chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Sensory disturbance
Clinical narrative: Patient presented for left eye watering, inability to blink, inability to raise his left elbow, and abnormal sensation in his mouth with difficulty chewing.  He has loss of forehead wrinkles on the left side with elevating his eyebrows.  He did receive his Pfizer COVID-19 vaccine 2 weeks ago.  Started noticing the abnormal sensation to his left eye on Sunday and then yesterday when he was eating he noticed the sensation to the left side of his tongue.  No difficulty swallowing, no speech impairment, no extremity weakness, no ataxia or dysarthria.  He is a diabetic and received the Pfizer vaccine.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Lethargy, Loss of consciousness, Muscle rigidity, Posture abnormal
Clinical narrative: Aprox 3 minutes after injection, rapid increase in body temp and loss of vision within 3- 10 seconds (felt like severe "head rush"), assumed loss of consciousness, pharmacy staff accounts claim patient unresponsive during 1 - 2 individual episodes of full-body convulsions/seizure within a few minutes, pharmacy staff had placed me on the floor to provide emergency treatment, staff removed outerwear and applied cold towel to head, began to regain consciousness during or immediately after application of epinephrine to right leg, I was severely confused and tired, little/no feeling in limbs, quickly became more responsive and less confused, I returned to sitting position, immediately followed up with local ER. I currently have a follow up appointment scheduled with a neurologist.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Aprox 3 minutes after injection, rapid increase in body temp and loss of vision within 3- 10 seconds (felt like severe "head rush"), assumed loss of consciousness, pharmacy staff accounts claim patient unresponsive during 1 - 2 individual episodes of full-body convulsions/seizure within a few minutes, pharmacy staff had placed me on the floor to provide emergency treatment, staff removed outerwear and applied cold towel to head, began to regain consciousness during or immediately after application of epinephrine to right leg, I was severely confused and tired, little/no feeling in limbs, quickly became more responsive and less confused, I returned to sitting position, immediately followed up with local ER. I currently have a follow up appointment scheduled with a neurologist.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Blood prolactin increased, Blood test normal, Body temperature increased, Confusional state
Clinical narrative: Aprox 3 minutes after injection, rapid increase in body temp and loss of vision within 3- 10 seconds (felt like severe "head rush"), assumed loss of consciousness, pharmacy staff accounts claim patient unresponsive during 1 - 2 individual episodes of full-body convulsions/seizure within a few minutes, pharmacy staff had placed me on the floor to provide emergency treatment, staff removed outerwear and applied cold towel to head, began to regain consciousness during or immediately after application of epinephrine to right leg, I was severely confused and tired, little/no feeling in limbs, quickly became more responsive and less confused, I returned to sitting position, immediately followed up with local ER. I currently have a follow up appointment scheduled with a neurologist.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypoaesthesia, Loss of consciousness, Seizure, Unresponsive to stimuli
Clinical narrative: Aprox 3 minutes after injection, rapid increase in body temp and loss of vision within 3- 10 seconds (felt like severe "head rush"), assumed loss of consciousness, pharmacy staff accounts claim patient unresponsive during 1 - 2 individual episodes of full-body convulsions/seizure within a few minutes, pharmacy staff had placed me on the floor to provide emergency treatment, staff removed outerwear and applied cold towel to head, began to regain consciousness during or immediately after application of epinephrine to right leg, I was severely confused and tired, little/no feeling in limbs, quickly became more responsive and less confused, I returned to sitting position, immediately followed up with local ER. I currently have a follow up appointment scheduled with a neurologist.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Death- 12 hours after vaccination
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Formication, Pruritus, Urticaria
Clinical narrative: hives, itchy eyes ,feeling like had the crawly feeling all over body ,left hand turned beet red, nurse said my lips were red and puffy
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Formication, Lip erythema, Lip swelling, Urticaria
Clinical narrative: hives, itchy eyes ,feeling like had the crawly feeling all over body ,left hand turned beet red, nurse said my lips were red and puffy
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Chills, Dysstasia, Headache, Lethargy
Clinical narrative: Patient reports within 2 mins after getting vaccinations she started feeling nausea (but did not vomit). 1 hour later she had a Headache, chills, temp went up to 99,  body aches.  After 4 hours he  bp dropped 70/50- for almost 8 hrs  Then her o2 saturation dropped - 88% RA Her HR bounced from 38 - 103 bpm In the middle of the night she got up to use to bathroom and she felt very weak was about to fall and her whole body was shaking she started feeling better the next day around 5pm (effects lasted about 30 hours).  She called her Cardiologist recommended not to get the second shot for at least three months. Her PCP recommended to not get the second dose and to call to report adverse reaction she had with the first dose.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oxygen saturation decreased, Tremor
Clinical narrative: Patient reports within 2 mins after getting vaccinations she started feeling nausea (but did not vomit). 1 hour later she had a Headache, chills, temp went up to 99,  body aches.  After 4 hours he  bp dropped 70/50- for almost 8 hrs  Then her o2 saturation dropped - 88% RA Her HR bounced from 38 - 103 bpm In the middle of the night she got up to use to bathroom and she felt very weak was about to fall and her whole body was shaking she started feeling better the next day around 5pm (effects lasted about 30 hours).  She called her Cardiologist recommended not to get the second shot for at least three months. Her PCP recommended to not get the second dose and to call to report adverse reaction she had with the first dose.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Headache, Nausea
Clinical narrative: Patient reports within 2 mins after getting vaccinations she started feeling nausea (but did not vomit). 1 hour later she had a Headache, chills, temp went up to 99,  body aches.  After 4 hours he  bp dropped 70/50- for almost 8 hrs  Then her o2 saturation dropped - 88% RA Her HR bounced from 38 - 103 bpm In the middle of the night she got up to use to bathroom and she felt very weak was about to fall and her whole body was shaking she started feeling better the next day around 5pm (effects lasted about 30 hours).  She called her Cardiologist recommended not to get the second shot for at least three months. Her PCP recommended to not get the second dose and to call to report adverse reaction she had with the first dose.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, Pain, Tremor
Clinical narrative: Patient reports within 2 mins after getting vaccinations she started feeling nausea (but did not vomit). 1 hour later she had a Headache, chills, temp went up to 99,  body aches.  After 4 hours he  bp dropped 70/50- for almost 8 hrs  Then her o2 saturation dropped - 88% RA Her HR bounced from 38 - 103 bpm In the middle of the night she got up to use to bathroom and she felt very weak was about to fall and her whole body was shaking she started feeling better the next day around 5pm (effects lasted about 30 hours).  She called her Cardiologist recommended not to get the second shot for at least three months. Her PCP recommended to not get the second dose and to call to report adverse reaction she had with the first dose.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 37 year old female (DOB: 06/06/1983) received the Moderna COVID-19 Vaccine Lot# 030A21A at the Church on 03/04/2021 @ 13:00. On 03/12/2021 morning, pt reported arm is red, raised, swollen at injection site, about the size of golf ball size, warm to touch, and the pt's temp. was 99.6F. Pt is allergic to Amoxicillin, Cefazolin, Clindamycin, and Arithromycin. Pt only takes vitamins. Pt was diagnosed with GERD, but has not taken medication for over a year. Pt had reaction to pertussis vaccine when pt was an infant, which resulted in a break out of a rash head to toe. Pt was advised to place warm compress on arm, apply hydrocortisone cream, and if symptoms worsen or do not resolve in 1-2 days to seek medical care and have arm examined. was consulted and Dr. was notified.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Reaction to previous exposure to any vaccine
Clinical narrative: 37 year old female (DOB: 06/06/1983) received the Moderna COVID-19 Vaccine Lot# 030A21A at the Church on 03/04/2021 @ 13:00. On 03/12/2021 morning, pt reported arm is red, raised, swollen at injection site, about the size of golf ball size, warm to touch, and the pt's temp. was 99.6F. Pt is allergic to Amoxicillin, Cefazolin, Clindamycin, and Arithromycin. Pt only takes vitamins. Pt was diagnosed with GERD, but has not taken medication for over a year. Pt had reaction to pertussis vaccine when pt was an infant, which resulted in a break out of a rash head to toe. Pt was advised to place warm compress on arm, apply hydrocortisone cream, and if symptoms worsen or do not resolve in 1-2 days to seek medical care and have arm examined. was consulted and Dr. was notified.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: day 1 - itching of injection site day 2- red, warm to touch circular red rash day 3-7  red warm to touch circular rash, hard lump, itchy, 5-6 cm  day 8-14 red warm to touch irregular rash , 10 cm welt, slight swelling toward elbow mottled reash Treatment:  cool compresses, Tylenol day 2-7  3-12-21 to doctor started on Zyrtec 10 mg 2x day, topical steroid fluocinonide .01 %  cream 2x day:  dicloxacillin 500 mg oral #40 cap 2x day
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: day 1 - itching of injection site day 2- red, warm to touch circular red rash day 3-7  red warm to touch circular rash, hard lump, itchy, 5-6 cm  day 8-14 red warm to touch irregular rash , 10 cm welt, slight swelling toward elbow mottled reash Treatment:  cool compresses, Tylenol day 2-7  3-12-21 to doctor started on Zyrtec 10 mg 2x day, topical steroid fluocinonide .01 %  cream 2x day:  dicloxacillin 500 mg oral #40 cap 2x day
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Urticaria
Clinical narrative: day 1 - itching of injection site day 2- red, warm to touch circular red rash day 3-7  red warm to touch circular rash, hard lump, itchy, 5-6 cm  day 8-14 red warm to touch irregular rash , 10 cm welt, slight swelling toward elbow mottled reash Treatment:  cool compresses, Tylenol day 2-7  3-12-21 to doctor started on Zyrtec 10 mg 2x day, topical steroid fluocinonide .01 %  cream 2x day:  dicloxacillin 500 mg oral #40 cap 2x day
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: This injection was not placed correctly in the deltoid muscle.  She experienced some pain and some redness.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Product administered at inappropriate site
Clinical narrative: This injection was not placed correctly in the deltoid muscle.  She experienced some pain and some redness.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Headache, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: COVID-19 breakthrough infection 2 months after second dose of Pfizer series. Symptoms include runny nose, loss of taste and smell, fatigue, and cough. Tested positive for SARS-CoV-2 via nasopharyngeal PCR swab on 3/12/21.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: COVID-19 breakthrough infection 2 months after second dose of Pfizer series. Symptoms include runny nose, loss of taste and smell, fatigue, and cough. Tested positive for SARS-CoV-2 via nasopharyngeal PCR swab on 3/12/21.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: COVID-19 breakthrough infection 2 months after second dose of Pfizer series. Symptoms include runny nose, loss of taste and smell, fatigue, and cough. Tested positive for SARS-CoV-2 via nasopharyngeal PCR swab on 3/12/21.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: Error: Booster Given Too Early
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: BEFORE  THE TIME WAS UP WAITING TO BE RELEASED AFTER THE SHOT. I STARTED TO SWEATING , JUST THOUGH IT WAS WARM IN BUILDING.  SO THEY SAID MY TIME WAS UP THAT I COULD LEAVE. MADE IT TO MY CAR OK  AND SETTING BEHIND THE WHEEL  , I TOOK A FEW SHIPS OF WATER .  THEN I TOLD MY WIFE I WAS FEELING  LIKE  I WAS GOING TO GET SICK. I TOLD HER GO GET SOME HELP AND SHE WENT BACK IN AND GOT SOME NURSES  AND THEY CAME RUNNING, BUT THE TIME THEY GOT BACK I WAS ALL READY PASSED OUT  .   THEN I THREW UP  THEY SAID . I DON'T  REMEMBER. THEY CALLED AN AMBULANCE  THEY GOT THERE  AND TOOK ME TO THE HOSPITAL EMERGENCY
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hyperhidrosis, Loss of consciousness, Malaise, Vomiting
Clinical narrative: BEFORE  THE TIME WAS UP WAITING TO BE RELEASED AFTER THE SHOT. I STARTED TO SWEATING , JUST THOUGH IT WAS WARM IN BUILDING.  SO THEY SAID MY TIME WAS UP THAT I COULD LEAVE. MADE IT TO MY CAR OK  AND SETTING BEHIND THE WHEEL  , I TOOK A FEW SHIPS OF WATER .  THEN I TOLD MY WIFE I WAS FEELING  LIKE  I WAS GOING TO GET SICK. I TOLD HER GO GET SOME HELP AND SHE WENT BACK IN AND GOT SOME NURSES  AND THEY CAME RUNNING, BUT THE TIME THEY GOT BACK I WAS ALL READY PASSED OUT  .   THEN I THREW UP  THEY SAID . I DON'T  REMEMBER. THEY CALLED AN AMBULANCE  THEY GOT THERE  AND TOOK ME TO THE HOSPITAL EMERGENCY
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Hyperhidrosis, Syncope
Clinical narrative: patient received the first dose of moderna vaccine. within 5 minutes of receiving the dose, patient reported dizziness, excessive sweating. We gave patient and ice bag to help with sweating and chills at that moment. patient was conscious during the entire event. 911 was called immediately. patient mentioned fatigue. untill  paramedic arrived, patient was comforted with just ice packs. patient started to feel better after 10 minutes  of the event. paramedics arrived and checked the vitals. patient was stable and not hospitalized due to adverse event.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: patient received the first dose of moderna vaccine. within 5 minutes of receiving the dose, patient reported dizziness, excessive sweating. We gave patient and ice bag to help with sweating and chills at that moment. patient was conscious during the entire event. 911 was called immediately. patient mentioned fatigue. untill  paramedic arrived, patient was comforted with just ice packs. patient started to feel better after 10 minutes  of the event. paramedics arrived and checked the vitals. patient was stable and not hospitalized due to adverse event.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Flushing, Muscle spasms
Clinical narrative: felt a little tightness on my chest and like a flush of heat; felt a little tightness on my chest and like a flush of heat; Felt muscle pain with cramps from my neck down to my toes; I might feel muscle pain and head ache, but instead I Felt muscle pain with cramps; hand and feet swelling; joints pain; chills; This is a spontaneous report from a contactable consumer reported herself via Pfizer sponsored program Pfizer RXPathways. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunization. Patient took the first dose of vaccine on an unknown date for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was told that she might feel muscle pain and headache, but instead she felt muscle pain with cramps from neck down to toes, hand and feet swelling, joints pain, and chills that lasted 12 hours. It has been three days after being vaccinated and patient had only felt a little tightness on my chest and like a flush of heat. The outcome of events "felt a little tightness on my chest and like a flush of heat" was unknown, the other events was recovered on an unknown date.  lot/batch number has been requested in follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: felt a little tightness on my chest and like a flush of heat; felt a little tightness on my chest and like a flush of heat; Felt muscle pain with cramps from my neck down to my toes; I might feel muscle pain and head ache, but instead I Felt muscle pain with cramps; hand and feet swelling; joints pain; chills; This is a spontaneous report from a contactable consumer reported herself via Pfizer sponsored program Pfizer RXPathways. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunization. Patient took the first dose of vaccine on an unknown date for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was told that she might feel muscle pain and headache, but instead she felt muscle pain with cramps from neck down to toes, hand and feet swelling, joints pain, and chills that lasted 12 hours. It has been three days after being vaccinated and patient had only felt a little tightness on my chest and like a flush of heat. The outcome of events "felt a little tightness on my chest and like a flush of heat" was unknown, the other events was recovered on an unknown date.  lot/batch number has been requested in follow-up.
Sex: F
Vaccine: PPV
Symptoms: Confusional state, Hypoaesthesia
Clinical narrative: had reaction to the pneumovax; Numbness in hand; Confused state; This spontaneous report has been received from a consumer via Pfizer, referring to herself, a female patient of unknown age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was not provided.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date not provided).  On an unknown date, the patient reported experiencing a reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccination complication) (did not know what kind of reaction), numbness in the right hand and finger (hypoaesthesia), and was in a confused state (confusional state). She was calling from a nursing home.  At the time of reporting, the outcome of the aforementioned events was not provided.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and vaccination complication was related. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) hypoaesthesia and confusional state was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX was administerd following a tempeature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T027301, expiring on 12-AUG-2022, 0.5 milliliter, once, for prophylaxis (route and site of administration were not reported) (product storage error).   The administered dose of the vaccine experienced a temperature excursion of -9°Celsius for 1 hours and 1 minutes. The vaccine had had a previous temperature excursion (no details provided).  There was no product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE's reported; temperature excursion involving VARIVAX.  VARIVAX was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-FEB-2021, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) 0,5ml, lot # T017681, expiring on 21-MAY-2022, for prophylaxis (dose, route and site of administration were not reported).   The administered dose of the vaccine experienced a temperature excursion of -7.4 degrees Celsius for 3 hours and 54 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; reporting a temperature excursion; This spontaneous report was received from a nurse (also reported as medical assistant) and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 05-FEB-2021, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), recombinant human albumin (rHA) (lot # S015962, expiration date: 23-MAY-2021 and with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S025608, expiration date: 18-AUG-2021); (strength, dose, frequency, route of administration and expiration date were not eported for both) both 1 dose for prophylaxis. No adverse effects were reported. According to the reporter, the temperature excursion was 16.7 degrees Fahrenheit for a time frame of 1 hour on 09-NOV-2020 (reported as 09-NOV-2021), with a previous temperature excursion 11.8 degrees Fahrenheit for a time frame of 1 hour on 06-NOV-2020 (reported as 06-NOV-2021), which was not detected by a digital dta logger.
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Geniculate ganglionitis, Odynophagia, Oropharyngeal pain
Clinical narrative: postherpetic geniculate ganglionitis: sore throat, a metallic taste in her mouth and pain in swallowing; Information has been received from a lawyer on regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or around 10-JAN-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered a sudden and severe sore throat, a metallic taste in her mouth and pain when swallowing. she was diagnosed with postherpetic geniculate ganglionitis (geniculate ganglionitis). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, her symptoms have resulted in physical limitations which were not present prior to using this vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanente and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At reporting time, pt was not recovered from geniculate ganglionitis and this event was considered to be related to zoster vaccine live (ZOSTAVAX) vaccine. Geniculate ganglionitis was considered to be a disabling event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoacusis, Post herpetic neuralgia
Clinical narrative: herpes zoster, postherpetic neuralgia and hearing problems; herpes zoster, postherpetic neuralgia and hearing problems; herpes zoster, postherpetic neuralgia and hearing problems; Information has been received regarding a case in litigation regarding a patient (pt) of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On or about 30-SEP-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, postherpetic neuralgia and hearing problems. As a result of these symptoms, the pt was seen and treated by medical providers in was still under their care. The pt symptoms resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX) product. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. The pt suffered serious, progressive, permanent (disability), and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the use of zoster vaccine live (ZOSTAVAX) the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The events were related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information. No PQC reported; Incorrect storage of drug; This spontaneous report as received from a medical assistant concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On an 03-MAR-2021, the patient was vaccinated with an improperly stored dose of   dose pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), prefilled syringe, 0.5mllliliter,  lot # T033369, expiration date: 26-MAY-2022,  for prophylaxis ((dose number, and  route of administration were not reported).     The administered dose of the vaccine experienced a temperature excursion 11 degrees Celsius  for 1 hour, as recorded by a data logger. No additional adverse evnt  information. No product quality complaint was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033369; expirationdate: 26-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Cellulitis, Lethargy, Malaise, Oropharyngeal pain
Clinical narrative: leg heaviness; fever; knee pain; cellulitis; malacia; sore throat; being lethargic; This spontaneous report was received from a consumer, a currently  70-year-old female patient reporting on herself. The patient's concurrent conditions included hypertension, blood cholesterol increased and gastrooesophageal reflux disease (GERD). She had a history of a drug reaction with unknown cholesterol medication. The patient's was under therapy with concomitant medication, but refused to provide.  On an unknown day in 1998, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, route of administration, lot # and expiration date were not reported) for pneumonia.   After vaccination on an unknown day in 1998, the patient experienced side effect of severe reaction including cellulitis, fever, knee pain, malacia, sore throat and being lethargic. The symptoms lasted for 2-3 weeks and on the same year, the patient recovered. The patient was unsure of the provider, who administered the vaccine. The patient also reported experiencing leg heaviness from taking unspecified cholesterol medication. She was unsure of the medication names. There were not laboratory tests or studies performed. The patient sought medical attention. The patient sought information on pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) ingredients in comparison to COVID-19 vaccine ingredients. No additional information was provided.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the occurrence of the events was not provided. Upon internal review, the event of cellulitis was determined to be medically significant.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: leg heaviness; fever; knee pain; cellulitis; malacia; sore throat; being lethargic; This spontaneous report was received from a consumer, a currently  70-year-old female patient reporting on herself. The patient's concurrent conditions included hypertension, blood cholesterol increased and gastrooesophageal reflux disease (GERD). She had a history of a drug reaction with unknown cholesterol medication. The patient's was under therapy with concomitant medication, but refused to provide.  On an unknown day in 1998, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, route of administration, lot # and expiration date were not reported) for pneumonia.   After vaccination on an unknown day in 1998, the patient experienced side effect of severe reaction including cellulitis, fever, knee pain, malacia, sore throat and being lethargic. The symptoms lasted for 2-3 weeks and on the same year, the patient recovered. The patient was unsure of the provider, who administered the vaccine. The patient also reported experiencing leg heaviness from taking unspecified cholesterol medication. She was unsure of the medication names. There were not laboratory tests or studies performed. The patient sought medical attention. The patient sought information on pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) ingredients in comparison to COVID-19 vaccine ingredients. No additional information was provided.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the occurrence of the events was not provided. Upon internal review, the event of cellulitis was determined to be medically significant.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Cellulitis, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: leg heaviness; fever; knee pain; cellulitis; malacia; sore throat; being lethargic; This spontaneous report was received from a consumer, a currently  70-year-old female patient reporting on herself. The patient's concurrent conditions included hypertension, blood cholesterol increased and gastrooesophageal reflux disease (GERD). She had a history of a drug reaction with unknown cholesterol medication. The patient's was under therapy with concomitant medication, but refused to provide.  On an unknown day in 1998, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, route of administration, lot # and expiration date were not reported) for pneumonia.   After vaccination on an unknown day in 1998, the patient experienced side effect of severe reaction including cellulitis, fever, knee pain, malacia, sore throat and being lethargic. The symptoms lasted for 2-3 weeks and on the same year, the patient recovered. The patient was unsure of the provider, who administered the vaccine. The patient also reported experiencing leg heaviness from taking unspecified cholesterol medication. She was unsure of the medication names. There were not laboratory tests or studies performed. The patient sought medical attention. The patient sought information on pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) ingredients in comparison to COVID-19 vaccine ingredients. No additional information was provided.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the occurrence of the events was not provided. Upon internal review, the event of cellulitis was determined to be medically significant.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: wrist pain; Top of her hand,Shooting pain up to her fingers; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-017744), license party for apixaban (ELIQUIS).  This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Top of her hand,Shooting pain up to her fingers) and ARTHRALGIA (wrist pain) in female patient of an unknown age who received apixaban (Eliquis) (batch no. 1790399) for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 immunisation. On an unknown date, the patient started Eliquis (batch no. 1790399) (unknown route). On 21-Jan-2021, the patient started Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced PAIN IN EXTREMITY (Top of her hand,Shooting pain up to her fingers) and ARTHRALGIA (wrist pain). The patient was treated with paracetamol (Tylenol Arthritis) for Pain in extremity and Wrist pain,. The action taken with Eliquis(Unknown) was unknown. At the time of the report, PAIN IN EXTREMITY and ARTHRALGIA was resolving. For Eliquis(Unknown), the reporter did not provide any causality assessments. It was reported The first one she received on 21 Jan 2021, and approximately 10 days after that, she started having wrist pain. From there, it went down to the top part of her hand and she experienced shooting pain up to her fingers. all of this is occurred in her left arm only. it did improve some because not much of the pain is in her elbow anymore, just a little bit, but the pain is still there when it hits. She does take a couple of Tylenol Arthritis. It gets very painful if she doesn't take something.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria
Clinical narrative: On Eliquis and on and off had bloody urine; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-020443), license party for apixaban (ELIQUIS).  This spontaneous case was reported by a patient family member or friend and describes the occurrence of haematuria (On Eliquis and on and off had bloody urine) in 78-year-old male patient who received apixaban (Eliquis) for Cerebrovascular accident prophylaxis. Co-Suspect Products included Covid-19 Vaccine for COVID-19 immunization. The patient's past medical history included Prostate cancer (about 10 years ago), Radiation therapy and Capillary fragility. On an unknown date, the patient started Eliquis (unknown route). On 24-Feb-2021, the patient started Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced haematuria (On Eliquis and on and off had bloody urine). The action taken with Eliquis (Unknown) was unknown. At the time of the report, haematuria resolved. Event reoccurred on 24-Feb-2021 For Eliquis (Unknown), the reporter did not provide any causality assessments. The reporter stated that the patient got the Covid vaccine the previous day, he had a history of prostate cancer from about 10 years ago and was treated by radiation, the radiation had caused capillaries in the penis to be fragile and so sometimes when he urinate, he urinate blood or little blood clots, neurologist was aware of it, cardiologist was aware of it but they did not treat it, they just waited for it to resolve itself. He was also on Eliquis for a Atrial fib so the previous day when we came home after he got the vaccine, he was bleeding with the clots and with the bloody urine which he had done in the past. He had a blood urine one hour post vaccination. She was shocked. It would take at least a few hours for the medication to get in the system before having any kind of reaction. It resolved on it's own he did not have a blood urine anymore. The second dose of the vaccine was due on 16-Mar-2021.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial Report Received on 10-Nov-2020  A nurse in the US (MA) reported to the HEPLISAV-B pregnancy registry that the "office has vaccinated a few of their pregnant patients with HEPLISAV-B but they have already delivered."  The exact number of patient or any details were not available. The reporter declined to enroll their patients in the pregnancy registry.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm with the shingles shot got red; Arm with the shingles shot got swollen; Swollen arm hurt less then the shingles patient had years ago; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included shingles (patient had shingles years ago) and shingles.   In September 2020, the patient received Shingles vaccine and Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 6 months after receiving Shingles vaccine and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm and pain in arm to be related to Shingles vaccine and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient got shingles shot and flu shot in September 2020. The arm with the shingles shot got red and swollen, but eventually it left once the doctor gave oral medication. The patient said that swollen arm hurt less than the shingles that they had years ago.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Inflammation, Pain
Clinical narrative: Inflamed area / about 3 inches in diameter; Inflamed area that is red / about 3 inches in diameter; Area that is / hot to the touch / about 3 inches in diameter; Area that is / sore / about 3 inches in diameter; This case was reported by a consumer and described the occurrence of inflammation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2021, the patient received the 2nd dose of Shingrix. On 2nd March 2021, 1 days after receiving Shingrix, the patient experienced inflammation, erythema, feeling hot and pain. On an unknown date, the outcome of the inflammation, erythema, feeling hot and pain were unknown.   It was unknown if the reporter considered the inflammation, erythema, feeling hot and pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, but was selected adult as per vaccine indication. The patient received second dose of shingrix on 1st March 2021. On 2nd March 2021, patient experienced inflammation, redness, feeling hot to touch and soreness in area about 3 inches in diameter that was located about 6"-8" inches from the injection site. No further information was reported.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Heart rate increased, Injection site pain, Pyrexia
Clinical narrative: Chills; mild fever between 98.5 and 99.5; increased pulse of a little over 100 bpm; muscle soreness - at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 31st December 2020, 3 hrs after receiving Shingrix, the patient experienced injection site muscle pain. In January 2021, the patient experienced chills, fever and pulse increased. In January 2021, the outcome of the injection site muscle pain, chills, fever and pulse increased were recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain, chills, fever and pulse increased to be related to Shingrix.  Additional details were reported as follows: The patient sated that a few hours later he experienced muscle soreness on his left arm at the injection site, which was not unusual after receiving an injection.  The reporter stated 12 hours after he experienced chills that resolved overnight, 14 hours after mild fever between 98.5 and 99.5 and an increased pulse of a little over 100 bpm.  During the day on 1st January 2021 a mild fever of pulse or minus one degree from normal and by midnight that evening all adverse reactions had resolved.  The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Neuralgia, Pain
Clinical narrative: burning nerve pain; Stomach issues; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nerve pain and stomach discomfort. On an unknown date, the outcome of the nerve pain and stomach discomfort were unknown.   The reporter considered the nerve pain and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The reporter stated that the patient on an online forum reported that he/she developed burning nerve pain and stomach issues from receiving the Shingrix vaccine. The reporter did not consent to follow up. No further information was provided. This case had been linked with US2021038319, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021038319:same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Aching of upper body; Headache; Feeling tired; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2021, the patient received the 1st dose of Shingrix (intramuscular). In February 2021, less than 2 weeks after receiving Shingrix, the patient experienced general body pain, headache and tiredness. On an unknown date, the outcome of the general body pain, headache and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, headache and tiredness to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in the left deltoid and had aching in the upper body, headache, and was feeling tired. The patient was unsure if it was because of the vaccine or a bug. Her doctor was aware of the side effects and she was awaiting a callback from the nurse. The patient gave permission to follow-up with her HCP, but she did not have HCP's email/fax to provide. The patient consented to follow up.