chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Influenza, Pain, Pyrexia
Clinical narrative: I felt like I was coming down with the flu, and it lasted 5 straight days after the day I received the vaccine. I experienced extreme fatigue, body aches and fever. I received the vaccine on Saturday, and the symptoms started on Sunday morning. I missed 3 days of work plus 1 day that was a holiday.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Chills and muscle aches, which cleared up in 24 hours.
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Dyspnoea, Hyporesponsive to stimuli, Lethargy, Nausea
Clinical narrative: 10 minutes following injection patient became lethargic and slow to respond to verbal stimulus. She reported nausea and stated that it was "hard to breathe". 911 was called for transport to ER, EPIPEN 0.3mg was administered, patient was transported to ER via EMS.
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Altered state of consciousness, Anaphylactic reaction, Asthma, Biopsy muscle abnormal, Cognitive disorder
Clinical narrative: 10 minutes following injection patient became lethargic and slow to respond to verbal stimulus. She reported nausea and stated that it was "hard to breathe". 911 was called for transport to ER, EPIPEN 0.3mg was administered, patient was transported to ER via EMS.
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Dizziness, Dyspnoea, Erythema, Extensive swelling of vaccinated limb, Feeling hot
Clinical narrative: 10 minutes following injection patient became lethargic and slow to respond to verbal stimulus. She reported nausea and stated that it was "hard to breathe". 911 was called for transport to ER, EPIPEN 0.3mg was administered, patient was transported to ER via EMS.
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Fibromyalgia, Flushing, Hypoaesthesia, Hypotension, Injection site bruising
Clinical narrative: 10 minutes following injection patient became lethargic and slow to respond to verbal stimulus. She reported nausea and stated that it was "hard to breathe". 911 was called for transport to ER, EPIPEN 0.3mg was administered, patient was transported to ER via EMS.
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site discolouration, Injection site erythema, Injection site rash, Nerve conduction studies abnormal, Nerve injury
Clinical narrative: 10 minutes following injection patient became lethargic and slow to respond to verbal stimulus. She reported nausea and stated that it was "hard to breathe". 911 was called for transport to ER, EPIPEN 0.3mg was administered, patient was transported to ER via EMS.
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pain, Pain in extremity, Paraesthesia, Peripheral coldness, Rash
Clinical narrative: 10 minutes following injection patient became lethargic and slow to respond to verbal stimulus. She reported nausea and stated that it was "hard to breathe". 911 was called for transport to ER, EPIPEN 0.3mg was administered, patient was transported to ER via EMS.
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Skin warm, Small fibre neuropathy, Speech disorder, Unresponsive to stimuli, Urticaria
Clinical narrative: 10 minutes following injection patient became lethargic and slow to respond to verbal stimulus. She reported nausea and stated that it was "hard to breathe". 911 was called for transport to ER, EPIPEN 0.3mg was administered, patient was transported to ER via EMS.
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Vertigo, Walking aid user, Wheelchair user
Clinical narrative: 10 minutes following injection patient became lethargic and slow to respond to verbal stimulus. She reported nausea and stated that it was "hard to breathe". 911 was called for transport to ER, EPIPEN 0.3mg was administered, patient was transported to ER via EMS.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: On 12/29/18  patient reported muscle weakness and pain. Patient was diagnosed with influenza 12/28/19 at an urgent care facility. Pain and weakness thought to be from active influenza infection at time of reporting. On 2/4/19 patient states arm is still sore and visited PCP.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain, Injection site rash, Lip swelling, Pruritus
Clinical narrative: Patient received Tetanus vaccine 2 months prior. Patient went home and noticed that her crotch, armpits, elbows, and ears started itching. Patient looked herself in the mirror and noticed lips were swollen. Also noticed rash on stomach, chest and back. There was a little near injection site. Arm was sore for about 3 days at site of injection. Patient went back to pharmacist and was directed to doctor. Patient took Benadryl, it helped, and had rash for a couple of days. Patient called doctor when it was almost gone and told not to come in. Doctor told patient not to get next dose.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient received Tetanus vaccine 2 months prior. Patient went home and noticed that her crotch, armpits, elbows, and ears started itching. Patient looked herself in the mirror and noticed lips were swollen. Also noticed rash on stomach, chest and back. There was a little near injection site. Arm was sore for about 3 days at site of injection. Patient went back to pharmacist and was directed to doctor. Patient took Benadryl, it helped, and had rash for a couple of days. Patient called doctor when it was almost gone and told not to come in. Doctor told patient not to get next dose.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Chronic Left Deltoid Pain with NEW SENIOR HIGH STRENGTH VACCINE, Pain is still present with Exacerbations. This did not happen with previous years on the Regular Flu vaccine.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/allergies. The nurse reported the patient received ROTATEQ, 2 ml, orally, lot # R012954 and expiration date 04-DEC-2019 for prophylaxis on the following dates: 15-AUG-2018, 17-OCT-2018, 26-DEC-2018 and on 30-JAN-2019 (inappropriate schedule of product administration) and (extra dose administered). The outcome of inappropriate schedule of product administration and extra dose administered was unknown.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Eye pain, Headache, Nausea
Clinical narrative: PATIENT EXPERIENCED FEVER, CHILLS, JOINT ACHES, SEVERE HEADACHE, NAUSEA, DULL ACHE IN LEFT EYE (SAME EYE AFFECTED WHEN SHE HAD SHINGLES BEFORE).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: PATIENT EXPERIENCED FEVER, CHILLS, JOINT ACHES, SEVERE HEADACHE, NAUSEA, DULL ACHE IN LEFT EYE (SAME EYE AFFECTED WHEN SHE HAD SHINGLES BEFORE).
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Blister, Papule, Pyrexia
Clinical narrative: Fever and generalized vesicles and papules.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, cold chills, sweats, congestion (unsure if sinus related), headaches.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: About 6 hours after I received the flu shot I was watching TV. In the short space of a few seconds, a grey-colored "curtain" appeared and blocked the vision in precisely the upper half of my right eye. The bottom-half vision of the right eye remained clear, and all of the left eye vision remained clear. The grey curtain blocking my vision was confined to the upper half of the right eye only. The curtain remained there for about 3-5 minutes (my best estimate of the time), then fairly quickly disappeared. The vision in the right eye returned to normal and is still normal today, 18 days later. I did not seek medical attention. I had no other medical issues occurring in the weeks before that vision episode. It was puzzling to me until I remembered that six hours earlier I had received the high dose "senior" flu shot. Whether that flu shot caused it or not, I of course cannot tell, but the timing (6 hours after the shot) seemed suspicious, so I am reporting it to you. As I'm sure you'll understand, I am reluctant to get my personal information recorded in multiple databases, so I have omitted the non-required name/address/etc. But if you need any follow-up information, you may contact me. Thank you for all the good work you do in helping make the medical care safe and effective.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Pruritus, Rash, Swelling
Clinical narrative: Patient is complaining of late onset injection site reaction. She is having side effects of a rash, swelling, raised bumps and itching.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Chills, severe headache, entire left deltoid was red and swollen, flu-like symptoms: severe fatigue for 2 days and fatigue day 3, nausea.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea
Clinical narrative: Chills, severe headache, entire left deltoid was red and swollen, flu-like symptoms: severe fatigue for 2 days and fatigue day 3, nausea.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Blood test, Injection site erythema, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: Mom reports that 2 days after vaccine was given patient developed a red and raised area to injection site and fever of 102 degrees. The following day was at daycare and had a witnessed seizure of around 5 minutes. Reportedly had been active prior to seizure and was playing and dancing at daycare. No fever had been reported by daycare provider. Was lethargic after seizure and was taken to ER for evaluation and had blood work done. The following day the patient, according to mom, was acting normal and had no further fever, and no further seizure activity.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: Mom reports that 2 days after vaccine was given patient developed a red and raised area to injection site and fever of 102 degrees. The following day was at daycare and had a witnessed seizure of around 5 minutes. Reportedly had been active prior to seizure and was playing and dancing at daycare. No fever had been reported by daycare provider. Was lethargic after seizure and was taken to ER for evaluation and had blood work done. The following day the patient, according to mom, was acting normal and had no further fever, and no further seizure activity.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left thigh, within 24 hour developed small area of redness. By 48 hours larger circular area of redness with induration 2 inches X 5 inches. No fever.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash around neck.
Age: 52.0
Sex: M
Vaccine: FLU4, HEP, PPV, TDAP
Symptoms: Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Patient states that he experienced swelling of the right arm, nausea, and fever. He received the vaccination on Fri. He called on Mon stating that the swelling had decreased but was still swollen to his elbow. He was going to wait another day to see if the swelling decreased more before seeking treatment.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT LEFT UPPER ARM BECAME SWOLLEN, RED AND PAINFUL SEVERAL HOURS AFTER INECTION. SYMPTOMS LASTED FOR ABOUT A WEEK.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness
Clinical narrative: About 4 hours after vaccine developed severe myalgia, chills, for about 2 hours I was incapacitated, took ALEVE, and felt better by 9 pm that evening. Since the vaccine I have developed severe ringing of the ears, and severe bil knee pain, and weakness of lower ext w extreme exercise, like not being able to lift my legs up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Tinnitus
Clinical narrative: About 4 hours after vaccine developed severe myalgia, chills, for about 2 hours I was incapacitated, took ALEVE, and felt better by 9 pm that evening. Since the vaccine I have developed severe ringing of the ears, and severe bil knee pain, and weakness of lower ext w extreme exercise, like not being able to lift my legs up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Essential tremor, Vaccine positive rechallenge
Clinical narrative: I have essential tremor that is usually mild. Overnight, my tremor was greatly exacerbated and continued for several hours before becoming my usual state. I  had the same reaction to the first dose and that one I reported to the manufacturer.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Headache, Injection site bruising, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Headache, swelling and bruising with pain at injection, nausea. Treated with TYLENOL and ice pack.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose increased, Diabetes mellitus, Glycosylated haemoglobin increased, Thirst, Vision blurred
Clinical narrative: Excessive thirst and blurred vision started on 2/2/19. At the emergency room on 2/4/19 patient had an elevated blood sugar and was treated with IV fluids and Sub Q insulin. Patient was discharged to follow up with an endocrinologist for new onset diabetes.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling & redness (warmth) from the injection site down to the elbow plus soreness.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Malaise, Pain, Pyrexia
Clinical narrative: Within a few hours I did not feel well. By morning I was experiencing flu like symptoms: fever of 102-103, chills, body aches, headache. This lasted for several days.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site mass, Myalgia, Peripheral swelling
Clinical narrative: Approximately 24 hrs after vaccination, patient's left arm swelled up and turned red. A tennis ball sized lump appeared about 3 inches below the injection site. Patient also experienced full body myalgia. He was able to go to work the following day. But was still pretty sore. The lump and redness had decreased.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Pallor, Rash generalised, Rash pruritic, Skin abrasion
Clinical narrative: Child received flu vaccine at last visit on 1/29/19 in late morning. Went home, later in day took nap. Around 6 PM woke up, and found with swelling of the left arm at the vaccine site that continued until 2/1/19. No fevers. Swollen area was painful. Developed a more generalized rash on 1/30/19 that is also itchy. The rash is not waxing and waning and dad doesn't think it is coming and going from place to place. On exam on 2/2/19: Large red round hyperemic area on left upper arm. Scattered oval raised blanching lesions on trunk and extremities but mostly on trunk. Few look urticarial but most do not. Some in bilateral popliteal fossae are excoriated.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Skin lesion, Urticaria, Vaccination site pain, Vaccination site swelling
Clinical narrative: Child received flu vaccine at last visit on 1/29/19 in late morning. Went home, later in day took nap. Around 6 PM woke up, and found with swelling of the left arm at the vaccine site that continued until 2/1/19. No fevers. Swollen area was painful. Developed a more generalized rash on 1/30/19 that is also itchy. The rash is not waxing and waning and dad doesn't think it is coming and going from place to place. On exam on 2/2/19: Large red round hyperemic area on left upper arm. Scattered oval raised blanching lesions on trunk and extremities but mostly on trunk. Few look urticarial but most do not. Some in bilateral popliteal fossae are excoriated.
Age: 70.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, swelling, and numbness of arm.
Age: 67.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Pain, Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: Patient was given FLUZONE HD and PNEUMOVAX 23 in the left deltoid muscle on afternoon of February 1, 2019. She received FLUZONE HD last year and did not have any reaction. The next day she noticed red rash, warm to touch and arm a little swollen. She says the swelling is not at injection site but lower on arm. She took BENADRYL and ADVIL. She called pharmacy 2 days later and says still sore and rash. I told her to put cold pack on arm and continue to take BENADRYL and ADVIL. I will check up with her tomorrow.
Age: 1.5
Sex: F
Vaccine: DTAP, MMR
Symptoms: Rash
Clinical narrative: Rash on arms starting 2-2-19 and spread to face and legs - itchy. Treatment calamine lotion, oatmeal baths.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Pt. cont. to cry nonstop for 8 hours straight after imm for 2mo. well check.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Stomatitis
Clinical narrative: 3 days after vaccine given, patient got sores in mouth. Diagnosed 1/21/19 at dental office as oral shingles. Treated w/acyclovir 200 mg 2 PO TID x 10 days. Patient has pictures if needed.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Fluid retention, Injection site pain, Muscular weakness, Vaccination site reaction
Clinical narrative: Employee states she has had left shoulder pain since vaccination and while doing pushups her arm gave out on her. 3cm fluid collection at vaccination site? Employee is able to move arm without no problem with ROM except when she has quick movements.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: Normal soreness from flu shot for 2 days then pain in shoulder and loss of range of motion and difficulty performing ADL's.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Paralysis
Clinical narrative: Fever 101.4 - 15 hrs, paralysis both legs - 10 hrs, incontinence - 10 hrs dissipated on own. Saw Dr 1/24/19.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diplegia, Pyrexia, Urinary incontinence
Clinical narrative: Fever 101.4 - 15 hrs, paralysis both legs - 10 hrs, incontinence - 10 hrs dissipated on own. Saw Dr 1/24/19.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diplegia, Incontinence, Pyrexia
Clinical narrative: Fever 101.4 - 15 hrs, paralysis both legs - 10 hrs, incontinence - 10 hrs dissipated on own. Saw Dr 1/24/19.
Age: 1.08
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: She developed a hive several hours after the vaccination along with a low grade fever. This was the first hive she has had. It disappeared shortly after it appeared. A couple of days later another hive appeared in a different location and then another hive appeared again a couple of days later each time disappearing shortly after appearing on the skin.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Listless, Pyrexia, Rash
Clinical narrative: Patient developed a febrile illness starting approximately 2 days after receipt of the vaccination.  7 days after the vaccination the fever seemed to subside and a rash appeared. However family reports fevers reoccurred on day 9 and continued for another 5 days by which time the rash had resolved. Patient was fussy and listless per the parents report.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Redness, swelling, and feverish at injection site measured 4 inches x 3 inches  for 3 days. Muscle soreness for 3 days. Very tired and slight fever first two days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness, swelling, and feverish at injection site measured 4 inches x 3 inches  for 3 days. Muscle soreness for 3 days. Very tired and slight fever first two days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Eye irritation, Fatigue, Feeling cold
Clinical narrative: Shivering (cold), muscle aches, stomach upset, eyes burning, tired, muscle weakness - flu-like symptoms for 2 days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Muscular weakness, Myalgia
Clinical narrative: Shivering (cold), muscle aches, stomach upset, eyes burning, tired, muscle weakness - flu-like symptoms for 2 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, red, hot, pain at injection site. Next day - 5 days later. Red rash surrounding site - next day thru 7 days. Sore arm- next day thru current over a month. Swollen - over a month.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, red, hot, pain at injection site. Next day - 5 days later. Red rash surrounding site - next day thru 7 days. Sore arm- next day thru current over a month. Swollen - over a month.
Age: 54.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Peripheral coldness
Clinical narrative: Arm soreness initially, followed by 101-degree fever, chills, muscle aches, cold extremities (hands and feet), fatigue about 12 hours after the vaccine and continuing into the next morning.
Age: 54.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: Arm soreness initially, followed by 101-degree fever, chills, muscle aches, cold extremities (hands and feet), fatigue about 12 hours after the vaccine and continuing into the next morning.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Itchy rash on back, legs, arms. Joint pain, headache, sore throat, nausea, fatigue. Onset of symptoms 2/1/19 at 7:00 PM; other symptoms were present when patient woke up on morning of 2/2/19.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on back, legs, arms. Joint pain, headache, sore throat, nausea, fatigue. Onset of symptoms 2/1/19 at 7:00 PM; other symptoms were present when patient woke up on morning of 2/2/19.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning two unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On 23-JUL-2018, the patients were vaccinated with improperly stored doses of VARIVAX lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. No adverse effect reported. The vaccines were stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The outcome of product storage error and no adverse event was unknown. This is a non-valid case due to lack of patient identifiers. As of 10-DEC-2018, all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received on 30-JAN-2019 from the registered nurse regarding a 15 years old male patient (previously unknown). The date of VARIVAX storage error was 22-JUL-2018. The vaccine was stored out of range at -6 degree Celsius for an approximate time of 15 minutes. The patient received VARIVAX the week immediately following the product storage error (product start date approximated as July 2018). No adverse events were reported. This case was previously considered as non-valid, but upon receipt of follow-up it was determined to be valid as patient identifiers are provided. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1902USA001085.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reaction and allergies were unknown. On 24-JAN-2019, the patient was vaccinated with first dose of ROTATEQ (strength, dose, frequency, route were unknown) (lot # R003148 and expiry date: 05-JUN-2019) for prophylaxis. On the same day, the patient was vaccinated with first dose of PEDVAXHIB (strength, dose, frequency, route were unknown) (lot # R014262 and expiry date: 26-MAR-2021) for prophylaxis. It was reported that the patient received one dose each of two different vaccines following a temperature excursion of 61 Fahrenheit for 2 hours' time frame. There was no previous temperature excursion. Data logger was yes. No adverse effect was reported. There was no product quality complaint reported.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test positive, Eye pruritus, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a 3 years 10 months old male patient. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a first dose of VARIVAX (exact dose, route of administration, lot number and expiration date were not reported) for prophylaxis. In October 2018, the patient experienced ophthalmic shingles. He sought medical attention. Blood work was performed in October 2018 and the patient had a positive titer for varicella-zoster virus. The patient was prescribed unspecified antivirals to treat the event. The patient was scheduled to follow up with an unspecified dermatologist and an unspecified ophthalmologist on unspecified dates. The outcome of ophthalmic shingles was reported as recovering. The patient still had itching on the eye. The relatedness between ophthalmic shingles and VARIVAX was not reported. Upon internal review, the ophthalmic shingles was determined to be medically significant.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 9 years old male patient. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On an unknown date in July 2018, the patient was vaccinated with VARIVAX lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes(product storage error). There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. The patient received VARIVAX the week immediately following the product storage error. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several reports from same reporter.; Sender's Comments: US-009507513-1807USA011693:
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 15 years old male patient. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On an unknown date in July 2018, the patient was vaccinated with VARIVAX, lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. No adverse effect reported. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes (product storage error). There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. The patient received VARIVAX the week immediately following the product storage error. The outcome of the event product storage error and no adverse event were unknown. This is one of the several reports from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 6 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 08-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 8 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 08-AUG-2018, the patient was vaccinated with improperly stored VARIVAX lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 12 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 13-AUG-2018, the patient was vaccinated with improperly stored VARIVAX lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 11 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 13-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 8 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 13-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 13 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 13-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 4 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 14-AUG-2018, the patient was vaccinated with improperly stored VARIVAX lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 3 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 14-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 12 months old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 22-AUG-2018, the patient was vaccinated with improperly stored VARIVAX ((product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter.; Sender's Comments: US-009507513-1807USA011693:
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 14 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 28-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 13 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 28-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 16 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 28-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 18 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 29-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 14 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 05-SEP-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 13 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 06-SEP-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.