chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eosinophilia, Heparin-induced thrombocytopenia, Injection site cellulitis, Malaise, Mouth ulceration
Clinical narrative: a rash all over his body well not all over his body but it was on his extremities, the upper and lower extremities and on his chest; Itching; Immune allergic reaction; This is a spontaneous report from a contactable Physician (her husband). A 75-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN6205) via an unspecified route of administration in Arm Right on 05Mar2021 11:34 as single dose for covid-19 immunisation. Medical history included joint injury, prostate infection and gastrooesophageal reflux disease. Concomitant medications were not reported. Patient lab data included blood tests the few days and everything was okay with that. On an unspecified date in mar2021, the patient developed Immune allergic reaction. On 12Mar2021, the patient developed rash and itching. Caller stated that his husband got his first dose of the Pfizer Covid 19 vaccine and developed a rash and itching. His HCP diagnosed this as immune allergic reaction and asked if it is safe for him to get the second dose of the vaccine. Additional Context included, Caller says she is a doctor in private practice in psychiatry. She wanted to see she was concerned and it may not be related to the COVID vaccine but something happened to her husband that she would like to ask if they have had any other reports of this. She confirms she is calling about the Pfizer COVID 19 vaccine. Her husband got the vaccine at the (facility name) on 05Mar2021 and on the 12Mar2021 he developed a rash all over his body well not all over his body but it was on his extremities, the upper and lower extremities and on his chest. He went to see his primary care doctor. She did not know if it was something related to the vaccination or not she doesn't know but he is still suffering from the rash. Patient was prescribed a corticosteroid cream, the itching responds well but the rash in itself is still there. The outcome of the event Immune allergic reaction, and itching was unknown and rash was not resolved.; Sender's Comments: Based on the known safety profile of the vaccine, a temporal relationship between the onset of events and the administration of vaccine cannot be excluded. However, the information mentioned in the report is limited. A complete medical assessment is not possible till information about concomitant medications of patient is provided.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pulmonary embolism, Pyrexia, Rash
Clinical narrative: a rash all over his body well not all over his body but it was on his extremities, the upper and lower extremities and on his chest; Itching; Immune allergic reaction; This is a spontaneous report from a contactable Physician (her husband). A 75-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN6205) via an unspecified route of administration in Arm Right on 05Mar2021 11:34 as single dose for covid-19 immunisation. Medical history included joint injury, prostate infection and gastrooesophageal reflux disease. Concomitant medications were not reported. Patient lab data included blood tests the few days and everything was okay with that. On an unspecified date in mar2021, the patient developed Immune allergic reaction. On 12Mar2021, the patient developed rash and itching. Caller stated that his husband got his first dose of the Pfizer Covid 19 vaccine and developed a rash and itching. His HCP diagnosed this as immune allergic reaction and asked if it is safe for him to get the second dose of the vaccine. Additional Context included, Caller says she is a doctor in private practice in psychiatry. She wanted to see she was concerned and it may not be related to the COVID vaccine but something happened to her husband that she would like to ask if they have had any other reports of this. She confirms she is calling about the Pfizer COVID 19 vaccine. Her husband got the vaccine at the (facility name) on 05Mar2021 and on the 12Mar2021 he developed a rash all over his body well not all over his body but it was on his extremities, the upper and lower extremities and on his chest. He went to see his primary care doctor. She did not know if it was something related to the vaccination or not she doesn't know but he is still suffering from the rash. Patient was prescribed a corticosteroid cream, the itching responds well but the rash in itself is still there. The outcome of the event Immune allergic reaction, and itching was unknown and rash was not resolved.; Sender's Comments: Based on the known safety profile of the vaccine, a temporal relationship between the onset of events and the administration of vaccine cannot be excluded. However, the information mentioned in the report is limited. A complete medical assessment is not possible till information about concomitant medications of patient is provided.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 49-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2rpeorted as PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 17Mar2021 09:30 (lot number: EN6208) as a single dose for covid-19 immunisation. Medical history included covid-19 prior vaccination. The patient has known allergies. The patient did not receive other vaccine in four weeks. There were no concomitant medications. On 17Mar2021 09:30, the patient had anaphylaxis which resulted in a doctor or other healthcare professional office/clinic visit. The adverse event required treatment which included diphenhydramine (BENADRYL). The patient has not been COVID tested post vaccination. The outcome of the event was recovered in Mar2021.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site (arm) is killing her; sore arm; This is a spontaneous report from a contactable consumer (patient).  A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in arm, on 19Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID-19 vaccine this morning (19Mar2021). On 19Mar2021, the patient's injection site (arm) was killing her (as reported) and she was advised not to take paracetamol (TYLENOL) unless she had severe symptoms and would like to know if she can take something for her sore arm. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Diarrhoea, Drug ineffective, Headache
Clinical narrative: All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19; All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19; her temperature went up to 102 degrees; terrible joint pains; she could not stay awake at all; diarrhea; nauseousness; headache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration, administered in the left arm on 12Feb2021 08:30 as a single dose for COVID-19 immunisation. Medical history included dental care from an unknown date and unknown if ongoing. No concomitant drugs were reported. The patient previously received penicillin as prophylaxis prior to dental care. The patient previously received the first dose of BNT162b2 in Jan2021 (about 3 weeks prior to second dose) (Lot Number: unknown) via an unspecified route of administration in the upper left arm for COVID-19 immunisation. The patient was administered her second dose of BNT162b2 on 12Feb2021. She initially had no reaction. Then on 12Mar2021, (about 3 weeks after second dose of BNT162b2), the patient experienced all symptoms of COVID minus chest congestion, described as temperature went up to 102 degrees; terrible joint pains; could not stay awake at all; diarrhea; nauseousness; headache. Patient called her doctor and thought she could get COVID test, but the doctor said she does not need it and told her not to worry. They automatically diagnosed the patient with late side effects. Doctor thinks it is late side effects of BNT162b2 because there are cases where the doctor has seen 3 weeks to a month out of people having side effects. She has had no known exposure to any infected persons; She has been isolating 99 percent of the time since this started. She went out a couple of times to the store but she was masked and did not get near anyone; The patient does not know if she might have caught COVID-19 infection and wonders if with these event symptoms, she might have caught a milder case of COVID. The patient reported that right now her temperature was 99.5 degrees. She did not use any antipyretic. The patient was recovering from the event, temperature went up to 102 degrees. Outcome of the events, all symptoms of COVID minus chest congestion/does not know if she might have caught COVID-19, temperature went up to 102 degrees; terrible joint pains; could not stay awake at all; diarrhea; nauseousness; headache was unknown.   Information about lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Somnolence, Suspected COVID-19
Clinical narrative: All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19; All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19; her temperature went up to 102 degrees; terrible joint pains; she could not stay awake at all; diarrhea; nauseousness; headache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration, administered in the left arm on 12Feb2021 08:30 as a single dose for COVID-19 immunisation. Medical history included dental care from an unknown date and unknown if ongoing. No concomitant drugs were reported. The patient previously received penicillin as prophylaxis prior to dental care. The patient previously received the first dose of BNT162b2 in Jan2021 (about 3 weeks prior to second dose) (Lot Number: unknown) via an unspecified route of administration in the upper left arm for COVID-19 immunisation. The patient was administered her second dose of BNT162b2 on 12Feb2021. She initially had no reaction. Then on 12Mar2021, (about 3 weeks after second dose of BNT162b2), the patient experienced all symptoms of COVID minus chest congestion, described as temperature went up to 102 degrees; terrible joint pains; could not stay awake at all; diarrhea; nauseousness; headache. Patient called her doctor and thought she could get COVID test, but the doctor said she does not need it and told her not to worry. They automatically diagnosed the patient with late side effects. Doctor thinks it is late side effects of BNT162b2 because there are cases where the doctor has seen 3 weeks to a month out of people having side effects. She has had no known exposure to any infected persons; She has been isolating 99 percent of the time since this started. She went out a couple of times to the store but she was masked and did not get near anyone; The patient does not know if she might have caught COVID-19 infection and wonders if with these event symptoms, she might have caught a milder case of COVID. The patient reported that right now her temperature was 99.5 degrees. She did not use any antipyretic. The patient was recovering from the event, temperature went up to 102 degrees. Outcome of the events, all symptoms of COVID minus chest congestion/does not know if she might have caught COVID-19, temperature went up to 102 degrees; terrible joint pains; could not stay awake at all; diarrhea; nauseousness; headache was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself) via medial information team. A 49-year-old female patient received first dose of BNT162B2 (PFIZER COVID VACCINE, Formulation: Solution for injection, Lot number and Expiry date were not reported) via an unspecified route of administration on 20Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Mar2021, she had hives behind the neck and forehead. Caller wanted to know if she should take the second dose of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, COVID-19, Chills, Drug ineffective
Clinical narrative: covid test result=Positive; covid test result=Positive; Fever 103; chills; muscle ache; joint pain; nausea; extreme headache; injection site pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 20Jan2021 08:45 (lot number: E18982) as single dose at the age of 54 years old, for COVID-19 immunisation. Medical history included interstitial cystitis, palpitations, high cholesterol and covid-19. The patient was not pregnant at the time of vaccination. Concomitant medications included pentosan polysulfate sodium (ELMIRON), metoprolol, oxybutynin, rosuvastatin and Vit (unspecified); all taken for an unspecified indication, start and stop date were not reported. The patient previously took levaquin and experienced allergies. No other vaccines received four weeks prior to COVID vaccination. On 11Feb2021 02:30, the patient experienced fever 103, chills, muscle ache, joint pain, nausea, extreme headache, injection site pain, and tiredness. No treatment was given for these events. On 18Mar2021, the patient's COVID-19 test (nasal swab) was positive. The patient recovered from fever 103, chills, muscle ache, joint pain, nausea, extreme headache, injection site pain, and tiredness on unspecified date. Outcome of the COVID-19 test positive was unknown.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "covid test result=Positive" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: covid test result=Positive; covid test result=Positive; Fever 103; chills; muscle ache; joint pain; nausea; extreme headache; injection site pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 20Jan2021 08:45 (lot number: E18982) as single dose at the age of 54 years old, for COVID-19 immunisation. Medical history included interstitial cystitis, palpitations, high cholesterol and covid-19. The patient was not pregnant at the time of vaccination. Concomitant medications included pentosan polysulfate sodium (ELMIRON), metoprolol, oxybutynin, rosuvastatin and Vit (unspecified); all taken for an unspecified indication, start and stop date were not reported. The patient previously took levaquin and experienced allergies. No other vaccines received four weeks prior to COVID vaccination. On 11Feb2021 02:30, the patient experienced fever 103, chills, muscle ache, joint pain, nausea, extreme headache, injection site pain, and tiredness. No treatment was given for these events. On 18Mar2021, the patient's COVID-19 test (nasal swab) was positive. The patient recovered from fever 103, chills, muscle ache, joint pain, nausea, extreme headache, injection site pain, and tiredness on unspecified date. Outcome of the COVID-19 test positive was unknown.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "covid test result=Positive" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: covid test result=Positive; covid test result=Positive; Fever 103; chills; muscle ache; joint pain; nausea; extreme headache; injection site pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 20Jan2021 08:45 (lot number: E18982) as single dose at the age of 54 years old, for COVID-19 immunisation. Medical history included interstitial cystitis, palpitations, high cholesterol and covid-19. The patient was not pregnant at the time of vaccination. Concomitant medications included pentosan polysulfate sodium (ELMIRON), metoprolol, oxybutynin, rosuvastatin and Vit (unspecified); all taken for an unspecified indication, start and stop date were not reported. The patient previously took levaquin and experienced allergies. No other vaccines received four weeks prior to COVID vaccination. On 11Feb2021 02:30, the patient experienced fever 103, chills, muscle ache, joint pain, nausea, extreme headache, injection site pain, and tiredness. No treatment was given for these events. On 18Mar2021, the patient's COVID-19 test (nasal swab) was positive. The patient recovered from fever 103, chills, muscle ache, joint pain, nausea, extreme headache, injection site pain, and tiredness on unspecified date. Outcome of the COVID-19 test positive was unknown.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "covid test result=Positive" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vaccination site rash
Clinical narrative: I had headache; achiness under where got the needle.; rash under where got the needle.; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program Covax Support. A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Her second one was 27Mar2021 ("next Saturday"). The patient medical history was not reported. The patient's concomitant medication included took gamunex c every 4 weeks, last dose was received on 19Mar2021. The patient experienced headache, achiness, and a rash under where got the needle on an unspecified date. The outcome was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 13:00 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization, received in the Public Health Clinic/Veterans Administration facility. The patient received the first dose on 29Jan2021 at 01:00 for covid-19 immunization. The patient did not receive other vaccines in four weeks. Medical history included kidney transplant from 2016, ongoing hypertension, ongoing high cholesterol. The patient had no COVID prior to vaccination. The patient was not COVID tested post vaccination. Concomitant medications included anti-rejection medication, hypertension and high cholesterol medications; all ongoing. The patient experienced mild bells palsy on 13Mar2021 at 10:00. Event resulted in physician's office visit. The patient received treatment for the event which included Anti viral medication- acyclovir 800mg. Outcome of the event was recovering, almost recovered at the time of report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable pharmacist (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2), 2 doses, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.   The patient's concomitant medications were not reported. The reporter is a pharmacist who took the 2 doses of Pfizer vaccine two months ago but unfortunately, she tested positive for corona now, and was really really sick. The patient was one of the first ones to receive the vaccine because he/she believed in it ,but the patient don't think the vaccine is 95% effective as you mentioned, and it did not even decrease the disease severity by 92%. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Off label use, Product use issue
Clinical narrative: anaphylactic reaction; patient was breastfeeding when she received the first dose; patient was breastfeeding when she received the first dose; This is a spontaneous report from contactable pharmacists. These pharmacists reported information for both mother and baby. This is the mother report.   A female patient of an unspecified age received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was breastfeeding when she received the first dose and had an anaphylactic reaction. The reporter wanted to know if the patient can start breastfeeding again. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of anaphylactic reaction due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided.,Linked Report(s) : PFIZER-2021308459 baby case
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: angioedema; This is a spontaneous report from a contactable physician. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 17:15 (at the age of 43years) as single dose for Covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. No known allergies. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced "uvula/soft palate/posterior oropharynx angioedema 5 days post vaccine" on 21Mar2021 (10:00AM). The adverse event resulted in Emergency room/department or urgent care. The patient was treated with Epinephrine, Benadryl, Solu-Medrol. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the available information and on the compatibility with the product's known safety profile, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of angioedema cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Fully vaccinated and tested positive (experiencing symptoms); Fully vaccinated and tested positive (experiencing symptoms); This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for four patients. This is the second of the four reports (reporter's mother). re A female patient of an unspecified age received the first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was fully vaccinated, and then had tested positive on rapid test in Mar2021. The patient was experiencing symptoms. The outcome of the events was unknown.  Information about lot/batch number is requested.; Sender's Comments: Linked Report(s) : report number 2021308848 same reporter/product/events, different patient
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Paraesthesia, Rash
Clinical narrative: Shingles  The following Monday morning (6 days after vaccine) I started feeling pain and tingling in my back. Three days later I saw a rash and was treated for shingles. The rash is around the left side of my torso.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia, Tachycardia
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient was having tachycardia after his dose. His heart rate went up to 142. We checked his blood pressure and heart rate 3 times. His vblood pressure was niormal but heart rate was consistenly elevated. WE called 911 and they took him to er
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Head discomfort, Malaise
Clinical narrative: Pressure in the head, general feeling of being unwell, moderate abdominal cramping
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: VS X 3-  1st BP 122/90, HR 100, RR 20, SATS 98% RA; 2nd bp126/92, hr 81, RR 18, O2 SATs 98 RA; 3rd BP130/82, HR 80, RR 20, O2 SATs 98% RA. delayed syncope episode < 5 minutes after IM injection, reported dream-like feeling before fainting, confusioned but recovered quickly.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: General fatigue began at 11:20pm that night.  Severe rounds of chills and fever followed for 24 hours.  Highest fever was 102.6. Nausea, headache, and all over body ache continued through 4/3/2021. Currently it is 7am on 4/4/2021, and my shoulders hurt and the injection site is painful, red, swollen/tight, itchy,  and warm.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: General fatigue began at 11:20pm that night.  Severe rounds of chills and fever followed for 24 hours.  Highest fever was 102.6. Nausea, headache, and all over body ache continued through 4/3/2021. Currently it is 7am on 4/4/2021, and my shoulders hurt and the injection site is painful, red, swollen/tight, itchy,  and warm.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: General fatigue began at 11:20pm that night.  Severe rounds of chills and fever followed for 24 hours.  Highest fever was 102.6. Nausea, headache, and all over body ache continued through 4/3/2021. Currently it is 7am on 4/4/2021, and my shoulders hurt and the injection site is painful, red, swollen/tight, itchy,  and warm.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild, Additional Details: pt got bruise on his left arm after the second dose of moderna covid vaccine. pt will keep monitor to see if the sx is getting better. pt discussed with pcp already and advise to continue to monitor
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Pyrexia
Clinical narrative: Fever, sweating, chills and diarrhea
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient displayed anxiousness.. gave her gatorade, she laid down then sat down until she felt better
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue, joint pain (whole body) fever an headache.  Start 10 hours post vaccine, lasted about 12 hours
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Hypoaesthesia
Clinical narrative: Systemic: increased in blood pressure-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient developed numbness in left arm, blood pressure mesured and it was elevated. Patient was monitored for 30 minutes and blood pressure decreased. Patient symptoms resolved on their own.  Patient did not required medical help at time and left with family members.  Patient was counseled to visit primary care or emergency room if symptom returns.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Mild fever, headache, chills, sweating, overall body soreness
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cold sweat, Drug ineffective, Dyspnoea
Clinical narrative: had serious COVID 19 symptoms after the second shot; had serious COVID 19 symptoms after the second shot; serious trouble breathing and wheezing with every breathe; serious trouble breathing and wheezing with every breathe; severe body aches; sever chills; mild fever; cold sweats; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2, via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:15 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, covid-19 from Mar2020 to an unknown date.    Albuterol Sulfate prescribed last year.  Patient had no known allergies. There were no concomitant medications. Historical vaccination information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot EN6203 on 26Feb2021 12:15 PM in the left arm, dose number 1, for covid-19 immunisation and the patient experienced flu-like symptoms after the first shot, and those subsided within 24 hours. Achiness, chills, sore muscles and difficulty breathing. On 20Mar2021 01:00, the patient had serious COVID 19 symptoms after the second shot that have so far lasted two days, but they seem to be abating somewhat. These were as bad, if not worse from, when he had COVID-19 in Mar2020. He had serious trouble breathing and wheezing with every breathe. He used the rescue inhaler albuterol sulfate. It didn't do much good. He sat on the couch just to be able to breathe. He thought that he was going to have to call #. After 6 doses over a 5 hour span he was able to breathe a bit better. During this time, he also had severe body aches, sever chills, mild fever, and cold sweats. Outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Wheezing
Clinical narrative: had serious COVID 19 symptoms after the second shot; had serious COVID 19 symptoms after the second shot; serious trouble breathing and wheezing with every breathe; serious trouble breathing and wheezing with every breathe; severe body aches; sever chills; mild fever; cold sweats; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2, via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:15 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, covid-19 from Mar2020 to an unknown date.    Albuterol Sulfate prescribed last year.  Patient had no known allergies. There were no concomitant medications. Historical vaccination information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot EN6203 on 26Feb2021 12:15 PM in the left arm, dose number 1, for covid-19 immunisation and the patient experienced flu-like symptoms after the first shot, and those subsided within 24 hours. Achiness, chills, sore muscles and difficulty breathing. On 20Mar2021 01:00, the patient had serious COVID 19 symptoms after the second shot that have so far lasted two days, but they seem to be abating somewhat. These were as bad, if not worse from, when he had COVID-19 in Mar2020. He had serious trouble breathing and wheezing with every breathe. He used the rescue inhaler albuterol sulfate. It didn't do much good. He sat on the couch just to be able to breathe. He thought that he was going to have to call #. After 6 doses over a 5 hour span he was able to breathe a bit better. During this time, he also had severe body aches, sever chills, mild fever, and cold sweats. Outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Somnolence
Clinical narrative: Drowsiness, sore injection site
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Injection site pain, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: MILD HYPOTENSION FOR 15 MINUTES AFTER ADMINISTRATION AND NAUSEA. BP GO BACK TO NORMAL AFTER 30 MINS. OXYGEN LEVEL NORMAL. FOLLOWED UP WITH PATIENT AFTER 6 HOURS, PATIENT IS DOING FINE. JUST A SORENESS AT THE SITE OF INJECTION.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: Sore nipples.  No treatment has been sought.  Still painful on day 4.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hypotension, Seizure
Clinical narrative: Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Seizure-Severe, Additional Details: Patient expressed that he didn't like needles. Patient stated that he has gotten flu shots in the past. Immediately after administering the vaccine, patient stopped responding, his eyes bulged, and his arms tensed and both arms went up to his chest. I was calling his name and asking if he was doing okay, he kept staring straight ahead and wasn't responding. Patient eventually came to after a minute. Measured blood pressure twice &, average ~90/55. Offered patient ambulance, patient declined.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing constant hissing in the ears. Never had tinnitus prior
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site haematoma, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Systemic: large hematoma around injection site, began 4 days after vaccination-Medium, Additional Details: large hematoma on left upper arm, about 6 inches in diameter, mild pain, no swelling or itching, not raised, began approximately 4 days after vaccine was administered
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Flushing, Injection site pain, Oropharyngeal pain
Clinical narrative: Over the course of 48 hours, I experienced flu or cold like symptoms including chills, flushing in the face, aches, fatigue, and sore throat. Extreme soreness at injection site also continues 48 hours after injection.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Over the course of 48 hours, I experienced flu or cold like symptoms including chills, flushing in the face, aches, fatigue, and sore throat. Extreme soreness at injection site also continues 48 hours after injection.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint injury, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest discomfort, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Vomiting-Medium, Additional Details: Patients states she cannot lift arm more than 45 degrees, difficulty breathing secondary to chest tightness.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Joint range of motion decreased, Nausea, Pain, Vomiting
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Vomiting-Medium, Additional Details: Patients states she cannot lift arm more than 45 degrees, difficulty breathing secondary to chest tightness.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: She felt her whole left side of her face and arm was causing a tingling and numbing sensation. Patient felt better, thinks it may have been a panic attack. left store without incident.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Injection site inflammation, Myalgia
Clinical narrative: Chills! Fever, headache, lots of muscle pain,  nausea, dizziness. Most gone by 10 pm the next night. Headache lasted two days. I still have pain and inflammation at the injection site.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills! Fever, headache, lots of muscle pain,  nausea, dizziness. Most gone by 10 pm the next night. Headache lasted two days. I still have pain and inflammation at the injection site.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Dyspnoea, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain when moving arm
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Epididymitis, Lymphadenopathy, Testicular swelling
Clinical narrative: Swollen lymph node in arm pit 2 days after shot.  4 days after vaccine, swollen testicle and tube (Epididymis). It has now been 6 days since vaccine and still swollen testicle and tube.  Armpit gland swelling has gone away.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Injection site pain, Lethargy, Pain
Clinical narrative: Woke up around 4 AM the morning after the vaccine. Had pains are crossed my entire trust and felt as if I was having a heart attack. Got up I had a couple glasses of water and a couple of ibuprofen and it seem to clear up after about 30 minutes. Next day I was very lethargic and had increased stomach issues. Injection site very sore
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: pain, swelling, heat, large red rash not extending to elbow, but circumferential to inner and outer upper arm
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling, tenderness, redness in the armpit of injected arm continuing at time of report.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Strong heart palpitations for 2-3 hours starting about 8 hours after injection. As soon as the palpitations passed I got an onslaught of symptoms including fever, chills, sore muscles, weakness, headache, and light headed.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Strong heart palpitations for 2-3 hours starting about 8 hours after injection. As soon as the palpitations passed I got an onslaught of symptoms including fever, chills, sore muscles, weakness, headache, and light headed.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Severe headache, body aches, fever of 102.6, sore throat,  nausea, discomfort in chest-center right.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe headache, body aches, fever of 102.6, sore throat,  nausea, discomfort in chest-center right.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: After my first dose of vaccine earlier in March I noticed a red pimply itchy  rash on the back of my left hand that emerged a couple of days after my vaccine. It lasted a few days then went away. Several days after  my second dose the same itchy pimply red  rash we appeared on my left hand,  only worse than the first time.  I?ve had the rash for about three days now.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: she is having itchiness on her body.; This is spontaneous report from a Pfizer sponsored program Covax  Support. A contactable consumer (Patient) reported herself that a female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced itchiness on her body in Mar2021.  She was asking if she can take Benadryl. The outcome was unknown.  Information on the lot/batch number has been requested.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Myalgia, Nausea, Somnolence
Clinical narrative: Dizzy ness diarrhea nausea muscle ache drowsyness
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Influenza like illness, Pain
Clinical narrative: Flu like symptoms which include: chills, body aches, extreme fatigue, dizziness
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Extreme tinnitus, now persistsnt
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: 8 days after I got the first Moderna vaccine my arm started to hurt again (pain had been gone for 5 days) and I have an oval shaped red mark around the injection site.  It hurts, is itchy and the spot is hot.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received her first covid-19 vaccine on 18Feb2021, a week later on Feb2021 she tested positive for covid-19; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 18Feb2021, at a single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first covid-19 vaccine on 18Feb2021, a week later on Feb2021 she tested positive for covid-19. She was inquiring if she should receive the second dose. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain, Pain in extremity, Pyrexia
Clinical narrative: A few minutes after leaving from getting my shot I had a cooling sensation go through my chest. It lasted for about 5 minutes.  Around 5:30 pm that same day I became very achy, had a fever, and felt spacey at times. The body aches lasted through the night, by the morning both my arms were just sore. The spaciness cleared up, but my fever continued till about midday.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient experienced COVID-19. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive for COVID. Clinical outcome of the event COVID-19 was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Joint swelling
Clinical narrative: shoulder pain lot of shoulder pain extremely harsh joint pain; swelled up; finger was very sore like arthritis; knee weakness; This is a spontaneous report from a contactable patient. A 72 years old female patient received her first shot of the Pfizer vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. The patient reportedly experienced ailments lot of shoulder pain extremely harsh joint pain, in her arm. Her hands swelled up a little bit, her finger was very sore like arthritis, knee weakness. Ten days after the vaccination the patient still has pain in arm and shoulders Outcome of the events weakness, arthritis and joint swelling were unknown.   Information on the lot/batch number has been requested.