chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Tinnitus, Vertigo
Clinical narrative: This is a spontaneous case initially received from other non-healthcare professional on 13-Jan-2019, concerning a 38-year-old, adult, male patient. The patient's historical drug included Zantac (ranitidine; as needed) but had not used in past 5 months. The patient had no relevant medical history. On 27-Oct-2018, the patient was administered FLUCELVAX (QIVc) (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252679 and expiry date: not reported) for influenza prophylaxis. On 18-Nov-2018, 22 days after the vaccination, the patient woke up with hearing loss in right ear, followed by vertigo, dizziness, and tinnitus. The patient went to the Internist on 29-Nov-2018, who misdiagnosed as congestion in the ear. As there was no improvement, the patient then saw an ear, nose, and throat specialist who diagnosed as sudden sensorineural hearing loss (reported as Sudden sensonoral hearing loss) and gave high dose of unspecified steroids. The patient had not recovered from the events and the side effects were continuing. The reporter assessed this case as non-serious. Reporter's Comments: A 38-year-old, male patient developed sudden sensorineural hearing loss manifested by vertigo, dizziness, and tinnitus 22 days after administration of FLUCELVAX QIV. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event (Sudden Sensorineural Hearing Loss) as serious (medically significant).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a female patient of unknown age (Unable to decipher date of birth reported) referring to herself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The female patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2012, the patient was administered the ZOSTAVAX by a healthcare provider at a medical center/hospital (lot number, dosage and route of administration not provided). In 2013, the patient was treated by a healthcare provider at a hospital for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, the spouse, and a 62-year old female patient referring to herself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The female patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 06-FEB-2012, the patient was administered the ZOSTAVAX by a healthcare provider at a clinic (lot number, dosage and route of administration not provided). In 2015, the patient was treated by a physician at the clinic for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Information has been received from a lawyer, the female patient and spouse of female patient regarding a case in litigation, concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2012, the female patient was administered the ZOSTAVAX by a pharmacist in a pharmacy (lot number, dosage and route of administration not provided). In 2012, the patient was treated by a healthcare provider at a hospital for the following injury resulting from her ZOSTAVAX use: Bell's Palsy. The patient claims damages as a result of injury to themselves, loss of consortium, and economic losses. The outcome of Bell's Palsy was unknown. Upon internal review, Bell's Palsy was determined to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: Information has been received from a lawyer and an administrator for the estate of a deceased female patient of unknown age (DOB reported). No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 23-AUG-2012, the female patient was administered the ZOSTAVAX by a healthcare provider at a store pharmacy (Lot number, dosage and route of administration not provided). On or about 07-JUN-2016, the patient was treated by a healthcare provider at a clinic for the following injury resulting from her ZOSTAVAX use: Shingles. The administrator for the estate of a deceased female patient claims damages as a result of injury to themselves, and economic losses. The outcome of Shingles was unknown. It was also reported that the patient died on 11-APR-2018. The cause of death was not reported. It was unknown if an autopsy was performed. Upon internal review, the event of Death was determined to be a medically significant event. Additional information has been requested. Reported Cause(s) of Death: Death.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from a health professional via Pfizer (manufacturer report # 2018433973) concerning a currently 48 years old female patient. The patient was allergic to COMPAZINE. Information on patient's medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, strength, dose number, therapy type, # lot and expiry date not provided). It was reported that, the patient had allergy to PNEUMOVAX 23. The action taken with suspect therapy and outcome of the event was unknown. Causality assessment was not reported. Sender's Comments: US-PFIZER INC-2018433973.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 94 year old male patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. In October 2011 the patient was administered ZOSTAVAX by a pharmacist (lot# and route unknown).  On or about 06-FEB-2017, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX.  The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. On or about 05-SEP-2012, the patient was administered ZOSTAVAX by a pharmacist (lot# and route unknown). On or about 18-DEC-2015, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown, born on date reported as "17205"). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. On or about 03-JAN-2013, the patient was administered ZOSTAVAX by a physician (lot# and route unknown).  On or about 26-DEC-2016, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 34 year old male patient (born on date reported as 17380). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. On or about 12-MAY-2009, the patient was administered ZOSTAVAX by a healthcare provider (lot# and route unknown). On or about 24-SEP-2014, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX.  The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 26-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 28-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 10-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 03-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 10-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 14-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 13-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 07-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 21-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 03-JAN-2019, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 22-OCT-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 20-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 20-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 13-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 12-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 06-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 21-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 09-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 14-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 08-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 10-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 17-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 13-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 11-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. There was no information regarding pertinent medical history and drug allergies or reactions. On 17-JAN-2019 the patient was vaccinated with improperly stored VARIVAX, lot # N023963, expiration date- 01-SEP-2019, for prophylaxis (product storage error). Concomitant therapies included sterile diluent. Temperature excursion was for the time frame of 50 minutes for 15F to 46F. Vaccine had previous temperature excursion of 6F to 14 F for 30 minutes and 15 F to 46F for 30 minutes. The call was because of a data logger. Patient experienced no adverse event.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, General physical health deterioration, Inflammation
Clinical narrative: Information has been received from a nurse referring to a 13 year old female patient. The patient was not pregnant. The patient's concomitant therapy included swine influenza virus vaccine (manufacturer unknown). The patient's concurrent condition included asthma and she was recovering from mononucleosis and unspecified immunocompromising condition, she was considered ''healthy and active'' at the time of vaccination. Information about drug reactions/allergies were unknown by reporter. On unknown date, the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. After vaccination, there was an unspecified decline in patient's health including an inflammatory response with joint pain. The reporter stated the patient received unspecified follow up treatment at an unspecified time at an identified place, but it was unknown if patient was hospitalized. The reporter also stated the patient did not complete GARDASIL immunization series. It was unknown if lab diagnostics/ studies were performed for the events. The patient had sought medical attention. The outcome of the events was reported as not recovered. The causality between the events and GARDASIL was not provided. The events were considered as serious by the reporter due to disability.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Irritability, Rash, Urticaria
Clinical narrative: Rash/welps on both of her arms and face. No fever. Fussy.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Arthralgia, Neck pain, Rash macular, Skin warm
Clinical narrative: Pain to Elbow to neck, red blotching to arm, hot to the touch. Patient took BENADRYL, and blotches went away in 24 hours and pain subsided within 48 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Vaccines received in addition in same leg was dtap. Major swelling, and soreness in the injection site. This lasted 4 days until medication was given to stop the reaction.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Activated partial thromboplastin time prolonged, Anaemia, Coagulation factor VII level decreased, Coagulation factor VII level increased, Coagulation factor VIII level decreased
Clinical narrative: Called pharmacy on to get information about the vaccine given. RPh there unsure if lot number is KB996 or KB99G. Pt given SHINGRIX then reported bruising that progressed across his body with eventual hematuria. Pt referred by outpatient MD for hematology due to anemia follow up and it was discovered his Factor VIII levels were undetectable and he had developed Bethesda + antibodies targeting his Factor VIII. Pt treated with NOVOSEVEN until HGB recovered. Pt is undergoing active treatment at this time with prednisone and cyclophosphamide + NOVOSEVEN. We are currently on day 5 of hospitalization but it is expected to be ongoing.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Haematuria, Haemoglobin decreased, Haemorrhage, Packed red blood cell transfusion
Clinical narrative: Called pharmacy on to get information about the vaccine given. RPh there unsure if lot number is KB996 or KB99G. Pt given SHINGRIX then reported bruising that progressed across his body with eventual hematuria. Pt referred by outpatient MD for hematology due to anemia follow up and it was discovered his Factor VIII levels were undetectable and he had developed Bethesda + antibodies targeting his Factor VIII. Pt treated with NOVOSEVEN until HGB recovered. Pt is undergoing active treatment at this time with prednisone and cyclophosphamide + NOVOSEVEN. We are currently on day 5 of hospitalization but it is expected to be ongoing.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Platelet count normal
Clinical narrative: Called pharmacy on to get information about the vaccine given. RPh there unsure if lot number is KB996 or KB99G. Pt given SHINGRIX then reported bruising that progressed across his body with eventual hematuria. Pt referred by outpatient MD for hematology due to anemia follow up and it was discovered his Factor VIII levels were undetectable and he had developed Bethesda + antibodies targeting his Factor VIII. Pt treated with NOVOSEVEN until HGB recovered. Pt is undergoing active treatment at this time with prednisone and cyclophosphamide + NOVOSEVEN. We are currently on day 5 of hospitalization but it is expected to be ongoing.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Feeling hot, Pain in extremity
Clinical narrative: Patient experienced sore arm, back pain, sore joints, and face became warm. She stated she took a tramadol for pain and an allergy tab. She is feeling much better the morning after receiving injection and has taken a Tylenol today. She did not go to a doctor.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Skin warm, Tenderness
Clinical narrative: Red rash, tender, warm to touch started on 1/17/19 symptoms continue to worsen.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a registered pharmacist, referring to a currently 24-year-old female patient. It was reported that the patient did not have any pertinent medical history or concomitant medication. It was reported that the patient had an allergy to gluten. On an unspecified date in 1996, the patient received the first dose of VARIVAX (strength, route, lot number and expiration date unknown by the reporter) for prophylaxis (reported as "recommended by pediatrician at the time"). On an unspecified date, after receiving the first dose, the patient developed chicken pox (varicella post vaccine). It was reported that the patient did not receive treatment for the event and there was no lab diagnostics or studies performed. On an unspecified date, the patient had recovered from the event. There was no causality assessment provided between the event and VARIVAX.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 31-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 11-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 27-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 10-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 17-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 05-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 02-JAN-2019, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Vomiting
Clinical narrative: Intense shivering, headache, vomiting, sore arm.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB
Symptoms: Injection site induration, Irritability, Lethargy, Poor feeding infant, Pyrexia
Clinical narrative: 2 month-old healthy baby boy received his 2 months shots, Hep B, PCV13 in the right leg, PENTACEL in the left and oral Rotavirus at 10:00am. He was fussy most of the day but feeding well and had wet diapers. By 11:00pm he had a fever of 100.7 axillary, was not feeding well and sleeping a lot/hard to wake. He was seen in our clinic on 9/8/2018 for evaluation. At that visit he had a rectal temperature of 98.9 and his exam revealed he had two areas of induration on the right thigh associated with his injection sites. No lethargy noted during that visit. One area was 1cm x 2.5cm and the other was smaller at < 0.3cm round induration. No fluctuance. Baby continued to have fever of this magnitude or lower for 3 days, have poor feeding and hard to wake. Parents describe him as "lethargic and could barely lift his head". He was treated with TYLENOL PRN and small frequent nursing. It took 1 week for him to fully recover, per parents, he did seem to recover fully. He has had 2 Well Child Checks since this event and he is growing, thriving and developing normally.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB
Symptoms: Somnolence
Clinical narrative: 2 month-old healthy baby boy received his 2 months shots, Hep B, PCV13 in the right leg, PENTACEL in the left and oral Rotavirus at 10:00am. He was fussy most of the day but feeding well and had wet diapers. By 11:00pm he had a fever of 100.7 axillary, was not feeding well and sleeping a lot/hard to wake. He was seen in our clinic on 9/8/2018 for evaluation. At that visit he had a rectal temperature of 98.9 and his exam revealed he had two areas of induration on the right thigh associated with his injection sites. No lethargy noted during that visit. One area was 1cm x 2.5cm and the other was smaller at < 0.3cm round induration. No fluctuance. Baby continued to have fever of this magnitude or lower for 3 days, have poor feeding and hard to wake. Parents describe him as "lethargic and could barely lift his head". He was treated with TYLENOL PRN and small frequent nursing. It took 1 week for him to fully recover, per parents, he did seem to recover fully. He has had 2 Well Child Checks since this event and he is growing, thriving and developing normally.