chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Normal soreness at injection site. After about 2 wks severe pain in shoulders and biceps. Ice bag and TYLENOL were used. Pain still elevated, hasn't decreased.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a female patient who received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site wheal and injection site pain. On an unknown date, the outcome of the injection site wheal and injection site pain were unknown. It was unknown if the reporter considered the injection site wheal and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a painful 4 inches raised welt on arm just below the injection site. The reporter was asking if that was an allergic reaction. The reporter was leery about having a second dose since reaction to the first was more severe than expected. The reporter was asking the effective rate of 1 dose of verses the other doses.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diverticulitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of diverticulitis in a 70-year-old female patient who received SHINGRIX. Concurrent medical conditions included diverticulosis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced diverticulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the diverticulitis was unknown. It was unknown if the reporter considered the diverticulitis to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the adverse event via click to chat forum. The pharmacist reported that he had a patient with known diverticulosis who developed diverticulitis within a few weeks of the SHINGRIX vaccine. No further information was available at the time of report.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid margin crusting, Eyelid rash, Hyperkeratosis, Hypersensitivity, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of keratosis in a 65-year-old female patient who received SHINGRIX. The patient's past medical history included mood disorder, stress, hives (during stress) and migraine (during stress). Concurrent medical conditions included allergy. Concomitant products included lamotrigine. In January 2018, the patient received the 1st dose of SHINGRIX. In February 2018, 14 days after receiving SHINGRIX, the patient experienced keratosis, eye crusting, pain, pruritus, allergy aggravated, rash toothache and eyelid rash. The patient was treated with Cortisone Cream. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the keratosis, eye crusting, pain, pruritus, allergy aggravated, rash, toothache and eyelid rash were recovered/resolved. The reporter considered the keratosis, eye crusting, pain, pruritus, allergy aggravated, rash, toothache and eyelid rash to be possibly related to SHINGRIX. Additional details were provided as follows: In late January 2018, the patient received SHINGRIX on the right arm. Approximately 2 weeks after receiving SHINGRIX, the patient experienced a crusty rash on her eyelids, and rash on forehead and behind the ear. The patient experienced more general allergies than before SHINGRIX therapy. The patient saw a dermatologist and a diagnosis of keratosis was made and a cortisone cream helped alleviated the skin issues of rash and crustiness on the eyelid. The permission was given to send a letter requesting physician information. This case has been linked with case US2018GSK088924 (next dose), reported by same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Toothache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of keratosis in a 65-year-old female patient who received SHINGRIX. The patient's past medical history included mood disorder, stress, hives (during stress) and migraine (during stress). Concurrent medical conditions included allergy. Concomitant products included lamotrigine. In January 2018, the patient received the 1st dose of SHINGRIX. In February 2018, 14 days after receiving SHINGRIX, the patient experienced keratosis, eye crusting, pain, pruritus, allergy aggravated, rash toothache and eyelid rash. The patient was treated with Cortisone Cream. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the keratosis, eye crusting, pain, pruritus, allergy aggravated, rash, toothache and eyelid rash were recovered/resolved. The reporter considered the keratosis, eye crusting, pain, pruritus, allergy aggravated, rash, toothache and eyelid rash to be possibly related to SHINGRIX. Additional details were provided as follows: In late January 2018, the patient received SHINGRIX on the right arm. Approximately 2 weeks after receiving SHINGRIX, the patient experienced a crusty rash on her eyelids, and rash on forehead and behind the ear. The patient experienced more general allergies than before SHINGRIX therapy. The patient saw a dermatologist and a diagnosis of keratosis was made and a cortisone cream helped alleviated the skin issues of rash and crustiness on the eyelid. The permission was given to send a letter requesting physician information. This case has been linked with case US2018GSK088924 (next dose), reported by same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Eyelid margin crusting, Eyelid rash, Hyperkeratosis, Hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of keratosis in a 65-year-old female patient who received SHINGRIX. The patient's past medical history included mood disorder, stress, hives (during stress) and migraine (during stress). Concurrent medical conditions included allergy. Concomitant products included SHINGRIX and lamotrigine. In April 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced keratosis, eye crusting, pain, pruritus, allergy aggravated, rash, toothache and eyelid rash. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the keratosis was unknown and the outcome of the eye crusting and eyelid rash were not recovered/not resolved and the outcome of the pain, pruritus and rash were recovering/resolving and the outcome of the allergy aggravated and toothache were unchanged. The reporter considered the keratosis, eye crusting, pain, pruritus, allergy aggravated, rash, toothache and eyelid rash to be possibly related to SHINGRIX. Additional details were provided as follows: In end of January 2018, the patient received 1st dose of SHINGRIX and experienced same events as after the 2nd dose, (refer case US2018078743). Approximately 2 weeks after receiving 2nd dose of SHINGRIX, the patient experienced a crusty rash on her eyelids, and rash on forehead and behind the ear. The patient experienced more general allergies than before SHINGRIX therapy. The patient saw a dermatologist and a diagnosis of keratosis was made and a cortisone cream helped in alleviating the skin issues of rash and crustiness on the eyelid. The permission was given to send a letter requesting physician information.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash, Toothache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of keratosis in a 65-year-old female patient who received SHINGRIX. The patient's past medical history included mood disorder, stress, hives (during stress) and migraine (during stress). Concurrent medical conditions included allergy. Concomitant products included SHINGRIX and lamotrigine. In April 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced keratosis, eye crusting, pain, pruritus, allergy aggravated, rash, toothache and eyelid rash. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the keratosis was unknown and the outcome of the eye crusting and eyelid rash were not recovered/not resolved and the outcome of the pain, pruritus and rash were recovering/resolving and the outcome of the allergy aggravated and toothache were unchanged. The reporter considered the keratosis, eye crusting, pain, pruritus, allergy aggravated, rash, toothache and eyelid rash to be possibly related to SHINGRIX. Additional details were provided as follows: In end of January 2018, the patient received 1st dose of SHINGRIX and experienced same events as after the 2nd dose, (refer case US2018078743). Approximately 2 weeks after receiving 2nd dose of SHINGRIX, the patient experienced a crusty rash on her eyelids, and rash on forehead and behind the ear. The patient experienced more general allergies than before SHINGRIX therapy. The patient saw a dermatologist and a diagnosis of keratosis was made and a cortisone cream helped in alleviating the skin issues of rash and crustiness on the eyelid. The permission was given to send a letter requesting physician information.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Swelling
Clinical narrative: Patient phoned the pharmacy stating that she was experiencing really bad itching and swelling approximately five inches side. Patient advised to use BENADRYL and follow up with doctor or urgent care for steroids and further evaluation. Pt says she will use rubbing alcohol on the area and follow up with the doctor if the condition worsens.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 58-year-old male patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On 9th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th March 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever with body temperature of 100 degree Fahrenheit.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of chills in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that they heard reports of severe chills after administration of GlaxoSmithKline shingles vaccine. The reporter wanted to know if the GlaxoSmithKline was aware of these reports and also wanted to know if there are any premedication or post-injection recommendations available to avoid this adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Influenza like illness
Clinical narrative: This case was reported by a consumer and described the occurrence of general malaise in a female patient who received SHINGRIX. Concomitant products included SHINGRIX. On 24th April 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced general malaise, chills, tiredness, appetite lost, sleepiness, energy decreased, pain in arm, injection site erythema and influenza-like symptoms. On an unknown date, the outcome of the general malaise, chills, tiredness, appetite lost, sleepiness, energy decreased, pain in arm, injection site erythema and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the general malaise, chills, tiredness, appetite lost, sleepiness, energy decreased, pain in arm, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. On 17th February 2018, the patient received 1st dose of SHINGRIX concomitantly and she had no issues at all. The patient had a reaction that gave her general malaise included chills, tiredness, loss of appetite, sleepiness, low energy, her arm hurt a lot with erythema around injection site. The patient described that reaction as flu like symptoms although without an elevated body temperature and the symptoms lasted about 24 hours. The reporter was asking if you need additional information, please contact him.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Malaise, Pain in extremity, Somnolence
Clinical narrative: This case was reported by a consumer and described the occurrence of general malaise in a female patient who received SHINGRIX. Concomitant products included SHINGRIX. On 24th April 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced general malaise, chills, tiredness, appetite lost, sleepiness, energy decreased, pain in arm, injection site erythema and influenza-like symptoms. On an unknown date, the outcome of the general malaise, chills, tiredness, appetite lost, sleepiness, energy decreased, pain in arm, injection site erythema and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the general malaise, chills, tiredness, appetite lost, sleepiness, energy decreased, pain in arm, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. On 17th February 2018, the patient received 1st dose of SHINGRIX concomitantly and she had no issues at all. The patient had a reaction that gave her general malaise included chills, tiredness, loss of appetite, sleepiness, low energy, her arm hurt a lot with erythema around injection site. The patient described that reaction as flu like symptoms although without an elevated body temperature and the symptoms lasted about 24 hours. The reporter was asking if you need additional information, please contact him.
Age: 0.58
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema
Clinical narrative: (R) thigh 2 cm x 3 cm redness at the site of PROQUAD S/C injection
Age: 18.0
Sex: M
Vaccine: HEPA, MMR, TDAP, VARCEL
Symptoms: Anaphylactic shock, Deafness, Loss of consciousness
Clinical narrative: Patient passed out after 4th shot. Patient states lost hearing. Anaphylaxis shock. Gave pt EPIPEN 0.3 mg.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Varicella vaccine given on 5-3-18 developed rash on 5-18-18 saw MD on 5-21-18 and diagnosed with chickenpox.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives to head and spreading to chest and back. Reaction started about 1 hour and 15 min later. BENADRYL given in office and symptoms resolved. No breathing concerns. No facial swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site reaction, Injection site vesicles, Pruritus, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 60-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On 23rd April 2018, the patient received the 1st dose of SHINGRIX. On 28th April 2018, 5 days after receiving SHINGRIX, the patient experienced welts, itchy legs and blister. On an unknown date, the outcome of the welts and blister were recovering/resolving and the outcome of the itchy legs was not recovered/not resolved. The reporter considered the welts, itchy legs and blister to be possibly related to SHINGRIX. Additional details were provided as follows: At the beginning, 5 to 6 days after receiving SHINGRIX, the patient experienced welts and blisters all over her upper back, upper shoulders, 1 on the leg, and 1 on her foot. The patient stated, it was super itchy (severity: severe). On the date of reporting, the symptoms were improved, the size was diminished, blisters were healing over. But, it was still very itchy.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pruritus, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 60-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On 23rd April 2018, the patient received the 1st dose of SHINGRIX. On 28th April 2018, 5 days after receiving SHINGRIX, the patient experienced welts, itchy legs and blister. On an unknown date, the outcome of the welts and blister were recovering/resolving and the outcome of the itchy legs was not recovered/not resolved. The reporter considered the welts, itchy legs and blister to be possibly related to SHINGRIX. Additional details were provided as follows: At the beginning, 5 to 6 days after receiving SHINGRIX, the patient experienced welts and blisters all over her upper back, upper shoulders, 1 on the leg, and 1 on her foot. The patient stated, it was super itchy (severity: severe). On the date of reporting, the symptoms were improved, the size was diminished, blisters were healing over. But, it was still very itchy.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Peripheral swelling, Skin discolouration, Wound secretion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of purpura in a 66-year-old male patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On 10th May 2018, the patient received SHINGRIX. On 11th May 2018, 1 days after receiving SHINGRIX, the patient experienced purpura, fatigue and fluid discharge. On an unknown date, the outcome of the purpura was unchanged and the outcome of the fatigue was not recovered/not resolved and the outcome of the fluid discharge was unknown. It was unknown if reporter considered the purpura, fatigue and fluid discharge to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm and developed two reddish purple bumps, not raised, on his right hand that appeared to be oozing the following morning. The patient also reported full body fatigue and this was added later upon subsequent discussion with reporter. The healthcare professional was unsure what blood pressure medication the patient was taking only that he had been taking it long term.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discharge, Fatigue, Purpura
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of purpura in a 66-year-old male patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On 10th May 2018, the patient received SHINGRIX. On 11th May 2018, 1 days after receiving SHINGRIX, the patient experienced purpura, fatigue and fluid discharge. On an unknown date, the outcome of the purpura was unchanged and the outcome of the fatigue was not recovered/not resolved and the outcome of the fluid discharge was unknown. It was unknown if reporter considered the purpura, fatigue and fluid discharge to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm and developed two reddish purple bumps, not raised, on his right hand that appeared to be oozing the following morning. The patient also reported full body fatigue and this was added later upon subsequent discussion with reporter. The healthcare professional was unsure what blood pressure medication the patient was taking only that he had been taking it long term.
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse referring to a 22 year old female patient. The patient did not have medical history, concurrent conditions or concomitant medications. The patient's had a drug reaction or allergy to CEDAX. On 10-MAY-2018, the patient was vaccinated once with Oka/Merck VARIVAX 0.5 ml, subcutaneously, lot number N031003 and expiration date of 03-NOV-2019 reported as 10-MAY-2018 (strength, dose number were not provided) for prophylaxis due to booster for employment reasons, the reporter stated that did not know the history or titer status of the patient only that she needed a "booster" dose. It was reported that on 17-MAY-2018, the patient took a home pregnancy test that was positive (exposure during pregnancy). The LMP (last menstrual period) was unknown. The pregnancy outcome was outcome pending. The patient made an appointment with the registered nurse.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angiogram, Back pain, Borrelia test, Cardiac function test, Chest X-ray
Clinical narrative: Perimyocarditis. SOB, chest pain. Treated with high dose aspirin, colchicine, lisinopril. Metoprolol.   At this time, her condition is improved. She is still weak and fatigued. Cardiology followup is pending.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Computerised tomogram thorax, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Perimyocarditis. SOB, chest pain. Treated with high dose aspirin, colchicine, lisinopril. Metoprolol.   At this time, her condition is improved. She is still weak and fatigued. Cardiology followup is pending.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Laboratory test, Muscle spasms, Myocardial infarction, Myocarditis
Clinical narrative: Perimyocarditis. SOB, chest pain. Treated with high dose aspirin, colchicine, lisinopril. Metoprolol.   At this time, her condition is improved. She is still weak and fatigued. Cardiology followup is pending.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Painful respiration, Troponin increased
Clinical narrative: Perimyocarditis. SOB, chest pain. Treated with high dose aspirin, colchicine, lisinopril. Metoprolol.   At this time, her condition is improved. She is still weak and fatigued. Cardiology followup is pending.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arteriogram coronary normal, Asthenia, Borrelia test negative, Chest X-ray abnormal, Chest pain
Clinical narrative: Perimyocarditis. SOB, chest pain. Treated with high dose aspirin, colchicine, lisinopril. Metoprolol.   At this time, her condition is improved. She is still weak and fatigued. Cardiology followup is pending.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea, Ejection fraction decreased, Fatigue, Myocarditis
Clinical narrative: Perimyocarditis. SOB, chest pain. Treated with high dose aspirin, colchicine, lisinopril. Metoprolol.   At this time, her condition is improved. She is still weak and fatigued. Cardiology followup is pending.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rheumatoid factor negative, Troponin increased
Clinical narrative: Perimyocarditis. SOB, chest pain. Treated with high dose aspirin, colchicine, lisinopril. Metoprolol.   At this time, her condition is improved. She is still weak and fatigued. Cardiology followup is pending.
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning an unknown number of patients of unknown ages and genders. The patients´ medical history, concurrent conditions and concomitant medications were not provided. On 03-APR-2018 (reported as probably), the patients were vaccinated with improperly stored doses of VARIVAX lot # M046005 with expiration date 20-SEP-2019; lot # N022996 with expiration date 23-AUG-2019; lot# N020016  with expiration date 17-JUL-2019; lot # M046926 with expiration date 28-NOV-2018 and, lot # M046005 with expiration date 18-NOV-2018. Furthermore the patients were also vaccinated with improperly stored doses of PROQUAD lot # N025928, (rHA) with expiration date 18-MAR-2019 and, lot # N023001, (rHA) with expiration date 19-FEB-2019 and, ZOSTAVAX lot # N025569 with expiration date 13-DEC-2018 and, lot # N025387 with expiration date 02-DEC-2018 (doses, frequencies and routes of administrations were not provided) which were reconstituted with a properly stored sterile diluent. No adverse effect reported. The vaccines were stored at a temperature of 6 Fahrenheit degree to 14 Fahrenheit degree, time frame of 1 hour with a previous temperature excursion of (6 Fahrenheit degree to 14 Fahrenheit degree for 30 minutes). Digital Data logger was involved.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 09-MAY-2018, the patient was vaccinated with an expired dose of GARDASIL 9, lot # L037339, expiration date 09-FEB-2018, intramuscular for prophylaxis (dose number was unspecified). No adverse effects reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse refers to an infant patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-SEP-2017, the patient received an improperly stored dose of RECOMBIVAX HB (lot # M031574, expiration date: 11-NOV-2018; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion occurred at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1710USA004063:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD Lot # N010865, expiration date 01-OCT-2018 (doses, routes and frequencies were not reported) for prophylaxis; that were reconstituted with properly stored sterile diluents (doses, routes and frequencies were not reported). The average temperature of excursion was reported as 13.3 Fahrenheit (F) (also reported as between 6F and 14 F), during a time frame of 2 hours. There was no previous temperature excursions. No adverse effects reported. There was a Digital Data Logger involved.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to a male patient of unknown age. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with (wistar ra 27-3) M-M-R II for prophylaxis (dose, route of administration, lot number and expiration date were not provided). On an unknown date, the patient had low titers. The outcome of the event was unknown. The relatedness between the event and (wistar ra 27-3) M-M-R II was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 18-MAY-2018, the patient was vaccinated with a dose of VAQTA (dose, frequency and route were unknown) lot # N012324 that had expired on 05-APR-2018, for prophylaxis. No adverse effect was reported.
Sex: M
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous report was received from a pediatrician via company representative, concerning a male patient of unknown age. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (Strength, dose, route, lot # and expiration date were not reported) as prophylaxis. On an unknown date, the patient developed postural orthostatic tachycardia syndrome. The outcome of postural orthostatic tachycardia syndrome was unknown. The reporter did not provide the causality between the event and GARDASIL.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 27 year old female patient. The patient's medical history, drug reaction, allergies or concomitant therapies were no provided. On 20-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, for prophylaxis (strength, dosage, frequency, lot# and expiration date were no provided). The pharmacist stated that on 24-JAN-2018, the patient received the second dose of GARDASIL 9 intramuscularly, for prophylaxis (strength, dosage, frequency, lot# and expiration date were no provided) and may have turned 27 years of age during that time.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient medical history, concurrent conditions, previous drug reactions or concomitant medications. On unspecified dates, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX lot number N020015, with expiration date on 17-JUL-2019 and Oka-Merck PROQUAD lot number N014950, with expiration date on 11-NOV-2018 for prophylaxis (strength, dose, routes of administration, anatomical locations, lot numbers and expiration dates were not reported for any of the vaccines). The MERCK STERILE DILUENT used for the reconstitution of the vaccines was properly stored. The administered doses of the vaccines experienced a temperature excursion in the range between -14 to -10 degrees Celsius (°C) for 52 minutes, as recorded by a data logger. The vaccines had a previous temperature excursions in the range between -14°C to -10°C for 67 minutes, There was no adverse events reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA008561.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood glucose normal, Full blood count, Loss of consciousness, Metabolic function test, Neutrophil count increased
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc., other manufacturer report number 00821766. A contactable medical assistant reported for a female patient of an unspecified age and race who received a dose of TRUMENBA (S56026, expiration 28Feb2019) and a dose of MENACTRA (U5848AA, expiration 01Mar2019) both in the left arm on 04May2018, for immunization. The patient passed out at the pharmacy and an ambulance was called on 04May2018. Medical assistant reported the patient went via ambulance to the emergency room. Medical assistant reported the patient had lab studies that included urinalysis, urinalysis for pregnancy, BMP and CBC, with results that showed glucose of 124, platelets 101 and neutrophils 8.9. Medical assistant reported the patient was observed in the emergency room and discharged on the same date. No additional information was provided. No follow-up attempts are possible. No further information is expected. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Platelet count decreased, Pregnancy test urine, Urine analysis
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc., other manufacturer report number 00821766. A contactable medical assistant reported for a female patient of an unspecified age and race who received a dose of TRUMENBA (S56026, expiration 28Feb2019) and a dose of MENACTRA (U5848AA, expiration 01Mar2019) both in the left arm on 04May2018, for immunization. The patient passed out at the pharmacy and an ambulance was called on 04May2018. Medical assistant reported the patient went via ambulance to the emergency room. Medical assistant reported the patient had lab studies that included urinalysis, urinalysis for pregnancy, BMP and CBC, with results that showed glucose of 124, platelets 101 and neutrophils 8.9. Medical assistant reported the patient was observed in the emergency room and discharged on the same date. No additional information was provided. No follow-up attempts are possible. No further information is expected. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Vaccination site swelling
Clinical narrative: This is a spontaneous report based on information received by Pfizer from company (manufacturer number: not available). A contactable consumer reported that a female patient of unspecified age and ethnicity received PREVNAR 13, (lot number: T78676, expiration date: not reported) via unspecified route of administration on 14May2018 at single dose for immunization. Patient had no known allergies and no medical conditions. Concomitant medications were not reported. On 14May2018, after administering the PREVNAR 13 vaccine, a large lump and redness was observed at the injection site. This was described as an unusual reaction for this patient. Swelling at vaccination site was also reported. After the other vials were observed, it was discovered that there were visible particles in the vials (pending clarification if vial received by the patient also had particles). No medical attention required for the events. Outcome of the events was unknown.
Sex: U
Vaccine: MENB
Symptoms: Back pain, Chills, Cyanosis, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable physician. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills, blue fingers, back pain and muscle pain all on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about lot number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable physician. A 79-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced drug allergies: prevnar on an unspecified date with outcome of unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse event 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 adverse event (serious criteria hospitalization). On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: Field representative states that he saw an email that was sent to one of his customers. The age at vaccination was not reported. The reporter stated the patient was hospitalized after receiving SHINGRIX. No other information was provided. The representative did not have the email himself. He was going to try and follow up with the person who sent the email to get more information.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: Began with shaking chills 12 hrs post vaccination. Fever of 101F @ 0700 today with mild headache, body aches, fatigue and general malaise. Treating with Ibuprofen 400mg q6hprn.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Began with shaking chills 12 hrs post vaccination. Fever of 101F @ 0700 today with mild headache, body aches, fatigue and general malaise. Treating with Ibuprofen 400mg q6hprn.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Myalgia
Clinical narrative: Extreme muscle pain and weakness all over. It began about 6 hours after the shot and continued for about 24-36 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fall, Loss of consciousness, Nausea
Clinical narrative: Woke up nauseous, tried to throw up but wasn't able to, next thing i knew I was on the bathroom floor and my husband was asking me if I was ok - I had blacked out and fallen down. Shakes, shivers and continued nausea. I took ZOFRAN and TYLENOL and felt somewhat better. I continued with these medications for the rest of the day. Little to no appetite for that day and the next. Low level nausea continued for the next 4 and a half days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Woke up nauseous, tried to throw up but wasn't able to, next thing i knew I was on the bathroom floor and my husband was asking me if I was ok - I had blacked out and fallen down. Shakes, shivers and continued nausea. I took ZOFRAN and TYLENOL and felt somewhat better. I continued with these medications for the rest of the day. Little to no appetite for that day and the next. Low level nausea continued for the next 4 and a half days.
Age: 19.0
Sex: M
Vaccine: TD
Symptoms: Chest pain, Cough, Dyspnoea, Throat irritation, Urticaria
Clinical narrative: PT EXPERIENCED DIFFICULTY BREATHING, CHEST PAIN, COUGH, SCRATCHY THROAT AND HIVES WITHIN 45 MINUTES OF RECEIVING VACCINE. HE ADMINISTERED HIS OWN EPI PEN AND MOM DROVE HIM TO ED. AFTER 4 HOURS OF OBSERVATION IN ED PT WAS DISCHARGED HOME.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient reported swelling, itching and pain to site of vaccine. Swelling continued to worsened along with redness. Patient was given antibiotics due to symptoms as it was treated for cellulitis.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received vaccine Fri PM, had fever next day 99.9 constant HA, muscle soreness. Still fever on Mon. Also thumbnail size raised area at inj site surrounded by redness, tender to touch and itchy.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Pt received vaccine Fri PM, had fever next day 99.9 constant HA, muscle soreness. Still fever on Mon. Also thumbnail size raised area at inj site surrounded by redness, tender to touch and itchy.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction
Clinical narrative: 10x7 RXN at injection site.
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Discomfort, Fluid retention, Headache, Myalgia, Pain in extremity
Clinical narrative: Arm hurt really bad when Med went in. Woke me up during my sleep if I moved. This morning every muscle hurts including my tongue. Headache. I know fibromyalgia pain. This pain burns and is very uncomfortable. I seem to have fluid built up in my hands. I feel absolutely horrible!!!
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Chills, Immediate post-injection reaction, Influenza like illness, Injection site pain, Pain
Clinical narrative: Arm hurt really bad when Med went in. Woke me up during my sleep if I moved. This morning every muscle hurts including my tongue. Headache. I know fibromyalgia pain. This pain burns and is very uncomfortable. I seem to have fluid built up in my hands. I feel absolutely horrible!!!
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Arm hurt really bad when Med went in. Woke me up during my sleep if I moved. This morning every muscle hurts including my tongue. Headache. I know fibromyalgia pain. This pain burns and is very uncomfortable. I seem to have fluid built up in my hands. I feel absolutely horrible!!!
Age: 18.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Back pain, Blood glucose decreased, Blood lactic acid increased, Chills, Dehydration
Clinical narrative: Started to have a fever up to 104, shaking, chills, pain from his neck down his back, trouble standing. Mom called 911, in ambulance O2 sat went down to 76% and BS was 40. Got to hospital and lab work showed dehydration and high lactic acid level. Don't have actual lab work in hand.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Dysstasia, Neck pain, Oxygen saturation decreased, Pyrexia, Tremor
Clinical narrative: Started to have a fever up to 104, shaking, chills, pain from his neck down his back, trouble standing. Mom called 911, in ambulance O2 sat went down to 76% and BS was 40. Got to hospital and lab work showed dehydration and high lactic acid level. Don't have actual lab work in hand.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left shoulder pain - She's had redness swelling and tenderness in that area starting ever since. It is incredibly painful to the touch. In fact when she took off pressure at this morning she screamed with pain. She has spreading redness in the area as well. Cellulitis this is quite possibly infection brought on by her immunization. It does not look like standard inflammation from an immunization. Plus its 2 weeks out from the immunization. Giving her Keflex and Bactrim. 1 tablet twice a day for 10 days for both medications. She will follow-up if this is not working. If this antibiotic does not work we may need to get imaging.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site rash, Pyrexia
Clinical narrative: Fever, chills, headache, rash on left shoulder 4/30 thru 5/1st.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 65 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In APR-2017, the patient was vaccinated with a proper stored dose of PNEUMOVAX 23 lot umber reported as R048403 and expiration date 18-APR-2018 (dose and route were not reported) "recommended for her age". On an unknown date, the patient experienced swelling at the injection site, after two weeks she was recovered from the event. The causal relationship between the event and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 10-MAY-2018, the patient was vaccinated with an expired dose of VAQTA intramuscularly(lot # M032492, expiration date: 03-MAR-2018, dose, strength were not provided) for prophylaxis. The nurse reports that VAQTA was properly stored. The patient did not experienced any adverse event.
Sex: F
Vaccine: HPV9
Symptoms: Cough
Clinical narrative: This spontaneous report was received from a 23-year-old female patient, who was reporting on herself. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 02-APR-2018, the patient was vaccinated with the first dose of GARDASIL 9 for route vaccination (dose, route of administration and anatomical location, lot# and expiration date were not reported). On an unknown date, approximately in 2018, the patient got a bad cough from her contagious colleague. The outcome of the event was unknown. The relatedness between event and GARDASIL 9 was not reported.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: ADDITION TO REPORTING CALLED MERCK FOR FURTHER INSTRUCTIONS .
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Hives, given Benadryl for treatment.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pain in left shoulder with limited motion.
Age: 57.0
Sex: M
Vaccine: YF
Symptoms: Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: Fever, chills, headache + profuse diarrhea.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Rash
Clinical narrative: Patient presents today 5/23/2018 at 9:00am with a rash to bilateral arms, from back of shoulder, (scapula area) down to hands, rash is slightly raised and pink, pt denies pruritus, or fever, states noticed rash this morning when she woke up. No other symptoms, denies known allergies, pt is not taking any OTC medications or supplements, Pt states arms were exposed to sun yesterday, Pt states sunblock was applied, no history of similar rash in past, Notified PCP and Regional oncall nurse of rash, no other recommendations given, recommended to continue to watch, if rash worsen or any other symptom occur, to return to clinic, or go to ER.
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction, Apparent life threatening event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult female patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 1984, the patient had a bad reaction to a flu vaccine. The patient stated that, she almost died.