chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events reported; Proquad was administered improperly stored; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 23-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA))(PROQUAD) at a dose of 0.5 ml, lot # T034614, has been confirmed to be a valid, expiration date 10-APR-2021 for prophylaxis (dose #, route and anatomical location were not provided). The temperature excursion was as follows: 6 degrees Fahrenheit (F) to 14 F (8.5 degrees F) for 18 minutes and 6 degrees F to 14 degrees F (11.9 degrees F) for 1 hour. There were no previous excursions reported. No adverse events were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medication was provided. On 07-OCT-2021, the patient was vaccinated with incorrectly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032317 with expiration date on 22-SEP-2021 (dose and route of administration were unknown) for prophylaxis. No adverse event was reported. The vaccine underwent the temperature excursion of 11.9 degrees Fahrenheit for 1 hour, also reported as 1 hour and 18 minutes.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored Proquad was administered to a patient; This spontaneous report as received from a medical assistant 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 29-SEP-2021, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot# T027115, expiration date: 07-FEB-2022, albumin status has been verified as recombinant human albumin (rHA), 0.5 (units not provided) (route of administration and anatomical location were not provided) for prophylaxis.   Administered dose of vaccine experienced the temperature excursions between 6 and 14 degrees Fahrenheit (F): (8.5 F) for 18 minutes, and 11.9 F for 1 hour. There were no previous excursions reported. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored dose of Proquad was administered to a patient; This spontaneous report as received from a medical assistant 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 22-OCT-2021, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot# U002534, expiration date was reported as 10-APR-2022, but upon internal validation process it was established as 24-JUL-2022, albumin status has been verified as recombinant human albumin (rHA), 0.5 mL (route of administration and anatomical location were not provided) for prophylaxis.   Administered dose of vaccine experienced the temperature excursions between 6 and 14 degrees Fahrenheit (F): (8.5 F) for 18 minutes, and 11.9 F for 1 hour. There were no previous excursions reported. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; PROQUAD that was administered after improperly stored; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 06-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: U002534, expiration date: 24-JUL-2022; route of administration not provided) 0.5 mL (product storage error). The vaccine was stored in temperatures 6 degrees Fahrenheit to 14 degrees Fahrenheit (8.5 degrees Fahrenheit) for 0 hours 18 minutes and 0 seconds; 6 degrees Fahrenheit to 14 degrees Fahrenheit (11.9 degrees Fahrenheit) for 1 hour 0 minutes and 0 seconds. There was no previous temperature excursion. No adverse event was reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a Certified Medical Assistant and refers to a 12 month old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 29-SEP-2021, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, dose, frequency, route of administration, were not reported) lot # T032317, expiration date 22-SEP-2022 for prophylaxis. No additional sdverse event details available.  On an unknown date, the temperature excursion was 8.5 (6-14) degrees Fahrenheit for a time frame of 18 minutes and 11.9 (6-14) degrees Fahrenheit fot 1 hour. There was no previous excursion.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report as received from a medical assistant refers to a 12-month-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 20-OCT-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T032932, expiration date: 28-SEP-2022; dose and route of administration not provided) (product storage error). The vaccine was stored in temperatures 6 degrees Fahrenheit to 14 degrees Fahrenheit (8.5 degrees Fahrenheit) for 0 hours 18 minutes and 0 seconds; 6 degrees Fahrenheit to 14 degrees Fahrenheit (11.9 degrees Fahrenheit) for 1 hour 0 minutes and 0 seconds. There was no previous temperature excursion. No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events reported; Proquad that was administered improperly stored; This spontaneous report was received from a Certified Medical Assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 20-SEP-2021, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot # T027115, expiration date 07-FEB-2022 (formulation, strength, frequency, route of administration, were not reported) for prophylaxis. No additional adverse events reported.  On an unknown date, the temperature excursion was 8.5 (6 to 14) degrees Fahrenheit, for a time frame of 18 minutes and 11.9 (6 to 14) degrees Fahrenheit for 1 hour. There was no previous temperature excursion. The digital data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported.; was administered improperly stored during a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 05-OCT-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA)(PROQUAD), 0.5 milliliter, lot # T034614, expiration date 10-APR-2022 (dose number and route of administration were not reported) for prophylaxis (product storage error).  The vaccine was stored for cumulative time frame of 1 hour and 18 minutes as following: in the temperature of 8.5 degrees Fahrenheit (F) for 18 minutes and in the temperature of 11.9 F for 1 hour. There was no previous temperature excursion.  No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; administered after improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 18-OCT-2021, the patient was vaccinated with improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) lot # U002534, expiration date 24-JUL-2022, dose of 0.5 milliliter (formulation, strength, anatomical location and route of administration were not reported) for prophylaxis. The temperature excursion was reported as 8.5 degrees Fahrenheit (F) for 18 minutes and 11.9 degrees F for 1 hour (cumulative timeframe of 1 hour and 18 minutes). It was not reported if a digital data logger was used to capture the temperatures. There was no previous temperature excursion. No further information given. No additional adverse events reported.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of unknown gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 29-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032317 , expiration date 22-SEP-2022 for prophylaxis (dose #, exact dose, route and anatomical location were not provided). The temperature excursion was as follows: 6 degrees Fahrenheit (F) to 14 F (8.5 degrees F) for 18 minutes and 6 degrees F to 14 degrees F (11.9 degrees F) for 1 hour. There were no previous excursions reported. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; PROQUAD that was administered improperly stored during a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 28-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) at a dose of 0.5 ml, lot # T027115 confirmed to be valid, expiration date 07-FEB-2022 for prophylaxis (dose #, exact dose, route and anatomical location were not provided). The temperature excursion was as follows: 6 degrees Fahrenheit (F) to 14 F (8.5 degrees F) for 18 minutes and 6 degrees F to 14 degrees F (11.9 degrees F) for 1 hour. There were no previous excursions reported. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; was administered improperly stored during a temperature excursion; 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, allergies, drug reactions, concomitant therapies or medical history provided. On 29-SEP-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027115 was verified as valid, expiration date: 17-FEB-2022, albumin status: rHa), in dose 0 .5 ml for prophylaxis (dose number, route of administration and anatomical location were not reported). The temperature to which the vaccine was exposed was: 6 degrees of Fahrenheit (F) to 14 F (8.5F) and the time frame was reported as 18 minutes and additionally 6F to 14F (11.9F) for 1 hour. Cumulative Timeframe was 1 hour and 18 minutes. No previous temperature excursion was reported.  It was unknown if digital data logger was involved. No adverse symptoms were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; was administered improperly stored during a temperature excursion found; 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, allergies, drug reactions, concomitant therapies or medical history provided. On 30-SEP-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027115 was verified as valid, expiration date: 17-FEB-2022, albumin status: rHa), in dose 0 .5 ml for prophylaxis (dose number, route of administration and anatomical location were not reported). The temperature to which the vaccine was exposed was: 6 degrees of Fahrenheit (F) to 14 F (8.5F) and the time frame was reported as 18 minutes and additionally vaccine was exposed to 6F to 14F (11.9F) for 1 hour. Cumulative Timeframe was 1 hour and 18 minutes. No previous temperature excursion was reported.  It was unknown if digital data logger was involved. No additional adverse events reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product quality issue, Syringe issue, Underdose
Clinical narrative: 12 month old who received a partial dose; Nurse could not verify if the involved syringe was part of the V AQT A prefilled syringe formulation or if had been another syringe used after drawing up; no additional AE reported; This spontaneous report was received from a nurse referring to a 12-month-old patient of unknown gender.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).  It was reported that, while vaccinating the patient at least half' of the vaccine "squirted out" into the glove of the medical assistant when she was administering the dose. The medical assistant confirmed the needle was tightly on the syringe and that the vaccine did not leak out from the "needle point" but instead "squirted out from the syringe somehow (product quality issue, underdose). No adverse events were reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA007317:
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE; that a patient was inadvertently administered a dose of PROQU AD on 10/26/2021 with a labeled expiry of 10/17/2021; Patient age: 13 years; This spontaneous report was received from a registered nurse, who was also a nursing manager and refers to a 13-year-old patient of unknown gender. There was no information regarding their medical history, concurrent condition nor concomitant therapies provided.  On 26-OCT-2021, the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) 0.5 mL, lot # T013539, expiration date 17-OCT-2021 (route of administration and anatomical location were not provided) for prophylaxis (expired product administered, product administered to patient of inappropriate age). The registered nurse stated the patient reported no adverse event (AE) after the administration.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Injection site rash, Irritability
Clinical narrative: rash on his thigh (injection site); has been really irritable; received Proquad and Varivax accidently; This spontaneous report was received from a patient's mother and refers to her son, 12-month-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 21-OCT-2021, the patient was accidently vaccinated with his first doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) both in left thigh for prophylaxis (reported as routine vaccination) (exact doses, routes, lot # and expiration dates were not provided).  On the same date, he developed rash on his thigh (injection site) and had been really irritable. He received ibuprofen (MOTRIN) and tylenol as a treatment. He had not any laboratory diagnostic done. The outcome of the events was reported as not resolved.   The causality assessement was not provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE or PQC reported; Improperly Stored Administered Vaccine; This spontaneous repot was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 30-OCT-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin)(M-M-R II) lot # U006489 was confirmed to be valid, expiration date 26-FEB-2023, 1 time dose for prophylaxis (exact dose, route and site of administration were not reported). The administered dose was exposed to the temperature of 20 degrees Celsius (C) for 168 hours. There was no previous temperature excursion. No signs or symptoms were reported. No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; an expired dose of RECOMBIVAX HB was administered; This spontaneous report was received from registered nurse concerning a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not provided.  On 02-NOV-2021, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # S022584, expiration date: 31-OCT-2021) (dose number, route of administration, and anatomical location were not reported) for prevention of hepatitis B (Expired product administered).  No additional adverse event was reported.  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA000945:
Age: 27.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional adverse experiences reported by the patient.; Nurse calling to report administration of an expired dose of VAQTA.; This spontaneous report was received from a Licensed Practical Nurse (LPN), referring to a 27-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 04-NOV-2021, the patient was vaccinated with a single expired dose of hepatitis a vaccine, inactivated (VAQTA) as prophylaxis (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number T017179 has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, expiration date reported and but upon internal validation established as 26-OCT-2021) (expired product administered). No prior temperature excursions reported on this product. No additional adverse experiences reported by the patient.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; vaccines were previously short dated for 1 month after excursion and then were administered after the short date; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history, previous drug reactions or allergies, and concomitant medications were not provided      On 20-OCT-2021 (also reported as 1 month after excursion and after the short date), the patient was vaccinated with an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration, and anatomical location were not reported; lot number T03232, had been verified to be a valid number; expiration date 22-SEP-2022). The  temperature  excursion was at 55.9 degrees Farhrenheit on 15-SEP-2021 for a time frame of 30 minutes. No additional adverse event reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA002247:
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to an elderly patient of unknown gender. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On 30-APR-2010 (at approximately 70 years old), the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, frequency, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as subsequently), the patient was treated by providers for the following injury resulting from patient's zoster vaccine live(ZOSTAVAX): herpes zoster. The outcome of herpes zoster was not provided. The lawyer considered herpes zoster to be related to zoster vaccine live(ZOSTAVAX).
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events; administration of PROQUAD to a 14 year old; This spontaneous report was received from a nurse referring to a 14 year old patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  The nurse reported that the patient had incomplete vaccination history and had a separate dose of "MMR and varicella" in May 2012. On 27-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # U015480, expiration date 13-NOV-2022 at a dose of 0.5 milliliter for prophylaxis (product administered to patient of inappropriate age). The patient was not experiencing any symptoms at this time. No additional adverse events reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; an expired MMR II was administered; This spontaneous report was received from an office manager referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     On 09-NOV-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S035352, expiration date 05-NOV-2021, at a dose of  0.5 milliliter for prophylaxis. The vaccine did not have a temperature excursion. No additional adverse event reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; VARIVAX was administered again 9NOV2021; Patient had MMRII vaccine administered 7OCT2021. Pateient then had VARIVAX administered on 24OCT2021, before 28 days; This spontaneous information was received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 07-OCT-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided). On 24-OCT-2021 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml for prophylaxis (lot number: U015688 with expiration date on 18-MAY-2023) (strength, frequency, route of administration and anatomical location were not provided) before 28 days (inappropriate schedule of product administration). Additionally, on 09-NOV-2021, the patient was vaccinated again with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) (inappropriate schedule of product administration).  No additional adverse event reported.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported; Medical assistant reports administration of an improperly stored dose of ROTATEQ; This spontaneous report has been received from a medical assistant referring to a 8 weeks old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported.  On 08-NOV-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ),  lot # 1821791, expiration date 26-JUL-2022, 2 milliliter for prophylaxis (route was not reported) (product storage error). No other adverse event reported. There was no previous temperature excursion. The improperly stored temperature and duration as follows: 34.7 Fahrenheit for 0 hours 25 minutes and 0 seconds; 35.4 Fahrenheit for 5 hours 0 minutes and 0 seconds; 35.6 Fahrenheit for 3 hours 20 minutes and 0 seconds;  35.9 Fahrenheit for 0 hours 25 minutes and 0 seconds; 35.7 Fahrenheit for 0 hours 25 minutes and 0 seconds; 35.2 Fahrenheit for 3 hours 20 minutes and 0 seconds; 33.8 Fahrenheit for 18 hours 20 minutes and 0 ; 32.1 Fahrenheit for 23 hours 45 minutes and 0 seconds; 32.5 Fahrenheit for 9 hours 35 minutes and 0 seconds.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; vaccine expired on 05NOV2021 and was administered on 09NOV2021; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 09-NOV-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA))(M-M-R II) 0.5 milliliter, lot number S035356, expiration date 05-NOV-2021 (route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported. The vaccine had not had any temperature excursion.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to an elderly patient of unknown gender. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2017 (at approximately 68 years old), the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (strength, dose, route, lot # and expiration date were not reported) by a healthcare provider at a pharmacy. On an unknown date, the patient was treated by a health care provider at eye care for the injury resulting from patient's zoster vaccine live (ZOSTAVAX) use: shingles. At the reporting time, the outcome of the event was unknown. The causality between the event and suspect vaccine was considered as related  by the lawyer.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles/herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 75-year-old patient (pt) of unknown gender. The pt's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date in 2016, the pt was administered the zoster vaccine live (ZOSTAVAX) vaccine (lot #, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist at the pharmacy. Subsequently, on an unknown date, the pt was treated by a healthcare provider at the clinic for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): shingles/herpes zoster. The outcome of the shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to a patient (pt) of unknown gender, whose age at the time of vaccination with zoster vaccine live (ZOSTAVAX) was at least 68 years old. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2015, the pt was administered zoster vaccine live (ZOSTAVAX) vaccine (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist at a pharmacy. Subsequently, on an unknown date, the pt was treated by a healthcare provider at a medical center for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Cerebrovascular accident
Clinical narrative: anaphylaxis/stroke; anaphylaxis/stroke; This spontaneous report was received from a physician (discrepant information, also reported as a consumer) via Pfizer and refers to a male patient, who was 24 years old at the time of the report. There was no information regarding his medical history, concurrent condition nor concomitant therapies provided.  On an unspecified date (reported as previously), the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (reported as chickenpox/varicella vaccine) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, after the vaccine administration, he experienced anaphylaxis or stroke. The outcome of the event was unknown.  The causal relationship between the event and the suspect vaccine was not reported.  Upon internal review, the events of anaphylactic reaction and cerebrovascular accident were considered to be medically significant.
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, Incorrect route of product administration, No adverse event
Clinical narrative: no additional AE; inadvertently administered a dose of PROQUAD with a labeled expiry of 10/17/2021; This initial spontaneous report was received from a License Practical Nurse (L.P.N) concerning a 9-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported.       On 12-NOV-2021, the patient was inadvertently vaccinated with a 0.5 mL dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route not provided) Lot # T013536 with a labeled expiry of 17-OCT-2021 (expired vaccine administered). No known temperature excursions involved. No additional events were reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2111USA005333:
Age: 7.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; a dose of PROQUAD on 11/12/2021 with a labeled expiry of 10/17/2021.; This spontaneous report was received from a nurse, referring to a 7-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 12-NOV-2021 the patient was vaccinated with expired one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T013536, expiration date 17-OCT-2021, 0.5 milliliter, strength and route were not provided) for prophylaxis (expired product administered. No known temperature excursions involved. Caller reports no additional adverse event.  This is one of two case from same reporter.; Sender's Comments:  US-009507513-2111USA005198:
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Immunoglobulin therapy, Kawasaki's disease, Vaccination failure
Clinical narrative: not have immunity for the Varicella virus, despite receiving her immunization; Kawasaki Disease; This spontaneous report was received from a patient's mother and refers to a 6-year-old non-pregnant female patient. The patient had an allergy to aspirin. No information regarding her medical history or concomitant medications was provided.  On 06-APR-1996, the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (reported as an unspecified "Varicella vaccine") one dose for prophylaxis (exact dose, lot #, expiration date, route and site of administration were not reported).  On an unspecified date in December 1996, she was diagnosed with Kawasaki's disease and received an unspecified immunoglobin therapy as a treatment.   On an unknown date in October 2021, the patient had bloodwork performed, which showed that she did not have immunity for the "Varicella vaccine", despite receiving immunization (vaccination failure). The reporter additionally mentioned that the patient was "fertility" and at the reporting time was in the process of trying to get pregnant. The outcome of the events was not reported.  The causality assessment was not provided, however the event of vaccination failure was determined to be related to the suspect vaccine.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA005479:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other issues or concerns noted; a patient received a dose of MMRII that had expired; This spontaneous report as received from a medical assistant (also conflictingly referred to as "customer") refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 16-NOV-2021, 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), lot # S035356, expiry date 05-NOV-2021 (dose, route and anatomical location of administration were not reported) for prophylaxis (expired product administered). No other issues or concerns were noted (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles (disease); This spontaneous report has been received from a other health professional via GLAXOSMITHKLINE, referring to a female patient of unknown age. As concurrent conditions a penicillin allergy was reported. The patient's medical history included COVID-19 and hospice care.  Concomitant medications were not provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, lot# and expiration date were not provided) subcutaneously for prophylaxis.    On an unknown date, the patient experienced shingles (disease) (herpes zoster). At the reporting, the outcome and the causal relationship between the event herpes zoster and zoster vaccine live (ZOSTAVAX) were not provided.
Sex: F
Vaccine: HEPA
Symptoms: Accidental exposure to product, Occupational exposure to product, Product quality issue, Syringe issue
Clinical narrative: "squirted out" into the glove of the medical assistant when she was administering the dose; "squirted out" into the glove of the medical assistant when she was administering the dose; Nurse could not verify if the involved syringe was part of the V AQT A prefilled syringe formulation or if had been another syringe used after drawing up; no additional AE reported; This spontaneous report as received from a nurse referring to a female medical assistant of unknown age.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  It was reported that, while vaccinating a child with hepatitis a vaccine, inactivated (VAQTA), at least half' of the vaccine "squirted out" into the glove of the medical assistant when she was administering the dose. The medical assistant confirmed the needle was tightly on the syringe and that the vaccine did not leak out from the "needle point" but instead "squirted out from the syringe somehow (product quality issue, occupational exposure to product and accidental exposure to product).  Nurse could not verify if the involved syringe was part of the hepatitis a vaccine, inactivated (VAQTA) prefilled syringe formulation or if had been another syringe used after drawing up from the vial formulation. No adverse events were reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA008094:
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Limb mass, Rheumatoid arthritis
Clinical narrative: flareup, pain in wrist; lump under left arm; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021177869), license party for etanercept (ENBREL).  This serious solicited report (USASL2021177869) was reported to Amgen on 09/NOV/2021 by a consumer from a commercial program (PSP00086) and involves a 48 year old female patient who had flareup, pain in wrist [PT: rheumatoid arthritis], lump under left arm [PT: limb mass] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were reported. The co-suspect medications included covid-19 vaccine. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date in 2021, the patient reported flare up, pain in wrist and lump under left arm after receiving second Covid vaccine in JUN/2021. No treatment information was received. The outcome of the events rheumatoid arthritis, limb mass were reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the events rheumatoid arthritis and limb mass. The causal relationship between the events rheumatoid arthritis, limb mass and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected. Follow up has been requested for lot number.  The reporter's assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Amgen comment:This individual case report does not change the safety profile of the product.  Amgen assessment: Amgen assessed the events Rheumatoid arthritis flare up, Upper extremity mass as serious and unrelated to etanercept.  No follow up attempts are possible. Information on the lot/batch number cannot be obtained.; Sender's Comments: Pfizer comment: Based on the information provided by the reporter, it appears unlikely that the suspect drugs contributed to the reported events, that most likely were due to underlying medical conditions.
Age: 16.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 Year-Old Received First Dose; Initial Report Received on 02-Sep-2021  A licensed practical nurse in the US (OH) reported that a 16 year-old male patient (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   The patient did not have any allergies. No other relevant medical history was reported.  No relevant concomitant medications were reported.  On 16-Aug-2021, a 16 year-old male patient received the first dose of HEPLISAV-B injection (Lot # 934976, expiration date 30-Jul-2022, and NDC # 43528-003-01; serial number not reported) in the left deltoid. No adverse effects were reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had vaccination, but had shingles/ suspected vaccination failure; had shingles, are bad bed fellow; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient had shingles, took the vaccination but had shingles again. The patient stated that, shingles were a bad bed fellow. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Age: 0.08
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only received the Rotarix diluent; Only received the Rotarix diluent; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a 6-week-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received only the Rotarix diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient was receiving multiple vaccines at the same visit. It was realized after the fact that the patient only received the Rotarix diluent. No further information was reported. The follow-up would not possible as no contact details were available.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash, manageable but annoying, Is very itchy; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of itchy rash in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 5th August 2021).   On 13th October 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced itchy rash. The patient was treated with hydrocortisone (Hydrocortisone Topical Cream). On an unknown date, the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient had received Shingrix and had now developed a rash in left knee and thigh that was very itchy for the last two weeks. The patient asked did this rash might be related to vaccine. The patient said it was manageable but annoying, controlling with topical hydrocortisone cream. Needed to rule out any other cause for this rash.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash pruritic
Clinical narrative: rash, head to toe; painful, head to toe rash, in agony; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced itchy rash and pain. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the itchy rash was not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the itchy rash and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had 2nd dose of Shingles and less than week later was covered in painful, itching rash head to toe.  The patient had been taking a lot of meds, but another week has gone by and could see no improvement in rash.  Steroids and vitracil helped, but the patient was in agony. This case was linked by US2021AMR216429, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR216429:Reporter tagged the other case's patient in a comment. US-GLAXOSMITHKLINE-US2021AMR216429:reporter tagged in comment