster) and at the time of the report, he/she was recovering from the first episode. The outcome of herpes zoster was reported as recovering. The reporter did not provide the causality assessment between zoster vaccine live(ZOSTAVAX) and herpes zoster.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Rash
Clinical narrative: Shingles; Neuralgia affecting the nerves of your torso; This spontaneous report was received from a consumer via Agency referring to a patient of unknown age and gender. Patient's concurrent conditions, historical condition and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, lot#, expiration date and anatomical location were not provided) for prophylaxis.   On an unknown date in 2018 ( three years ago), after taking the zoster vaccine live (ZOSTAVAX), the patient had shingles manifested by Rash one evening and it was gone in next morning and had neuralgia affecting the nerves of your torso which was very painful. On an unknown date, Patient took new vaccine to prevent another outbreak and the patient stated that, would recommend the vaccine, 15% of people who get the shingles develop neuralgia ! why is that not mentioned?  The outcome of the events was unknown.   The reporter did not provide the causality assessment between zoster vaccine live (ZOSTAVAX), shingles and neuralgia.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; PROQUAD was administered to a patient after a temperature excursion; This spontaneous report was received from a vaccine coordinator and referred to a patient of unknown age and gender. No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies and concomitant medications were provided.  On an unknown date the patient was vaccinated with the dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), subcutaneously 0.5 milliliter (ml), lot # U022728 has been verified to be a valid lot number, expiration date was reported and established as 16-JAN-2023, vaccination site was not provided) for prophylaxis.   On 29-DEC-2021, it was reported that measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), was administered to a patient after temperature excursion (product storage error). The vaccine was stored at a temperature of 8.1 Celsius (C) for a time frame of 2 hours and 58 minutes. No information was provided regarding previous temperature excursion.   No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a vaccine coordinator, and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not provided. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHa, dose:0.5 ml, lot # U022728 expiration date: 16-JAN-2023 as prophylaxis (route of administration and anatomical location were not provided). On 28-DEC-2021, the doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) had a temperature excursion (product storage error) of 8.1 degree Celsius for 2 hours 58 minutes and 0 seconds. No additional adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no adverse event; Administration of expired M-M-R II to a patient; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies and concomitant medications were provided.  On 03-JAN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (recombinant Human albumin) (M-M-R II) 0.5 milliliter (ml) (lot # S039312 has been verified to be a valid lot number, expiration date was reported and established as 04-DEC-2021), subcutaneously for prophylaxis (expired product administered).   No product quality complaint (PQC) and no additional adverse event (AEs) were reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; Administration of expired ROTATEQ; This spontaneous report was received from a licensed practical nurse referring to a 2-month-old patient of unreported gender. The patient's relevant medical history, drug reactions or allergies, and concomitant medications were not provided.    On 04-JAN-2022, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter (expired product administered) (lot number T033812, expiration date 29-DEC-2021; dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis. Nurse inquiring viability of expired dose.     No product quality complaints reported and no additional adverse events (no adverse event) were reported.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AE's reported; M-M-R II was administered intramuscular Instead of subcutaneous; This spontaneous report as received from pharmacist referring to a 24-year-old female patient. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 03-JAN-2022, the patient was mistakenly vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA)(M-M-R II) (lot # T016197 and expiration date 11-MAY-2022), 0.5 ml, intramuscular (Instead of SC) in left deltoid muscle for prophylaxis (incorrect route of product administration). No additional AEs reported. No PQC.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Dose of ROTATEQ involved in the temperature excursion was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 23-DEC-2021, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2.0 ml, (lot # 1707499 and expiration date reported as 30-MAR-2022) involved in the temperature excursion for prophylaxis (Product storage error).  The temperature of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), was stored at 13.9C for 2 hours 50 minutes. No previous temperature excursion involved. No additional AE was reported. No PQC reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AEs; Administered an expired dose of ROTATEQ; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions or allergies, and concomitant medications were not provided.      On 04-JAN-2022, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter (expired product administered) (lot number T033510, expiration date 28-DEC-2021; dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis.    No product quality complaints reported and no additional adverse events (no adverse event) were reported.
Sex: U
Vaccine: MMRV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Temperature excursion; This spontaneous report was received from an office manger referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 12-AUG-2021, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot # U026795, expiration date: 26-FEB-2023 (dose, frequency, route of administration were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) with lot # 1742463, expiration date: 20-SEP-2022 (dose, frequency, route of administration were not provided) for prophylaxis had temperature excursions. Temperature for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was -14 degree C to -10 degree C (-10.1 degree C) for 0 hours 46 minutes and 0 seconds. Temperature for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was above 9 degree C (9.79 degree C) for 0 hours 45 minutes and 0 seconds. The caller could not confirm if measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) were administered.  No Additional AE, NO PQC and no additional information was provided.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered to a patient after a temperature excursion.; This spontaneous report has been received from vaccine coordinator referring to a patient of unknown age and gender. No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided  On 28-DEC-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD),0.5 ml (lot number # U022728 has been verified to be a valid lot number, expiration date reported and established as 16-JAN-2023,) after a temperature excursion (product storage error) (doses, vaccination schemes, routes of administration and anatomical site of vaccination were not reported), as prophylaxis.   The vaccine was exposed to a temperature of 8.1 C, for a time frame of 2 hours 58 minutes and 0 seconds. There was no information regarding previous temperature excursions.   No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported. On 06-DEC-2021, the patient was vaccinated with improperly stored Varicella virus vaccine live (oka/merck)(VARIVAX) (Lot# U015680 and expiration date 18-MAY-2023) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 13.6 Celsius) for 0 hours 45 minutes and 0 seconds and minus 14 degree Celsius to minus 10 degree Celsius (minus 13.5 Celsius) for 0 hours 45 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report received from a consumer and refers to a patient of unknown age and gender. The information about patient's pertinent medical history, drug reactions and allergies, and concomitant medications were unknown. On an unknown date, the patient vaccinated with Zoster Vaccine Live (ZOSTAVAX) (reported as shingles vaccine) (route of administration, frequency, indication, lot number and expiration date were not reported. The patient reported that, the first bout of shingles was over 5 years ago and still had post herpetic neuralgia. The patient had three lesser flare ups in the 5 years and confirmed that had all shingles shots. The patient had first shot years ago and had shingles three years ago. Because of the vaccine the patient did not realize and had only rash one evening and it was gone the next morning. The patient suffered with neuralgia since then (very painful) no cure. The patient had new vaccine to prevent another outbreak. Outcome of the events was unknown. The reporter did not assess the causality between Zoster Vaccine Live (ZOSTAVAX) and events shingles and post herpetic neuralgia.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported. On 28-DEC-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Lot# U015680 and expiration date 18-MAY-2023) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 13.6 Celsius) for 0 hours 45 minutes and 0 seconds and minus 14 degree Celsius to minus 10 degree Celsius (minus 13.5 Celsius) for 0 hours 45 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported. On 29-NOV-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHA (Lot# U002530 and expiration date 24-JUL-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 13.6 Celsius) for 0 hours 42 minutes and 0 seconds and minus 14 degree Celsius to minus 10 degree Celsius (minus 13.5 Celsius) for 0 hours 45 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product in use; No additional adverse effect reported, no further information provided; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 30-NOV-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHA (Lot# U002530 and expiration date 24-JUL-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 13.6 Celsius) for 0 hours 42 minutes and 0 seconds and minus 14 degree Celsius to minus 10 degree Celsius (minus 13.5 Celsius) for 0 hours 45 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product in use; No additional adverse effect reported, no further information provided; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 30-DEC-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Lot# U015680 and expiration date 18-MAY-2023) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 13.6 Celsius) for 0 hours 45 minutes and 0 seconds and minus 14 degree Celsius to minus 10 degree Celsius (minus 13.5 Celsius) for 0 hours 45 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported. On 22-NOV-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Lot# U015680 and expiration date 18-MAY-2023) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 13.6 Celsius) for 0 hours 45 minutes and 0 seconds and minus 14 degree Celsius to minus 10 degree Celsius (minus 13.5 Celsius) for 0 hours 45 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product in use; No additional adverse effect reported, no further information provided; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 23-NOV-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Lot# U015680 and expiration date 18-MAY-2023) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 13.6 Celsius) for 0 hours 45 minutes and 0 seconds and minus 14 degree Celsius to minus 10 degree Celsius (minus 13.5 Celsius) for 0 hours 45 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product in use; No additional adverse effect reported, no further information provided; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 09-DEC-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHA (Lot# U002530 and expiration date 24-JUL-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 13.6 Celsius) for 0 hours 42 minutes and 0 seconds and minus 14 degree Celsius to minus 10 degree Celsius (minus 13.5 Celsius) for 0 hours 45 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported. On an unspecified date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHA (Lot# U002535and expiration date 24-JUL-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of 6.4 Fahrenheit for 2 hours 30 minutes and 0 seconds. There was no previous temperature excursion. No further information provided.
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient received ROTATEQ and VAXELIS after a temperature excursion; This spontaneous report as received from a Licensed Practical Nurse to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapies were not provided.      On 12-SEP-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # T040207, expiration date of 18-JUL-2022, orally and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) lot# u7124AA expiration date of 13-JUL-2024, after a temperature excursion (product storage error) for prophylaxis. The temperature excursion was 49F and lasted 1 hour 24 minutes. There was no previous temperature excursion. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 04-JAN-2022.The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around April 2015, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly, after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles. As direct and proximate results of defective Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX), also the patient 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), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX) wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) conduct, 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 shingles was not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  The event shingles was considered to be disabling by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; zoster-related conditions; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 2017, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a physician, for shingles, and other zoster-related conditions. As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff has and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was reported as not recovered. The lawyer considered shingles, and other zoster-related conditions to be related to zoster vaccine live(ZOSTAVAX).   .
Sex: M
Vaccine: VARZOS
Symptoms: Labyrinthitis
Clinical narrative: acute labyrinthitis; This spontaneous report was received from a lawyer and a male patient of unknown age regarding a case in litigation on 04-JAN-2022.The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around February 2013, the patient was vaccinated 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 acute labyrinthitis. As direct and proximate results of defective Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX), also the patient experienced mental and emotional distress due to resulting physical limitations and seriousness his conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Zoster Vaccine Live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX) wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) conduct, 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 acute labyrinthitis was not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  The event acute labyrinthitis was considered to be disabling by the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from an vaccine coordinator referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 30-DEC-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U016065, expiration date 20-MAY-2023) 0.5 mL (route, anatomical location and frequency not reported) for prophylaxis. The vaccine was stored at 8.1 degrees Celsius (C) for 2 hours, 58 minutes and 0 seconds. No previous temperature excursion were reported and it was unknown is a digital data logger was involved. No additional adverse events (AEs) were reported.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: the injection bumped up and had some bleeding; the injection bumped up and had some bleeding; Patient experienced swelling at injection site; This spontaneous report as received from a pharmacist refers to a 84 year old female patient.      The patient's concurrent conditions, medical history, and concomitant medications were not provided.  On 04-JAN-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Lot # T039322, 09-SEP-2022) 0.5 mL, intramuscularly in the right arm for prophylaxis (The dose number was not reported).    The patient experienced swelling at injection site (vaccination site swelling) after the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The pharmacist reported that the patient has thin arms and reported that the injection bumped up (vaccination site mass) and had some bleeding (vaccination site haemorrhage). The pharmacist reported that the swelling was going down.   The outcome of the events was reported as recovering. The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Pain
Clinical narrative: Herpes Zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In or around 23-AUG-2012, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live(ZOSTAVAX) Plaintiff suffered severe pain and blisters and was diagnosed with Herpes Zoster. As a direct and proximate result  of defective zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff's symptoms had resulted in physical limitations not present prior to using the product. Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of  zoster vaccine live(ZOSTAVAX), Plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, Plaintiff 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 Defendants' conduct, Plaintiff has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The lawyer considered shingles, and other zoster-related conditions to be related to zoster vaccine live(ZOSTAVAX).  The lawyer considered the events to be disabling.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's current condition, pertinent medical history and concomitant therapy were not reported. On 21-DEC-2021 the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027936 and expiration date 18-AUG-2022) for prophylaxis (product storage error). The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA)(M-M-R II) was 27.4C for 53 Hours and 30 Minutes. There is no previous temperature excursion.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. The patient's current condition, pertinent medical history and concomitant therapy were not reported. On 25-OCT-2021, the patient had inadvertent concomitant administration of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (lot # T037955 and expiration date reported as 09-MAY-2022), 0.5 ml and varicella virus vaccine live (oka/merck)(VARIVAX) (Lot # T035400 and expiration date reported as 16-Oct-2022), 0.5 ml for prophylaxis (accidental overdose). No additional adverse events reported. No product quality complaints reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP reports no other AE's; Administration of proquad to 15-year-old female; This spontaneous report was received from a nurse referring to a 15-Year-old female patient. Patient's concurrent conditions,medical history and concomitant medications were not provided.     On 05-JAN-2022, the 15- year-old patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha) (PROQUAD) injection 0.5 milliliter one time with lot # U022729 and expiration date: 16-JAN-2023 for prophylaxis (Product administered to patient of inappropriate age). No other AEs, no PQC nor further information was reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Temprature excursion; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 21-DEC-2021, Vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rha) (M-M-R II) with lot # T027936, expiration date:18-AUG-2022 ( dose, frequency, route of administration were not provided) for prophylaxis had temperature excursion (Product storage error). Temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rha) (M-M-R II) was 27.4C, time frame: 52 hours and 30 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 23-DEC-2021, the patient was vaccinated with improperly stored , mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (Lot# T027936 and expiration date 18-AUG-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of 27.4 degree Celsius. Time frame was 52 hour and 30 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Expired vaccine administered; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 03-JAN-2022, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (expiration date 04-NOV-2021) (dose, route, frequency, anatomical location and lot # were unknown) for prophylaxis (expired product administered). No additional adverse events were reported.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; The RECOMBIVAX HB was administered on 03JAN2022 and expired on 04NOV2021; This spontaneous report was received from a medical assistant and refers to an 8-week-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 03-JAN-2022, the patient was vaccinated with an expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB), lot #S002770, expiration date: 04-NOV-2021, administered for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PROQUAD was inadvertantly administered to 32 year old patient; No Additional AE; This spontaneous report as received from a Nurse referring to a 32-year-old patient of unknown gender. Patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug reactions, or allergies were unknown.   On 06-JAN-2022, the patient was inadvertently administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rha (recombinant human albumin) (PROQUAD) with lot # T035392 and expiration date: 14-Apr-2022 (dose, frequency, route of administration was not provided) for prophylaxis (product administered to patient of inappropriate age). No additional Adverse event, no PQC and no additional information was provided.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: First Dose Heplisav-B Second Dose Engerix; Initial Report Received on 10-Nov-2021  A registered nurse reported that a patient (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization for the first dose and a second hepatitis B vaccine was given, which was Engerix.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported), route and site not reported.   Just over a month later, a second hepatitis B vaccine was given, which was Engerix. No adverse reactions were reported.  No additional information was reported. The reporter refused to provide any further details.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.