chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea
Clinical narrative: Anaphylaxis; Shortness of breath; Chest pain; This case was reported by a other health professional via call center representative and described the occurrence of anaphylaxis in a 30-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 4MA5A, expiry date 30th June 2020) for prophylaxis.   On 25th September 2019, the patient received FluLaval Tetra 2019-2020 season. On 25th September 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced anaphylaxis (serious criteria GSK medically significant), shortness of breath and chest pain. The patient was treated with epinephrine and steroids nos (Steroids). On 25th September 2019, the outcome of the anaphylaxis, shortness of breath and chest pain were recovered/resolved.   It was unknown if the reporter considered the anaphylaxis, shortness of breath and chest pain to be related to FluLaval Tetra 2019-2020 season.  Additional information was reported as follows: This case was reported by an immunization program specialist at health center. The patient received a dose of Flulaval vaccine at an employee health clinic. The patient experienced anaphylaxis. The patient was treated with Epinephrine in the office and transported to the emergency room. In the emergency room, the patient was treated with steroids. The symptoms resolved that same day. The reporter consented to follow up. This case has been linked with case US2019178156, reported by the same reporter. The outcome of anaphylaxis, shortness of breath and chest pain were reported as recovered/resolved in the system however in source document, it was mentioned as recovered/resolved with sequel.
Age: 68.0
Sex: F
Vaccine: PPV, FLU3, FLU3, PPV
Symptoms: Chest pain, Erythema, Flushing, Hyperhidrosis, Spinal pain
Clinical narrative: patient received 2 vaccines today, a pneumovax23 and a high dose flu shot. She was doing fine for about 2 minutes and then started to experience a rapid onset of side effects, she began with flushing to a bright red and sweating , noticed her back was wet and room to the touch, she felt as if she was having difficulty breathing and started to feel pain. She wanted to lie down and we put her down and elevated her head slightly and she reported a pain on 10 out of 10 scale that was pulsating down her spine and to her head . the pain would not subside. the squad arrived and she had a elevated bp 150's over 90. her pain level had decreased to a level of 5 within 15 minutes but still at pain in her spinal fluid and head. .
Age: 68.0
Sex: F
Vaccine: PPV, FLU3, FLU3, PPV
Symptoms: Feeling hot, Flushing, Headache, Hyperhidrosis, Spinal pain
Clinical narrative: patient received 2 vaccines today, a pneumovax23 and a high dose flu shot. She was doing fine for about 2 minutes and then started to experience a rapid onset of side effects, she began with flushing to a bright red and sweating , noticed her back was wet and room to the touch, she felt as if she was having difficulty breathing and started to feel pain. She wanted to lie down and we put her down and elevated her head slightly and she reported a pain on 10 out of 10 scale that was pulsating down her spine and to her head . the pain would not subside. the squad arrived and she had a elevated bp 150's over 90. her pain level had decreased to a level of 5 within 15 minutes but still at pain in her spinal fluid and head. .
Age: 68.0
Sex: F
Vaccine: PPV, FLU3, FLU3, PPV
Symptoms: Blood pressure increased, Dyspnoea, Erythema, Flushing, Headache
Clinical narrative: patient received 2 vaccines today, a pneumovax23 and a high dose flu shot. She was doing fine for about 2 minutes and then started to experience a rapid onset of side effects, she began with flushing to a bright red and sweating , noticed her back was wet and room to the touch, she felt as if she was having difficulty breathing and started to feel pain. She wanted to lie down and we put her down and elevated her head slightly and she reported a pain on 10 out of 10 scale that was pulsating down her spine and to her head . the pain would not subside. the squad arrived and she had a elevated bp 150's over 90. her pain level had decreased to a level of 5 within 15 minutes but still at pain in her spinal fluid and head. .
Age: 68.0
Sex: F
Vaccine: PPV, FLU3, FLU3, PPV
Symptoms: Hyperhidrosis, Pain, Spinal pain
Clinical narrative: patient received 2 vaccines today, a pneumovax23 and a high dose flu shot. She was doing fine for about 2 minutes and then started to experience a rapid onset of side effects, she began with flushing to a bright red and sweating , noticed her back was wet and room to the touch, she felt as if she was having difficulty breathing and started to feel pain. She wanted to lie down and we put her down and elevated her head slightly and she reported a pain on 10 out of 10 scale that was pulsating down her spine and to her head . the pain would not subside. the squad arrived and she had a elevated bp 150's over 90. her pain level had decreased to a level of 5 within 15 minutes but still at pain in her spinal fluid and head. .
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pallor, Paraesthesia oral
Clinical narrative: Anaphylactic reaction; Tingling in mouth and tongue; Trouble swallowing; This case was reported by a nurse via call center representative and described the occurrence of anaphylaxis in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 4MA5A, expiry date 30th June 2020) for prophylaxis.   On 30th September 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 30th September 2019, less than an hour after receiving FluLaval Tetra 2019-2020 season, the patient experienced anaphylaxis (serious criteria GSK medically significant), tingling mouth and swallowing difficult. The patient was treated with steroids nos (Steroids) and benadryl (nos) (Benadryl). On 30th September 2019, the outcome of the anaphylaxis, tingling mouth and swallowing difficult were recovered/resolved.   It was unknown if the reporter considered the anaphylaxis, tingling mouth and swallowing difficult to be related to FluLaval Tetra 2019-2020 season.  Additional information was reported as follows: The patient received a dose of Flulaval vaccine on the left arm. Within 30 minutes after vaccination, the patient experienced an anaphylactic reaction, tingling in the mouth and tongue and trouble swallowing. The patient went to the emergency room (ER) and was monitored in the ER for 4 hours before she was released. The symptoms was resolved on the same day. The reporter did not provide any additional information. This case has been linked with case US2019177091, reported by the same reporter. The outcome of anaphylaxis, tingling mouth and swallowing difficult were reported as recovered/resolved in the system however in source document, it was mentioned as recovered/resolved with sequel.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Dysphagia, Paraesthesia oral
Clinical narrative: Anaphylactic reaction; Tingling in mouth and tongue; Trouble swallowing; This case was reported by a nurse via call center representative and described the occurrence of anaphylaxis in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 4MA5A, expiry date 30th June 2020) for prophylaxis.   On 30th September 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 30th September 2019, less than an hour after receiving FluLaval Tetra 2019-2020 season, the patient experienced anaphylaxis (serious criteria GSK medically significant), tingling mouth and swallowing difficult. The patient was treated with steroids nos (Steroids) and benadryl (nos) (Benadryl). On 30th September 2019, the outcome of the anaphylaxis, tingling mouth and swallowing difficult were recovered/resolved.   It was unknown if the reporter considered the anaphylaxis, tingling mouth and swallowing difficult to be related to FluLaval Tetra 2019-2020 season.  Additional information was reported as follows: The patient received a dose of Flulaval vaccine on the left arm. Within 30 minutes after vaccination, the patient experienced an anaphylactic reaction, tingling in the mouth and tongue and trouble swallowing. The patient went to the emergency room (ER) and was monitored in the ER for 4 hours before she was released. The symptoms was resolved on the same day. The reporter did not provide any additional information. This case has been linked with case US2019177091, reported by the same reporter. The outcome of anaphylaxis, tingling mouth and swallowing difficult were reported as recovered/resolved in the system however in source document, it was mentioned as recovered/resolved with sequel.
Sex: M
Vaccine: HEP, IPV, PNC, VARCEL
Symptoms: Decreased appetite, Henoch-Schonlein purpura, Malaise
Clinical narrative: henoch-schonlein purpura; anorexic; generalized illness; Information has been downloaded from regulatory authority (HQ9914319APR2001).   This spontaneous report was received from an other health professional concerning a 13 month old male patient. His concurrent condition, medical history and concomitant therapy were not reported.   On 22-MAR-2001, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (batch/lot# 0546K, 1 dosage form, subcutaneous), Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (batch/lot# 1523K, 1 dosage form, intramuscular), pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (batch/lot# 474-728, 1 dosage form, intramuscular) and poliovirus vaccine inactivated (unspecified) (batch/lot# T0506, 1 dosage form, subcutaneous) for immunisation.   On 26-MAR-2001, the patient experienced Henoch-Schonlein purpura, anorexic and generalized illness. All the events caused hospitalization. The outcome of all the events was unknown at the reporting time. Action taken with suspect drugs was not applicable.   The causality between al the events and suspect drugs was not reported.  The new case of US-009507513-1910USA005772 has been created as safety report US-009507513-1909USA013835 was submitted with an invalid WWID of HQ9914319APR2001 that does not refer to an existing case. As such US- 009507513- 1909USA013835 will be nullified and this new safety report will be maintained as the master case file.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Fatigue, Pain, Pyrexia, Sinus congestion
Clinical narrative: Patient reported headaches, high fever, muscle aches, stuffy nose and pressure in head.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Head discomfort, Headache, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: Patient reported headaches, high fever, muscle aches, stuffy nose and pressure in head.
Age: 21.0
Sex: M
Vaccine: MMR
Symptoms: Disturbance in attention, Loss of personal independence in daily activities, Psychotic disorder, Restlessness
Clinical narrative: My son suffered adverse reactions the day after and everyday after receiving the MMR vaccination. This included : difficulty concentrating, restlessness and psychosis. He had to leave his academic undergraduate " 4.0" standing and  stop his studies to come home. He endured multiple hospitalizations . 40 days total. Discharged with anti psychotic medications.
Age: 66.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Gait disturbance, Nausea, Vertigo
Clinical narrative: Lightheaded and dizzy 15 minutes after injection. Slightly queasy and dizzy for over 24 hours and then it seemed like I was getting better. Went to bed and woke up 38 hours after injection and had extreme vertigo. Couldn't walk straight and had a strong pulling to the right. Going to drink lots of water and sit or lay down today hoping it passes. I am 66 years old, 5'11" and weigh 155 pounds. I ride a bike 40 miles per week and am in good to excellent health.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Diarrhoea, Dizziness, Flatulence, Gastrointestinal disorder
Clinical narrative: 10/2/19:  5pm - Intestinal symptoms begin (thought it was my IBS).  6pm - Nausea begins  7:20pm - Vomiting begins, intestinal symptoms continue.  Vomiting episodes continue until around midnight - was able to sleep fitfully, a couple small fluid only vomiting episodes the next morning.  10/3/19: Diarhhea begins - uncontrollable, with no warning, continuing throughout the day.  Missed a day of work.  10/4/19: Extreme flatulence continuing throughout the day.  Still feeling weak and lightheaded.  Introducing food gradually.  Missed a day of work.  10/5/19: Flatulence continues, but beginning to decrease.  Still feeling weak and lightheaded.  10/6/19: Flatulence mostly done.  Still feeling weak and lightheaded.  10/7/19: Still feeling lightheaded, returning to work.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Impaired work ability, Nausea, Poor quality sleep, Vaccination complication, Vomiting
Clinical narrative: 10/2/19:  5pm - Intestinal symptoms begin (thought it was my IBS).  6pm - Nausea begins  7:20pm - Vomiting begins, intestinal symptoms continue.  Vomiting episodes continue until around midnight - was able to sleep fitfully, a couple small fluid only vomiting episodes the next morning.  10/3/19: Diarhhea begins - uncontrollable, with no warning, continuing throughout the day.  Missed a day of work.  10/4/19: Extreme flatulence continuing throughout the day.  Still feeling weak and lightheaded.  Introducing food gradually.  Missed a day of work.  10/5/19: Flatulence continues, but beginning to decrease.  Still feeling weak and lightheaded.  10/6/19: Flatulence mostly done.  Still feeling weak and lightheaded.  10/7/19: Still feeling lightheaded, returning to work.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored dose of gardasil 9 was administered to the patient; No adverse effect; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on medical history, concurrent condition, concomitant medications and drug reactions/ allergies were unknown.  On an unknown date, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N022952 and expiry date 14-JUN-2020 (strength, frequency, dose, route, anatomical location were not reported) for prophylaxis. The suspect vaccines experienced the temperature excursion below 36-degree Fahrenheit (F) (32.1 F) for 8 hours. It was reported that no previous temperature excursion was done. Data logger was involved. There was no adverse effects reported. No product quality compliant reported in the case.
Age: 59.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pancreatic carcinoma
Clinical narrative: pancreatic cancer; This spontaneous report was received from the patient's wife concerning to her 76 year old husband, who had no known allergies. The patient's concurrent conditions included heartburn. The patient's concomitant therapies included NEXIUM (esomeprazole sodium) (started 20 years ago).     On 09-OCT-2002,  when the patient was 59 year old, he may had received a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23)  (confirmed by paper work from the site where the vaccine was obtained) (dose, route, lot# and expiration date were not provided) as vaccine for pneumonia. it was a Merck vaccine. On the same date, the patient also received an unspecified influenza virus vaccine inactivated (unspecified) (reported as "flu shot") as well.  Afterwards, on an unspecified date, the patient experienced pancreatic cancer.              At the time of the report, the outcome of the event was unknown.  The causal relationship between pancreatic cancer and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was unknown.  Upon internal review, pancreatic cancer was determined to be medically significant.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Autoimmune thyroiditis, Fatigue, Laboratory test abnormal, Neck mass, Thyroidectomy
Clinical narrative: Hashimoto's Disease; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of unknown age. No information regarding the pt's medical history and concomitant medications was reported. On or around 06-JUL-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "a couple of months after"), the pt became increasingly severely fatigued and noticed a small midline anterior neck mass. She sought treatment with her primary care physician and following a multitude of lab tests was diagnosed with Hashimoto's Disease, an autoimmune disorder believed to be triggered by a viral infection/response-including herpes zoster (shingles). The pt underwent extensive medical treatment including thyroid lobectomy. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using Merck's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality was related.  The event of Hashimoto's Disease was considered to be disabling.  Upon internal review, the event of Hashimoto's Disease was determined to be medically significant.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Autoimmune thyroiditis, Fatigue, Herpes zoster, Laboratory test, Neck mass
Clinical narrative: Hashimoto's Disease; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of unknown age. No information regarding the pt's medical history and concomitant medications was reported. On or around 06-JUL-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "a couple of months after"), the pt became increasingly severely fatigued and noticed a small midline anterior neck mass. She sought treatment with her primary care physician and following a multitude of lab tests was diagnosed with Hashimoto's Disease, an autoimmune disorder believed to be triggered by a viral infection/response-including herpes zoster (shingles). The pt underwent extensive medical treatment including thyroid lobectomy. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using Merck's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality was related.  The event of Hashimoto's Disease was considered to be disabling.  Upon internal review, the event of Hashimoto's Disease was determined to be medically significant.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Thyroidectomy
Clinical narrative: Hashimoto's Disease; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of unknown age. No information regarding the pt's medical history and concomitant medications was reported. On or around 06-JUL-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "a couple of months after"), the pt became increasingly severely fatigued and noticed a small midline anterior neck mass. She sought treatment with her primary care physician and following a multitude of lab tests was diagnosed with Hashimoto's Disease, an autoimmune disorder believed to be triggered by a viral infection/response-including herpes zoster (shingles). The pt underwent extensive medical treatment including thyroid lobectomy. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using Merck's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality was related.  The event of Hashimoto's Disease was considered to be disabling.  Upon internal review, the event of Hashimoto's Disease was determined to be medically significant.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Patient was administered with Improperly stored dose of VARIVAX; This spontaneous report as received from a medical assistant refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported.  On 25-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S015460, expiry date: 20-MAY-2021) (dose, frequency and route were not reported) for prophylaxis. The sterile diluent was properly stored.  The vaccine was stored in temperature of -12.3 degree Celsius (C) for 13 hours and 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effect; Four month old baby was administered a dose of GARDASIL 9; This spontaneous report was received from a healthcare professional referring to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), (1 dosage form, intramuscular) (strength, anatomical location and lot number with expiration date were not reported) for prophylaxis. On 27-SEP-2019, a four month old baby was administered with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age) and  the patient had no adverse event. The outcome of product administered to patient of inappropriate age and no adverse event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; one dose of an improperly stored vaccine, PROQUAD, has been administered to one patient on 30-SEP-2019; This spontaneous received was received from a nurse regarding a patient of unknown age and gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 30-SEP-2019, the patient was administered an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Lot No. S008578 and expiration date 16-SEP-2020 have been verified to be a valid) for prophylaxis. The vaccine was reconstituted with a sterile diluent (reported lot number S026376 and expiration date 24-MAR-2022) that was at a correct storage temperature range. The vaccine was a stored a temperature of 8.5 Celsius degrees for a time frame of 25 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: the mother reported her daughter has a doctor's appointment on 10/1/2019 for an "unrelated issue"; This spontaneous report was received from a the patient's mother, referring to a female patient of unknown age. No information was provide regarding the patient's medical history, current conditions, concomitant medications, drug reactions or allergies.  On 22-APR-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophyylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported). On an unknown date in May 2019 (also reported as "one month later"), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophyylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported).   On 12-OCT-2019, the patent had a doctor's appointment for an "unrelated issue" (adverse event) and she wanted to know if her daughter could be administered the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The reporter didn't want to share the reason for the doctor's appointment.  At the time of the report, the outcome of the event was not reported. The reporter considered the event to be not related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient was administered a dose of improper stored ZOSTAVAX; This spontaneous report was received from a registered nurse concerning to a 60-year-old patient of unknown gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 20-SEP-2019, the patient was vaccinated with an improperly stored dose of Zoster Vaccine Live (ZOSTAVAX) lot number S000617 with expiration date on 06-APR-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion from 15 to 46 degrees Fahrenheit (F) (45 F) for 720 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: no adverse effects; administered one dose of expired VAQTA; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 02-OCT-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 1 dose, lot # R027987, with expiration date on 09-AUG-2019 (dosage schedule, route and anatomical location were not reported), for prophylaxis (expired product administered).
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Injection site rash, Muscular weakness, Nausea, Pyrexia
Clinical narrative: fever of 102F; nausea; dizziness; weakness in the arm where the vaccination was administered; rash that extended from the injection site "all the way down the patient's arm"; rash that extended from the injection site "all the way down the patient's arm"; Indication for PNEUMOVAX: the patient is diabetic and the patient just had pneumonia; This spontaneous report was received from a medical assistant referring to a 53 year old male patient. The patient concurrent conditions included diabetes mellitus, pneumonia and hypertension. Concomitant therapies included atorvastatin calcium (LIPITOR), pioglitazone hydrochloride (ACTOS) and metoprolol. The patient did not have any drug reactions or allergies.  On 01-OCT-2019, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular, lot # S005857 with expiration date 03-DEC-2020, indication reported as "the patient was diabetic and the patient just had pneumonia" (product use in unapproved indication).  Subsequently on the same day, the patient developed a fever of 102 Fahrenheit (F) (pyrexia), nausa, dizziness, weakness in the arm where the vaccination was administered (muscular weakness), and a rash that extended from the injection site "all the way down the patient's arm (vaccination site rash, rash). The patient sought for medical attention and went to an office visit. It was unknown by the reporter if treatment was given for the adverse event. No laboratory diagnostics or studies were performed. At the reporting time, the status of the patient was reported as not recovered.  The causality assessment was not provided by the reporter.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: fever of 102F; nausea; dizziness; weakness in the arm where the vaccination was administered; rash that extended from the injection site "all the way down the patient's arm"; rash that extended from the injection site "all the way down the patient's arm"; Indication for PNEUMOVAX: the patient is diabetic and the patient just had pneumonia; This spontaneous report was received from a medical assistant referring to a 53 year old male patient. The patient concurrent conditions included diabetes mellitus, pneumonia and hypertension. Concomitant therapies included atorvastatin calcium (LIPITOR), pioglitazone hydrochloride (ACTOS) and metoprolol. The patient did not have any drug reactions or allergies.  On 01-OCT-2019, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular, lot # S005857 with expiration date 03-DEC-2020, indication reported as "the patient was diabetic and the patient just had pneumonia" (product use in unapproved indication).  Subsequently on the same day, the patient developed a fever of 102 Fahrenheit (F) (pyrexia), nausa, dizziness, weakness in the arm where the vaccination was administered (muscular weakness), and a rash that extended from the injection site "all the way down the patient's arm (vaccination site rash, rash). The patient sought for medical attention and went to an office visit. It was unknown by the reporter if treatment was given for the adverse event. No laboratory diagnostics or studies were performed. At the reporting time, the status of the patient was reported as not recovered.  The causality assessment was not provided by the reporter.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Dehydration, Dizziness, Full blood count, Metabolic function test, Nausea
Clinical narrative: dehydration; dizziness; body aches; rash at site of vaccination; fever; nausea; vomiting; indication: a history of diabetes; This spontaneous report was received from a nurse regarding a 53 year old male patient. The patient's medical history was not reported. The patient did not have any drug reactions or allergies. The patient's concurrent condition included diabetes. The patient's concomitant therapies included atorvastatin, sitagliptin phosphate (JANUVIA), empagliflozin (JARDIANCE) and zolpidem. On 25-SEP-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R033079, expiration date: 06-JUN-2020, subcutaneously for a history of diabetes (product use in unapproved indication). Beginning on 26-SEP-2019 through 27-SEP-2019, the patient experienced fever, body aches, dizziness, dehydration, vomiting, nausea and rash at the site of vaccination. The patient called the physician who instructed the patient to go to the emergency department on 29-SEP-2019. The patient was seen the emergency department with a three day history of those events. Comprehensive Metabolic Panel (CMP), Complete Blood Count (CBC) and urinalysis were done with unknown results. The patient was given one liter of Normal Saline intravenously (IV) and ondansetron (ZOFRAN) and sent home with oral ondansetron (ZOFRAN). There were no interventions to prevent seriousness criteria. The patient recovered between 30-SEP-2019 and 01-OCT-2019. The reporter's causality assessment was not reported. No product quality complaints were involved.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia, Urine analysis, Vaccination site rash, Vomiting
Clinical narrative: dehydration; dizziness; body aches; rash at site of vaccination; fever; nausea; vomiting; indication: a history of diabetes; This spontaneous report was received from a nurse regarding a 53 year old male patient. The patient's medical history was not reported. The patient did not have any drug reactions or allergies. The patient's concurrent condition included diabetes. The patient's concomitant therapies included atorvastatin, sitagliptin phosphate (JANUVIA), empagliflozin (JARDIANCE) and zolpidem. On 25-SEP-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R033079, expiration date: 06-JUN-2020, subcutaneously for a history of diabetes (product use in unapproved indication). Beginning on 26-SEP-2019 through 27-SEP-2019, the patient experienced fever, body aches, dizziness, dehydration, vomiting, nausea and rash at the site of vaccination. The patient called the physician who instructed the patient to go to the emergency department on 29-SEP-2019. The patient was seen the emergency department with a three day history of those events. Comprehensive Metabolic Panel (CMP), Complete Blood Count (CBC) and urinalysis were done with unknown results. The patient was given one liter of Normal Saline intravenously (IV) and ondansetron (ZOFRAN) and sent home with oral ondansetron (ZOFRAN). There were no interventions to prevent seriousness criteria. The patient recovered between 30-SEP-2019 and 01-OCT-2019. The reporter's causality assessment was not reported. No product quality complaints were involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; A patient was administered with improperly stored PROQUAD; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 01-OCT-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) injection (lot # S003170, expiry date: 30-JUL-2020) (dose, frequency and route were not reported) for prophylaxis.  The vaccine was stored at a temperature of 6 degree Fahrenheit (F) to 14 F (13.8 F) for 9 hours. There was previous temperature excursion reported 6 F to 14 F (5.5 F) for 2 hours. A digital data logger was not involved. No adverse effects were reported. No product quality complaint was involved.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Immediate post-injection reaction, Influenza like illness, Nausea
Clinical narrative: tenderness; Cold sore; Little cluster of blisters on the side of his face; Was exhausted all day; Temperature of 102; Violent shaking; Full blown flu; Feeling of nausea that was really bad; Felt pain  immediately after receiving the second dose / Achy feeling; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 20th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th September 2019, immediately after receiving Shingrix, the patient experienced pain in arm. On 21st September 2019, the patient experienced fever, tremor, influenza-like symptoms and nausea. On 22nd September 2019, the patient experienced exhaustion. On 24th September 2019, the patient experienced cold sores, blister and tenderness. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the cold sores, blister, tenderness, fever, tremor, influenza-like symptoms, nausea and exhaustion were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the cold sores, blister, pain in arm, tenderness, fever, tremor, influenza-like symptoms, nausea and exhaustion to be related to Shingrix.  Additional details were provided as follows: The patient broke out with a cold sore which he described as a little cluster of blisters on the side of his face which he was treating with valacyclovir. The patient reported that he felt pain immediately after receiving the second dose of Shingrix on his left arm IM. The pain got worse and then he had a very sore arm. The soreness had resolved with a little tenderness. The patient got a temperature of 102, he almost went to the ER with violent shaking. The patient reported an achy feeling and full blown flu with a feeling of nausea that was really bad and exhausted all day. The patient consented to follow up.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes, Pain, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: tenderness; Cold sore; Little cluster of blisters on the side of his face; Was exhausted all day; Temperature of 102; Violent shaking; Full blown flu; Feeling of nausea that was really bad; Felt pain  immediately after receiving the second dose / Achy feeling; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 20th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th September 2019, immediately after receiving Shingrix, the patient experienced pain in arm. On 21st September 2019, the patient experienced fever, tremor, influenza-like symptoms and nausea. On 22nd September 2019, the patient experienced exhaustion. On 24th September 2019, the patient experienced cold sores, blister and tenderness. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the cold sores, blister, tenderness, fever, tremor, influenza-like symptoms, nausea and exhaustion were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the cold sores, blister, pain in arm, tenderness, fever, tremor, influenza-like symptoms, nausea and exhaustion to be related to Shingrix.  Additional details were provided as follows: The patient broke out with a cold sore which he described as a little cluster of blisters on the side of his face which he was treating with valacyclovir. The patient reported that he felt pain immediately after receiving the second dose of Shingrix on his left arm IM. The pain got worse and then he had a very sore arm. The soreness had resolved with a little tenderness. The patient got a temperature of 102, he almost went to the ER with violent shaking. The patient reported an achy feeling and full blown flu with a feeling of nausea that was really bad and exhausted all day. The patient consented to follow up.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: tenderness; Cold sore; Little cluster of blisters on the side of his face; Was exhausted all day; Temperature of 102; Violent shaking; Full blown flu; Feeling of nausea that was really bad; Felt pain  immediately after receiving the second dose / Achy feeling; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 20th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th September 2019, immediately after receiving Shingrix, the patient experienced pain in arm. On 21st September 2019, the patient experienced fever, tremor, influenza-like symptoms and nausea. On 22nd September 2019, the patient experienced exhaustion. On 24th September 2019, the patient experienced cold sores, blister and tenderness. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the cold sores, blister, tenderness, fever, tremor, influenza-like symptoms, nausea and exhaustion were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the cold sores, blister, pain in arm, tenderness, fever, tremor, influenza-like symptoms, nausea and exhaustion to be related to Shingrix.  Additional details were provided as follows: The patient broke out with a cold sore which he described as a little cluster of blisters on the side of his face which he was treating with valacyclovir. The patient reported that he felt pain immediately after receiving the second dose of Shingrix on his left arm IM. The pain got worse and then he had a very sore arm. The soreness had resolved with a little tenderness. The patient got a temperature of 102, he almost went to the ER with violent shaking. The patient reported an achy feeling and full blown flu with a feeling of nausea that was really bad and exhausted all day. The patient consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Genital herpes
Clinical narrative: Reoccurrence of genital herpes; This case was reported by a consumer via sales rep and described the occurrence of genital herpes in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received Shingrix. On 16th September 2019, 6 days after receiving Shingrix, the patient experienced genital herpes. On an unknown date, the outcome of the genital herpes was unknown.   It was unknown if the reporter considered the genital herpes to be related to Shingrix.  Additional details were provided as follows: The patient experienced a reoccurrence of genital herpes. The patient stated that not had an active incidence of herpes for approximately 4 years.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Influenza like illness, Rash
Clinical narrative: Shingles; Rash; Back Pain; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received Shingrix. In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced back pain and influenza-like symptoms. On 20th September 2019, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles, back pain, influenza-like symptoms and rash were unknown.   It was unknown if the reporter considered the shingles, back pain, influenza-like symptoms and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 87 or 88 years. The patient experienced some flu like symptoms followed by back pain all within two weeks of the shot. The patient also developed rash. The patient was diagnosed with Shingles and she was on a medication protocol currently.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced a shingles outbreak after their 1st dose of vaccine. The reporter gave consent to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This case was reported by a other health professional and described the occurrence of adverse reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season. On an unknown date, less than 2 months after receiving FluLaval Tetra 2019-2020 season, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The message received from the commercial team that an adverse event following administration of Flulaval MDV had been reported a subsidiary of reported hospitalizations following the administration of Flulaval MDV to their employees. The reporter did not know how many employees received the vaccine. They have pulled all other MDVs from use. The reporter wanted to make you aware of this situation in case this is not an isolated event. The reporter asked is there a way to monitor this internally. This is 3 of 3 case having same reporter.