chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Patient is reporting this adverse event. Therefore, some technical and outcome information is missing.  In addition to side effects listed on info sheet, a red intensely itchy rash appeared on 6-22-2019 on both arms from injection site on left upper arm (same location on right arm) to wrists. Also a 1.5" red patch four inches above left wrist adjacent to a previously healed scratch that became red and blistered. Rash has moved to legs, noticed at 9 p.m. 6-23-2019 (Sunday). I will go to the clinic early 6-24-2019 to advise and seek help for this concerning side effect.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Scratch
Clinical narrative: Patient is reporting this adverse event. Therefore, some technical and outcome information is missing.  In addition to side effects listed on info sheet, a red intensely itchy rash appeared on 6-22-2019 on both arms from injection site on left upper arm (same location on right arm) to wrists. Also a 1.5" red patch four inches above left wrist adjacent to a previously healed scratch that became red and blistered. Rash has moved to legs, noticed at 9 p.m. 6-23-2019 (Sunday). I will go to the clinic early 6-24-2019 to advise and seek help for this concerning side effect.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Nausea, Vertigo, Vomiting
Clinical narrative: Extreme headache with strong vertigo (walking very dificult due to vertigo) accompanied with stomach nausea and throwing up. Still have headache and some vertigo as of 6/24 at 8:00am.
Age: 11.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site reaction, Skin lesion, Vaccination site induration
Clinical narrative: Faint pale/pink coloration superiorly around upper vaccine site; inverted equilateral triangle with ~3 cm side over lower vaccine site that is indurated and warm to touch, small amount of ecchymosis along bottom border of upper tricep; entire lesion is 8 cm long and 4 cm wide. Palpably firm inner upper tricep with no color change or bruising.
Age: 11.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Vaccination site warmth
Clinical narrative: Faint pale/pink coloration superiorly around upper vaccine site; inverted equilateral triangle with ~3 cm side over lower vaccine site that is indurated and warm to touch, small amount of ecchymosis along bottom border of upper tricep; entire lesion is 8 cm long and 4 cm wide. Palpably firm inner upper tricep with no color change or bruising.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Chicken pox like rash on trunk of body, didn't seem itchy or bothersome at all. Mostly gone after 24 hours
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects; patient received an expired dose of VAQTA; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.      On 29-MAY-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # R010954, expiration date: 27-MAY-2019) intramuscularly (strength, dose and frequency were not reported) for prophylaxis (expired vaccine used). No unknown adverse effects.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was reconstituted with expired Diluent; Vaccine was reconstituted with expired Diluent; No adverse effects reported; This spontaneous report was received from a nurse prescriber concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On an unknown date the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R029514, expiration date 14-OCT-2020 for prophylaxis which was reconstituted with and expired sterile diluent (STERILE DILUENT) (lot# unknown, expiration date 28-MAY-2019) (dose, route, frequency and anatomical site were unknown). No adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Adverse reaction
Clinical narrative: Unspecified adverse reaction; This spontaneous report was received from a physician via a company representative, concerning a female patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were unknown.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, frequency, route, anatomical site, lot# and expiration date were not reported).  On an unknown date, the patient experienced an unspecified adverse reaction after administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that led her to visit unspecified emergency room. It was unknown whether the patient was admitted to the hospital.  The outcome of the unspecified adverse reaction was unknown.  The reporter considered the unspecified adverse reaction to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; a patient was inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 18-JUN-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # N014630, expiration date reported as 11-MAY-2019, but upon internal validation established as 11-AUG-2019 (conflicting information), subcutaneously (strength, dose, and anatomical location were not provided) for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: NO ADVERSE EFFECT; Patient was inadvertantly administered a dose of pediatric dose ,instead of adult dose; 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 and medical history provided.    On 14-JUN-2019 the patient was inadvertently administered with a dose of hepatitis a vaccine, inactivated (VAQTA) (Lot#S005723, Expiry date 10-JUL-2020), instead of an adult dose for prophylaxis (product administered to patient of inappropriate age).  No adverse effect reported. No further information provided.    The outcome of product administered to patient of inappropriate age and no adverse event was unknown. Causality was not reported.
Sex: F
Vaccine: HEP
Symptoms: Blood blister, Blood test, Food allergy, Seasonal allergy
Clinical narrative: food and seasonal allergies; food and seasonal allergies; blood blisters; This spontaneous report was received from a currently 42 years old female patient. The patient was not pregnant at the time of this report. The patient's historical vaccine included a "BTP" vaccine. The patient's concurrent conditions included Hepatitis B and Polio. The patient did not receive any concomitant therapies. On an unknown date between May and August of 1999, the patient was vaccinated with an unspecified hepatitis vaccine (hepatitis b vaccine (recombinant)) (manufacturer unknown) (lot number and expiration date were not reported) 3 doses received in the arm for Hepatitis B. On an unknown date in 2001, the patient experienced blood like blisters on her body that look like red pin dots (PT: blood blister). On an unknown date in 2009 (reported as 10 years after receiving the vaccine), the patient developed food and seasonal allergies. On an unknown date, unspecified blood work was performed, and the results were not provided. The patient received treatment for the events. There was no product quality complaint associated with this report. The outcome of the events was reported as not recovered.   The causality assessment was not provided.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: no adverse event; wrong technique; This spontaneous report was received from a medical assistant refers to a 9-month-old patient. The patient's medical history, current conditions and concomitant medications were not reported. On 18-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R002510 and expiration date 25-JAN-2020) (dose, units and frequency unknown). On 18-JUN-2019, the drug was reconstituted with non-company sterile diluent (lot # A31443 and expiration date 01-AUG-2021 NDC 0409 4887 17) to 9-month-old infant (wrong technique in product usage process). No adverse effect reported. No PQC (product quality complaint) was reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 71 year old. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On or about 27-DEC-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes zoster and she was treated by a physician for the event. The outcome of the event herpes zoster was not reported. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 75 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 25-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 60 year old female patient. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In May 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes zoster and she was treated by a physician for the event. The outcome of the event herpes zoster was not reported. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 29-OCT-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 76 year old. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes zoster and she was treated by a physician for the event. The outcome of the event herpes zoster was not reported. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 year old male patient. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On or about 12-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes zoster. He was treated by a physician for the event. The outcome of the event herpes zoster was not reported. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In September 2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, dose number, lot#, expiration date and route were not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced Herpes Zoster.  On an unspecified date, the patient was treated by a healthcare provider for Herpes Zoster. The outcome of the event was not reported. The reporter considered the Herpes Zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old male patient. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In July 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes zoster. He was treated by a physician for the event. The outcome of the event herpes zoster was not reported. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old female patient. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes zoster. She was treated by a physician for the event. The outcome of the event herpes zoster was not reported. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: the patient had her wisdom teeth removed in between the first and second dose administration; the patient began to experience dizzy spells, 10 days after the second dose; Information has been received from a physician via a field representative referring to a 15 year old female patient.  The patient had no concomitant medications, pertinent medical history or drug reactions/allergies.   On unknown dates, the patient was respectively vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, lot number and expiration date unknown) for human papilloma virus (HPV) prevention.     The physician stated that the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was administered without incidence. The physician noted that the patient had her wisdom teeth removed in between the first and second dose administration. On an unknown date, 10 days after the second dose, the patient began to experience dizzy spell. No treatment was given to the patient. No lab diagnostics/studies were performed. The outcome of the event was reported as not recovered.   The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; Patient was administered improperly stored VARIVAX; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 06-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number R035222 with expiration date in 04-DEC-2020 (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008721: US-009507513-1906USA008722: US-009507513-1906USA008723: US-009507513-1906USA008724: US-009507513-1906USA008725:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; Patient was administered improperly stored VARIVAX; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 14-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number R035222 with expiration date in 04-DEC-2020 (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662: US-009507513-1906USA008722: US-009507513-1906USA008723: US-009507513-1906USA008724: US-009507513-1906USA008725:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; Patient was administered improperly stored VARIVAX; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 06-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number R035222 with expiration date in 04-DEC-2020 (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662: US-009507513-1906USA008721: US-009507513-1906USA008723: US-009507513-1906USA008724: US-009507513-1906USA008725:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; Patient was administered improperly stored VARIVAX; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 14-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number R035222 with expiration date in 04-DEC-2020 (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008722: US-009507513-1906USA008662: US-009507513-1906USA008721: US-009507513-1906USA008724: US-009507513-1906USA008725:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; Patient was administered improperly stored VARIVAX; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 07-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number R035222 with expiration date in 04-DEC-2020 (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008723: US-009507513-1906USA008722: US-009507513-1906USA008662: US-009507513-1906USA008721: US-009507513-1906USA008725:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; Patient was administered improperly stored VARIVAX; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 07-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number R035222 with expiration date in 04-DEC-2020 (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662: US-009507513-1906USA008721: US-009507513-1906USA008724: US-009507513-1906USA008722: US-009507513-1906USA008723:
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: fever; chills; feeling tired; sore throat; nasal congestion; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced fever, chills, tiredness, sore throat and nasal congestion. On an unknown date, the outcome of the fever, chills, tiredness, sore throat and nasal congestion were unknown.   It was unknown if the reporter considered the fever, chills, tiredness, sore throat and nasal congestion to be related to Shingrix.  Additional details were provided as follows: Yesterday from the date of reporting the patient received a dose of Shingrix and experienced slight fever and chills and was tired. The patient knows these are the side effects, but along with this the patient also had a bit of a sore throat and some nasal congestion. The patient asked whether the sore throat and nasal congestion are the side effects of the vaccine or not.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Condition aggravated, Fatigue, Immediate post-injection reaction
Clinical narrative: injection site pain; Migraine headache; Chills; Achiness; Exhausted; less of agility; could not keep her eyes open; condition aggravated.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included sumatriptan tablet for migraine.   Concurrent medical conditions included migraine (Migraine headache).   On 17th April 2019, the patient received the 1st dose of Shingrix. On 18th April 2019, the patient started sumatriptan (oral) 50 mg at an unknown frequency. On 17th April 2019, immediately after receiving Shingrix and an unknown time after starting sumatriptan, the patient experienced injection site pain, migraine headache, chills, pain, exhaustion, feelings of weakness, sleepiness and condition aggravated. The patient was treated with sumatriptan (Imitrex). On 18th April 2019, the outcome of the migraine headache, chills, pain, exhaustion, sleepiness and condition aggravated were recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the feelings of weakness was unknown.   It was unknown if the reporter considered the injection site pain, migraine headache, chills, pain, exhaustion, feelings of weakness, sleepiness and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the left arm, on 17th April 2019 at around 11:30am. 8 hours and 30 minutes after vaccination with Shingrix, the patient experienced with exhaustion and sleepiness. Less than a day after vaccination, the patient experienced migraine headache, chills and pain. On 18th April 2019 at 10:30pm, less than a day after receiving Sumatriptan, the patient recovered with migraine headache. The patient stated that, it took longer than normal, but usually it took 1.5 hours for her migraine headaches to resolve after taking the generic product. The reporter did not consent to follow up. The reporter was unable to provide any additional information.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Migraine, Pain, Somnolence
Clinical narrative: injection site pain; Migraine headache; Chills; Achiness; Exhausted; less of agility; could not keep her eyes open; condition aggravated.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included sumatriptan tablet for migraine.   Concurrent medical conditions included migraine (Migraine headache).   On 17th April 2019, the patient received the 1st dose of Shingrix. On 18th April 2019, the patient started sumatriptan (oral) 50 mg at an unknown frequency. On 17th April 2019, immediately after receiving Shingrix and an unknown time after starting sumatriptan, the patient experienced injection site pain, migraine headache, chills, pain, exhaustion, feelings of weakness, sleepiness and condition aggravated. The patient was treated with sumatriptan (Imitrex). On 18th April 2019, the outcome of the migraine headache, chills, pain, exhaustion, sleepiness and condition aggravated were recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the feelings of weakness was unknown.   It was unknown if the reporter considered the injection site pain, migraine headache, chills, pain, exhaustion, feelings of weakness, sleepiness and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the left arm, on 17th April 2019 at around 11:30am. 8 hours and 30 minutes after vaccination with Shingrix, the patient experienced with exhaustion and sleepiness. Less than a day after vaccination, the patient experienced migraine headache, chills and pain. On 18th April 2019 at 10:30pm, less than a day after receiving Sumatriptan, the patient recovered with migraine headache. The patient stated that, it took longer than normal, but usually it took 1.5 hours for her migraine headaches to resolve after taking the generic product. The reporter did not consent to follow up. The reporter was unable to provide any additional information.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaemia, Blood test abnormal, Chills, Influenza like illness, Night sweats
Clinical narrative: Flu Like Symptoms; Fever; Night Sweats; Chills; Anemia; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 8th April 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, night sweat and chills. In April 2019, the patient experienced anemia. The patient was treated with antibiotics nos. On an unknown date, the outcome of the influenza-like symptoms, fever, night sweat and anemia were unknown and the outcome of the chills was recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, fever, night sweat, chills and anemia to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and at evening after receiving the dose, the patient experienced flu like symptoms, high to low grade fever, night sweats, and chills. The chills had decreased but she still gets them from time to time. After receiving the vaccine, the patient spoke to her doctor on the phone and was then prescribed antibiotics. About 2 and half weeks later she had her blood work carried out, which showed that she had anemia. The doctor does not know the cause of anemia, therefore she was going to undergo bone marrow biopsy, and she was also scheduled for malaria test since she was out of country. The patient also had her blood work done during her annual physical was normal on 5th March 2019.. The reporter did not consent to follow-up.      Lab Comments: On an unknown date in Apr2019, the patient had blood work done which showed anemia.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Flu Like Symptoms; Fever; Night Sweats; Chills; Anemia; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 8th April 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, night sweat and chills. In April 2019, the patient experienced anemia. The patient was treated with antibiotics nos. On an unknown date, the outcome of the influenza-like symptoms, fever, night sweat and anemia were unknown and the outcome of the chills was recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, fever, night sweat, chills and anemia to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and at evening after receiving the dose, the patient experienced flu like symptoms, high to low grade fever, night sweats, and chills. The chills had decreased but she still gets them from time to time. After receiving the vaccine, the patient spoke to her doctor on the phone and was then prescribed antibiotics. About 2 and half weeks later she had her blood work carried out, which showed that she had anemia. The doctor does not know the cause of anemia, therefore she was going to undergo bone marrow biopsy, and she was also scheduled for malaria test since she was out of country. The patient also had her blood work done during her annual physical was normal on 5th March 2019.. The reporter did not consent to follow-up.      Lab Comments: On an unknown date in Apr2019, the patient had blood work done which showed anemia.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: swelling near left elbow/ it is about 5 inches in circumference and the area is swollen; redness below elbow; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number Y2D94, expiry date 21st September 2021) for prophylaxis.   On 10th June 2019, the patient received Shingrix (intramuscular). On 11th June 2019, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and erythema of extremities. On an unknown date, the outcome of the extensive swelling of vaccinated limb was not recovered/not resolved and the outcome of the erythema of extremities was recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and erythema of extremities to be related to Shingrix.  Additional details were reported as follows: The reporter was a floater pharmacist for the pharmacy. The patient received a dose of Shingrix on the left deltoid. The next day after vaccination, the patient experienced redness at the area just above the elbow. The injection was given higher above that redness, in the upper arm in the deltoid.   The patient told that, it was about 5 inches in circumference and the area was swollen (extensive swelling of vaccinated limb).  The patient was seen by a physician on Wednesday, 12th June 2019, but no definitive diagnosis was made. The physician did mark the area and asked for a repeat visit.   During the pharmacist's conversation with the patient, the area of redness was receding. The emergency room visit required. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Patient is "sick at her stomach," and injection site is swollen and red.  Patient reports injection site feels hot to the touch.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Oxygen saturation decreased, Respiratory disorder
Clinical narrative: Respiratory events.  Multiple apneic events with desat.  Needed mild to vigorous stimulation
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling cold, Headache, Somnolence
Clinical narrative: Six hours after getting injection became very cold. Took 2 500 mg tylenol. Felt better. Went to bed. Twelve hours after receiving shot woke up with awful headache, felt groggy. About 17-18 hours after receiving shot still had awful headache, foggy feeling and felt cold. Took 2 500 mg tylenol. The headache eased some, along with the coldness and groggy feeling .
Age: 15.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Headache, Migraine with aura
Clinical narrative: Mother contacted office 5/31 to report pt had been experiencing a headaches since 5/25 (day after injection received).  Mom had been treating with ibuprofen which was slightly effective. Worsen with screen time and reading, headache reported at top of head and brow line. Family saw ophthalmology and diagnosed as ocular migraine per moms report.  As of 6/13 per moms report was sill having sporadic headaches, worsened after piano lessons. As of 6/13 DR (physician at agency) suspected headaches would resolve over the next two weeks. Mom did not have pt evaled at our practice
Age: 15.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Blindness, Deafness, Headache, Migraine with aura, Photophobia
Clinical narrative: Mother contacted office 5/31 to report pt had been experiencing a headaches since 5/25 (day after injection received).  Mom had been treating with ibuprofen which was slightly effective. Worsen with screen time and reading, headache reported at top of head and brow line. Family saw ophthalmology and diagnosed as ocular migraine per moms report.  As of 6/13 per moms report was sill having sporadic headaches, worsened after piano lessons. As of 6/13 DR (physician at agency) suspected headaches would resolve over the next two weeks. Mom did not have pt evaled at our practice
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy artery normal, Cardiac monitoring normal, Computerised tomogram normal, Influenza like illness, Injection site pain
Clinical narrative: Very sore injection site, flu like symptoms, after 1 1/2 months, I had blurry vision in my right eye. Was admitted hospital, had a 5 day stay. Had artery bx on both sides of my head, 2 MRI's, pet scan, ct scan, spinal tap, heart monitoring, all negative for blood clot, cancer and giant cell arteritis. My vision is still compromised. But improving. Diagnosed with ischemic optic neuropathy.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Optic ischaemic neuropathy, Positron emission tomogram normal, Vision blurred
Clinical narrative: Very sore injection site, flu like symptoms, after 1 1/2 months, I had blurry vision in my right eye. Was admitted hospital, had a 5 day stay. Had artery bx on both sides of my head, 2 MRI's, pet scan, ct scan, spinal tap, heart monitoring, all negative for blood clot, cancer and giant cell arteritis. My vision is still compromised. But improving. Diagnosed with ischemic optic neuropathy.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza, Nausea, Pain
Clinical narrative: Patient experienced flu symptoms;  nausea, headache, body aches, fever and chills
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient experienced flu symptoms;  nausea, headache, body aches, fever and chills
Sex: M
Vaccine: MMR
Symptoms: Blood test, Cholecystectomy, Computerised tomogram, Endoscopy, Nuclear magnetic resonance imaging
Clinical narrative: Gall bladder removal; multiple attacks of pancreatitis; This spontaneous report was received from a consumer (patient's wife) refers to an adult male patient of unknown age. The patient's allergies included cramps from codeine. Pertinent medical history and concomitant medication were reported to ne none. On an unspecified date (reported as when the patient was infant), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, lot and expiry was not reported) via subcutaneous route for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with Merck sterile diluent. On an unknown date in approximately 1988 (reported as at the age of 26), the patient was hospitalized and had gallbladder removal (cholecystectomy) done (hospital details unspecified). On an unknown date in November 2018, the patient experienced multiple attacks of pancreatitis and that got recovered on an unknown date of March 2019. On an unknown date of 2019, the patient visited the emergency room where he was diagnosed with pancreatitis and he was started therapy with fentanyl for his pain and subsequently was sent home. On unknown dates, the patient performed computerized axial tomography (cat scan), endoscopy, magnetic resonance imaging (MRI) and blood test (details and results were unspecified). Causality assessment was not provided.  Upon internal review, the event pancreatitis was considered to be medically significant.
Sex: M
Vaccine: MMR
Symptoms: Pain, Pancreatitis
Clinical narrative: Gall bladder removal; multiple attacks of pancreatitis; This spontaneous report was received from a consumer (patient's wife) refers to an adult male patient of unknown age. The patient's allergies included cramps from codeine. Pertinent medical history and concomitant medication were reported to ne none. On an unspecified date (reported as when the patient was infant), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, lot and expiry was not reported) via subcutaneous route for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with Merck sterile diluent. On an unknown date in approximately 1988 (reported as at the age of 26), the patient was hospitalized and had gallbladder removal (cholecystectomy) done (hospital details unspecified). On an unknown date in November 2018, the patient experienced multiple attacks of pancreatitis and that got recovered on an unknown date of March 2019. On an unknown date of 2019, the patient visited the emergency room where he was diagnosed with pancreatitis and he was started therapy with fentanyl for his pain and subsequently was sent home. On unknown dates, the patient performed computerized axial tomography (cat scan), endoscopy, magnetic resonance imaging (MRI) and blood test (details and results were unspecified). Causality assessment was not provided.  Upon internal review, the event pancreatitis was considered to be medically significant.