chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a registered nurse via company representative and refers to 20-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown date in 2018 (reported as within the last 3 months), the patient was vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot# and expiration date were not reported), both in the same arm. The patient had a return visit to the practice and was diagnosed with cellulitis on an unknown date in 2018. The patient might have been admitted to the hospital due to the event, however it could not be confirmed. The patient was treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between the event and suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1812USA008995: US-009507513-1812USA008996: US-009507513-1812USA007804.
Sex: U
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to 76-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown date in 2018 (reported as within the last 3 months), the patient was vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot# and expiration date were not reported), both in the same arm. The patient had a return visit to the practice and was diagnosed with cellulitis on an unknown date in 2018. The patient might have been admitted to the hospital due to the event, however it could not be confirmed. The patient was treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between the event and suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1812USA008995; US-009507513-1812USA007804; US-009507513-1812USA008994.
Sex: U
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Rash, Swelling
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to 76-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown date in 2018 (reported as within the last 3 months), the patient was vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot# and expiration date were not reported), both in the same arm. The patient had a return visit to the practice and was diagnosed with cellulitis on an unknown date in 2018. The patient might have been admitted to the hospital due to the event, however it could not be confirmed. The patient was treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between the event and suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1812USA008995; US-009507513-1812USA007804; US-009507513-1812USA008994.
Sex: U
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to 76-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown date in 2018 (reported as within the last 3 months), the patient was vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot# and expiration date were not reported), both in the same arm. The patient had a return visit to the practice and was diagnosed with cellulitis on an unknown date in 2018. The patient might have been admitted to the hospital due to the event, however it could not be confirmed. The patient was treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between the event and suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1812USA008995; US-009507513-1812USA007804; US-009507513-1812USA008994.
Sex: U
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Bandaemia, Chills, Dysphagia, Erythema, Inflammation
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to 56-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown date in 2018 (reported as within the last 3 months), the patient was vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot # and expiration date were not reported), both in the same arm. The patient had a return visit to the practice and was diagnosed with cellulitis on an unknown date in 2018. The patient might have been admitted to the hospital due to the event, however it could not be confirmed. The patient was treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1812USA007804: US-009507513-1812USA008996: US-009507513-1812USA008994.
Sex: U
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Ultrasound scan normal
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to 56-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown date in 2018 (reported as within the last 3 months), the patient was vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot # and expiration date were not reported), both in the same arm. The patient had a return visit to the practice and was diagnosed with cellulitis on an unknown date in 2018. The patient might have been admitted to the hospital due to the event, however it could not be confirmed. The patient was treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1812USA007804: US-009507513-1812USA008996: US-009507513-1812USA008994.
Sex: U
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Urine analysis abnormal, Urticaria, Viral infection, Vomiting, White blood cell count increased
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to 56-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown date in 2018 (reported as within the last 3 months), the patient was vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot # and expiration date were not reported), both in the same arm. The patient had a return visit to the practice and was diagnosed with cellulitis on an unknown date in 2018. The patient might have been admitted to the hospital due to the event, however it could not be confirmed. The patient was treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1812USA007804: US-009507513-1812USA008996: US-009507513-1812USA008994.
Sex: U
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to 56-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown date in 2018 (reported as within the last 3 months), the patient was vaccinated with PNEUMOVAX 23 in the unspecified arm (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis (reported as routine vaccine) and with influenza virus vaccine (unspecified) (exact dose, route of administration, lot # and expiration date were not reported), both in the same arm. The patient had a return visit to the practice and was diagnosed with cellulitis on an unknown date in 2018. The patient might have been admitted to the hospital due to the event, however it could not be confirmed. The patient was treated with unspecified antibiotics. The outcome of the event was unknown. The relatedness between suspect therapies was not provided. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1812USA007804: US-009507513-1812USA008996: US-009507513-1812USA008994.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Gait inability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Guillain-Barre syndrome in a 78-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of no adverse event. On 22nd July 2018, the patient received the 1st dose of SHINGRIX. On 31st July 2018, 9 days after receiving SHINGRIX, the patient experienced Guillain-Barre syndrome (serious criteria hospitalization and GSK medically significant), fall (serious criteria hospitalization) and speech disorder (serious criteria hospitalization). On an unknown date, the outcome of the Guillain-Barre syndrome, fall and speech disorder were unknown. The reporter considered the Guillain-Barre syndrome to be related to SHINGRIX. It was unknown if the reporter considered the fall and speech disorder to be related to SHINGRIX. Additional details were provided as follows: The case was a potential legal case. The patient reported that she fell four times and she could not get up. The next morning, she fell again and called 911. The patient was not making sense when talking. The patient was admitted to hospital for about a week and was diagnosed with Guillain-Barre Syndrome after doing the spinal tap. The physician transferred the patient to therapy for 7 weeks and released her and said that she was going to have home care. The patient did home care and she was at the time of reporting, doing physical therapy 3 times a week. The patient consented to follow up. The patient asked if the company would help her pay her bills and all the things that had happened as a result of the SHINGRIX vaccine. The patient also asked if it was necessary for her to get a lawyer and file a lawsuit to get such assistance. The patient asked how to get such process started and was provided legal department's address and fax number. The patient had provided details of her physician.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fall, Guillain-Barre syndrome, Lumbar puncture abnormal, Speech disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Guillain-Barre syndrome in a 78-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of no adverse event. On 22nd July 2018, the patient received the 1st dose of SHINGRIX. On 31st July 2018, 9 days after receiving SHINGRIX, the patient experienced Guillain-Barre syndrome (serious criteria hospitalization and GSK medically significant), fall (serious criteria hospitalization) and speech disorder (serious criteria hospitalization). On an unknown date, the outcome of the Guillain-Barre syndrome, fall and speech disorder were unknown. The reporter considered the Guillain-Barre syndrome to be related to SHINGRIX. It was unknown if the reporter considered the fall and speech disorder to be related to SHINGRIX. Additional details were provided as follows: The case was a potential legal case. The patient reported that she fell four times and she could not get up. The next morning, she fell again and called 911. The patient was not making sense when talking. The patient was admitted to hospital for about a week and was diagnosed with Guillain-Barre Syndrome after doing the spinal tap. The physician transferred the patient to therapy for 7 weeks and released her and said that she was going to have home care. The patient did home care and she was at the time of reporting, doing physical therapy 3 times a week. The patient consented to follow up. The patient asked if the company would help her pay her bills and all the things that had happened as a result of the SHINGRIX vaccine. The patient also asked if it was necessary for her to get a lawyer and file a lawsuit to get such assistance. The patient asked how to get such process started and was provided legal department's address and fax number. The patient had provided details of her physician.
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Computerised tomogram head, Differential white blood cell count, Foaming at mouth, Full blood count, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 18-month-old female patient who received HAVRIX (batch number 379P7, expiry date 31st January 2021) for prophylaxis. On 12th December 2018 13:00, the patient received HAVRIX (intramuscular) .5 ml. On 12th December 2018 14:30, 1 hr 30 min after receiving HAVRIX, the patient experienced seizure (serious criteria GSK medically significant), pain, stiffness, tremor, foaming at mouth and screaming. On an unknown date, the outcome of the seizure, pain, stiffness, tremor and foaming at mouth were recovered/resolved and the outcome of the screaming was unknown. It was unknown if the reporter considered the seizure, pain, stiffness, tremor, foaming at mouth and screaming to be related to HAVRIX. Additional details were received as follows: This case was received from office Manager. At around 1 pm, the patient received HAVRIX and about 2:30 pm the patient's mother said that the patient was screaming with a lot of pain, stiffing up and shaking. The patient went to emergency room. At the ER, the patient was foaming at the mouth, having seizure like symptoms. The patient had a Computerised tomogram (CT) scan and blood work done. After several hours the patient was back to normal.
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Irritability, Musculoskeletal stiffness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 18-month-old female patient who received HAVRIX (batch number 379P7, expiry date 31st January 2021) for prophylaxis. On 12th December 2018 13:00, the patient received HAVRIX (intramuscular) .5 ml. On 12th December 2018 14:30, 1 hr 30 min after receiving HAVRIX, the patient experienced seizure (serious criteria GSK medically significant), pain, stiffness, tremor, foaming at mouth and screaming. On an unknown date, the outcome of the seizure, pain, stiffness, tremor and foaming at mouth were recovered/resolved and the outcome of the screaming was unknown. It was unknown if the reporter considered the seizure, pain, stiffness, tremor, foaming at mouth and screaming to be related to HAVRIX. Additional details were received as follows: This case was received from office Manager. At around 1 pm, the patient received HAVRIX and about 2:30 pm the patient's mother said that the patient was screaming with a lot of pain, stiffing up and shaking. The patient went to emergency room. At the ER, the patient was foaming at the mouth, having seizure like symptoms. The patient had a Computerised tomogram (CT) scan and blood work done. After several hours the patient was back to normal.
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Blood test, Computerised tomogram, Foaming at mouth, Musculoskeletal stiffness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 18-month-old female patient who received HAVRIX (batch number 379P7, expiry date 31st January 2021) for prophylaxis. On 12th December 2018 13:00, the patient received HAVRIX (intramuscular) .5 ml. On 12th December 2018 14:30, 1 hr 30 min after receiving HAVRIX, the patient experienced seizure (serious criteria GSK medically significant), pain, stiffness, tremor, foaming at mouth and screaming. On an unknown date, the outcome of the seizure, pain, stiffness, tremor and foaming at mouth were recovered/resolved and the outcome of the screaming was unknown. It was unknown if the reporter considered the seizure, pain, stiffness, tremor, foaming at mouth and screaming to be related to HAVRIX. Additional details were received as follows: This case was received from office Manager. At around 1 pm, the patient received HAVRIX and about 2:30 pm the patient's mother said that the patient was screaming with a lot of pain, stiffing up and shaking. The patient went to emergency room. At the ER, the patient was foaming at the mouth, having seizure like symptoms. The patient had a Computerised tomogram (CT) scan and blood work done. After several hours the patient was back to normal.
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Screaming, Seizure, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 18-month-old female patient who received HAVRIX (batch number 379P7, expiry date 31st January 2021) for prophylaxis. On 12th December 2018 13:00, the patient received HAVRIX (intramuscular) .5 ml. On 12th December 2018 14:30, 1 hr 30 min after receiving HAVRIX, the patient experienced seizure (serious criteria GSK medically significant), pain, stiffness, tremor, foaming at mouth and screaming. On an unknown date, the outcome of the seizure, pain, stiffness, tremor and foaming at mouth were recovered/resolved and the outcome of the screaming was unknown. It was unknown if the reporter considered the seizure, pain, stiffness, tremor, foaming at mouth and screaming to be related to HAVRIX. Additional details were received as follows: This case was received from office Manager. At around 1 pm, the patient received HAVRIX and about 2:30 pm the patient's mother said that the patient was screaming with a lot of pain, stiffing up and shaking. The patient went to emergency room. At the ER, the patient was foaming at the mouth, having seizure like symptoms. The patient had a Computerised tomogram (CT) scan and blood work done. After several hours the patient was back to normal.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms, chills, shakes, tingling, headache, body ache, arm very sore, upset stomach.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Tremor
Clinical narrative: Flu-like symptoms, chills, shakes, tingling, headache, body ache, arm very sore, upset stomach.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an adult dose of VAQTA 50/1.0 U/ml (dosage schedule, route and anatomical location were not reported), lot # R024008, expiration date 15-NOV-2018, indicated for prophylaxis. No adverse effect was reported.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 18 year old patient of unknown gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with a fourth dose of GARDASIL 9 for prophylaxis (strength, dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported). No adverse effects were reported.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Malaise, Mobility decreased, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 76-year-old male patient. The patient had not any medical history, concurrent conditions or concomitant medications. The patient was vaccinated on  an unknown date in September 2017 with PREVNAR 13 and on anunspecified date in September 2018 with influenza virus vaccine inactivated (unspecified). On 28-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R016638, expiration date 28-JAN-2020, (dosage schedule, route and anatomical location were not reported). On approximately the same day, (reported as "not sure if on 28-NOV-2018 or 29-NOV-2018), the patient experienced sharp pain in the arm, at injection site, as well as,  decreased limb mobility, skin warm and malaise. The reporter stated that the patient did not sought medical attention and received treatment for the events but at the time of reporting the patient was not recovered. Laboratory diagnostics or studies were not performed. The causality assessment between the adverse events and the suspect vaccine was not provided at the time of this report.
Age: 1.0
Sex: U
Vaccine: FLUX, HEPA
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: This spontaneous report as received from a pharmacist regarding a 3 year and 5 months old Child patient of unknown gender. There was no information regarding concurrent condition, concomitant and historical medication. At the age of 12 months approximately in 2015 patient was vaccinated with first dose of VAQTA 25/0.5 (units unknown) for prophylaxis. Now at the age of 3 year and 5 months approximately in 2018, the patient was vaccinated with second dose of VAQTA for prophylaxis. Patient was also vaccinated with the flu vaccine influenza virus vaccine (unspecified) in 2018.  On 05-DEC-2018, the patient inadvertently received the third dose of VAQTA instead of flu booster (extra dose administered and wrong product administered). No adverse event was reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Cold sweat, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a consumer regarding a 72 year old female patient. Currently patient had osteoporosis and blood pressure high. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included ABALOPARATIDE. Concomitant therapies included METOPROLOL and CALCIUM (UNSPECIFIED). On an unknown date the patient experienced redness, swelling and pain at the injection site, and cold sweats and hair loss. The outcome of dizziness and alopecia was unknown. The outcome of redness, swelling and pain at the injection site, and cold sweats was resolved (reported as lasted for 48 hours). Causality assessment was not provided.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer regarding a 72 year old female patient. Currently patient had osteoporosis and blood pressure high. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included ABALOPARATIDE. Concomitant therapies included METOPROLOL and CALCIUM (UNSPECIFIED). On an unknown date the patient experienced redness, swelling and pain at the injection site, and cold sweats and hair loss. The outcome of dizziness and alopecia was unknown. The outcome of redness, swelling and pain at the injection site, and cold sweats was resolved (reported as lasted for 48 hours). Causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician via company representative refers to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant medication were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. The patient was inadvertently administrated GARDASIL 9 instead of intended flu shot. It was unknown why there was confusion between the two products. The patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not provided and could not be calculated. The pregnancy outcome was pending. This is one of two reports received from the same reporter (1812USA003886).; Sender's Comments: US-009507513-1812USA003886:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Exposure to communicable disease, Fatigue, Myalgia
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 14-year-old male patient. The patient's pertinent medical history, concomitant medications and drug reactions and allergies were reported as none. On 14-APR-2005, the patient was vaccinated with the first dose of VARIVAX, subcutaneously, for prophylaxis (also reported as vaccine) (dose, lot number and expiration date were not reported). On 17-APR-2008, the patient was vaccinated with the second dose of VARIVAX, subcutaneously (lot number: 1916U) (dose and expiration date were not reported). On an unknown date (reported as a couple of weeks ago), the patient was exposed to a family member diagnosed with shingles. On 04-DEC-2018, the patient began experiencing symptoms of chicken pox including myalgia, fatigue, a mildly itchy rash all over his body, sore throat, and red lesions with vesicles. No lab diagnostics or studies were performed. The patient sought medical attention and was seen in office. An unspecified treatment was given for the event. At the time of reporting, the patient was recovering from the event. The relationship between the event and the vaccine was not reported. Lot number 1916U has been verified to be a valid lot number for VARIVAX.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Oropharyngeal pain, Rash generalised, Rash pruritic, Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 14-year-old male patient. The patient's pertinent medical history, concomitant medications and drug reactions and allergies were reported as none. On 14-APR-2005, the patient was vaccinated with the first dose of VARIVAX, subcutaneously, for prophylaxis (also reported as vaccine) (dose, lot number and expiration date were not reported). On 17-APR-2008, the patient was vaccinated with the second dose of VARIVAX, subcutaneously (lot number: 1916U) (dose and expiration date were not reported). On an unknown date (reported as a couple of weeks ago), the patient was exposed to a family member diagnosed with shingles. On 04-DEC-2018, the patient began experiencing symptoms of chicken pox including myalgia, fatigue, a mildly itchy rash all over his body, sore throat, and red lesions with vesicles. No lab diagnostics or studies were performed. The patient sought medical attention and was seen in office. An unspecified treatment was given for the event. At the time of reporting, the patient was recovering from the event. The relationship between the event and the vaccine was not reported. Lot number 1916U has been verified to be a valid lot number for VARIVAX.
Age: 1.58
Sex: U
Vaccine: MMR
Symptoms: Leukocytosis, Pyrexia
Clinical narrative: This spontaneous report has been received from a registered nurse via a company representative, referring a 19 months patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (strength, dose, frequency, anatomical site of injection, lot # and expiration date were not reported) for prophylaxis. On an unknown date, reported as "10 days later", the patient experienced fever of 104 Fahrenheit (pyrexia), the patient sought for medical attention; however the event was not resolved with unspecified treatment. On an unknown date, the patient was hospitalized with a diagnosis of leukocytosis. At the time of this report the patient had not recovered from the adverse events. The causality assessment between M-M-R II was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot # and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-MAY-2010, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 19-OCT-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot # and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 01-OCT-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 17-SEP-2014, a healthcare provider, at a medical office, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In SEPTEMBER 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-SEP-2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 01-APR-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-DEC-2018, the patient was vaccinated with a dose of ROTATEQ lot # R021055, expiration date on 01-APR-2020 (dose, anatomical location and administration route were not reported) for prophylaxis. The reporter stated that the patient received a dose of ROTATEQ that may have been invalid due to shipping issues. No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On 17-DEC-2018, the patient was vaccinated with an expired dose of ZOSTAVAX lot # N025701, expiration date 16-DEC-2018 (dose, route and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent lot # N027626, expiration date 20-MAY-2019. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a physician and the mother of an unspecified child of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (the dosage regiment information was not reported) for prophylaxis. On an unknown date, the patient experienced fever. The fever did resolve, and the patient continued to complete the series without further incident. No relatedness assessment was provided.; Sender's Comments: US-009507513-1812USA009298:
Age: 45.0
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Initial Report Received: 12-Dec-2018. A nurse reported that patient, a 45-year-old female patient (race not provided) was administered with HEPLISAV-B (hepatitis B vaccine) for an unknown indication and received an extra dose of HEPLISAV-B. Relevant medical history included pneumonia and encephalopathy. The patient had no known allergies. The patient was not on any known medications. The patient received the first dose of HEPLISAV-B in Sep-2018, the second dose of HEPLISAV-B on Nov-2018, and the third dose of HEPLISAV-B on 12-Dec-2018 (lot # 1033384, expiration date 06-Apr-2019, NDC 43528-002-01). No further information was provided. The patient did not provide permission to contact her. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of extra dose administered as non-serious. The event of extra dose administered is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of extra dose administered as non-serious. The event of extra dose administered is unlisted per HEPLISAV-B USPI.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 5-year-old female patient who received KINRIX for prophylaxis. On 28th November 2018, the patient received KINRIX. In November 2018, less than a week after receiving KINRIX, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were unknown. It was unknown if the reporter considered the erythema of extremities and skin warm to be related to KINRIX. Additional details were reported as follows: The reporting nurse was grandmother of patient. She asked if it was a common reaction for a 5 year old to have redness and hot to touch from the top to half way down upper arm after KINRIX vaccine. The reporter had not seen this reaction before. The patient's mother called the office and was told this was a common reaction. The reporter had seen redness before but not hot to touch. When asked about consent for GSK to follow up with the patient's physician regarding event, the reporter stated she should really check with patient's mother first.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, IPV, MMR, MNQ, TD
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling, Injection site warmth
Clinical narrative: Patient complain of swelling to right arm after receiving immunization. Assessment: Extensive swelling noted to right arm, shoulder to elbow and warm to touch.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There was no adverse reaction the Hep b was given in error and I was instructed by management to report this to VAERS.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Nervousness
Clinical narrative: Ache at site and over all. Shaky, no fever. Flu like symptoms.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dry skin, Injection site erythema, Injection site reaction
Clinical narrative: Rough, Red area around site of injection. No pain or itching reported.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash
Clinical narrative: Rough, Red area around site of injection. No pain or itching reported.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Nausea, Pyrexia, Swelling, Vomiting
Clinical narrative: Swelling x4 days, fever x2 days, nausea x2days, vomiting x2days, severe headache x2days.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Pruritus, Urticaria
Clinical narrative: On 12/19/18 patient returned to Employee health stating 2 hours after Tdap given on 12/18/18 her chest began to itch. She took an ALLEGRA which did not help. She states a few hours later she developed hives on her upper chest and hairline. She took a BENADRYL, went to bed and when she woke up in the AM on 12/19 the symptoms had resolved. There was no issues at the injection site; she states the area where the BAND AID was slightly reddened but no swelling or pain.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure decreased, Hyperhidrosis, Pallor, Syncope
Clinical narrative: After patient was given the flu vaccine, her blood pressure drop, she was sweating and pale skin.  Patient remained in a sitting position until she fainted and then 911 was called. No CPR or EPI PEN shot was given. No signs of allergy was noticed. This all happen in a 30 minute period.
Age: 19.0
Sex: M
Vaccine: FLUN4, HEPAB, TYP
Symptoms: Dysgraphia, Grip strength decreased, Guillain-Barre syndrome, Hypoaesthesia, Influenza virus test negative
Clinical narrative: Member states that he had numbing and paralysis starting in his fingers and toes. He began to start having trouble turning door knobs and writing. Urgent Care clinic tested him for Swine Flu but it came back negative. Member was referred to a neurologist who documented that he had acquired Guillain-Barre Syndrome from the flu vaccination.
Age: 19.0
Sex: M
Vaccine: FLUN4, HEPAB, TYP
Symptoms: Paralysis, Vaccination complication
Clinical narrative: Member states that he had numbing and paralysis starting in his fingers and toes. He began to start having trouble turning door knobs and writing. Urgent Care clinic tested him for Swine Flu but it came back negative. Member was referred to a neurologist who documented that he had acquired Guillain-Barre Syndrome from the flu vaccination.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Cellulitis, Dizziness, Hyperhidrosis, Injection site erythema
Clinical narrative: Patient received single dose vial of PREVNAR 13 in left upper arm late morning on Dec 6th 2018. Patient reported to me, her daughter, that next morning, Dec 7th 2018, she was violently vomiting, was dizzy, and felt very weak. Patient also developed fever that day. Patient then stated that during night time hours into the following morning of Saturday Dec 8 2018, she was still feverish and had profuse sweating. Fever then dissipated on Saturday Dec 8 2018. Following day Sunday Dec 9th patient was homebound and felt very dizzy and weak. She did not want to go to the urgent care clinic as she thought this was a reaction to the injection and was told by the RN that she was sensitive to it and the reaction was normal. On Tuesday Dec 10th around 5 PM in the afternoon, the patient showed me her left upper arm where the injection took place as she said it was very sore. The arm was bright red from the shoulder down to the elbow, swollen and very hot to the touch. I immediately called Dr.'s office, but it was closed. The On Call triage nurse advised that she should be seen by Dr. the next day and to use warm moist compresses on the site to alleviate pain. Patient was then seen by Dr. on Wednesday Dec 11th and was given a 7 day dose of antibiotics for cellulitis.