chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: M
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: This spontaneous case, initially received from other health professional on 16-Oct-2018, concerning a 1-year-old, infant, male patient. The patient had no medical history and received no concomitant medications. On 13-Oct-2018, the patient (less than 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252229, anatomical location: left thigh, expiry date: 31-May-2019 and route of administration: not reported) (inappropriate age at vaccine administration). On the same day after vaccination, the patient developed fever, which resolved in less than 12 hours. It was reported that, the patient was no hospitalised. At the time of the report, the patient had recovered from the event fever. The reporter assessed the event as non-serious.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Decreased activity, Pyrexia, Vomiting
Clinical narrative: Fever 39.4 C, hypoactivity, vomits starting 4 to 5 hrs after vaccination, went to ER where rectal TYLENOL and 2 MG ondansetron administered, observed and discharged afebrile and tolerating PO.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 20th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In December 2018, less than a month after receiving SHINGRIX, the patient experienced injection site swelling, headache, nausea, pain, fatigue, axillary lymph nodes enlarged, lymph node tenderness and foot pain. On an unknown date, the outcome of the injection site swelling, headache, nausea, pain, fatigue, axillary lymph nodes enlarged, lymph node tenderness and foot pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, headache, nausea, pain, fatigue, axillary lymph nodes enlarged, lymph node tenderness and foot pain to be related to SHINGRIX. Additional details were provided as follows: The patient was veterinarian. The patient received the 1st dose of SHINGRIX in left arm. The patient stated that she experienced swelling at the injection site after receiving the vaccine. Approximately 10 to 12 hours after receiving the vaccine, she developed a headache, nausea, shooting pains throughout her body, extreme fatigue, swollen axillary lymph nodes, tender inguinal lymph nodes, and achy feet. The reporter stated that these symptoms lasted approximately 2 to 3 days. The reporter did not consent to follow up and she was also reporting this event online.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 20th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In December 2018, less than a month after receiving SHINGRIX, the patient experienced injection site swelling, headache, nausea, pain, fatigue, axillary lymph nodes enlarged, lymph node tenderness and foot pain. On an unknown date, the outcome of the injection site swelling, headache, nausea, pain, fatigue, axillary lymph nodes enlarged, lymph node tenderness and foot pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, headache, nausea, pain, fatigue, axillary lymph nodes enlarged, lymph node tenderness and foot pain to be related to SHINGRIX. Additional details were provided as follows: The patient was veterinarian. The patient received the 1st dose of SHINGRIX in left arm. The patient stated that she experienced swelling at the injection site after receiving the vaccine. Approximately 10 to 12 hours after receiving the vaccine, she developed a headache, nausea, shooting pains throughout her body, extreme fatigue, swollen axillary lymph nodes, tender inguinal lymph nodes, and achy feet. The reporter stated that these symptoms lasted approximately 2 to 3 days. The reporter did not consent to follow up and she was also reporting this event online.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 20th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In December 2018, less than a month after receiving SHINGRIX, the patient experienced injection site swelling, headache, nausea, pain, fatigue, axillary lymph nodes enlarged, lymph node tenderness and foot pain. On an unknown date, the outcome of the injection site swelling, headache, nausea, pain, fatigue, axillary lymph nodes enlarged, lymph node tenderness and foot pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, headache, nausea, pain, fatigue, axillary lymph nodes enlarged, lymph node tenderness and foot pain to be related to SHINGRIX. Additional details were provided as follows: The patient was veterinarian. The patient received the 1st dose of SHINGRIX in left arm. The patient stated that she experienced swelling at the injection site after receiving the vaccine. Approximately 10 to 12 hours after receiving the vaccine, she developed a headache, nausea, shooting pains throughout her body, extreme fatigue, swollen axillary lymph nodes, tender inguinal lymph nodes, and achy feet. The reporter stated that these symptoms lasted approximately 2 to 3 days. The reporter did not consent to follow up and she was also reporting this event online.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 20th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In December 2018, less than a month after receiving SHINGRIX, the patient experienced injection site swelling, headache, nausea, pain, fatigue, axillary lymph nodes enlarged, lymph node tenderness and foot pain. On an unknown date, the outcome of the injection site swelling, headache, nausea, pain, fatigue, axillary lymph nodes enlarged, lymph node tenderness and foot pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, headache, nausea, pain, fatigue, axillary lymph nodes enlarged, lymph node tenderness and foot pain to be related to SHINGRIX. Additional details were provided as follows: The patient was veterinarian. The patient received the 1st dose of SHINGRIX in left arm. The patient stated that she experienced swelling at the injection site after receiving the vaccine. Approximately 10 to 12 hours after receiving the vaccine, she developed a headache, nausea, shooting pains throughout her body, extreme fatigue, swollen axillary lymph nodes, tender inguinal lymph nodes, and achy feet. The reporter stated that these symptoms lasted approximately 2 to 3 days. The reporter did not consent to follow up and she was also reporting this event online.
Age: 75.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Asthenia, Chronic fatigue syndrome, Cough, Diarrhoea, Gastrointestinal disorder
Clinical narrative: I have done this twice. I just got an email from you all asking the brand name of the vaccine, the manufacture and the lot number! Really! I am pretty sure you need to be asking the "quack" that attended me, when I had an infection, and gave me a vaccine I DID NOT AGREE TO! I consented to a Tetanus and she gave me a Dtap or Tdap, ruining my health, ability to work and attend church. I hope you will do your job, find out from her the details of her quackery profession, all I am sure for her benefit, and pull her license since she violated the Hipp Oath!!!!!!! There is not other way to contact you all since you DO NOT answer the phone. And please, NEVER forget, that the CDC had on their site NEVER GIVE A VACCINATION WHEN THERE IS AN INFECTION PRESENT. You all quickly took that down the third time I went to your site! I wish I had the energy and money to press forward with the deprivation in my life she has caused me! P.S.  I have not answered questions due to the site NOT ALLOWING me too! My descriptions have been sent to you TWO times. 159498
Age: 75.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Hypersensitivity, Impaired healing, Influenza, Nerve injury, Pain in extremity
Clinical narrative: I have done this twice. I just got an email from you all asking the brand name of the vaccine, the manufacture and the lot number! Really! I am pretty sure you need to be asking the "quack" that attended me, when I had an infection, and gave me a vaccine I DID NOT AGREE TO! I consented to a Tetanus and she gave me a Dtap or Tdap, ruining my health, ability to work and attend church. I hope you will do your job, find out from her the details of her quackery profession, all I am sure for her benefit, and pull her license since she violated the Hipp Oath!!!!!!! There is not other way to contact you all since you DO NOT answer the phone. And please, NEVER forget, that the CDC had on their site NEVER GIVE A VACCINATION WHEN THERE IS AN INFECTION PRESENT. You all quickly took that down the third time I went to your site! I wish I had the energy and money to press forward with the deprivation in my life she has caused me! P.S.  I have not answered questions due to the site NOT ALLOWING me too! My descriptions have been sent to you TWO times. 159498
Age: 75.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: I have done this twice. I just got an email from you all asking the brand name of the vaccine, the manufacture and the lot number! Really! I am pretty sure you need to be asking the "quack" that attended me, when I had an infection, and gave me a vaccine I DID NOT AGREE TO! I consented to a Tetanus and she gave me a Dtap or Tdap, ruining my health, ability to work and attend church. I hope you will do your job, find out from her the details of her quackery profession, all I am sure for her benefit, and pull her license since she violated the Hipp Oath!!!!!!! There is not other way to contact you all since you DO NOT answer the phone. And please, NEVER forget, that the CDC had on their site NEVER GIVE A VACCINATION WHEN THERE IS AN INFECTION PRESENT. You all quickly took that down the third time I went to your site! I wish I had the energy and money to press forward with the deprivation in my life she has caused me! P.S.  I have not answered questions due to the site NOT ALLOWING me too! My descriptions have been sent to you TWO times. 159498
Age: 68.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Loss of consciousness, Pain, Pyrexia
Clinical narrative: PATIENT HAD PAIN AT SITE OF INJECTION AND RAN A FEVER FOR 24 HOURS AND REPORTED PASSING OUT AN HOUR AFTER THE INJECTION OCCURED.
Age: 68.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Injection site pain, Loss of consciousness, Pyrexia
Clinical narrative: PATIENT HAD PAIN AT SITE OF INJECTION AND RAN A FEVER FOR 24 HOURS AND REPORTED PASSING OUT AN HOUR AFTER THE INJECTION OCCURED.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia
Clinical narrative: Awake for nearly 24hrs after the shot.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle and bone aches, headache, 101.5 fever, chills.
Sex: U
Vaccine: MMR, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a patient of an unknown age and gender. The concurrent conditions, medical history, drug allergies/reactions and concomitant medication were not provided. On 03-JAN-2019, the patient was vaccinated with M-M-R II (lot # N026828, expiration date: 27-SEP-2019) (route of administration, anatomical location, dose number were not reported). It was reported that the dose of M-M-R II was inadvertently reconstituted with a dose of MENACTRA instead of diluent. The nurse stated that the vial of MENACTRA was mistaken for a vial of diluent, but she believed the cause to be human error and not any confusion between the two products. No adverse effect reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous case was received from a pharmacist and refers to unspecified patient of unknown age and gender. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not reported. On unknown date, the patient was vaccinated with a with M-M-R II rHA lot # R019687 with expiration on 09-JUL-2020 (strength, dose # and anatomical side of the injection were not reported) for prophylaxis. The dose was administrated intramuscularly. No adverse effects reported nor quality complain involved.
Sex: U
Vaccine: HEP, 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 16-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) and 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 vaccines were 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, 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-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) and 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 vaccines were 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, 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 30-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) and 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 vaccines were 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 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). On 20-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 vaccines were 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, 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 07-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) and 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 vaccines were 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: HEPA
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-OCT-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: HEPA
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 VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: HEPA
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 VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: HEPA
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 VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: HEPA
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 VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: HEPA
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-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: HEPA
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 01-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: HEPA
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 16-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: HEPA
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 30-OCT-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: HEPA
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 VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: HEPA
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 VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: HEPA
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-DEC-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: HEPA
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 19-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) 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: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Back pain, Dysstasia, Fatigue
Clinical narrative: This spontaneous report was received from a 88 year old female patient regarding herself. The patient's medical history included double pneumonia which occurred twice when she was a child at the age of 10 years and had a slight case of pneumonia, 2 years prior to receiving a pneumococcal vaccine. The patient had no drug reactions/allergies. The concomitant therapies included prednisone, CELEBREX, calcium and multivitamin. On 11-JAN-2019 (Also reported as Friday), the patient was vaccinated at a retail pharmacy, in the left arm with PNEUMOVAX 23 (Strength, lot # and expiry date were not reported) 1 injection to avoid pneumococcal disease. On the same day, minutes after receiving the injection, the patient began to experience pain and extreme weakness in her "joints hip", back and was unable to stand. The patient was offered a chair and sought medical attention. The paramedics were called to the pharmacy. The lab diagnostics/studies performed included unspecified checks by the paramedics. It was reported that after 30-40 minutes, the patient stated that her strength returned to her and the pain went away. The patient went home without receiving treatment. Approximately on an unknown date in January 2019, the patient felt tired for two days after receiving the PNEUMOVAX 23. There was no product quality complaint associated with this report. The outcome of the events of arthralgia, asthenia, back pain, dysstasia and fatigue was reported to be recovered (Also reported as fully recovered). The causal relationship between the events of arthralgia, asthenia, back pain, dysstasia, fatigue and the therapy with PNEUMOVAX 23 was considered to be related.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of ankle swelling in a 16-year-old female patient who received BEXSERO for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis and MENACTRA for prophylaxis. Previously administered products included Flu shot (dose received each year) and MENINGOCOCCAL ACW135Y VACCINE (received 5 years ago with no issues). On 29th December 2018, the patient received BEXSERO .5 ml, Influenza vaccine Quadrivalent 2018-2019 season .5 ml and MENACTRA. On 29th December 2018, less than a day after receiving BEXSERO and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced ankle swelling, swelling of feet, foot pain, pain ankle and rash. On an unknown date, the outcome of the ankle swelling, swelling of feet, foot pain, pain ankle and rash were recovered/resolved. It was unknown if the reporter considered the ankle swelling, swelling of feet, foot pain, pain ankle and rash to be related to BEXSERO and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient received a flu shot possibly GSK flu FLUARIX or FLULAVAL 0.5ml pre-filled syringe. Within 24 hours of vaccination with BEXSERO, Influenza vaccine Quadrivalent 2018-2019 season and MENACTRA, the patient had bilateral pain in both feet and ankles with swelling, and a rash on both feet and ankles. The symptoms resolved and the physician was not sure if these were due to any of the vaccines administered. It was unknown if the reporter considered the ankle swelling, swelling of feet, foot pain, pain ankle and rash to be related to MENACTRA. The reporter agreed to be followed up.
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Influenza vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, immediately after receiving Influenza vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient always gets the flu vaccine and it only hurts a little. The reporter did not consent to follow up. This case has been linked with the case US2019006866, reported for same patient.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 68-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced myalgia, fever and pain in arm. On an unknown date, the outcome of the myalgia, fever and pain in arm were recovered/resolved. It was unknown if the reporter considered the myalgia, fever and pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the physician for his friend. The patient received a dose of SHINGRIX and had a severe reaction to her dose including severe myalgia, Fever of 102 degree F and sore arm for 3 to 4 days.  The physician classifies the reaction to a dose of SHINGRIX as a grade 3 reaction. The physician did not know where the patient had received SHINGRIX since the patient was in a different location than his. The physician denied consent to be follow up. Lab Comments: On an unknown date, the patient had performed Body temperature.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a male patient who received SHINGRIX for prophylaxis. On 11th January 2019, the patient received SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The injection site was red, sore and warm to the touch. Pharmacist does not had additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that the SHINGRIX vaccine was very painful. The patient always gets the flu vaccine and it only hurts a little. SHINGRIX hurt a lot more. The reporter did not consent to follow up. This case has been linked with US2019GSK010444, reported by same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood iron, Fatigue, Full blood count, Hepatitis viral test, Immunology test
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation skin in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose was received on 4th May 2018). Concomitant products included Calcium, Vitamin D3, Escitalopram, WELLBUTRIN, Vitamin B6)and magnesium. In August 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced burning sensation skin, pruritus and fatigue. In November 2018, the patient experienced white blood cell count decreased and red blood cell count decreased. On an unknown date, the outcome of the burning sensation skin, pruritus, white blood cell count decreased and red blood cell count decreased were unknown and the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the burning sensation skin, pruritus, fatigue, white blood cell count decreased and red blood cell count decreased to be related to SHINGRIX. Additional details were provided as follows: In September, the patient started to experience a burning skin sensation on her arms bilaterally. It was itching on her left lower forearm and she was fatigued. The pharmacist stated it could be lingering nerve sensation from the injection. In October, the fatigue worsened. In November, the patient's family doctor ran a complete blood count (CBC), metabolic panel, checked for iron deficiency, autoimmune conditions, hepatitis, etc. Her white and red blood cells were low. The hematologist repeated tests in December. White cells were still low. He would see patient again in March 2019.  The patient went home early from work twice in December due to fatigue and she lost pay. The fatigue was somewhat better now but was still there. Although her doctors did not think it was related to SHINGRIX, the patient thinks it was and wanted to call and report this event.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Metabolic function test, Pruritus, Red blood cell count decreased, Skin burning sensation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation skin in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose was received on 4th May 2018). Concomitant products included Calcium, Vitamin D3, Escitalopram, WELLBUTRIN, Vitamin B6)and magnesium. In August 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced burning sensation skin, pruritus and fatigue. In November 2018, the patient experienced white blood cell count decreased and red blood cell count decreased. On an unknown date, the outcome of the burning sensation skin, pruritus, white blood cell count decreased and red blood cell count decreased were unknown and the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the burning sensation skin, pruritus, fatigue, white blood cell count decreased and red blood cell count decreased to be related to SHINGRIX. Additional details were provided as follows: In September, the patient started to experience a burning skin sensation on her arms bilaterally. It was itching on her left lower forearm and she was fatigued. The pharmacist stated it could be lingering nerve sensation from the injection. In October, the fatigue worsened. In November, the patient's family doctor ran a complete blood count (CBC), metabolic panel, checked for iron deficiency, autoimmune conditions, hepatitis, etc. Her white and red blood cells were low. The hematologist repeated tests in December. White cells were still low. He would see patient again in March 2019.  The patient went home early from work twice in December due to fatigue and she lost pay. The fatigue was somewhat better now but was still there. Although her doctors did not think it was related to SHINGRIX, the patient thinks it was and wanted to call and report this event.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: White blood cell count decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation skin in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose was received on 4th May 2018). Concomitant products included Calcium, Vitamin D3, Escitalopram, WELLBUTRIN, Vitamin B6)and magnesium. In August 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced burning sensation skin, pruritus and fatigue. In November 2018, the patient experienced white blood cell count decreased and red blood cell count decreased. On an unknown date, the outcome of the burning sensation skin, pruritus, white blood cell count decreased and red blood cell count decreased were unknown and the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the burning sensation skin, pruritus, fatigue, white blood cell count decreased and red blood cell count decreased to be related to SHINGRIX. Additional details were provided as follows: In September, the patient started to experience a burning skin sensation on her arms bilaterally. It was itching on her left lower forearm and she was fatigued. The pharmacist stated it could be lingering nerve sensation from the injection. In October, the fatigue worsened. In November, the patient's family doctor ran a complete blood count (CBC), metabolic panel, checked for iron deficiency, autoimmune conditions, hepatitis, etc. Her white and red blood cells were low. The hematologist repeated tests in December. White cells were still low. He would see patient again in March 2019.  The patient went home early from work twice in December due to fatigue and she lost pay. The fatigue was somewhat better now but was still there. Although her doctors did not think it was related to SHINGRIX, the patient thinks it was and wanted to call and report this event.
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 28th December 2018, the patient received SHINGRIX. On 28th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 29th December 2018, the patient experienced disorientation. On an unknown date, the outcome of the injection site pain and disorientation were unknown. It was unknown if the reporter considered the injection site pain and disorientation to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was reporter's neighbor and limited information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold symptoms in a female patient who received SHINGRIX for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cold symptoms. On an unknown date, the outcome of the cold symptoms was unknown. It was unknown if the reporter considered the cold symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient was due to her 2nd dose of SHINGRIX by 25th January 2019. The reporter wanted to know, if the patient could opt out of 2nd dose. The call center representative advised to the reporter to follow up with their physician and informed that the patient did not have to receive 2nd dose if the patient chooses not to, however there was no guarantee of any effectiveness with only receiving one dose. The reporter would follow up with a physician. No other information could be obtained as the reporter disconnected the call. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received the 1st dose of SHINGRIX on left arm approximately 5 months ago. The patient experienced severe pain in left arm after receiving vaccine and could not raise or move her arm for 5 days. The pain lasted for 5 days. The reporter consented to follow up and the patient did not provide the date of birth.