chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient tested positive with Covid; On 26Apr2021, the patient tested positive with Covid using rapid test; This is a spontaneous report from a contactable reporter (Patient's daughter) via Pfizer sponsored program.   The male patient (reporter's father) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on 05Apr2021, as a single dose for Covid-19 immunization. On 26Apr2021, the patient tested positive with Covid using rapid test (Covid-19 and drug ineffective). Second dose was scheduled on 29Apr2021. Caller asked if her father needs to proceed with the 2nd dose of the vaccine or has to be rescheduled. The outcome of the events was not reported.   No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Coma, Electrocardiogram
Clinical narrative: Heart stopped (15Feb2021) day after second shot; coma; This is a spontaneous report from a contactable consumer (patient).   An 85-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration (at the age of 85-years-old), administered in Arm Right on 14Feb2021 12:00 (Lot Number: E9262) as single dose for COVID-19 immunisation. Medical history included Distal dystrophy, allergies to Sulfur. The patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. Concomitant medication included citalopram, levothyroxine, vitamin D3; all taken for unspecified indications, start and stop dates were not reported. The patient previously took Plaquenil [hydroxychloroquine phosphate] and experienced allergies. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 85-years-old), administered in Arm Right on an unspecified date (Lot Number: E9269) as single dose for COVID-19 immunisation. The patient's heart stopped (15Feb2021, 04:00 PM) on the day after second shot. In ICU, induced into coma, hospitalized 6 weeks. No history of heart problems, "had EKG several weeks before 1st shot\ -v was normal." Still under doctors' care. The patient underwent lab tests and procedures which included electrocardiogram: normal on an unspecified date. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for the events for 42 days. Therapeutic measures were taken as a result of the events which included "Coded 2x, Incubated, induced coma, pacemaker." The outcome of the events was recovering. No other vaccine in four weeks. The patient was not tested for COVID post vaccination.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Catheterisation cardiac normal, Computerised tomogram normal, Electroencephalogram normal, Magnetic resonance imaging normal
Clinical narrative: Heart stopped (15Feb2021) day after second shot; coma; This is a spontaneous report from a contactable consumer (patient).   An 85-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration (at the age of 85-years-old), administered in Arm Right on 14Feb2021 12:00 (Lot Number: E9262) as single dose for COVID-19 immunisation. Medical history included Distal dystrophy, allergies to Sulfur. The patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. Concomitant medication included citalopram, levothyroxine, vitamin D3; all taken for unspecified indications, start and stop dates were not reported. The patient previously took Plaquenil [hydroxychloroquine phosphate] and experienced allergies. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 85-years-old), administered in Arm Right on an unspecified date (Lot Number: E9269) as single dose for COVID-19 immunisation. The patient's heart stopped (15Feb2021, 04:00 PM) on the day after second shot. In ICU, induced into coma, hospitalized 6 weeks. No history of heart problems, "had EKG several weeks before 1st shot\ -v was normal." Still under doctors' care. The patient underwent lab tests and procedures which included electrocardiogram: normal on an unspecified date. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for the events for 42 days. Therapeutic measures were taken as a result of the events which included "Coded 2x, Incubated, induced coma, pacemaker." The outcome of the events was recovering. No other vaccine in four weeks. The patient was not tested for COVID post vaccination.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received the second dose of bnt162b2 (Lot Number: En6203), via an unspecified route of administration, administered in right arm on an unspecified date (at the age of 25-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history included COVID prior vaccination on unspecified date. The patient had no known allergies. Concomitant medication included unspecified birth control pills. The patient previously received the first dose of bnt162b2 (Lot Number: En9581) in the right arm on 09Feb2021 at 02:00 PM (at the age of 25-year-old) as single dose for COVID-19 immunization. No other vaccine in four weeks. On 21Mar2021 at 14:00 after her second vaccine the patient had an anaphylactic reaction. It was something she had eaten before so not new to her body. It happened again on 27Apr2021. Still from things she eats normally. Both occurrences happened 30 minutes after eating and came on quickly. The event resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the event which included Benedryl, steroids, and given an epipen. The patient recovered from the event on unspecified date.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between the suspect drug and the event cannot be excluded.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis, SARS-CoV-2 test
Clinical narrative: myocarditis; Chest pain; This is a spontaneous report from a contactable Physician. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 2 intramuscular on 23Apr2021 (43-year-old  at time of vaccination) (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Patient had no prior vaccination. Patient had no known allergies. Patient previously took dose 1 of BNT162B2 (lot number: not available/provided to reporter at the time of report completion) for COVID-19 immunisationThe patient presented with chest pain found to have myocarditis on 27Apr2021. The patient was hospitalized for myocarditis and chest pain for 2 days.  Patient resulted visiting emergency room and physician office due to myocarditis. Patient had test post vaccination test which is nasal swab (COVID-19 virus test) on 27Apr2021, and the result was negative. Outcome of the event s was not recovered.  The events assessed serious as these caused hospitalization, disability and was life threatening.  Information on the lot/batch number has been requested.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Disease recurrence, Myocardial infarction, Thrombosis
Clinical narrative: blood clot in her leg; blood clot in her leg; Cardiac arrest; Heart attack; This is a spontaneous report from a contactable consumer (patient's daughter). A 96-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 29Jan2021 (Lot Number: EL9265) as SINGLE DOSE for COVID-19 immunization. Medical history included blood clots in her legs from an unknown date and unknown if ongoing , diabetec, bone infection, surgery and anemic; all from an unknown date and unknown if ongoing; and a family history of gangrene from an unknown date and unknown if ongoing of her mother. Concomitant medications included apixaban (ELIQUIS) taken as blood thinner and furosemide (FUROSEMIDE) taken for an unspecified indication; both start and stop date were not reported. The patient previously had BNT162B2 (Lot Number: EL1283) dose 1 on 08Jan2021 for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, the patient died due to a heart attack and cardiac arrest. The patient developed a blood clot in her leg and had to have her leg taken off. The date of surgery was 05Feb2021, not early Mar2021 like was originally stated at the hospital. The patient was admitted either on 01Feb2021 or 02Feb2021 and discharged on 23Feb2021. They had a bunch of bad weather and then they put the patient in the nursing facility for about a month and when she was brought home she had a heart attack and died due to cardiac arrest. She doesn't know about the blood clot and this being related to the COVID vaccines but the patient had surgery a week after she had her second shot. The heart attack was on 15Mar2021. The patient had a history of blood clots in her legs before and she had problems with that so that might of made it worse but she doesn't know for sure. The patient died on 15Mar2021.  An autopsy was not performed. The outcome of the event blood clot in her leg was unknown.  No follow-up attempts are possible; information about lot/batch number has been obtained.; Reported Cause(s) of Death: heart attack; cardiac arrest
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic stroke
Clinical narrative: hemorrhage stroke; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable nurse. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history included CVA. The patient's concomitant medication included oral clopidogrel bisulfate (PLAVIX) for CVA at 25 mg, 1x/day (25 mg once everyday). It was reported that a patient who had the Covid vaccine, 3 days later the patient had hemorrhage and she passed away. It was clarified that patient had a hemorrhage stroke and passed away. The reporter did not know the date the patient passed away, but this was called on the office on 16Apr2021. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, a causal association between the reported hemorrhagic stroke and the suspect drug, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  cannot be completely excluded. Of note, patient has a medical history of CVA. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: hemorrhage stroke
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted; This is a spontaneous report from a contactable consumer (patient). A 28 year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 28Mar2021 (at the age of 27 years old) as a single dose for covid-19 immunization. The patient's medical history was not reported.  Patient was not pregnant at the time of vaccination and the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies of any kind. The patient had no concomitant medications. Patient was not taking any medications/supplements. Patient had no other vaccine in four weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was in a pharmacy or drug store. Patient fainted on an unspecified date in 2021 after her first dose. No treatment was received in response to the event. Since the vaccination, the patient was not tested for COVID-19. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: DTAP
Symptoms: Amniotic cavity infection, Exposure during pregnancy
Clinical narrative: chorioamnionitis; vaccine exposure during pregnancy; Initial unsolicited report received from literature on 18 June 2015.   This case is linked to case ID's: 2015SA090249, 2015SA090258, 2015SA090259, 2015SA090260, 2015SA090261, 2015SA090262. (Same literature, reporter and event)   This case involves five pregnant female patients (age unspecified) who had chorioamnionitis (amniotic cavity infection), after they received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [TDAP] (exposure during pregnancy).  Data regarding this pregnancy were received prospectively.    The last menstrual period and estimated date of delivery was not reported.   Gestation period at exposure was unknown.  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patients received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) [lot number, expiry date were not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patients developed a serious chorioamnionitis (amniotic cavity infection), (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant.  It was also a case of vaccine exposure during pregnancy. (Latency: on the same day of vaccination)   It was not reported if the patients received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.   There will be no information available on the batch number for this case.  Follow up information received on 19-Apr-2021 regarding an unsolicited valid serious case received from other healthcare professional via health authorities (under reference number: 583520 and US-SA-2015SA090257).  Event exposure during pregnancy updated as diagnosis from symptom. Report type of the case updated (unsolicited literature to unsolicited non-literature), listedness updated, seriousness for event exposure during pregnancy updated (serious to non-serious) and complete narrative updated accordingly.; Sender's Comments: Follow-up information was received on 19-Apr-2021 changes the previous assessment of the case: This case involved five pregnant female patients (age unspecified) who had exposure during pregnancy and amniotic cavity infection after the administration of TDAP vaccine. Time of onset was unknown for amniotic cavity infection and compatible for exposure during pregnancy. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Amniotic cavity infection, Exposure during pregnancy
Clinical narrative: chorioamnionitis/amniotic cavity infection; vaccine exposure during pregnancy; Initial unsolicited literature report received from a healthcare professional on 18 June 2015.   This case is linked to: 2015SA090249, 2015SA090258, 2015SA090259, 2015SA090257, 2015SA090261, 2015SA090262. (Same literature, reporter and event)   This case involves 2 female patients who experienced chorioamnionitis/amniotic cavity infection (amniotic cavity infection), after they received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and INFLUENZA VACCINE. while they were pregnant.  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  It was no reported if patients had previous pregnancy.  On an unknown date, the patients each received a dose DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) and INFLUENZA VACCINE (produced by unknown manufacturer) (batch number, frequency, dosing details and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patients developed a serious amniotic cavity infection/chorioamnionitis (amniotic cavity infection), (unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and INFLUENZA VACCINE. This event was assessed as medically significant.  Pregnancy exposure timing was unknown.  It was also a case of vaccine exposure during pregnancy (latency same day).  Laboratory investigations and corrective treatments were not reported.   The outcome of the pregnancy is unknown.  At time of reporting, the patients were recovering from the event amniotic cavity infection.  Follow up information received on 19-Apr-2021 regarding an unsolicited valid serious case received from the other health care professional.  The outcome for event amniotic cavity infection was updated from unknown to recovering.  Report type was updated to Unsolicited non-literature  Seriousness for event exposure during pregnancy updated (serious to non serious) and listedness updated.; Sender's Comments: This case concerns a 2 female patients who experienced amniotic cavity infection and exposure during pregnancy, after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (unknown manufacturer) and INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patient's medical history, concomitant medication, medical condition at time of vaccination and other lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed. US-SA-2015SA090249:CLUSTER US-SA-2015SA090257:CLUSTER US-SA-2015SA090258:CLUSTER US-SA-2015SA090259:CLUSTER US-SA-2015SA090261:CLUSTER US-SA-2015SA090262:CLUSTER
Sex: F
Vaccine: DTAP, HPVX
Symptoms: Amniotic cavity infection, Exposure during pregnancy
Clinical narrative: chorioamnionitis; patient was pregnant during vaccination; Initial unsolicited literature report received from a healthcare professional on 18 June 2015.   This case is linked to case ID's: 2015SA090249, 2015SA090258, 2015SA090259, 2015SA090257, 2015SA090260 ,2015SA090262. (same literature, reporter and event).  This case involves a pregnant female patient (age not reported) who experienced chorioamnionitis (amniotic cavity infection), after she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and HUMAN PAPILLOMA VACCINE (HPV4) (exposure during pregnancy).  Data regarding this pregnancy were received prospectively.   The date of last menstrual period was not reported. Gestation period was unknown  The estimated due date was not reported.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date not reported) and a  dose of suspect HUMAN PAPILLOMA VACCINE not produced by Sanofi Pasteur (lot number and expiry date not reported) both via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious chorioamnionitis (amniotic cavity infection) (unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and HUMAN PAPILLOMA VACCINE. This event was assessed as medically significant.  It was a case of vaccine exposure during pregnancy (latency same day).   Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  Pregnancy outcome was unknown at the time of report.  The event outcome was unknown for chorioamnionitis.  Batch number has been requested for suspect product for this case.  Follow up information received on 19-Apr-2021 regarding an unsolicited valid serious case received from other healthcare professional via health authorities (under reference number: 583525).  Report type of the case updated (unsolicited literature to unsolicited non-literature), seriousness for event exposure during pregnancy updated (serious to non serious) and narrative updated accordingly; Sender's Comments: This case concerns a pregnant female patient (age not reported) who presented with chorioamnionitis after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (unknown manufacturer) and HUMAN PAPILLOMA VACCINE (other manufacturer). The time to onset was unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed. US-SA-2015SA090249:CLUSTER US-SA-2015SA090257:CLUSTER US-SA-2015SA090258:CLUSTER US-SA-2015SA090259:CLUSTER US-SA-2015SA090260:CLUSTER US-SA-2015SA090262:CLUSTER
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: I have type 1 diabetes. Blood sugar raised to 250 about 2 hours after injection and stayed that high for about 18 hours even with corrective insulin given. (This only happened after the first dose)
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Eye pain, Eye pruritus, Hypoaesthesia
Clinical narrative: After the COVID vaccine, it started numbness in hand fingers while sleeping, slowly, slowly and day by day it become more. Last four days I could not able to sleep, whole body getting numb while sleeping, and it getting all blood to the hands, legs and hand figures, foot fingers are becoming numb.   And also getting pains in the bone joints, specially in fingers. Getting Itchy, eye pain due to no sleep. Some one should call and provide remedy immediately, otherwise I may die, this responsible is control organization. This I am entering at May 4th 2:00AM CST.  I already registered online, no responded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Gait disturbance
Clinical narrative: Shivering and chills despite being 11c outdoors and being inside and in pajamas and under a duvet. Strong muscle spasm cramping in calves, made it difficult to walk to get even get water. Very sore arm, could not lift, and strong fatigue GI issues (slight diarrhea clumps but not many)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Limb immobilisation, Muscle spasms, Pain in extremity
Clinical narrative: Shivering and chills despite being 11c outdoors and being inside and in pajamas and under a duvet. Strong muscle spasm cramping in calves, made it difficult to walk to get even get water. Very sore arm, could not lift, and strong fatigue GI issues (slight diarrhea clumps but not many)
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: For around 5-minute duration: - Stomach knot - Sudden strong sweating in the upper part of my body including my forehead, felt very hot - Dizziness  Never experienced such symptoms before in my life
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: I skip period on birth control pills for half a year now, so I don?t get my period at all. After the first dose, I?ve been spotting everyday. It?s not a lot that I need a pad. It?s enough whenever I wipe after peeing, I see a little spot of blood. After the second dose, the spotting continues but start to become heavier. A week later after second dose, the spotting is a bit heavier that I need to wear a panty liner.  This spotting been going for a month now since my first dose.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Chills during the middle of the night and constant nausea
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Nasal discomfort, Pharyngeal swelling, Pyrexia
Clinical narrative: Fever of 102 - from about hour 18 to hour 24 it was the worst. It broke at 39 hours. Sweat in bed. Fatigue, from about hour 4 to hour 39 after the shot, I felt completely drained. Swelling of the throat and sinus passages. A full 74 hours later so I don?t know if it?s related or if it is some allergy outside.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Intense headache lasting for sixteen days which did not respond to any medication(s)
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Somnolence
Clinical narrative: Flu-like symptoms for 48 hours, extreme fatigue and sleepiness for 3 weeks post-vaccine
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Cough, Fatigue, Pain
Clinical narrative: Patient developed COVID.  Symptoms of  loss of smell, bodyaches, cough, fatigue and congestion started on 4/30/21.  She denies covid exposure, but reports that her child was exposed to covid positive person.  She tested negative for covid on 5/1, symptoms worsened, she was retested on 5/3 and found to be positive for COVID.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Patient developed COVID.  Symptoms of  loss of smell, bodyaches, cough, fatigue and congestion started on 4/30/21.  She denies covid exposure, but reports that her child was exposed to covid positive person.  She tested negative for covid on 5/1, symptoms worsened, she was retested on 5/3 and found to be positive for COVID.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: Cough and allergy type symptoms
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Vomiting projectile
Clinical narrative: Projectile vomitting, headache, chills Sore throat from the intensity of the vomitting.  I usually cannot and do not vomit
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pyrexia
Clinical narrative: Fever Shortness of Breath cough
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Asthenia, Chills, Cold sweat, Decreased appetite
Clinical narrative: Day 1 ? sore arm, fatigue, headache Day 2 ? fever, chills, nausea, dizziness, extreme fatigue (weakness), much lighter period than normal (period had just started when I got the shot and is always very heavy), headache Day 3 ? clammy, intermittent fever, fatigue (weakness), lack of appetite, lighter than normal period, sleeplessness, headache Day 4 ? weak,  tired, lighter than normal period, sleepless , strange dreams, headache ongoing but returning to normal
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Insomnia, Menstrual disorder
Clinical narrative: Day 1 ? sore arm, fatigue, headache Day 2 ? fever, chills, nausea, dizziness, extreme fatigue (weakness), much lighter period than normal (period had just started when I got the shot and is always very heavy), headache Day 3 ? clammy, intermittent fever, fatigue (weakness), lack of appetite, lighter than normal period, sleeplessness, headache Day 4 ? weak,  tired, lighter than normal period, sleepless , strange dreams, headache ongoing but returning to normal
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Day 1 ? sore arm, fatigue, headache Day 2 ? fever, chills, nausea, dizziness, extreme fatigue (weakness), much lighter period than normal (period had just started when I got the shot and is always very heavy), headache Day 3 ? clammy, intermittent fever, fatigue (weakness), lack of appetite, lighter than normal period, sleeplessness, headache Day 4 ? weak,  tired, lighter than normal period, sleepless , strange dreams, headache ongoing but returning to normal
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue, Headache
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: May treat fevers and body aches with Tylenol or Motrin Please keep well hydrated May use hot tea with lemon and honey or gargle warm salt water for sore throat if desired for symptomatic relief May use saline nasal spray for congestion
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Productive cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: Patient states that he has a lump of productive cough after getting the first Covid vaccine on April 13 and developed fevers in 12 hours and has been having fever, fatigue and generalized body aches since that time.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: Moderna COVID-19 Vaccine EUA. Headache; fatigue; muscle & body ache; shortness of breath; chills. Duration 48 hours.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Moderna COVID-19 Vaccine EUA. Headache; fatigue; muscle & body ache; shortness of breath; chills. Duration 48 hours.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Feeling cold, Headache, Nausea
Clinical narrative: I received the vaccine with no issues, within a few hours i experienced a minor headache. I went to class and woke up the next morning cold. I couldn?t get out of bed, I was weak, Nauseous, head was pounding. I was brought 800mg of ibroprofen and a thermometer. I temperature was a 103.7. I monitored my temperature all day long. My fever broke around noon, still sick. Around 3:00pm it returned at a 100.6. I went to bed for the day with the fever after taking more ibroprofen later that day and woke the next morning with a headache but other than that without symptoms. On today (May 4th) I still have a headache, but without symptom.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pyrexia, SARS-CoV-2 test, Sneezing
Clinical narrative: Fever, cough, fatigue and sneezing
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye discharge, Eye pain, Headache, Migraine
Clinical narrative: Joint pain, skin pain, muscle pain, fever, headache, migraine, eye pain, eye discharge, vaginal discharge
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain of skin, Pyrexia, Vaginal discharge
Clinical narrative: Joint pain, skin pain, muscle pain, fever, headache, migraine, eye pain, eye discharge, vaginal discharge
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hyperhidrosis, Injection site erythema, Injection site warmth
Clinical narrative: Extreme fatigue for 48 hours, low-grade fever for 8 hours (99.9°), profuse sweating for 6 hours beginning 55 hours after the shot. Reduced endurance after 72 hours, shot site felt warm and was slightly red for a week.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue for 48 hours, low-grade fever for 8 hours (99.9°), profuse sweating for 6 hours beginning 55 hours after the shot. Reduced endurance after 72 hours, shot site felt warm and was slightly red for a week.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Throat feels itchy  115/77, HR 88, O2Sat 98%
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Violent shaking chills, 104 fever, vomiting, body aches. All of these symptoms lasted over 48 hours.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: 36 hours of extreme fatigue (sleeping for 12 hours a day). On 04/25/2021, body aches started and lasted for about 6-8 hours
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported; a temperature excursion on VAQTA that was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies. On 22-APR-2021, the patient received one improperly stored dose of hepatitis a vaccine, inactivated (VAQTA), lot # T023913 and expiration date 31-MAR-2022 for prophylaxis (dose was reported as 1 time dose; anatomical location and route of administration were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion of above 47 degrees Fahrenheit (48.2 degrees Fahrenheit) for 2 hours. No data logger was involved. There were no previous excursions reported. No signs or symptoms were reported. This is one of several reports received from the same reporter. Combination product report: Yes; Brand Name: VAQTA SYRINGE (DEVICE); Common Device Name: Hepatitis A Vaccine, Inactivated; Product Code: FMF; Device Type: SYRINGE, PISTON (FMF); Device lot number: T023913; Expiration date: 31-MAR-2022; Device age and unit: 0 ; Malfunction: Unknown; Device usage: Initial; Reason for non eval: 81 Other; Labeled single use device: No; mdc pre-portability: No; mdc pre-rationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007215.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion on VARlVAX.; This spontaneous report was received from a medical assistant referring to a 14 month old patient of unknown gender. The patient's concomitant medication, pertinent medical history, and drug reactions/allergies were not provided.   On 08-APR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength and dose were not provided; lot# was T021826 and expiration date was 25-JUN-2022) involved in temperature excursion for prophylaxis (product storage error). No additional adverse event (AE) was reported.   The administered dose experienced temperature excursions from - 58 degree Fahrenheit to + 5 degree Fahrenheit for 6 hours 0 minutes 30 seconds and - 58 degree Fahrenheit to + 5 degree Fahrenheit for 0 hours 7 minutes 30 seconds. There was previous temperature excursion. It was detected by a data logger.; Sender's Comments:  US-009507513-2104USA008022: US-009507513-2104USA008081: US-009507513-2104USA008255: US-009507513-2104USA008342:
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Dermatitis contact, Post herpetic neuralgia
Clinical narrative: contact dermatitis; balance problems; postherpetic neuralgia; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. Patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiry date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), patient suffered of contact dermatitis, balance problems and, postherpetic neuralgia. As a result of these symptoms, patient was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experience 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), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, 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 company's conduct, patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The events of contact dermatitis, balance problems and, postherpetic neuralgia  were considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This case was reported by a physician via  call center representative and described the occurrence of headache in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had headaches and fatigue after vaccination. The reporter described the headaches and fatigue had not gotten any better or worse since they began. The reporter did not provide demographics for the patient and did not had lot number or expiration date of dose of Shingrix. The reporter consented to follow up. No additional information was provided. For tolerance with 2nd dose refer case US2021094723. This is 1 of 4 cases reported by the same reporter.  Note-It was not clear from narrative that the patient experienced event after which dose 1st or 2nd or both hence as conservative approach 1st dose case was kept valid.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094723:case for husband,same patient, same reporter 2nd dose US-GLAXOSMITHKLINE-US2021094725:same reporter, different patient, wife case US-GLAXOSMITHKLINE-US2021094721:same reporter, different patient, wife case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have them and had the shot years ago/ suspected vaccination failure; I have them and had the shot years ago; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient had shingles and had received the shot years ago. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Me / have got Shjngles after being vaccinated / Suspected Vaccination Failure; Me / have got Shjngles after being vaccinated; Can still my shingle "rash" areas; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated that he/she had got shingles after being vaccinated. The patient did not get it as bad. The patient had no open soars, but after 3 years could still his/her shingle rash areas. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. This case has been linked with US2021AMR095125, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR095125:Same reporter. Master case -Others-.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Others have got Shjngles after being vaccinated / Suspected Vaccination Failure; Others have got Shjngles after being vaccinated; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the patients got shingles after being vaccinated with Shingles vaccine. The patients did not get it as bad.  This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. This case had been linked with case US2021AMR095110, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR095110:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I was vaccinated and still got Shingles, suspected vaccination failure; still got Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  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 was vaccinated with Shingles vaccine but still got shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Horrible even after getting vaccine shot ?? / Suspected vaccination failure; Horrible even after getting vaccine shot ??; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination which was horrible. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting. This case had been linked with case US2021AMR073595, as reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Somnolence
Clinical narrative: Headache / experienced headache; Body aches; Tiredness; has been having to take a nap during the day since the vaccination; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on an unknown date and experienced headache and fatigue, tolerance of 1st dose refer case US2021094725). Concomitant products included COVID 19 VACCINE.   On 13th April 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th April 2021, less than a day after receiving Shingrix, the patient experienced headache, general body pain, tiredness and daytime sleepiness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, general body pain and tiredness were not recovered/not resolved and the outcome of the daytime sleepiness was unknown.   The reporter considered the headache, general body pain, tiredness and daytime sleepiness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and later that same day, she experienced headache, body aches and tiredness.  She stated, she had been taking a nap during the day since the vaccination. These symptoms were ongoing and had not yet resolved. She followed up with her health care provider (HCP). The physician also reported about this patient as she experienced headaches and fatigue after receiving Shingrix.  The HCP did not have lot number or expiration date of doses of Shingrix. The HCP described the headaches and fatigue had not gotten any better or worse since they began.  The HCP noted that, 14 days before dose two of Shingrix, the patient had received Covid vaccine.  No additional information was provided. The reporter consented to follow up. This is 1 of 4 cases reported by the the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094723:same reporter (husband case) US-GLAXOSMITHKLINE-US2021AMR095072:husband case US-GLAXOSMITHKLINE-US2021094725:same reporter