chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Oxygen saturation decreased, Throat tightness
Clinical narrative: hurts her throat; Difficulty breathing; Throat closing; Headache; Shivering; Cough; could not sleep; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 20-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number M5325, expiry date 30th June 2020) for prophylaxis.   On 30th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 30th October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced difficulty breathing, throat constriction, headache, shivering, cough and insomnia. On 31st October 2019, the patient experienced throat pain. The patient was treated with epinephrine, epinephrine (Epi Pen) and paracetamol (Tylenol). On 31st October 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the difficulty breathing and throat constriction were recovered/resolved and the outcome of the headache and cough were not recovered/not resolved and the outcome of the insomnia and throat pain were unknown.   It was unknown if the reporter considered the difficulty breathing, throat constriction, headache, shivering, cough, insomnia and throat pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The reporter indicated that her daughter never had an allergic reaction to anything before. The patient received vaccine in left deltoid. The patient received Fluarix Quadrivalent vaccine 30th October 2019 at 8:47 am. A minute or two after receiving the vaccine, patient began to experienced difficulty breathing and her throat was closing. Within two minutes she was given an Epi-pen by the physician and was sent to the emergency room. The patient was observed at the emergency room for a couple of hours and discharged. Three or four hours after discharge, less than a day after vaccination, patient began to shiver, developed a cough, and had headache. She took Tylenol but she still had the symptoms and could not sleep most of the night.  The next morning, the shivering was resolved but she was still having headaches that come and go.  When she coughs on day of reporting, 1 day after vaccination it hurts her throat. The reporter unable to obtain additional details because his daughter was in another state at college. The reporter consent to follow up.
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Cough, Dyspnoea, Headache, Insomnia
Clinical narrative: hurts her throat; Difficulty breathing; Throat closing; Headache; Shivering; Cough; could not sleep; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 20-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number M5325, expiry date 30th June 2020) for prophylaxis.   On 30th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 30th October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced difficulty breathing, throat constriction, headache, shivering, cough and insomnia. On 31st October 2019, the patient experienced throat pain. The patient was treated with epinephrine, epinephrine (Epi Pen) and paracetamol (Tylenol). On 31st October 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the difficulty breathing and throat constriction were recovered/resolved and the outcome of the headache and cough were not recovered/not resolved and the outcome of the insomnia and throat pain were unknown.   It was unknown if the reporter considered the difficulty breathing, throat constriction, headache, shivering, cough, insomnia and throat pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The reporter indicated that her daughter never had an allergic reaction to anything before. The patient received vaccine in left deltoid. The patient received Fluarix Quadrivalent vaccine 30th October 2019 at 8:47 am. A minute or two after receiving the vaccine, patient began to experienced difficulty breathing and her throat was closing. Within two minutes she was given an Epi-pen by the physician and was sent to the emergency room. The patient was observed at the emergency room for a couple of hours and discharged. Three or four hours after discharge, less than a day after vaccination, patient began to shiver, developed a cough, and had headache. She took Tylenol but she still had the symptoms and could not sleep most of the night.  The next morning, the shivering was resolved but she was still having headaches that come and go.  When she coughs on day of reporting, 1 day after vaccination it hurts her throat. The reporter unable to obtain additional details because his daughter was in another state at college. The reporter consent to follow up.
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Oropharyngeal pain, Throat tightness
Clinical narrative: hurts her throat; Difficulty breathing; Throat closing; Headache; Shivering; Cough; could not sleep; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 20-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number M5325, expiry date 30th June 2020) for prophylaxis.   On 30th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 30th October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced difficulty breathing, throat constriction, headache, shivering, cough and insomnia. On 31st October 2019, the patient experienced throat pain. The patient was treated with epinephrine, epinephrine (Epi Pen) and paracetamol (Tylenol). On 31st October 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the difficulty breathing and throat constriction were recovered/resolved and the outcome of the headache and cough were not recovered/not resolved and the outcome of the insomnia and throat pain were unknown.   It was unknown if the reporter considered the difficulty breathing, throat constriction, headache, shivering, cough, insomnia and throat pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The reporter indicated that her daughter never had an allergic reaction to anything before. The patient received vaccine in left deltoid. The patient received Fluarix Quadrivalent vaccine 30th October 2019 at 8:47 am. A minute or two after receiving the vaccine, patient began to experienced difficulty breathing and her throat was closing. Within two minutes she was given an Epi-pen by the physician and was sent to the emergency room. The patient was observed at the emergency room for a couple of hours and discharged. Three or four hours after discharge, less than a day after vaccination, patient began to shiver, developed a cough, and had headache. She took Tylenol but she still had the symptoms and could not sleep most of the night.  The next morning, the shivering was resolved but she was still having headaches that come and go.  When she coughs on day of reporting, 1 day after vaccination it hurts her throat. The reporter unable to obtain additional details because his daughter was in another state at college. The reporter consent to follow up.
Age: 76.0
Sex: F
Vaccine: FLUA3, VARZOS, FLUA3, VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Feeling abnormal, Injection site pain, Insomnia
Clinical narrative: Sore arm / Pain in right arm is localized to the injection site only; Headache; sleeplessness; Diarrhea; Rash on face; Red raised itchy blotches appearing on face and behind ears; Red raised itchy blotches appearing on face and behind ears; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   On 28th October 2019, the patient received the 1st dose of Shingrix (intramuscular) and FLUAD. On 28th November 2009, less than a day after receiving Shingrix, the patient experienced upset stomach. In October 2019, the patient experienced rash, blotchy rash and pruritus. On 28th October 2019, the patient experienced injection site pain, headache, sleeplessness and diarrhea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain, headache, sleeplessness, diarrhea, upset stomach, rash, blotchy rash and pruritus were unknown.   It was unknown if the reporter considered the injection site pain, headache, sleeplessness, diarrhea, upset stomach, rash, blotchy rash and pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in right arm and FLUAD 65 plus vaccine in left arm. The same night of vaccination patient started to experienced upset stomach, diarrhea, sore arm, headache, sleeplessness.  The patient stated the pain in her right arm was localized to the injection site only.  The next days, less than a week after vaccination she started to notice red raised itchy blotches appearing on face and behind ears. The patient took Benadryl on night, day before reporting as directed by her pharmacist.  On day of reporting she stated the rash on her face had subsided some, but still there. Additional information was not provided. It was unknown if the reporter considered the injection site pain, headache, sleeplessness, diarrhea, upset stomach, rash, blotchy rash and pruritus to be related to FLUAD 65. The reporter consent to follow up.
Age: 76.0
Sex: F
Vaccine: FLUA3, VARZOS, FLUA3, VARZOS
Symptoms: Rash erythematous, Rash macular, Rash papular, Rash pruritic
Clinical narrative: Sore arm / Pain in right arm is localized to the injection site only; Headache; sleeplessness; Diarrhea; Rash on face; Red raised itchy blotches appearing on face and behind ears; Red raised itchy blotches appearing on face and behind ears; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   On 28th October 2019, the patient received the 1st dose of Shingrix (intramuscular) and FLUAD. On 28th November 2009, less than a day after receiving Shingrix, the patient experienced upset stomach. In October 2019, the patient experienced rash, blotchy rash and pruritus. On 28th October 2019, the patient experienced injection site pain, headache, sleeplessness and diarrhea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain, headache, sleeplessness, diarrhea, upset stomach, rash, blotchy rash and pruritus were unknown.   It was unknown if the reporter considered the injection site pain, headache, sleeplessness, diarrhea, upset stomach, rash, blotchy rash and pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in right arm and FLUAD 65 plus vaccine in left arm. The same night of vaccination patient started to experienced upset stomach, diarrhea, sore arm, headache, sleeplessness.  The patient stated the pain in her right arm was localized to the injection site only.  The next days, less than a week after vaccination she started to notice red raised itchy blotches appearing on face and behind ears. The patient took Benadryl on night, day before reporting as directed by her pharmacist.  On day of reporting she stated the rash on her face had subsided some, but still there. Additional information was not provided. It was unknown if the reporter considered the injection site pain, headache, sleeplessness, diarrhea, upset stomach, rash, blotchy rash and pruritus to be related to FLUAD 65. The reporter consent to follow up.
Age: 76.0
Sex: F
Vaccine: FLUA3, VARZOS, FLUA3, VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Injection site pain, Insomnia
Clinical narrative: Sore arm / Pain in right arm is localized to the injection site only; Headache; sleeplessness; Diarrhea; Rash on face; Red raised itchy blotches appearing on face and behind ears; Red raised itchy blotches appearing on face and behind ears; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   On 28th October 2019, the patient received the 1st dose of Shingrix (intramuscular) and FLUAD. On 28th November 2009, less than a day after receiving Shingrix, the patient experienced upset stomach. In October 2019, the patient experienced rash, blotchy rash and pruritus. On 28th October 2019, the patient experienced injection site pain, headache, sleeplessness and diarrhea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain, headache, sleeplessness, diarrhea, upset stomach, rash, blotchy rash and pruritus were unknown.   It was unknown if the reporter considered the injection site pain, headache, sleeplessness, diarrhea, upset stomach, rash, blotchy rash and pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in right arm and FLUAD 65 plus vaccine in left arm. The same night of vaccination patient started to experienced upset stomach, diarrhea, sore arm, headache, sleeplessness.  The patient stated the pain in her right arm was localized to the injection site only.  The next days, less than a week after vaccination she started to notice red raised itchy blotches appearing on face and behind ears. The patient took Benadryl on night, day before reporting as directed by her pharmacist.  On day of reporting she stated the rash on her face had subsided some, but still there. Additional information was not provided. It was unknown if the reporter considered the injection site pain, headache, sleeplessness, diarrhea, upset stomach, rash, blotchy rash and pruritus to be related to FLUAD 65. The reporter consent to follow up.
Age: 76.0
Sex: F
Vaccine: FLUA3, VARZOS, FLUA3, VARZOS
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Sore arm / Pain in right arm is localized to the injection site only; Headache; sleeplessness; Diarrhea; Rash on face; Red raised itchy blotches appearing on face and behind ears; Red raised itchy blotches appearing on face and behind ears; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   On 28th October 2019, the patient received the 1st dose of Shingrix (intramuscular) and FLUAD. On 28th November 2009, less than a day after receiving Shingrix, the patient experienced upset stomach. In October 2019, the patient experienced rash, blotchy rash and pruritus. On 28th October 2019, the patient experienced injection site pain, headache, sleeplessness and diarrhea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain, headache, sleeplessness, diarrhea, upset stomach, rash, blotchy rash and pruritus were unknown.   It was unknown if the reporter considered the injection site pain, headache, sleeplessness, diarrhea, upset stomach, rash, blotchy rash and pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in right arm and FLUAD 65 plus vaccine in left arm. The same night of vaccination patient started to experienced upset stomach, diarrhea, sore arm, headache, sleeplessness.  The patient stated the pain in her right arm was localized to the injection site only.  The next days, less than a week after vaccination she started to notice red raised itchy blotches appearing on face and behind ears. The patient took Benadryl on night, day before reporting as directed by her pharmacist.  On day of reporting she stated the rash on her face had subsided some, but still there. Additional information was not provided. It was unknown if the reporter considered the injection site pain, headache, sleeplessness, diarrhea, upset stomach, rash, blotchy rash and pruritus to be related to FLUAD 65. The reporter consent to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Inflammation, Influenza like illness, Injection site pain
Clinical narrative: flu-like symptoms: large swelling at injection site, pain at injection site, muscle pain, whole body soreness/ache, headache, extreme fatigue, rash left thigh and buttock,  inflamed lumps left thigh and buttock
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pain, Rash
Clinical narrative: flu-like symptoms: large swelling at injection site, pain at injection site, muscle pain, whole body soreness/ache, headache, extreme fatigue, rash left thigh and buttock,  inflamed lumps left thigh and buttock
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Injection site induration, Rash
Clinical narrative: 10cm long rash, hot, redness after 24 hours  rash lasted for 3 days, at first injection site very hard
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Amniorrhoea, Exposure during pregnancy, Pre-eclampsia, Premature delivery
Clinical narrative: Loss of amniotic fluid, was seen at medical clinic frequently, up until the shot, baby was measuring normally as well as fluids. Once shot was administered I started experiencing leaking (went to Labor and Delivery ER), however they could not determine if it was amniotic fluid. Follow up appointment June 19th was when I was told baby was not measuring as she should. Estimated due date was August 11th, she was born on July 17th, due to low amniotic fluid and preeclampsia. Birth weight was 5lbs 3onces
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: 7x10cm area of dependent erythema down to deltoid. No fevers, chills, N/S.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Pt had erythema and swelling after flu shot, starting about 36 hours later; she had the same reaction last year and was treated for cellulitis; however, today it appears to be an immune response and not cellulitis
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Feeling cold, Headache, Neck pain
Clinical narrative: Neck pain, headaches, fatigue, shaking in the hands, anorexia, feeling cold all the time and pain on the right side of the head that feels like is an episode when he had shingles in the past.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Neck pain, headaches, fatigue, shaking in the hands, anorexia, feeling cold all the time and pain on the right side of the head that feels like is an episode when he had shingles in the past.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Pain
Clinical narrative: Initially I had the usual discomfort in the injection site. After  a few days I had pain radiating from my bicep down my inner arm. The pain eventually settled in my inner forearm and I continue to have this pain (ache, soreness). The mobility in my left arm has been severely affected.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Dizziness, Influenza like illness, Injection site inflammation, Injection site swelling
Clinical narrative: symptoms: dizziness, muscle/joint pain, flu-like symptoms, swelling/inflammation at injection site of left arm; symptoms started in the middle of the night on the day of administration
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Myalgia
Clinical narrative: symptoms: dizziness, muscle/joint pain, flu-like symptoms, swelling/inflammation at injection site of left arm; symptoms started in the middle of the night on the day of administration
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Rash erythematous, Rash papular
Clinical narrative: Multiple small red raised non itchy non painful bumps located over the left upper arm and left shoulder. Afebrile. No other reported symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches and fever (100.6) for about 24 hours.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy abnormal, Cryotherapy, Papilloma viral infection
Clinical narrative: "CIN2" with abnormal cells; On another unspecified date in 2008 after her vaccinations in 2008 her daughter was diagnosed with "HPV".; This spontaneous report was received from a consumer referring to her 27 years old daughter. The patient's medical history included gallbladder removal with digestive issues. Concomitant therapies included iron, B12 shots and birth control. The patient was allergy to amoxicillen and penicillin.  On unspecified date in 2008, the patient was vaccinated with 3 complete doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (route reported as "3 shots in arm"; strength, dose, frequency, lot # and expiration date were not provided) for prophylaxis.         On another unspecified date in 2008 after her vaccinations in 2008, the patient was diagnosed with human papillomavirus (HPV). On unspecified date in 2019, the patient was then diagnosed with cervical intraepithelial neoplasia II (CIN2) with abnormal cells after "colposcopy" was performed. Afterwards, on another unspecified date in "late September of 2019" the patient had cryotherapy. The outcome of events was recovering. The patient sought medical attention for the events. The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored VARIVAX; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information about pertinent medical history, drug reactions or allergies was not provided.         On 30-AUG-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S005078, expiration date 19-FEB-2021, or lot # R019237, expiration date 04-JUL-2020, route of administration was not provided) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion of -9.74 degrees Centigrade (C) for unknown time. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Improper storage of product in use; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent (lot # N030413, expiration date 05-JUL-2020).  Information about pertinent medical history, drug reactions or allergies was not provided.      On 15-SEP-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S002874, expiration date 29-JAN-2021, route of administration was not provided) for prophylaxis. The sterile diluent used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. Administered dose of vaccine experienced temperature excursion of 7.64 degrees Fahrenheit (F) for 20 minutes. There was previous temperature excursion of 19.34 degrees Fahrenheit (F) for 34 minutes. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; received improperly stored VARlVAX; This spontaneous report was received from a nurse referring to a patient of unknown age. Concomitant therapies included sterile diluent. Information about pertinent medical history and drug reactions/allergies was not provided.      On 12-SEP-2019, the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S005078, expiration date 19-FEB-2021 or lot # R019237, expiration date 04-JUL-2020; strength, dose, frequency and route, were not provided) for prophylaxis. (product storage error). Both lots of varicella virus vaccine live (oka/merck) (VARIVAX) that underwent the temperature excursion were added to the case since the office did not know which lot was given to which patient. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect was reported. It was stated that the vaccines were exposed to a temperature between -14 to -10 Celsius degrees (-9.74 Celsius). Time frame was unknown. A digital data logger was involved. No previous temperature excursion was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored VARlVAX; This spontaneous report was received from a nurse referring to a patient of unknown age. Concomitant therapies included sterile diluent. Information about pertinent medical history and drug reactions/allergies was not provided.     On 05-SEP-2019, the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S005078, expiration date 19-FEB-2021 or lot # R019237, expiration date 04-JUL-2020; strength, dose, frequency and route, were not provided) for prophylaxis.  (product storage error). Both lots of varicella virus vaccine live (oka/merck) (VARIVAX) that underwent the temperature excursion were added to the case since the office did not know which lot was given to which patient. It was stated that the vaccines were exposed to a temperature between -14 to -10 Celsius degrees (-9.74 Celsius). Time frame was unknown. A digital data logger was involved. No previous temperature excursion was reported. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; received improperly stored VARlVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Concomitant medication included sterile diluent. Information about pertinent medical history and drug reactions/allergies was not provided.   On 12-SEP-2019, the patient vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (single dose, lot # S005078, expiration date 19-FEB-2021 or lot # R019237, expiration date 04-JUL-2020(which lot was given to the patient was unknown); vaccine dosage detail not reported) for prophylaxis (product storage error). The storage temperatures of the varicella virus vaccine live (oka/merck) (VARIVAX) were -14 Celsius degrees to -10 Celsius degrees (-9.74 Celsius degrees) for unknown duration. There was no previous temperature excursion. Data logger was involved. The varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effects noted.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; improperly stored VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Concomitant medication included sterile diluent. The patient's pertinent medical history and drug reactions/allergies were not provided.   On 12-SEP-2019, the patient vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S005078, expiration date 19-FEB-2021 or lot # R019237, expiration date 04-JUL-2020(which lot was given to the patient was unknown); vaccine dosage detail was not reported) for prophylaxis(product storage error). The varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored sterile diluent. The storage temperatures of varicella virus vaccine live (Oka/Merck) (VARIVAX) were -14 Celsius degrees to -10 Celsius degrees (-9.74 Celsius degrees) for unknown duration. There was no previous temperature excursion. No adverse effects noted. Data logger was involved.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient received dose of PNEUMOVAX 23 that was improperly stored.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.    On 28-SEP-2019, the patient received improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (lot #: S012246, expiration date: 10-FEB-2020) (strength, dose, frequency and route of administration were not provided) as prophylaxis (product storage error). The vaccines were exposed to temperature of 68 degrees Fahrenheit for 8 hours. Previous excursions was reported as 57 degrees Fahrenheit for 2 hours. The data logger was involved. No adverse effects were reported.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Loss of consciousness, Mobility decreased, Muscle spasms, Pain, Tremor
Clinical narrative: patient passed out; patient was shaking uncontrollably; patient had "painful muscle spasms, especially in his hand"/patient "could not move his fingers"; Information has been received from a medical assistant referring to a 16 years old male patient. The patient had no concomitant medication, pertinent medical history or allergies.  On 25-OCT-2019, the patient was administered a dose of hepatitis a vaccine, inactivated (VAQTA) (lot number S002460 and expiration date 15-MAY-2020; dose number was unknonw) intramuscularly in the left upper arm for health maintenance.         After administration of the vaccine on 25-OCT-2019, the patient did not wait 15 minutes for observation but got up and left shortly. On his way to the car, the patient passed out and was shaking uncontrollably. The reporter stated that the patient did not had a seizure but had painful muscle spasms, especially in his hand. Entire event lasted 20-30 minutes and during the event patient could not move his fingers. The patient was assessed at office and upon recovery was sent home on the same date.  No product quality complaint (PQC) was involved. No treatment was given for the events and no labs was performed. The patient sought medical attention. The causality assessment between the events and hepatitis a vaccine, inactivated (VAQTA) was not provided.  Upon internal review, the event passed out was determined to be medically significant.
Age: 4.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse effects reported; Wrong vaccine administered; This spontaneous report was received from a medical assistant via a company representative referring to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 06-SEP-2016, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) reconstituted with a correct storage sterile diluent; instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, anatomical location, route of administration were not reported) lot# L043704 with expiration date on 04-NOV-2017 for prophylaxis (wrong product administered).   The reporter stated that the lot# for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was actually found to be the lot# for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). In addition, this was considered a medication error by another medical assistant.   No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; The patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 04-NOV-2019 or 05-NOV-2019, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S004253 with expiration date: 21-OCT-2020; dose and route of administration were not reported) for prophylaxis.  There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion below 36 degrees Fahrenheit for 2 hours and 18 minutes. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA001917: US-009507513-1911USA001926: US-009507513-1911USA001946: US-009507513-1911USA002043: US-009507513-1911USA002053: US-009507513-1911USA002198: US-009507513-1911USA002263: US-009507513-1911USA002388:
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported in the patient; A 13 year old male patient received a dose of GARDASIL 9 on 11/4/2019, after it expired; This spontaneous report was received from a medical assistant referring to a 13-year-old male patient.   The patients' medical history, concurrent conditions and concomitant medications were not reported.  On 04-NOV-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (lot # R024264 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported and establish as 29-OCT-2019) (strength, dose, route of administration and frequency were not provided).   No adverse effect was reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Arm pain; Extreme fatigue; Muscle pain; Joint pain; This case was reported by a consumer and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain in arm, fatigue, myalgia and arthralgia. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the fatigue, myalgia and arthralgia were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue, myalgia and arthralgia to be related to Shingrix.  Additional details were profidd as follows: On 22nd october, one week ago, the patient received dose of Shingrix. After vaccination the patient had arm pain that subsided. The patient had extreme fatigue, muscle and joint pain which were getting worse after each day with today being the worst so far.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient received dose of Shingrix and experienced adverse drug reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache
Clinical narrative: Headache; Tiredness; Upset stomach; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2019, the patient received the 1st dose of Shingrix. On 29th October 2019, 1 days after receiving Shingrix, the patient experienced headache, fatigue and abdominal discomfort. On an unknown date, the outcome of the headache, fatigue and abdominal discomfort were unknown.   It was unknown if the reporter considered the headache, fatigue and abdominal discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient age group was not reported but selected as an adult as per vaccine indication. The day before reporting, the patient received dose of Shingrix. On the day of reporting, the patient experienced Headache, tiredness and upset stomach. The patient asked, if over the counter medicines were ok to take.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Bad Ache; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown 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 provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. No patient demographics available at the time of the call. The pharmacist stated that the patient who complained that the solution going in upon Shingrix administration and had really bad ache. The reporter has been given the consent for the follow up. This case is 1 of 2 cases, reported by the same reporter.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased
Clinical narrative: Temperature is going up- 101; This case was reported by a consumer and described the occurrence of body temperature increased in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2019, the patient received the 1st dose of Shingrix. On 29th October 2019, 1 days after receiving Shingrix, the patient experienced body temperature increased. On an unknown date, the outcome of the body temperature increased was not recovered/not resolved.   It was unknown if the reporter considered the body temperature increased to be related to Shingrix.  Additional details were provided as follows: The day before reporting, the patient received dose of Shingrix. On the day of reporting, the patient had mild side effect of temperature 101.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Malaise, Pain
Clinical narrative: Body aches; Not feeling very good; Not a lot of energy; This case was reported by a consumer and described the occurrence of general body pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced general body pain, feeling bad and loss of energy. On an unknown date, the outcome of the general body pain, feeling bad and loss of energy were unknown.   It was unknown if the reporter considered the general body pain, feeling bad and loss of energy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and not feeling well and had body aches and not a lot of energy.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness; Soreness; Swollen; Warm; This case was reported by a consumer via sales rep and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema, pain, swelling and skin warm. On an unknown date, the outcome of the erythema, pain, swelling and skin warm were unknown.   It was unknown if the reporter considered the erythema, pain, swelling and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after the 2nd shingle shot had redness, soreness, about 2" in diameter swollen and a little warm. The patient asked is that pretty normal for second one the first one had nothing. The patient was concern about the events occurred after vaccination.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Injection site erythema, Injection site pain, Injection site swelling, Joint dislocation
Clinical narrative: Pain at the injection site; Redness at the injection site; Swelling at the injection site; Expired vaccine administered; Shoulder drop; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 60-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number 3BS44,for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Fluarix Tetra 2019-2020 season .5 ml. In October 2019, less than a week after receiving Fluarix Tetra 2019-2020 season, the patient experienced acromioclavicular separation. On 23rd October 2019, the patient experienced injection site pain, injection site erythema, injection site swelling and expired vaccine used. The patient was treated with ibuprofen, benadryl (nos) (Benadryl) and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, acromioclavicular separation and expired vaccine used were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and acromioclavicular separation to be related to Fluarix Tetra 2019-2020 season.  Additional details were provided as follows: The batch number was updated from 38S44 to 3BS44, as per sales data sheet. The patient had reaction at injection site within 24hours of vaccine administration pain redness and swelling. The redness lasted for over one week. The patient took ibuprofen and patient states that she has shoulder drop the physician that she works for looked at it initially and told her to take Benadryl and ibuprofen for pain and apply ice packs. The reporter did not consent to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 103; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had fever of 103 degree F. The reporter asked for medical informations phone to call them.      Lab Comments: Lab test performed on unknown date
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: Injection site discomfort; This case was reported by a nurse via call center representative and described the occurrence of injection site discomfort in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was recovered/resolved.   It was unknown if the reporter considered the injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The reporter consent to follow up. For tolerance of 2nd dose, refer case US2019AMR199259. The case has been linked to the cases US2019AMR199264 and US2019AMR199268, reported by same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Arm soreness; Headache; Dizziness; This case was reported by a nurse and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site discomfort (received 1st dose on 28th August 2019, refer case US2019AMR199256).   On 28th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain in arm, headache and dizziness. On an unknown date, the outcome of the pain in arm, headache and dizziness were recovering/resolving.   It was unknown if the reporter considered the pain in arm, headache and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had arm soreness, headache and dizziness. No additional information was provided. The reporter consent to follow up. This case linked with US2019AMR199264 and US2019AMR199268, reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Crying, Immediate post-injection reaction, Pain
Clinical narrative: Cries a lot due to pain; This case was reported by a nurse via sales rep and described the occurrence of pain in a infant patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 3Y9KM, expiry date unknown) for prophylaxis.   Previously administered products included Fluzone (received on an unknown date ).   On an unknown date, the patient received FluLaval Tetra 2019-2020 season. On an unknown date, immediately after receiving FluLaval Tetra 2019-2020 season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that they have noticed that when an infant receives the Flulaval PFS vaccine the infant cries a lot due to pain. The healthcare professional office has received two lots of the Flulaval PFS vaccine for 2019 and 2020, lot 3Y9km and lot 24PP4. The reporter stated that if an infant is asleep and given the Fluzone vaccine manufactured by Sanofi, the infant would continue to sleep, but if an infant was asleep and was given the Flulaval PFS vaccine (GSK), the infant would wake up and cry and scream when the vaccine was being administered due to pain.  The patients demographics were not provided. The reporter consented to follow up.