chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Dysarthria, Hemiparesis
Clinical narrative: Pt had slurred speech and left-sided weakness day after vaccine he presented to ER and appears to have CVA
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Dysphagia, Gait inability, Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: Pt had slurred speech and left-sided weakness day after vaccine he presented to ER and appears to have CVA
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever, rigor, headache, body ache 6 days post vaccination
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Severe headache, muscle and body aches
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: A red rash on injection arm that has not gone away and a red rash that showed up on my neck, back and chest that comes and goes.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Cellulitis-like patch couple an inch or so below injection site. Warm, taut, and red puffy skin
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: tested positive both with a rapid and standard test; tested positive both with a rapid and standard test; This is a spontaneous report from contactable consumer. A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who was in a nursing home received the vaccine first dose on 04Jan2021. On 10Jan2021, he tested positive both with a rapid and standard test. His fever at the highest was 100.3 and he had chills and a cough but that's all gone now. Thought maybe it's because he received the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received the 1st dose on 01Dec2020 and tested positive for COVID on 15Dec2020 but was asymptomatic.; received the 1st dose on 01Dec2020 and tested positive for COVID on 15Dec2020 but was asymptomatic.; This is a spontaneous report from a contactable other healthcare professional reported that 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 01Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The reporter was asking what the recommendations are for the administration of the 2nd dose for a patient who received the 1st dose on 01Dec2020 and tested positive for COVID on 15Dec2020 but was asymptomatic. She missed the dosing window of the 2nd dose scheduled on 30Dec2020 due to quarantine. Caller mentioned that patient is recovered and is back to work. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Dec2020.  Information about lot/batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Muscular weakness, Pain, Pain in extremity
Clinical narrative: lethargic, headache, generalized body ache , arm weakness, arm pain swollen and painful
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: lethargic, headache, generalized body ache , arm weakness, arm pain swollen and painful
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Headache, Muscle spasms, Nausea
Clinical narrative: cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient) and another consumer. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: 30Apr2021), intramuscular (right arm) on 11Jan2021 (around 1:10-1:30pm) at single dose for Covid-19 immunization. The patient received the first dose of COVID Vaccine (BNT162B2, lot number: EK5730, expiration date: 31Mar2021) on 21Dec2020, intramuscular (right arm) for Covid-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021, the patient experienced nausea, some vomiting which has subsided, diarrhea, headache and body aches. The patient also stated that she woke up at 3 a.m. this morning (12Jan2021) vomiting. She vomited for about an hour and half. The vomiting has subsided and now she is just nauseated. The diarrhea initially began about 7:30 a.m. She had 3 bowel movements and she hasn't had a movement since about 8:30. She still has cramping but nothing else. The body aches started within last half hour or so. The headache has been the entire time since 3 a.m., starting when the vomiting occurred. The vomiting was more important at that moment, but she knows her head hurting at the time. The patient verified it was her second COVID vaccine. She received the vaccine yesterday (11Jan2021), between 1:10-1:30p.m. The patient reported that she did have bloodwork, but not in regard to the COVID vaccine. She had bloodwork done Monday, 04Jan2021. The outcome of vomiting was recovering; outcome of event cramping was unknown; while the outcome of other events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient) and another consumer. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: 30Apr2021), intramuscular (right arm) on 11Jan2021 (around 1:10-1:30pm) at single dose for Covid-19 immunization. The patient received the first dose of COVID Vaccine (BNT162B2, lot number: EK5730, expiration date: 31Mar2021) on 21Dec2020, intramuscular (right arm) for Covid-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021, the patient experienced nausea, some vomiting which has subsided, diarrhea, headache and body aches. The patient also stated that she woke up at 3 a.m. this morning (12Jan2021) vomiting. She vomited for about an hour and half. The vomiting has subsided and now she is just nauseated. The diarrhea initially began about 7:30 a.m. She had 3 bowel movements and she hasn't had a movement since about 8:30. She still has cramping but nothing else. The body aches started within last half hour or so. The headache has been the entire time since 3 a.m., starting when the vomiting occurred. The vomiting was more important at that moment, but she knows her head hurting at the time. The patient verified it was her second COVID vaccine. She received the vaccine yesterday (11Jan2021), between 1:10-1:30p.m. The patient reported that she did have bloodwork, but not in regard to the COVID vaccine. She had bloodwork done Monday, 04Jan2021. The outcome of vomiting was recovering; outcome of event cramping was unknown; while the outcome of other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: "symptoms"/tested positive for covid; "symptoms"/tested positive for covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 76 with no unit) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if she should get her second dose of vaccine on 25Jan2021, after receiving the first dose on 04Jan2021 and having symptoms and testing positive for COVID on 08Jan2021. The patient continued to have symptoms (unspecified) at the time of report. The patient was taking Tylenol for the symptoms. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Moderna COVID-19 Vaccine EUA Red, itchy, hot rash at injection site 9 days after the vaccine was given.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old female patient received (not pregnant) her first dose of bnt162b2 (BNT162B2 also reported as Covid 19brand Pfizer BioNTech, lot EJ1685), intramuscular in the left arm 22Dec2020 10:00 at SINGLE DOSE for Covid-19 immunisation. She received the vaccine in a hospital. Medical history included covid prior vaccination: Yes. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced chills, low grade fever, body aches, headache " brain fog" on 23Dec2020 01:00. No treatment was given. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cough, Dizziness, Fatigue
Clinical narrative: Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint pain; Cough; feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 09Jan2021 11:00 at single dose for Covid-19 immunization. Medical history included asthma and hypertension. The patient received an unspecified medication in two weeks. The patient previously took codeine and experienced allergy. 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 pulsating headaches, blurry vision, nausea, 102.2 fever, body aches, hand tremors, dizziness, joint pain, cough, and feeling of exhaustion on 09Jan2021 (12:00 PM). There was no treatment received for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint pain; Cough; feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 09Jan2021 11:00 at single dose for Covid-19 immunization. Medical history included asthma and hypertension. The patient received an unspecified medication in two weeks. The patient previously took codeine and experienced allergy. 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 pulsating headaches, blurry vision, nausea, 102.2 fever, body aches, hand tremors, dizziness, joint pain, cough, and feeling of exhaustion on 09Jan2021 (12:00 PM). There was no treatment received for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint pain; Cough; feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 09Jan2021 11:00 at single dose for Covid-19 immunization. Medical history included asthma and hypertension. The patient received an unspecified medication in two weeks. The patient previously took codeine and experienced allergy. 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 pulsating headaches, blurry vision, nausea, 102.2 fever, body aches, hand tremors, dizziness, joint pain, cough, and feeling of exhaustion on 09Jan2021 (12:00 PM). There was no treatment received for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness even while sitting, light to moderate
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, X-ray
Clinical narrative: Left leg numbness; This is a spontaneous report from a contactable nurse (patient). A 57-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), intramuscular (left arm) on 23Dec2020 at 15:00 at a single dose for COVID-19 immunization. Medical history was not reported. The patient had no known allergies (NKA). The patient had no COVID prior vaccination. The patient is not pregnant. Concomitant medications included unspecified medications administered in two weeks; no other vaccines received in four weeks. The patient experienced left leg numbness on 25Dec2020 at 16:00. Treatment done for the event included tests and procedures which included magnetic resonance imaging (MRI) and X-ray-both with unknown results on an unknown date. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not tested post vaccination. The event was resolving.   No follow up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash on upper arm near vaccination site a week after shot was administered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival erythema, Gingival swelling, Lip swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: lymph nodes in neck swollen/tender; lymph nodes in neck swollen/tender; Swelling of lips; gums red and swollen; gums red and swollen; soft palate; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 07Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included hyperthyroidism, menopause and COVID prior vaccination. The patient is not pregnant. Concomitant medications included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), dexamethasone (DEXAMETHASONE), methimazole (METHIMAZOLE), estrogens conjugated (PREMARIN), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE]), azithromycin (Z-PAK), and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient had no other vaccine in four weeks. The patient previously took Erythromycin (EES) and Levaquin and experienced allergies. The patient experienced swelling of lips, gums red and swollen, soft palate, lymph nodes in neck swollen/tender on 08Jan2021 at 10:00. The patient had not tested for COVID post-vaccination. No treatment was administered for the events. The events had not resolved.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Palatal disorder
Clinical narrative: lymph nodes in neck swollen/tender; lymph nodes in neck swollen/tender; Swelling of lips; gums red and swollen; gums red and swollen; soft palate; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 07Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included hyperthyroidism, menopause and COVID prior vaccination. The patient is not pregnant. Concomitant medications included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), dexamethasone (DEXAMETHASONE), methimazole (METHIMAZOLE), estrogens conjugated (PREMARIN), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE]), azithromycin (Z-PAK), and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient had no other vaccine in four weeks. The patient previously took Erythromycin (EES) and Levaquin and experienced allergies. The patient experienced swelling of lips, gums red and swollen, soft palate, lymph nodes in neck swollen/tender on 08Jan2021 at 10:00. The patient had not tested for COVID post-vaccination. No treatment was administered for the events. The events had not resolved.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Sore throat; Headache; Fatigue; Muscle and Joint pain; Muscle and Joint pain; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302; expiry date: unknown) intramuscular, in the left arm, on 11Jan2021 at 09:15, at a single dose, for COVID-19 immunization. Medical history included gastrooesophageal reflux disease  (GERD), and seasonal allergies. Concomitant medications included minerals NOS, vitamins NOS (PRENATAL VITAMINS), calcium, fexofenadine hydrochloride (ALLEGRA), and esomeprazole magnesium (NEXIUM).  The patient previously received ibuprofen and drospirenone and experienced allergies; and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) intramuscular in the left arm, on 21Dec2020, for COVID-19 immunization. On 11Jan2021, at 22:30, the patient experienced headache, fatigue, muscle and joint pain, and sore throat. The patient received naproxen and Tylenol as treatment for the events. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Baseball size red circle. Itchy and warm 11 days after vaccine
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever; nausea; vomiting; chills; body aches; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date then received the second dose on the left arm on 11Jan2021 08:00 both via an unspecified route of administration at a single dose for Covid-19 immunization. The patient medical history was reported as none. The patient takes multivitamins. On 11Jan2021 19:00, the patient experienced fever, nausea, vomiting, chills and body aches. The patient did not received any treatment for all the reported events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Fatigue, muscle aches/body aches and fever
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El 3248), via an unspecified route of administration in left arm on 09Jan2021 12:45 at single dose for COVID-19 immunization. Medical history included high blood pressure, asthma and shellfish, turmeric and antibiotics allergies; all from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL), fexofenadine hydrochloride (ALLEGRA), hctz, montelukast sodium (SINGULAIR) and budesonide, formoterol fumarate (SYMBICORT). The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 11Jan2021 05:00 AM, 2 days later from the vaccination, the patient experienced nausea and headache. No treatment was given to the patient for the events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea and diarrhea on unspecified date. Outcome of the events nausea and diarrhea was unknown.   No follow up attempts are possible. Information on Lot/Batch number could not be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19 and her only symptom is sore throat; tested positive for COVID-19 and her only symptom is sore throat; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date were not reported), via an unspecified route of administration on 23Dec2020 at a single dose for covid-19 immunization. The patient's medical history included in contact with somebody who was COVID-positive prior to getting the vaccine. Concomitant medications were not reported. It was reported that the patient was vaccinated last 23Dec2020 and tested positive for COVID-19 and her only symptom is sore throat that lasted for 3 days on unspecified date. She said she is all cleared now and had finished the 14-day quarantine. Is it safe to take the second dose of the COVID-19 vaccine as scheduled? Outcome of the events tested positive for COVID-19 and her only symptom is sore throat was recovered on unspecified date.  Information about Lot/batch no has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Myalgia, Pyrexia
Clinical narrative: For two days low grade fever, severe muscle aches, fatigue, chills, mild cough and congestion.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: For two days low grade fever, severe muscle aches, fatigue, chills, mild cough and congestion.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Headache, Hyperhidrosis
Clinical narrative: Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL0142, expiry date not reported), via an unspecified route of administration on 11Jan2021 11:30 at a single dose in the left arm for Covid-19 immunization (as patient works in a nursing home and wanted to get it). Medical history included ongoing asthma and had COVID back in Apr2020 to an unknown date.  There were no concomitant medications. The patient previously had flu shot and had arm red and sore. Patient had a reaction after receiving her Covid shot yesterday at 11:30 AM. Patient mentioned that she woke up this morning (12Jan2021) at around 3 AM with chills, a headache and fever at 102-degree Fahrenheit and felt that she has to move her legs every time to feel better. She has asthma but stated that her breathing was fine. Patient wanted to know if this was normal and when this will go away. She called her doctor and left a message to let them know. She had COVID back in Apr2020, but got the vaccine yesterday, which she wanted. She was unsure what was going on. She was also shivering and cannot settle down, like her legs. She just has a massive headache with chills, shivering, and some sweating (12Jan2021). Her arm was also red and sore (12Jan2021). It was like she gets with the Flu shot, but she never has had any other symptoms with the flu shot. The events were reported as non-serious. Therapeutic measures were taken as a result of chills/shivering, fever at 102-degree Fahrenheit, headache, and arm was sore and red. Patient took Tylenol this morning when she woke up at 3 AM. She did not fall asleep until 5 AM. Then she got up at 7 AM and took some more. She will take more at 11 AM. The outcome of the events chills/shivering, fever at 102-degree Fahrenheit, headache, sweating, and arm was sore and red was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL0142, expiry date not reported), via an unspecified route of administration on 11Jan2021 11:30 at a single dose in the left arm for Covid-19 immunization (as patient works in a nursing home and wanted to get it). Medical history included ongoing asthma and had COVID back in Apr2020 to an unknown date.  There were no concomitant medications. The patient previously had flu shot and had arm red and sore. Patient had a reaction after receiving her Covid shot yesterday at 11:30 AM. Patient mentioned that she woke up this morning (12Jan2021) at around 3 AM with chills, a headache and fever at 102-degree Fahrenheit and felt that she has to move her legs every time to feel better. She has asthma but stated that her breathing was fine. Patient wanted to know if this was normal and when this will go away. She called her doctor and left a message to let them know. She had COVID back in Apr2020, but got the vaccine yesterday, which she wanted. She was unsure what was going on. She was also shivering and cannot settle down, like her legs. She just has a massive headache with chills, shivering, and some sweating (12Jan2021). Her arm was also red and sore (12Jan2021). It was like she gets with the Flu shot, but she never has had any other symptoms with the flu shot. The events were reported as non-serious. Therapeutic measures were taken as a result of chills/shivering, fever at 102-degree Fahrenheit, headache, and arm was sore and red. Patient took Tylenol this morning when she woke up at 3 AM. She did not fall asleep until 5 AM. Then she got up at 7 AM and took some more. She will take more at 11 AM. The outcome of the events chills/shivering, fever at 102-degree Fahrenheit, headache, sweating, and arm was sore and red was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Pain, Pyrexia
Clinical narrative: Caregiver received Dose 1 12/29/20.  Her vaccination card had the previous date's sticker on it indicating Pfizer.  The 12/29/20 vaccination was distributing Moderna.  Ignoring what was said to her verbally that she received Moderna and the different prompts for timing of 2nd dose, she signed up and received a Pfizer Dose 2 on 1/20/21.  She developed a fever and achiness after her first Moderna administration in alignment with typical vaccine reaction.  She developed similar reaction after her Pfizer second dose.  She recovered fully both vaccinations after 48hrs.  We disclosed this misadministration and recited the CDC guidelines to monitor and not vaccinate with a 3rd dose.  Caregiver took the finding well.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Fatigue, Nausea, Peripheral swelling
Clinical narrative: Red welts/hives; blisters; rash started on feet, legs arms and buttocks within 12-20 hrs; nausea; fever; chills; fatigue; Right foot swollen with blisters; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the second dose of BNT162b2 (lot number: Ek4176), via an unspecified route of administration in left arm on 09Jan2021 15:00 at single dose for covid-19 immunization. Medical history included depression, irritable bowel syndrome (IBS). Concomitant medication included venlafaxine hydrochloride (EFFEXOR), desogestrel, ethinylestradiol (APRI), cetirizine hydrochloride (ZYRTEC), loratadine (CLARITIN), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC) , ibuprofen (MOTRIN). The patient previously took tramadol and cranberry and both experienced allergies. The patient previously received the first dose of BNT162b2 (lot number: Ek5730), at the age of 37-year-old, via an unspecified route of administration in left arm on 20Dec2020 15:00 at single dose for covid-19 immunization. The patient experienced red welts/hives/blisters/rash started on feet, legs arms and buttocks within 12-20 hrs. And nausea, fever, chills, fatigue. Right foot swollen with blisters. The above events were occurred on 10Jan2021 and received the treatments Steroid cream and atarax. The above events resulted in Emergency room/department or urgent care. The outcome of the events were not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Red welts/hives; blisters; rash started on feet, legs arms and buttocks within 12-20 hrs; nausea; fever; chills; fatigue; Right foot swollen with blisters; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the second dose of BNT162b2 (lot number: Ek4176), via an unspecified route of administration in left arm on 09Jan2021 15:00 at single dose for covid-19 immunization. Medical history included depression, irritable bowel syndrome (IBS). Concomitant medication included venlafaxine hydrochloride (EFFEXOR), desogestrel, ethinylestradiol (APRI), cetirizine hydrochloride (ZYRTEC), loratadine (CLARITIN), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC) , ibuprofen (MOTRIN). The patient previously took tramadol and cranberry and both experienced allergies. The patient previously received the first dose of BNT162b2 (lot number: Ek5730), at the age of 37-year-old, via an unspecified route of administration in left arm on 20Dec2020 15:00 at single dose for covid-19 immunization. The patient experienced red welts/hives/blisters/rash started on feet, legs arms and buttocks within 12-20 hrs. And nausea, fever, chills, fatigue. Right foot swollen with blisters. The above events were occurred on 10Jan2021 and received the treatments Steroid cream and atarax. The above events resulted in Emergency room/department or urgent care. The outcome of the events were not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Systemic: Body aches, chills, muscle fatigue (whole body), mild fever (ranging from 99.8-101)  Local: slight itchiness at injection site, muscle swelling at site, hardening of muscles at injection site, soreness in arm at site 7 days later
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Pain, Pyrexia
Clinical narrative: Systemic: Body aches, chills, muscle fatigue (whole body), mild fever (ranging from 99.8-101)  Local: slight itchiness at injection site, muscle swelling at site, hardening of muscles at injection site, soreness in arm at site 7 days later
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Myalgia
Clinical narrative: within 2 hours extreme fatigue; more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back; more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back; more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back; headache; fever; This is a spontaneous report from a contactable healthcare professional (patient herself). A 53-year-old female patient received the second dose of bnt162b2 (BNT162B2, Pfizer, lot number was not reported), via an unspecified route of administration on the left arm on 11Jan2021 15:00 at a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient is not pregnant. Concomitant medication included metformin, atorvastatin calcium (ATORVASTIN), vortioxetine hydrobromide (TRINTELLIX) and insulin glargine, lixisenatide (SOLIQUA). The patient previously took the first dose of BNT162B2 (Pfizer, lot number was not reported) on 23Dec2020 on the left arm and experienced tingly lips; and previously took codeine and experienced allergies. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. On 11Jan2021 18:00, the patient experienced within 2 hours extreme fatigue, lots more muscle soreness than the first. This soreness went across the back and to the other shoulder then down the back. The patient slept from 6 pm to 8 am and would wake to take ibuprofen and TYLENOL. Ran some fever. Had a headache since 6 pm. She had extreme fatigue and stayed in bed all day. The patient did not receive treatment for "within 2 hours extreme fatigue" and "more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back". The patient has not recovered from the events.   Information about lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: within 2 hours extreme fatigue; more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back; more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back; more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back; headache; fever; This is a spontaneous report from a contactable healthcare professional (patient herself). A 53-year-old female patient received the second dose of bnt162b2 (BNT162B2, Pfizer, lot number was not reported), via an unspecified route of administration on the left arm on 11Jan2021 15:00 at a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient is not pregnant. Concomitant medication included metformin, atorvastatin calcium (ATORVASTIN), vortioxetine hydrobromide (TRINTELLIX) and insulin glargine, lixisenatide (SOLIQUA). The patient previously took the first dose of BNT162B2 (Pfizer, lot number was not reported) on 23Dec2020 on the left arm and experienced tingly lips; and previously took codeine and experienced allergies. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. On 11Jan2021 18:00, the patient experienced within 2 hours extreme fatigue, lots more muscle soreness than the first. This soreness went across the back and to the other shoulder then down the back. The patient slept from 6 pm to 8 am and would wake to take ibuprofen and TYLENOL. Ran some fever. Had a headache since 6 pm. She had extreme fatigue and stayed in bed all day. The patient did not receive treatment for "within 2 hours extreme fatigue" and "more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back". The patient has not recovered from the events.   Information about lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm was sore just a little bit; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FL3246, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 15:15 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient took no other medications in two weeks. The patient experienced that left arm was sore just a little bit on 09Jan2021 . No treatment was received for the adverse events. Clinical outcome of the event was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Had no reaction but soreness for 2 days after injection.  Everything went away and then on day 8 I woke up with a huge knot, redness, swelling, and hot to touch.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: started feeling like I could not smell/no smell or taste; did not have flavor/no smell or taste; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 05Jan2021 at a single dose for covid-19 immunization. The patient's patient medical history and concomitant medications were not reported. The patient reported that she received her first dose of the vaccine on Tuesday. She stated on Sunday (10Jan2021) that she started feeling like she could not smell and did not have flavor and it was getting worse on Sunday and Saturday. She does not have no fever, no headache, nothing from Covid. She stated she received a Covid test and the test was negative. She called to see if this is a side effect of the vaccine. The patient further mentioned that she has no smell or taste and wanted to know if it is related to the vaccine. She mentioned that she does not have any other COVID symptoms and she had a COVID test that was negative on an unspecified date. The outcome of the events was not recovered.  The following information on the batch/lot number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Malaise
Clinical narrative: headache; feeling unwell; received the first dose on 18Dec2020 injection in left arm at 07:00am/ second dose on 11Jan2021 at 15:30; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, in the left arm on 11Jan2021 at 15:30, at a single dose, for COVID-19 immunisation (prevent COVID). Relevant medical history included seizures diagnosed in 2014. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) injection on 18Dec2020 at 07:00 A.M. in the left arm for COVID-19 immunisation (prevent COVID). She was ok on 19Dec2020. After mid-day around noon she did not feel well, and it was hard for her to work on the 19th. She missed two days of work. On 20Dec2020, she could not get up from the bed. Concomitant medications included topiramate for seizures and levetiracetam (KEPPRA). The patient did not receive other vaccines within four weeks prior to and on the same day of COVID vaccination. The vaccine was administered in the hospital. The patient received the COVID vaccine yesterday (11Jan2021). She missed work today (12Jan2021) since she was feeling unwell and having a headache. She works in housekeeping. She started feeling unwell and her headache started after 3 in the morning. She wanted to stay home. Last night she was quite unwell, but she was better after taking second dose of Tylenol. She may need to take more medicine in 2 hours. The events did not require emergency room or physician visit. She does not have lot, NDC, or expiration date to provide for either dose. Outcome of the events headache and feeling unwell was recovering.  Information about lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Defaecation urgency, Diarrhoea
Clinical narrative: I felt mostly fine all day.  A little tired and my arm was sore.  About 4:45pm, I started sweating and getting really hot.  I felt like I might need to use the restroom (soon) and I was at the grocery store.  So, I immediately left.  My house is 5-7 minutes from the store.  During this time, I experienced terrible pains in my stomach and lower abdomen.  I barely made it through my door and had to run to my bathroom.  I experienced diarrhea like I?ve never experienced in my life.  It was painful and explosive.  This lasted about 30 minutes on and off.  Mostly on.  Once I cleaned myself up, I was very tired and weak.  I felt nauseous this entire night but have not had any other episodes.  I also have not invested anything except water since this happened.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: I felt mostly fine all day.  A little tired and my arm was sore.  About 4:45pm, I started sweating and getting really hot.  I felt like I might need to use the restroom (soon) and I was at the grocery store.  So, I immediately left.  My house is 5-7 minutes from the store.  During this time, I experienced terrible pains in my stomach and lower abdomen.  I barely made it through my door and had to run to my bathroom.  I experienced diarrhea like I?ve never experienced in my life.  It was painful and explosive.  This lasted about 30 minutes on and off.  Mostly on.  Once I cleaned myself up, I was very tired and weak.  I felt nauseous this entire night but have not had any other episodes.  I also have not invested anything except water since this happened.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: large blisters erupted in 2 separate locations on arm of injection and several inches from injection site; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the right arm, on 10Jan2021 at a single dose for covid-19 immunization. Medical history included hypothyroidism, high blood pressure, high cholesterol and known allergies: wasp venom, jellyfish and hydroids. The patient is not pregnant. The patient was not diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. Concomitant medications included levothyroxine, valsartan, and simvastatin. On 11Jan20201, the patient experienced large blisters erupted in 2 separate locations on arm of injection and several inches from injection site. "I had used a heating pad on my arm the evening of the vaccination and noticed the blisters, ranging in size from 1/8 inch to 1/2 Inch and 1/8 inch high, after taking a hot bath the next evening. There are 2 groups with 2-4+ blisters and appear to be filled with clear liquid. They are not painful and do not itch." Therapeutic measure was taken as a result of the event. Outcome of the event was recovering.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Sensory disturbance
Clinical narrative: Dizziness/ lightheadedness, pulsing sensation through body, epigastric sore/cramp-like 8pm-present
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Presyncope
Clinical narrative: extreme episode of over heating (at night); almost passed out; This is a spontaneous report from a contactable nurse. A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685), via an unspecified route of administration, on her left arm on 17Dec2020 at a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism, attention deficit hyperactivity disorder (ADD) and known seasonal allergies; all from an unknown date and unknown if ongoing. The patient previously took erythromycin and experienced allergies. On day 5 after both shots (unspecified date), patient had an extreme episode of overheating (at night) the first time, got up and almost passed out. There was no treatment received for the events. The outcome of the events was recovering.