chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal sensation in eye, Headache, Influenza like illness, Pharyngeal oedema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old female patient who received SHINGRIX. Concomitant products included simvastatin, hydrochlorothiazide and TYLENOL. On 19th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th March 2018, 6 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms, throat swelling, abnormal sensation in eye and headache. On an unknown date, the outcome of the influenza-like symptoms and abnormal sensation in eye were not recovered/not resolved and the outcome of the throat swelling and headache were recovering/resolving. The reporter considered the influenza-like symptoms, throat swelling, abnormal sensation in eye and headache to be almost certainly related to SHINGRIX. Additional details were reported as follows: At 12:30, the patient received SHINGRIX at a pharmacy. Less than a day after vaccination, the patient experienced throat swelling. The patient felt a sharp pain in the right side of her head and the pain subsided to a headache status. The patient experienced flu like symptoms, throat swelling and eyes feeling funny.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Seizure like phenomena
Clinical narrative: Brought to ED on 3/31/18 with reported seizure like activity following fever of 103. Pt had been diagnosed w/ear infection on 3/23/18 and placed on AUGMENTIN. Pt seen 3/30/18 and had improved. DtaP administered on 3/30/18.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Secretion discharge, Swelling, Ulcer
Clinical narrative: Slight swelling with an open ulcer, with slight drainage since 01/04/2018.
Age: 31.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 1.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMR, PNC13, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No reaction.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm pain, swelling and redness at injection site x 3 days. Patient with left upper arm swelling and redness for 2 days. She had PNEUMOVAX on same arm at 2 PM and her symptoms started around 6 PM. Her whole upper arm was swollen and was difficult to even raise the arm. The swelling has improved, but redness is worse. She has applied ice and heat.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site rash
Clinical narrative: Localized clear bumps to upper left arm in area of administration of Dtap vaccine. 15 mins before the appearance clear bumps.
Age: 54.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Pruritus, Pyrexia
Clinical narrative: Red, itchy. Tactile fever. Ibuprofen.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site discomfort, Swelling
Clinical narrative: Patient received vaccine on 2/27/18. He returned to office 03/08/18 complaining that his upper arm and upper left pectoral region felt tight and uncomfortable. He had a little swelling in the first 2 days but this had resolved when seen. He had no redness or swelling, normal range of motion.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb immobilisation, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient's whole arm in pain. Shoulders to below elbow. She had to see MD and get pain medication and be put on sling.
Age: 79.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: No adverse event
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist reporting for himself. A 79-years-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration into the left arm on 22Jun2015 at single dose for immunisation. Medical history included immunisation in the past, but never had an experience like this. The patient's concomitant medications were not reported. The patient experienced waffle design rash, pains in his neck and across his shoulder, little use of his left arm and no muscle tone, pain to his fingertips, bronchitis twice, brachial neuritis, constant pain from his neck to shoulder, including down the back, lost of muscle tone of the biceps and triceps of the left arm all on an unspecified date with outcome of unknown and about one day after he received this injection, on unspecified date in Jun2015 his left arm became red and swollen including below the shoulder, on an unspecified date with outcome of unknown. His diagnosis was determined to be brachial neuritis or Parsonage-Turner Syndrome.
Age: 79.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Back pain, Bronchitis, Hypotonia, Injected limb mobility decreased, Injection site erythema
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist reporting for himself. A 79-years-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration into the left arm on 22Jun2015 at single dose for immunisation. Medical history included immunisation in the past, but never had an experience like this. The patient's concomitant medications were not reported. The patient experienced waffle design rash, pains in his neck and across his shoulder, little use of his left arm and no muscle tone, pain to his fingertips, bronchitis twice, brachial neuritis, constant pain from his neck to shoulder, including down the back, lost of muscle tone of the biceps and triceps of the left arm all on an unspecified date with outcome of unknown and about one day after he received this injection, on unspecified date in Jun2015 his left arm became red and swollen including below the shoulder, on an unspecified date with outcome of unknown. His diagnosis was determined to be brachial neuritis or Parsonage-Turner Syndrome.
Age: 79.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site swelling, Musculoskeletal pain, Neck pain, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist reporting for himself. A 79-years-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration into the left arm on 22Jun2015 at single dose for immunisation. Medical history included immunisation in the past, but never had an experience like this. The patient's concomitant medications were not reported. The patient experienced waffle design rash, pains in his neck and across his shoulder, little use of his left arm and no muscle tone, pain to his fingertips, bronchitis twice, brachial neuritis, constant pain from his neck to shoulder, including down the back, lost of muscle tone of the biceps and triceps of the left arm all on an unspecified date with outcome of unknown and about one day after he received this injection, on unspecified date in Jun2015 his left arm became red and swollen including below the shoulder, on an unspecified date with outcome of unknown. His diagnosis was determined to be brachial neuritis or Parsonage-Turner Syndrome.
Age: 79.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Radiculitis brachial, Rash
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist reporting for himself. A 79-years-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration into the left arm on 22Jun2015 at single dose for immunisation. Medical history included immunisation in the past, but never had an experience like this. The patient's concomitant medications were not reported. The patient experienced waffle design rash, pains in his neck and across his shoulder, little use of his left arm and no muscle tone, pain to his fingertips, bronchitis twice, brachial neuritis, constant pain from his neck to shoulder, including down the back, lost of muscle tone of the biceps and triceps of the left arm all on an unspecified date with outcome of unknown and about one day after he received this injection, on unspecified date in Jun2015 his left arm became red and swollen including below the shoulder, on an unspecified date with outcome of unknown. His diagnosis was determined to be brachial neuritis or Parsonage-Turner Syndrome.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: This case was reported by a consumer and described the occurrence of cellulitis in a patient who received SHINGRIX. On 7th March 2017, the patient received SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant), upset  stomach (serious criteria hospitalization), chills (serious criteria hospitalization) and fatigue (serious criteria hospitalization). On an unknown date, the outcome of the cellulitis, upset stomach, chills and fatigue were unknown. It was unknown if the reporter considered the cellulitis, upset stomach, chills and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine and developed cellulitis, felt fatigued, had an upset stomach and chills. The medical treatment was sought at a hospital.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Cellulitis, Chills, Fatigue
Clinical narrative: This case was reported by a consumer and described the occurrence of cellulitis in a patient who received SHINGRIX. On 7th March 2017, the patient received SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant), upset  stomach (serious criteria hospitalization), chills (serious criteria hospitalization) and fatigue (serious criteria hospitalization). On an unknown date, the outcome of the cellulitis, upset stomach, chills and fatigue were unknown. It was unknown if the reporter considered the cellulitis, upset stomach, chills and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine and developed cellulitis, felt fatigued, had an upset stomach and chills. The medical treatment was sought at a hospital.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Pruritus, Rash
Clinical narrative: Severe itching on chest, arms, neck and hands; mild rash; diarrhea. OTC topical BENADRYL and oral BENADRYL.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood potassium decreased, Chromaturia, Diarrhoea, Hepatic enzyme increased, Rash generalised
Clinical narrative: Severe itching on chest, arms, neck and hands; mild rash; diarrhea. OTC topical BENADRYL and oral BENADRYL.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Fatigue, Insomnia, Peripheral swelling
Clinical narrative: PATIENT CALLED THE PHARMACY AT 06:00 AM ON APRIL 3RD, 2018. PATIENT COMPLAINED TO HAVE HARD TIME SLEEPING AT NIGHT DUE TO THE INJECTION SITE ON THE RIGHT ARM. THE PATIENT COMPLAINED OF SYMPTOMS THAT OCCURRED AT NIGHT ON RIGHT ARM OF MASSIVE SWELLING (TWICE IT'S SIZE), NIGHT CHILLS, DIARRHEA, AND FATIGUE. RECOMMENDED TO TAKE AN ANTI-HISTAMINE AND ANTI-INFLAMMATION MEDICATION AND TO CALL THE DOCTOR. WILL FURTHER FOLLOW UP THE OUTCOME.
Sex: U
Vaccine: HEP, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, patients were vaccinated with improperly stored doses of ROTATEQ (dose, units, frequency and route not reported) (lot # N005626 and expiration date: 26-NOV-2018), GARDASIL 9 (dose, units, frequency and route not reported) (lot # N020353 and expiration date: 28-APR-2020) and RECOMBIVAX HB (dose, units, frequency and route not reported) (lot # M022077; expiration date: 10-MAR-2019 and lot# M010212; expiration date: 02-JAN-2019) at an unknown temperature for an unknown time frame. It was unknown whether temperature excursion had occurred previously or not. Data logger was involved. No product quality complaint involved. This is a non-valid spontaneous report due to lack of patient identifiers. Follow-up information was received from the medical assistant on 08-MAR-2018. The temperature excursion ranged between 0 degrees Celsius (°C) to 1°C on an unknown date for a time frame of 214 hours and exact temperature and time below 0°C (-0.4°C) for 4 hours and 30 minutes. Follow-up information was received from the medical assistant on 12-MAR-2018. All vaccines had multiple excursions starting on 18-JAN-2018 until 01-MAR-2018. GARDASIL 9 was exposed to 0 C to 1 C (1.2) for total of 8 hours and 10 minutes prior to being administered from 18-JAN-2018 until 29-JAN-2018, it continued with excursions until 01-MAR-2018 with total time: excursion below 0 C (-0.4 C) for 4 h 30 min which occurred after 29-JAN-2018 and that the total time at 0 C to 1 C was for 214 h. This is a non-valid due to lack of patient identifiers. Follow-up information was received from the medical assistant on 12-MAR-2018. Who stated that one patient total received on 29-JAN-2018, a dose of improperly stored GARDASIL 9 with lot #M040412 exp date 30-JUN-2019.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administration error, Exposure via eye contact, Exposure via skin contact, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 26-MAR-2018, the patient was vaccinated with ZOSTAVAX lot number N025567 with expiration date on 13-DEC-2018, subcutaneous for prophylaxis (strength, dose and anatomical location were not reported). It was reported that during the vaccine administration process, when the nurse pulled the needle out of the patient, some of the ZOSTAVAX went on the patient's face and into the patient's eye. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 28-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot #M036059 with expiration date of 03-JUN-2019 for prophylaxis (dose, route of administration and anatomical location were not reported). On 26-SEP-2017, the patient was vaccinated with the second dose of GARDASIL 9 lot # N002720 with expiration date of 12-MAY-2019, 0.5 ml, intramuscularly for prophylaxis (anatomical location was not reported). No adverse effects were reported.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 19 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unspecified date, the patient was inadvertently vaccinated with a pediatric dose of VAQTA for prophylaxis (strength, route, lot # and expiration date were not reported). No adverse effects were reported.
Age: 4.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: After 2 hours of receiving the VARIVAX-she had a little redness in the (L) arm-which turned into an egg-sized redness and swelling turning bruised by the following morning (ecchymotic peripherally with central erythema.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Skin lesion
Clinical narrative: Secondary lesions x2 to lateral right arm; 2 cm in size; secondary lesion to right anterior thigh. 4-5 cm in size.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: 103.7 fever, Nauseous, Headache, Lethargy, shoulder to elbow redness, tenderness, hot to the touch.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: 103.7 fever, Nauseous, Headache, Lethargy, shoulder to elbow redness, tenderness, hot to the touch.
Age: 20.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Neurological examination normal, Nuclear magnetic resonance imaging, Tremor
Clinical narrative: Hand tremors bilateral and facial tremors (mouth are) she was seen at the Student Health Center  on 3/30/18. Exam unremarkable. Difficulty seeing tremors. Was to fly home and if worse to be seen there. She went to our local ED and was seen that evening of 3/30/18. MRI inconclusive. Consult with neurologist at referral hospital and they reviewed case and determined it was not Guillain-Barre syndrome. She was given VALIUM for MRI and tremors stopped. She was seen again at the Student Health Center and neuro exam was normal except for fine tremor in hands. She was given prescription for ATIVAN and she is to see neurologist at home for determination of vaccine reaction.
Age: 20.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Nuclear magnetic resonance imaging normal, Tremor
Clinical narrative: Hand tremors bilateral and facial tremors (mouth are) she was seen at the Student Health Center  on 3/30/18. Exam unremarkable. Difficulty seeing tremors. Was to fly home and if worse to be seen there. She went to our local ED and was seen that evening of 3/30/18. MRI inconclusive. Consult with neurologist at referral hospital and they reviewed case and determined it was not Guillain-Barre syndrome. She was given VALIUM for MRI and tremors stopped. She was seen again at the Student Health Center and neuro exam was normal except for fine tremor in hands. She was given prescription for ATIVAN and she is to see neurologist at home for determination of vaccine reaction.
Age: 20.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Hand tremors bilateral and facial tremors (mouth are) she was seen at the Student Health Center  on 3/30/18. Exam unremarkable. Difficulty seeing tremors. Was to fly home and if worse to be seen there. She went to our local ED and was seen that evening of 3/30/18. MRI inconclusive. Consult with neurologist at referral hospital and they reviewed case and determined it was not Guillain-Barre syndrome. She was given VALIUM for MRI and tremors stopped. She was seen again at the Student Health Center and neuro exam was normal except for fine tremor in hands. She was given prescription for ATIVAN and she is to see neurologist at home for determination of vaccine reaction.
Age: 20.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Fatigue, Injection site pain, Pyrexia, Tremor
Clinical narrative: Hand tremors bilateral and facial tremors (mouth are) she was seen at the Student Health Center  on 3/30/18. Exam unremarkable. Difficulty seeing tremors. Was to fly home and if worse to be seen there. She went to our local ED and was seen that evening of 3/30/18. MRI inconclusive. Consult with neurologist at referral hospital and they reviewed case and determined it was not Guillain-Barre syndrome. She was given VALIUM for MRI and tremors stopped. She was seen again at the Student Health Center and neuro exam was normal except for fine tremor in hands. She was given prescription for ATIVAN and she is to see neurologist at home for determination of vaccine reaction.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Sudden death
Clinical narrative: Patient passed away suddenly without previous illness. Patient complained of chest pain to her husband several hours before the event as reported by Dr.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Cataplexy, Narcolepsy, Pain, Paralysis, Sleep disorder
Clinical narrative: Initially she started with tremors while asleep, progressed to nightime paralysis, sleep disorder symptoms, cataplexy, etc. Sleep studies and doctor investigations eventually led to diagnosis of cataplexy and narcolepsy, non-genetic, caused by damage.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Sleep study, Tremor
Clinical narrative: Initially she started with tremors while asleep, progressed to nightime paralysis, sleep disorder symptoms, cataplexy, etc. Sleep studies and doctor investigations eventually led to diagnosis of cataplexy and narcolepsy, non-genetic, caused by damage.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2-month-old female patient. Her medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 12-MAR-2018, the patient might have been vaccinated with an improperly stored dose of ROTATEQ orally, lot number reported as N021099, expiration date 02-FEB-2019 (dose not reported) as prophylaxis. The vaccine was stored for 10 minutes in the range 47 Fahrenheit degrees to 77 Fahrenheit degrees. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to an 8-year-old patient of an unknown gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient was vaccinated with the two doses of GARDASIL 9 (dose, route and site of administration, lot number and expiration date were not reported). No adverse effect was reported.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reaction, allergies or medical history provided. On 18-AUG-2014, the patient was vaccinated with a dose of GARDASIL lot # K003520, expiry date 20-NOV-2016, intramuscularly for prophylaxis. On 29-MAR-2018, the patient was vaccinated with a dose of GARDASIL 9 lot # N020352, expiry date 10-OCT-2020, intramuscularly for prophylaxis. No adverse effects were reported.
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 3/31/18.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: 12 hours after the injection, started to have increasing chills, then high fever reaching 101, and headache -- all of which lasted, on and off, for about 36 hours. Also had fatigue that lasted 3 days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Tenderness
Clinical narrative: Very high fever and red tender arm, persisted for 12 hours.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hyporesponsive to stimuli, Hypotonia, Pallor
Clinical narrative: Patient with pallor hypotonia and decreased responsiveness within 1 minute of 2 month vaccines.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: At approximately 10:41am on Monday, April 2, 2018 I gave patient an adult dose of Hep B vaccination. He had no adverse effects.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Hypotension
Clinical narrative: Patient stated the night after immunization she was hot and cold and had low blood pressure.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of nausea in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea and vomiting. On an unknown date, the outcome of the nausea and vomiting were recovered/resolved. The reporter considered the nausea and vomiting to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that this incident occurred a month before the date of reporting and he had forgotten the details at the time of reporting. The reporter did not report to GlaxoSmithKline initially, as he read in the product information (PI) that this was a known adverse event following SHINGRIX administration. No additional information provided.
Age: 37.0
Sex: M
Vaccine: MNQ
Symptoms: Arthropathy, Fatigue, Muscular weakness, Pyrexia
Clinical narrative: Patient was vaccinated on 3/27/2018 with MENACTRA because he was going for a work-related trip. He returned to the clinic the next day with symptoms of fever, fatigue, muscle and joint weakness. Temp at clinic was 100 degrees F. Was given TYLENOL, 325mg at time of office visit and instructed to take TYLENOL q 4 to 6 hours as needed for fever relief. Emailed individual today to find out how he was doing. He called to say that the fever peaked to 103.8 degrees on Thursday night, 3/29/2018. Continued to have joint and muscle weakness. No other symptoms. Fever abated by Friday and resolved completely by Sunday. He is completely well today, 4/3/2018.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: EXTREME REDNESS AT INJECTION SITE FOR 3 DAYS EXTREME PAIN AT INJECTION SITE FOR 3 DAYS, ITCHING/HARDNESS AT INJECTION SITE FOR 3 DAYS, RASH ON LOWER PORTION OF INJECTION ARM FOR 3 DAYS, REDNESS ON UPPER PART OF LEGS FOR 3 DAYS, ICE APPLIED TO INJECTION SITE INTERMITTENTLY FOR PAST 48 HOURS, DIPHENHYDRAMINE TAKEN EVERY 6 HOURS FOR PAST 24 HOURS WITH NO REDUCTION IN REDNESS, PAIN MEDS HAVE LITTLE TO NO EFFECT ON PAIN LEVEL.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: EXTREME REDNESS AT INJECTION SITE FOR 3 DAYS EXTREME PAIN AT INJECTION SITE FOR 3 DAYS, ITCHING/HARDNESS AT INJECTION SITE FOR 3 DAYS, RASH ON LOWER PORTION OF INJECTION ARM FOR 3 DAYS, REDNESS ON UPPER PART OF LEGS FOR 3 DAYS, ICE APPLIED TO INJECTION SITE INTERMITTENTLY FOR PAST 48 HOURS, DIPHENHYDRAMINE TAKEN EVERY 6 HOURS FOR PAST 24 HOURS WITH NO REDUCTION IN REDNESS, PAIN MEDS HAVE LITTLE TO NO EFFECT ON PAIN LEVEL.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Severe swelling in hand with very painful joints in fingers and difficult movement. Some pain in knee also.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Fatigue, Hypersensitivity, Influenza like illness, Pain
Clinical narrative: On-set of symptoms after 5 hours of injection. Severe allergic reaction, anaphylactic in nature, tiredness, full body pain, flu-like symptoms. Abated in 24 hours.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: Patient received the SHINGRIX vaccine on 3/28/2018. On 3/29 patient began feeling flu like symptoms (headache, muscle pain, fever, upset stomach and nausea). Symptoms resolved on 3/30.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient received the SHINGRIX vaccine on 3/28/2018. On 3/29 patient began feeling flu like symptoms (headache, muscle pain, fever, upset stomach and nausea). Symptoms resolved on 3/30.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Patient received the SHINGRIX vaccine on 3/28/2018. On 3/29 patient began feeling flu like symptoms (headache, muscle pain, fever, upset stomach and nausea). Symptoms resolved on 3/30.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Patient received the SHINGRIX vaccine on 3/28/2018. On 3/29 patient began feeling flu like symptoms (headache, muscle pain, fever, upset stomach and nausea). Symptoms resolved on 3/30.
Age: 52.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Blood glucose normal, Blood uric acid normal, Colonoscopy abnormal, Computerised tomogram abdomen abnormal
Clinical narrative: Patient started course of 4 rabies IMOVAX vaccines on 09/15/2017 at Medical Center ER and was supposed to complete the series on 10/6/2017. He did also receive a dose of Rabies Immunoglobulin on 9/15/2017He presents to our office complaining of intermittent diarrhea on 10/11/2017 which started after receiving his rabies vaccine. Stool Cultures were negative and he was referred to gastroenterologist for further evaluation. Colonoscopy was remarkable for 4 small polyps. CT Scan Abd/Pelvis remarkable for a renal cyst on 12/17/2017. Symptoms to date have persisted with out finding an etiology. In addition, he had developed arthralgia symptoms, neck, hip and has been referred for Rheumatologic workup.
Age: 52.0
Sex: M
Vaccine: RAB
Symptoms: Culture stool negative, Diarrhoea, Full blood count normal, Large intestine polyp, Lipids normal
Clinical narrative: Patient started course of 4 rabies IMOVAX vaccines on 09/15/2017 at Medical Center ER and was supposed to complete the series on 10/6/2017. He did also receive a dose of Rabies Immunoglobulin on 9/15/2017He presents to our office complaining of intermittent diarrhea on 10/11/2017 which started after receiving his rabies vaccine. Stool Cultures were negative and he was referred to gastroenterologist for further evaluation. Colonoscopy was remarkable for 4 small polyps. CT Scan Abd/Pelvis remarkable for a renal cyst on 12/17/2017. Symptoms to date have persisted with out finding an etiology. In addition, he had developed arthralgia symptoms, neck, hip and has been referred for Rheumatologic workup.
Age: 52.0
Sex: M
Vaccine: RAB
Symptoms: Metabolic function test normal, Renal cyst
Clinical narrative: Patient started course of 4 rabies IMOVAX vaccines on 09/15/2017 at Medical Center ER and was supposed to complete the series on 10/6/2017. He did also receive a dose of Rabies Immunoglobulin on 9/15/2017He presents to our office complaining of intermittent diarrhea on 10/11/2017 which started after receiving his rabies vaccine. Stool Cultures were negative and he was referred to gastroenterologist for further evaluation. Colonoscopy was remarkable for 4 small polyps. CT Scan Abd/Pelvis remarkable for a renal cyst on 12/17/2017. Symptoms to date have persisted with out finding an etiology. In addition, he had developed arthralgia symptoms, neck, hip and has been referred for Rheumatologic workup.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66yr-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 22nd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 1 day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. The reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced severe pain in deltoid muscle at site of injection following vaccination with SHINGRIX. The reporter had limited information about the severity or onset of the patient's symptoms but indicated that it was severe enough that she might not want to receive the second dose.
Sex: F
Vaccine: RV1
Symptoms: Accidental underdose, Immediate post-injection reaction, Oral administration complication, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a infant female patient who received ROTARIX lyophilized formulation (batch number Y5CZ7, expiry date 26th February 2019). On an unknown date, the patient received ROTARIX lyophilized formulation. On an unknown date, immediately after receiving ROTARIX lyophilized formulation, the patient experienced vomiting and accidental underdose. On an unknown date, the outcome of the vomiting and accidental underdose were unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: The age at vaccination was not reported. The patient immediately vomited the administered dose of ROTARIX, which led to accidental underdose.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Cough, Pyrexia, Secretion discharge
Clinical narrative: Patient got a fever of 105 degrees green mucus, cough.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Joint contracture, Tremor
Clinical narrative: Parents state that 3 days after patient received 1 MMR vaccine, started having episode of first clenching and shaking. Lasts just a couple seconds, then self-resolved. Pt alert and awake with normal alertness after episodes. Occurs 3-5 times per day.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A day after getting vaccination, mother noticed swelling and redness on his Rt thigh Rt anterior thigh 4x3 cm area of erythema without fluctuance. Rx Cephalexin Monohydrate 2ML PO QID for 10 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site reaction, Rash, Rash pruritic
Clinical narrative: Patient said she had a "knot" at injection sight night of injection. It subsided on 3/25/18 and became a painful, itchy rash 3 inches in diameter.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia, Skin irritation
Clinical narrative: Swelling, redness, extreme irritation to Left arm post PPV23 vaccine. Patient reported to ER that evening for major reaction, fevers and chills post ER visit.
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the attack experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were unknown. It was unknown if the reporter considered the pain in arm and swelling arm to be related to BOOSTRIX. Additional details were provided as follows: The age at the vaccination was not reported. The healthcare professional reported the patient developed a painful, swollen arm after receiving a dose of Tdap years ago. The healthcare professional was unsure if the vaccine was BOOSTRIX or an alternate brand. No further information was available at the time of report.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of Guillain Barre syndrome in a 60-year-old male patient who received SHINGRIX. On 23rd March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 59 or 60 years old. The pharmacist reported that he overheard information about the patient presenting the Guillain Barre Syndrome after vaccination. The patient was taken to the emergency room and then transferred to another hospital. The patient was in intensive care unit. The pharmacist overheard that the patient might be released on 29th March 2018 and moved to a rehabilitation center. This was all the information that the representative was provided with.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 63-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020. On 14th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 15th March 2018, 1 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: No other vaccines were administered to this patient in the last 4 weeks from this pharmacy. The patient was administered SHINGRIX in the left arm. The patient reported to her health care professional and to the pharmacy. The patient stated the rash on shoulder started the next day after the injection. The patient's health care professional instructed the patient to not get the remainder of the SHINGRIX series. The pharmacy did not have additional information pertaining to this adverse event. No QA was reported.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Choking, Cough, Oral administration complication
Clinical narrative: This spontaneous report was received from a Nurse Practitioner via company representative, referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients received a dose of ROTATEQ, orally, for prophylaxis (dose, lot number and expiration date were not provided). The Nurse Practitioner reported that the patients would had choked after receiving the dose of ROTATEQ. It was not reported if the patients sought medical attention, if treatment was given for the event or if lab diagnostics or studies were performed. The outcome of the event choking and the causal relationship between the event and vaccination with ROTATEQ were not reported. Upon internal review, choking was considered to be medically significant. Follow up information was received on 29-MAR-2018 from Nurse Practitioner and refers to a female patient. At the time of vaccination the patient was almost 6 months old and had nasal discharge and otitis media in right ear. The patient had no preexisting (physician-diagnosed) allergies, birth defects or medical conditions. On 14-DEC-2017, the patient was vaccinated with third dose of ROTATEQ orally (lot # N005078). Other suspect therapies included third doses of PENTACEL (intramuscular into right arm) and PREVNAR 13 (intramuscular into left arm). After ROTATEQ was given, patient started couching, there was no color change, lungs were clear. The event resolved immediately. The experience required prescription drug treatment. The outcome of choking was reported as recovered/resolved. The causal relationship between the event and vaccination with ROTATEQ was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Pancreatitis
Clinical narrative: Information has been received from a physician via a company representative referring to a 15 year old female patient. Information about concurrent condition, concomitant medication, medical history and reactions/allergies was unknown. In November 2017, the patient was vaccinated with GARDASIL 9 (route, batch/lot number and expiration date were not provided) for routine vaccination. On an unknown date in February 2018, the patient was ''admitted in the hospital with pancreatitis". The outcome of the event was unknown. The causality between the events and GARDASIL 9 was not provided. Upon internal review, pancreatitis was determined to be medically significant.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a 17 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 02-APR-2018, the patient was vaccinated with the third dose of improperly stored GARDASIL 9 intramuscularly, lot # N020353 with expiration date 28-APR-2020, for prophylaxis. No adverse effects were reported. It was stated that the vaccine was exposed to a temperature of 28 Fahrenheit degrees for 12 hours and to a temperature of 27 Fahrenheit degrees for 12 hours and 43 minutes. No previous temperature excursion was reported. A digital data logger was involved.
Sex: U
Vaccine: PNC13
Symptoms: Skin irritation
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received PREVNAR 13 on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced most irritation out of all vaccines given. Clinical outcome was unknown at time of this report. The information on the lot number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. An elderly (Age: 65+) patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and swelling both on an unspecified date with outcome of unknown. The reporting pharmacist saw higher frequency and severity of redness and swelling with patients receiving pneumococcal 13-val conj vac (dipht crm197 protein) compared to other vaccines administered at this pharmacy.
Age: 0.83
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Medical assistant forgot to mix the Hib part to the DTaP/IPV component so patient only received the DTaP and IPV and not the Hib part.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Eyelid ptosis, Hypersomnia, Pyrexia, Rash erythematous, Rhinorrhoea
Clinical narrative: 3-6-18 patient received above immunizations. 3-20-18 mom called stating patient had broken out in a red rash on 3-18-18. He had a fever up to 100 degrees. A follow up call was made 3-28-18. Mom stated the rash was almost gone. He had not had a fever since taking TYLENOL the morning before. He has a clear runny nose, droopy eyes and slept a lot the day before.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Malaise, Nausea
Clinical narrative: Significant chills (I assume fever), body aches, headache, nausea (enough to result in vomiting), stomach upset.  I'm as sick as I can recall being in quite a while.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Significant chills (I assume fever), body aches, headache, nausea (enough to result in vomiting), stomach upset.  I'm as sick as I can recall being in quite a while.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, VARCEL
Symptoms: Contusion, Face injury, Fall, Lip injury, Seizure
Clinical narrative: Near immediate (likely vasovagal) syncopal event with short (less than 20 sec) seizure. Lip laceration and cheek contusion as result of falling forward from exam table and striking face on adjacent cabinet. Return to normal (aside from laceration and contusion) over 15-20 minutes.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Near immediate (likely vasovagal) syncopal event with short (less than 20 sec) seizure. Lip laceration and cheek contusion as result of falling forward from exam table and striking face on adjacent cabinet. Return to normal (aside from laceration and contusion) over 15-20 minutes.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Development of cellulitis in right shoulder/arm; treatment was 10 day course of antibiotic Doxycycline; currently still on antibiotic.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Pain
Clinical narrative: Severe pain, swelling, and tenderness at injection site, fever (don't know how high), chills, body aches, and headache that lasted for approximately 12 hours. Symptoms started approx. 30 hours after vaccination.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Severe pain, swelling, and tenderness at injection site, fever (don't know how high), chills, body aches, and headache that lasted for approximately 12 hours. Symptoms started approx. 30 hours after vaccination.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal distension, Ascites, Blood test normal, Body fluid analysis, CSF test normal
Clinical narrative: Twin A w h/o IUGR re-admitted to hospital on (3/13/18) for several days' history of poor feeding - found to have elevated transaminases, abdominal distention, severe ascites, respiratory distress.  Transferred to PICU at hospital where he was worked up including exam of CSF, ascites fluid, blood, urine - all negative. Clinical picture c/w DIC but no organism ever isolated. Genetics workup including microarray and WES is pending. Possible underlying metabolic disorder. Discharged home 4/3/18.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Cytogenetic analysis, Intensive care, Poor feeding infant, Respiratory distress, Transaminases increased
Clinical narrative: Twin A w h/o IUGR re-admitted to hospital on (3/13/18) for several days' history of poor feeding - found to have elevated transaminases, abdominal distention, severe ascites, respiratory distress.  Transferred to PICU at hospital where he was worked up including exam of CSF, ascites fluid, blood, urine - all negative. Clinical picture c/w DIC but no organism ever isolated. Genetics workup including microarray and WES is pending. Possible underlying metabolic disorder. Discharged home 4/3/18.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Urine analysis normal
Clinical narrative: Twin A w h/o IUGR re-admitted to hospital on (3/13/18) for several days' history of poor feeding - found to have elevated transaminases, abdominal distention, severe ascites, respiratory distress.  Transferred to PICU at hospital where he was worked up including exam of CSF, ascites fluid, blood, urine - all negative. Clinical picture c/w DIC but no organism ever isolated. Genetics workup including microarray and WES is pending. Possible underlying metabolic disorder. Discharged home 4/3/18.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Blood magnesium, Blood thyroid stimulating hormone, Computerised tomogram head, Confusional state, Dyskinesia
Clinical narrative: Patient presented to the ER with mother for evaluation of possible seizure. Patient had been sleeping on mother's lap for about an hour when the child went stiff and then began to have rigid uncontrolled movements of extremities, eyes rolled back in his head, and would not respond to verbal commands. Mother stated this lasted approximately 3-4 minutes. Patient was fatigued and mildly confused after the episode. Denies any incontinence, nausea, dental/oral trauma during the incident. Mother informed the ER that child had received immunizations at office 3/27/18 and denies any history of seizures with prior immunizations. At the time of the ER visit patient was alert and per mother is at baseline. Mother also denies any recent illness, recent travel, fever, or other ill family members.