chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, chills, myalgias, joint pain, fever started approximately 12 hours after vaccine and lasted approximately 12 hours total. Most symptoms improved with Tylenol and naproxen but fever 100.4F persisted for 6 hours despite medications.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Loss of personal independence in daily activities, Nausea, Pain
Clinical narrative: High fever to 102.5, chills, nausea, severe headache, body aches, unable to function with severe weakness for 1 day, very sore arm, swollen arm
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: High fever to 102.5, chills, nausea, severe headache, body aches, unable to function with severe weakness for 1 day, very sore arm, swollen arm
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Mild nausea,  diffuse myalgia, chills, fever to 101.5.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: After 1 week of receiving the vaccine, I woke up with my arm red, warm, swollen and itchy. It had become that way on the 3rd day but had  resolved. It has now resolved.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Disturbance in attention, Dizziness, Fatigue, Nausea
Clinical narrative: Elevated blood pressure, dizziness, difficulty concentrating, fatigue, nausea.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Elevated blood pressure, dizziness, difficulty concentrating, fatigue, nausea.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Elevated blood pressure, dizziness, difficulty concentrating, fatigue, nausea.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pyrexia, Vomiting
Clinical narrative: Migraine headache, vomiting 2pm day of Overnight fever 101.5
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Muscle spasms
Clinical narrative: Day 1 of shot- soreness after a couple of hours at injection site Day 2- extreme fatigue (slept most of day), severe pain in left shoulder (couldn't move arm forward), chills, widespread muscle and joint aching Day 3- improved widespread S/S but still with pain specifically with left shoulder flexion and internal and external rotation Day 4- felt significantly better and able to raise arm overhead without pain, able to go about daily tasks Day 5- 5:45 am in morning- woke up with injection arm in severe spasm- painful to lift forward and rotate again, noticed decrease in sensation in anterolateral left shoulder to touch Day 6- 4:45 am- woke up with left arm in spasm again, pain with movement or weight bearing up to 8/10, feels swollen in chest and anterolateral left shoulder, referred pain in front of arm into biceps insertion, pain in injection site in anterolateral aspect of left shoulder
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Paraesthesia, Swelling, Weight bearing difficulty
Clinical narrative: Day 1 of shot- soreness after a couple of hours at injection site Day 2- extreme fatigue (slept most of day), severe pain in left shoulder (couldn't move arm forward), chills, widespread muscle and joint aching Day 3- improved widespread S/S but still with pain specifically with left shoulder flexion and internal and external rotation Day 4- felt significantly better and able to raise arm overhead without pain, able to go about daily tasks Day 5- 5:45 am in morning- woke up with injection arm in severe spasm- painful to lift forward and rotate again, noticed decrease in sensation in anterolateral left shoulder to touch Day 6- 4:45 am- woke up with left arm in spasm again, pain with movement or weight bearing up to 8/10, feels swollen in chest and anterolateral left shoulder, referred pain in front of arm into biceps insertion, pain in injection site in anterolateral aspect of left shoulder
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Cognitive disorder, Cold sweat
Clinical narrative: 1 hour after injection mild headache starts. 6 hours after injection headache intensity increases cold sweat starts run down feeling start cognitive fog sets in 9 hour after injection headache turn in to migraine. sweating on and off with hot and cold chills 12 hours after injection my joints began to hurt arm pain increases to the point its hard to move my arm and i now feel flu like and am more run down i am now 9 days out i still have arm pain still feel flu like and even more run down with a heavy chest i can still tease and smell but feel like i have a full blown flu and my skin is on fire but have no fever
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling of body temperature change, Hyperhidrosis, Influenza like illness, Migraine
Clinical narrative: 1 hour after injection mild headache starts. 6 hours after injection headache intensity increases cold sweat starts run down feeling start cognitive fog sets in 9 hour after injection headache turn in to migraine. sweating on and off with hot and cold chills 12 hours after injection my joints began to hurt arm pain increases to the point its hard to move my arm and i now feel flu like and am more run down i am now 9 days out i still have arm pain still feel flu like and even more run down with a heavy chest i can still tease and smell but feel like i have a full blown flu and my skin is on fire but have no fever
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Skin burning sensation
Clinical narrative: 1 hour after injection mild headache starts. 6 hours after injection headache intensity increases cold sweat starts run down feeling start cognitive fog sets in 9 hour after injection headache turn in to migraine. sweating on and off with hot and cold chills 12 hours after injection my joints began to hurt arm pain increases to the point its hard to move my arm and i now feel flu like and am more run down i am now 9 days out i still have arm pain still feel flu like and even more run down with a heavy chest i can still tease and smell but feel like i have a full blown flu and my skin is on fire but have no fever
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Tremor, Tunnel vision
Clinical narrative: Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted about 5 minutes but generalized weakness lasted for about an hour.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria to neck at 11:00, approx 2.5 hrs after immunization. No airway involvement. Took Zyrtec 10mg.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Pain
Clinical narrative: Body aches and fatigue about 5 hours after injection. Worsening body aches and head ache around 9pm on same day. 5am on 1/6 severe body aches and temperature  of 100.3
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: at approximately 11:30 am 12/23/20 began to have: generalized body aches and weakness,headache,severe pain in left arm , chills, temperature max 99.9 degrees F; extreme fatigue,drowsy,small area of redness at injection site with mild itchiness. Symptoms resolved approximately 12 hours later. I took Motrin 800mg at onset of symptoms and Excedrin extra strength (2) caplets approximately 8 hours later for lingering headache.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pain, Pain in extremity, Somnolence
Clinical narrative: at approximately 11:30 am 12/23/20 began to have: generalized body aches and weakness,headache,severe pain in left arm , chills, temperature max 99.9 degrees F; extreme fatigue,drowsy,small area of redness at injection site with mild itchiness. Symptoms resolved approximately 12 hours later. I took Motrin 800mg at onset of symptoms and Excedrin extra strength (2) caplets approximately 8 hours later for lingering headache.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Raised, itchy red circular area to left arm below injection site 1 week after injection
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Paraesthesia
Clinical narrative: Around 1/5/2021 started feeling slight tingling of R foot which has carried on till present time 1/6/21 0600.  Around 1/5/21 2100 started experiencing frequents stools leading to persistent diarrhea until present time.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: Fifteen minutes after getting vaccine passed out and went unconscious. Heart rate 148 and 02 at 85. Placed on 2l02 and brought to hospital to where I was dischsrhed.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eyelid disorder, Loss of consciousness, Seizure like phenomena
Clinical narrative: Fifteen minutes after getting vaccine passed out and went unconscious. Heart rate 148 and 02 at 85. Placed on 2l02 and brought to hospital to where I was dischsrhed.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased
Clinical narrative: Fifteen minutes after getting vaccine passed out and went unconscious. Heart rate 148 and 02 at 85. Placed on 2l02 and brought to hospital to where I was dischsrhed.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient experienced seizure-like symptoms. No limb movement, but eye fluttering and unconscious.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eyelid disorder, Loss of consciousness, Seizure like phenomena
Clinical narrative: Patient experienced seizure-like symptoms. No limb movement, but eye fluttering and unconscious.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased
Clinical narrative: Patient experienced seizure-like symptoms. No limb movement, but eye fluttering and unconscious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity
Clinical narrative: Initial sore arm, approximately 31 hours after injection developed a slight headache. By 6am on the 2nd day had an intense migraine headache.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Welts to lower extremity evening on the day of vaccination. Systemic rash 4 days later with severe itching.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Irritability, Pain
Clinical narrative: body aches / body chills / head ache / high fever / lack of appetite / irritability.  rest / hydration / small amounts of food / light activity to avoid bed sorness. all at home
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: body aches / body chills / head ache / high fever / lack of appetite / irritability.  rest / hydration / small amounts of food / light activity to avoid bed sorness. all at home
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea exertional, Fatigue, Impaired work ability
Clinical narrative: Woke up very fatigued 12/25 only minimal activity performed creating additional fatigue.  Was sleeping 12 plus hours a day without feeling rested in the least. No problems with sleep. Also had heaviness of chest - felt like rib cage made of iron- this dissipated by the 28-29th. No excessive cough or fever, did have dyspnea with any exertion and this continues but seems to be lessening. Was not able to work due to fatigue. Yesterday remained tired but felt noticeably different-felt lighter-and today seems promising.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test normal, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Woke up very fatigued 12/25 only minimal activity performed creating additional fatigue.  Was sleeping 12 plus hours a day without feeling rested in the least. No problems with sleep. Also had heaviness of chest - felt like rib cage made of iron- this dissipated by the 28-29th. No excessive cough or fever, did have dyspnea with any exertion and this continues but seems to be lessening. Was not able to work due to fatigue. Yesterday remained tired but felt noticeably different-felt lighter-and today seems promising.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Developed itchy painful rash 8 days after vaccination at injection site about 4 inches x 4 inches
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling on chin area that was filled with juvaderm 7 months ago
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Influenza virus test negative, Lymphadenopathy
Clinical narrative: enlarged lymphnodes not decreasing in size, chronic fatigue, NVDx5 days, fever, chills, general unwellness since vaccine.  Nausea and Diarrhea hasn't subsided yet and lymphnodes still enlarged.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Metabolic function test, Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: enlarged lymphnodes not decreasing in size, chronic fatigue, NVDx5 days, fever, chills, general unwellness since vaccine.  Nausea and Diarrhea hasn't subsided yet and lymphnodes still enlarged.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, White blood cell count decreased
Clinical narrative: enlarged lymphnodes not decreasing in size, chronic fatigue, NVDx5 days, fever, chills, general unwellness since vaccine.  Nausea and Diarrhea hasn't subsided yet and lymphnodes still enlarged.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein increased, Cellulitis, Differential white blood cell count
Clinical narrative: Initial swelling and soreness right after injection.  Swelling and pain continued for the next few days, Motrin 800mg and Benadryl 25mg  at bedtime were taken.  Swelling and pain persisted.  Area became hard, red, itchy and raised over the holiday.  Swelling, redness and itchiness became worse over the weeknd into Monday. I was unable to lift my arm, bring it behind my back or reach.  It was very painful and hot.   I then contacted employee health.  They did not feel it was infected but was the delayed reaction to the moderna vaccine.  I did not feel comfortable with this and I then contacted my physician who looked at it and felt it was in fact cellulitis, I was sent for a ultrasound to rule out a blood clot and labs and an IV infusion of Rocephin as well as oral antibiotics.  I received my first infusion yesterday.  The swelling has improved greatly, however the redness has spread beyond the marked area on my arm and I will be receiving another dose of IV Rocephin today.  My labs showed my CRP was elevated  and my ALT/AST were elevated as well.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Full blood count, Immediate post-injection reaction, Induration, Joint range of motion decreased
Clinical narrative: Initial swelling and soreness right after injection.  Swelling and pain continued for the next few days, Motrin 800mg and Benadryl 25mg  at bedtime were taken.  Swelling and pain persisted.  Area became hard, red, itchy and raised over the holiday.  Swelling, redness and itchiness became worse over the weeknd into Monday. I was unable to lift my arm, bring it behind my back or reach.  It was very painful and hot.   I then contacted employee health.  They did not feel it was infected but was the delayed reaction to the moderna vaccine.  I did not feel comfortable with this and I then contacted my physician who looked at it and felt it was in fact cellulitis, I was sent for a ultrasound to rule out a blood clot and labs and an IV infusion of Rocephin as well as oral antibiotics.  I received my first infusion yesterday.  The swelling has improved greatly, however the redness has spread beyond the marked area on my arm and I will be receiving another dose of IV Rocephin today.  My labs showed my CRP was elevated  and my ALT/AST were elevated as well.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: Initial swelling and soreness right after injection.  Swelling and pain continued for the next few days, Motrin 800mg and Benadryl 25mg  at bedtime were taken.  Swelling and pain persisted.  Area became hard, red, itchy and raised over the holiday.  Swelling, redness and itchiness became worse over the weeknd into Monday. I was unable to lift my arm, bring it behind my back or reach.  It was very painful and hot.   I then contacted employee health.  They did not feel it was infected but was the delayed reaction to the moderna vaccine.  I did not feel comfortable with this and I then contacted my physician who looked at it and felt it was in fact cellulitis, I was sent for a ultrasound to rule out a blood clot and labs and an IV infusion of Rocephin as well as oral antibiotics.  I received my first infusion yesterday.  The swelling has improved greatly, however the redness has spread beyond the marked area on my arm and I will be receiving another dose of IV Rocephin today.  My labs showed my CRP was elevated  and my ALT/AST were elevated as well.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Initial swelling and soreness right after injection.  Swelling and pain continued for the next few days, Motrin 800mg and Benadryl 25mg  at bedtime were taken.  Swelling and pain persisted.  Area became hard, red, itchy and raised over the holiday.  Swelling, redness and itchiness became worse over the weeknd into Monday. I was unable to lift my arm, bring it behind my back or reach.  It was very painful and hot.   I then contacted employee health.  They did not feel it was infected but was the delayed reaction to the moderna vaccine.  I did not feel comfortable with this and I then contacted my physician who looked at it and felt it was in fact cellulitis, I was sent for a ultrasound to rule out a blood clot and labs and an IV infusion of Rocephin as well as oral antibiotics.  I received my first infusion yesterday.  The swelling has improved greatly, however the redness has spread beyond the marked area on my arm and I will be receiving another dose of IV Rocephin today.  My labs showed my CRP was elevated  and my ALT/AST were elevated as well.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Swollen tongue, Tongue blistering
Clinical narrative: 99.7 fever, fatigue, swelling and painful blisters on tongue
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional AE; VARIVAX was improperly stored and administered; This spontaneous report was received from a medical assistant and refers to a 1-year-old old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-DEC-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot # T002843, expiry date 23-JAN-2022 for prophylaxis (strength and route of administration were not reported). There was no adverse event reported. Administered dose of vaccine experienced the temperature excursion of 31.6 degrees Fahrenheit for 22 days. Data logger was not involved. There were no previous excursions reported.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: interchange of vaccine products; vaccine administered outside the recommended dosing schedule; This spontaneous report was received from a pharmacist and refers to a 23 year old female patient. The patients concurrent conditions, pertinent medical history or drug reactions were not reported.   On 06-AUG-2012, at 15 years old, the patient began series with the initial dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)  (strength, lot #, expiration date, dose, route and frequency were not reported), the next doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) were administered to the patient on 08-JAN-2020 and 15-JUN-2020, both for prophylaxis at 0.5 milliliter dosage (strength, lot #, expiration date, route and frequency were not reported) (interchange of vaccine products and inappropriate schedule of product administration).
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AE; Patient was inadvertently administered an expired dose of ROTATEQ; This spontaneous report has been received from a registered nurse concerning a 7 months-old male patient. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.         On 15-DEC-2020, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 ml, Lot # S017630, expiration date 06-DEC-2020 for prophylaxis (dosage regimen was not reported).  The administered dose did not experience any temperature excursion and no additional adverse events were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Improperly stored VARIVAX was administered to the patient; This spontaneous report was received from a registered nurse and refers to a 12 month old patient, gender not reported. The patient's concurrent conditions, drug reactions or allergies and pertinent medical history were not reported.      On 21-DEC-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T000344, expiration date 05-JAN-2022 ( dose and route were not reported) for prophylaxis. The vaccine was stored at -8.5 Celsius degrees (°C) for 8 hours. The vaccine also had previous temperatures excursions at -14.1°C for 1 hour and -11.9°C for 2 hours and 30 minutes. The vaccine was reconstituted with a properly store sterile diluent (MERCK STERILE DILUENT). No additional adverse event. The call was made due to "data logger".
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQCs reported; Administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.         On 05-NOV-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) for prophylaxis, lot number reported as T015598 and expiration date as 02-NOV-2021 (dose, vaccination scheme and route of administration were not provided). No additional adverse event reported.             The vaccine had a temperature excursion of 20.5°F (degree Fahrenheit) for a time frame of 1 hour 54 minutes, and the data was recorded by a digital data logger. It was also reported a previous temperature excursion of 6°F to 14°F (12.3F) for 23 hours.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE/PQCs reported; Administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.         On 02-NOV-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) for prophylaxis, lot number reported as T015598 and expiration date as 02-NOV-2021 (dose, vaccination scheme and route of administration were not provided). No additional adverse event reported.             The vaccine had a temperature excursion of 20.5°F (degree Fahrenheit) for a time frame of 1 hour 54 minutes, and the data was recorded by a digital data logger. It was also reported a previous temperature excursion of 6°F to 14°F (12.3°F) for 23 hours.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.   This is one of several reports received from the same reporter.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEPA, HPV9, UNK, UNK
Symptoms: Product storage error
Clinical narrative: Caller reporting temperature excursion, product was administered; This spontaneous report was received from a registered nurse referring to a 14-year-old patient. The patient's pertinent concurrent conditions, medical history and concomitant medications were not reported.    On 15-DEC-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number 1637641 and expiration date reported 16-FEB-2022) and hepatitis a vaccine, inactivated (VAQTA) (lot number T013204 and reported expiration date 03-DEC-2021) both as prophylaxis at a dose of 0.5 milliliter, concentrations, vaccination scheme frequency, routes of administration and anatomical locations were not reported.  According to the reporter, the temperature excursion of both vaccines was 0.38 degrees Celsius for a time frame of four hours and 45 minutes and 11.09 degrees Celsius for 1 hour and 30 minutes on an unspecified date (product storage error), hepatitis a vaccine, inactivated (VAQTA) without any previous temperature excursion, however the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine had a previous temperature of excursion of 17.52 degrees Celsius for 2 hours and 42 minutes; which were detected by a digital data logger.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Improperly stored PROQUAD was administered to patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies or reactions or concomitant medications was not provided.  On 27-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported; lot number S021326 verified to be valid with expiration date of 05-JAN-2021). The administered dose of the vaccine experienced a temperature excursion at an unknown temperature and timeframe. It was unknown by the reporter if there were previous temperature excursion.
Age: 17.0
Sex: U
Vaccine: HEPA, HPV9, UNK, UNK
Symptoms: Product storage error
Clinical narrative: Nurse reported temperature excursion with GARDASIL 9 and VAQTA.; This spontaneous report as received from a Registered Nurse referring to a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 15-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter (strength, route, frequency, and anatomical location were unknown) with lot # 1637641 and expiration date on 16-FEB-2022; and finally with an improperly stored dose of Hepatitis A Vaccine, Inactivated(VAQTA) 0.5 milliliter (strength, route, frequency, and anatomical location were unknown) with lot # T013204 and expiration date on 03-DEC-2021 for prophylaxis.    The administered doses of vaccines experienced temperature excursion (0.38 degrees Celsius) for 4 hours and 45 minutes and (11.09 degrees Celsius) for 1 hour and 30 minutes. There was a digital data logger invloved, but no previous temperature excursion for Hepatitis A Vaccine, Inactivated(VAQTA) but there was a previous temperature excursion with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (17.52  degrees Celsius) for 2 hours and 42 minutes.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE details available at this time; Caller reported temperature excursion.; This spontaneous report was received from a registered nurse, referring to a 12-months-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 21-DEC-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T017688, which has been verified to be valid, expiration date reported and validated as 21-MAY-2022). The vaccine administered experienced a temperature excursion of -13.3 degrees Celsius (C), for a time frame of 4 hours and 15 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse events were reported.       This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013093: US-009507513-2012USA013095: US-009507513-2012USA013524: US-009507513-2012USA013539:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; Caller reported temperature excursion / Caller reported multiple administrations of product; This spontaneous report was received from a nurse, referring to a 12-month-old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported.  On 10-NOV-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T017688, expiration date: 21-MAY-2022) as prophylaxis, that experienced a temperature excursion (product storage error). No additional adverse effect (AE) information provided.  On unknown dates, the vaccine underwent a temperature excursion of minus 13.3 degrees Celsius (C) for 4 hours and 15 minutes, as recorded by a data logger. There was no previous temperature excursion.; Sender's Comments:  US-009507513-2012USA013501:
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a dentist referring to a 14-month-old Caucasian female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) 1 dosage form (route of administration, lot number and expiration date were not provided) for prophylaxis.       In December 2020 the patient experienced full body rash. On 16-DEC-2020 the patient experienced fussiness (irritability) and low-grade fever. The outcome of irritability and pyrexia was reported as recovered on that same day. The outcome of rash was unknown. The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and the events was reported as probably.
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Ophthalmic herpes zoster, Pneumonia
Clinical narrative: reoccurring pneumonia; congestive heart failure; herpes zoster dermatitis of the eyelid; Information has been received regarding a case in litigation from a lawyer and referred to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 15-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered reoccurring pneumonia resulting in multiple hospitalizations. The patient was diagnosed with pneumonia and congestive heart failure. The patient additionally suffered from and was diagnosed with herpes zoster dermatitis of the eyelid. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causality assessment between all the events and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    Upon internal review, pneumonia, congestive heart failure and herpes zoster dermatitis of the eyelid were determined to be medically significant. The lawyer considered all the events to be disability.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: varicella type rash; low-grade fever; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. In or around 28-JAN-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered a varicella type rash on her body and a low-grade fever. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events varicella type rash on her body and a low-grade fever was not recovered. The lawyer considered varicella type rash on her body and a low-grade fever to be related to zoster vaccine live (ZOSTAVAX).  The lawyer considered the events varicella type rash on her body and a low-grade fever to be disability.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cataract nuclear, Eye pain, Glaucoma, Inflammation, Migraine
Clinical narrative: glaucoma; Eye pain both eyes; burning eyes; Nuclear catarct; possible sinus problems; migraine; This case was reported by a lawyer and described the occurrence of glaucoma in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2018, the patient received Shingrix (intramuscular) .5 mg. On an unknown date, an unknown time after receiving Shingrix, the patient experienced glaucoma (serious criteria GSK medically significant) and eye pain. On an unknown date, the outcome of the glaucoma and eye pain were unknown.   It was unknown if the reporter considered the glaucoma and eye pain to be related to Shingrix.  The initial information received on 10 December 2020 via medical records. As per records the female patient was non smoker.As per records on 22 May 2018 and on 19 October 2018, she had Shingrix 50mcg injection 0.5 ml into the muscle, repeat in 2 to 6 months. On 19 February 2019, she had follow-up of ocular pain, both eyes. She described to have pain as aching and burning and stated that was an aggravating problem. This eye pain began several months ago and is symptomatic almost constantly. She states that this seems to be gradually improving. On 29 January 2019, she stated eyes have been painful since having the shingles shot. She had Ocular pain, possible sinus problems, Inflammation from shingles shot, nuclear cataract and migraine
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: glaucoma; Eye pain both eyes; burning eyes; Nuclear catarct; possible sinus problems; migraine; This case was reported by a lawyer and described the occurrence of glaucoma in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2018, the patient received Shingrix (intramuscular) .5 mg. On an unknown date, an unknown time after receiving Shingrix, the patient experienced glaucoma (serious criteria GSK medically significant) and eye pain. On an unknown date, the outcome of the glaucoma and eye pain were unknown.   It was unknown if the reporter considered the glaucoma and eye pain to be related to Shingrix.  The initial information received on 10 December 2020 via medical records. As per records the female patient was non smoker.As per records on 22 May 2018 and on 19 October 2018, she had Shingrix 50mcg injection 0.5 ml into the muscle, repeat in 2 to 6 months. On 19 February 2019, she had follow-up of ocular pain, both eyes. She described to have pain as aching and burning and stated that was an aggravating problem. This eye pain began several months ago and is symptomatic almost constantly. She states that this seems to be gradually improving. On 29 January 2019, she stated eyes have been painful since having the shingles shot. She had Ocular pain, possible sinus problems, Inflammation from shingles shot, nuclear cataract and migraine
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Muscle disorder, Tendon discomfort
Clinical narrative: shoulder pain; feels like the muscle/tendon coming off; feels like the muscle/tendon coming off; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2020). Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 14th June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, between 3 and 4 months after receiving Shingrix and less than 6 months after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced shoulder pain, tendon discomfort and muscle disorder. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the shoulder pain, tendon discomfort and muscle disorder were not recovered/not resolved.   The reporter considered the shoulder pain, tendon discomfort and muscle disorder to be possibly related to Shingrix.  Additional details were provided as follows: The patient reported himself. The reporter stated that he has received dose 1 of Shingrix (around Feb 2020) and dose 2 of Shingrix  (on 14th June 2020 as then later a flu shot.  The reporter did not have the exact dates of the shots but did provide the pharmacy's phone number so that we could obtain the dates of the injections, lot number/exp date, and confirm if they were given intramuscularly. The reporter did not specified the brand name of the flu shot.  The reporter stated the most recent Shingrix shot was given intramuscularly in the deltoid. He said it was given in the top left muscle of the arm but he was not sure if it was given intramuscularly or subcutaneously. The reporter informed that he felt like it went just into the skin but he was not sure.   A few weeks ago (almost 2 months ago) the patient begin experiencing shoulder pain. It feels like the muscle,tendon coming off, has tried using ice and massage but it has not been helping (The left arm was the arm where he received the second Shingrix shot). This has not resolved. It had been lingering, and it had been over 30 days. The reporter said he was wondering if this was due to the Shingrix shot. The reporter consented to follow up. This case was liked with case US2020236577 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236577:same reporter.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Myasthenia gravis, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; developed Myasthenia Gravis after the second Shingrix; had shingles when he received his second vaccination / he still has shingles; is very Painful; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had Shingles in February 2020) and shingles. Concurrent medical conditions included shingles.   In July 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), myasthenia gravis (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the myasthenia gravis, shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix. It was unknown if the reporter considered the myasthenia gravis to be related to Shingrix.  Additional details were reported as follows: The patient had shingles in July 2020 when he received his first vaccination of Shingrix in his right arm and still had shingles when he received his second vaccination of Shingrix in his left arm. He stated that he still had shingles, but it occurs intermittently and was very Painful.  He had been to his pharmacy, his doctor, the urgent care and the emergency room and had no relief. He developed Myasthenia Gravis after the second Shingrix dose.  This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR242160:Same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased, Laboratory test
Clinical narrative: spike in liver enzymes; This case was reported by a consumer via call center representative and described the occurrence of elevated liver enzymes in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th November 2020, 15 days after receiving Shingrix, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown.   It was unknown if the reporter considered the elevated liver enzymes to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient's blood work showed a spike in liver enzymes. The reporter consented to follow up.