chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Palpitations
Clinical narrative: Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned red and warm and face turned red and warm; redness of hands; Rushing feeling-hands turned red and warm and face turned red and warm; Palpitations-increases heart rate; Palpitations-increases heart rate; Increased blood pressure; This is a spontaneous report from a contactable Nurse.  A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Dec2020 at 04:15 (at the age of 43-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. The patient was allergic to morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in a workplace clinic. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 24Dec2020 at 04:30  the patient experienced a rushing feeling during which her hands turned red and warm and her face turned red and warm. At this same time, she also experienced increased blood pressure, palpitations and increases in her heart. The patient did not receive any treatment for the events. The clinical outcomes of rushing feeling during which her hands and face were warm and turned red, increased blood pressure, palpitations, increased heart rate were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Fever; body-ache; joint pain; head-ache; fatigue; light-headedness; This is a spontaneous report from a contactable consumer (the patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK9231), via an unspecified route of administration on 22Dec2020 at 22:30 (at the age of 25-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date and Post COVID Inflammatory Response which resulted in exercise induced asthma afterwards (dates not specified). The patient is allergic to mangoes. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 24Dec2020 at 09:00, the patient experienced fever, body ache, joint pain, headache, fatigue and light-headedness. The patient did not receive any treatment for the events. The clinical outcomes of fever, body-ache, joint pain, headache, fatigue and light-headedness were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; body-ache; joint pain; head-ache; fatigue; light-headedness; This is a spontaneous report from a contactable consumer (the patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK9231), via an unspecified route of administration on 22Dec2020 at 22:30 (at the age of 25-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date and Post COVID Inflammatory Response which resulted in exercise induced asthma afterwards (dates not specified). The patient is allergic to mangoes. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 24Dec2020 at 09:00, the patient experienced fever, body ache, joint pain, headache, fatigue and light-headedness. The patient did not receive any treatment for the events. The clinical outcomes of fever, body-ache, joint pain, headache, fatigue and light-headedness were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dry throat, Oropharyngeal pain
Clinical narrative: Cough and dry throat; sore throat; Cough and dry throat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration on 18Dec2020 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced cough and sore throat on 24Dec2020 and dry throat in Dec2020. It was further reported that patient just got the vaccine on 18th and patient drove down from one city to another couple of days ago and yesterday (24Dec2020) in the afternoon, patient started feeling sore throat and a cough. Patient would like to know if it was an adverse reaction of the vaccine or was it cold. When paraphrased the concern, patient stated, "I don't know if these are the negative side effect of the vaccine itself or there is something else like climate or something like that". The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; body ache; Chills; Headache; This is a spontaneous report from a contactable Nurse (patient). A 45-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose to prevent COVID. Medical history included ongoing cholesterol abnormal. Concomitant medication included metformin and Cholesterol Medicine. The patient experienced Fever, body ache, Chills, Headache on 22Dec2020. Nurse stated, he have some question regarding the side effects of COVID Vaccine. He received the COVID Vaccine on 21Dec2020 (Monday), he was a nurse and knew it was normal to get fever in some cases but he has had a fever, body ache, the chills, the headaches. He did take Ibuprofen, Tylenol to cut the fever around the clock for the last three days. Nurse further stated, "he wanted to know how long he was going to expect the fever, the chills, the body ache. It was a bit too long and started to worry him. When probed for the causality, Nurse stated, "These are related to vaccine because he tested negative to COVID-19 on 21Dec2020 (Monday) and these symptoms started the next day after the vaccine on 22Dec2020." Therapeutic measures were taken as a result of fever. The outcome of the events was unknown. The causality assessment for events Fever, body ache, Chills, Headache was provided as related by Reporter via Method of assessment Global Introspection.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysgeusia, Feeling hot, Heart rate, Heart rate increased
Clinical narrative: Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 sec; with in 5 minutes of inoculation experienced an odd taste in my mouth; Warm sensation in Left upper arm for at least 15 minutes.; This is a spontaneous report from a contactable other Health Care Professional (HCP). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 at 13:15 (at the age of 53-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included pneumonia, high cholesterol, eczema rashes from perfumes/beauty products/soaps and hand dermatitis all on unknown dates.The patient is allergic to amoxicillin (rash trunk) and experiences seasonal allergies in the eyes/nose/with coughing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 13:20 (reported as "within 5 minutes of inoculation") the patient experienced an odd taste in her mouth, a pounding heart rate felt in her chest that lasted less than 30 seconds (may have been shorter). She stated that she was trying to stay calm. Also, she experienced a warm sensation in the left upper arm for at least 15 minutes as well as a very painful shoulder twenty-four hours later; there was no swelling nor redness noted. Her shoulder was much improved by the third day.The patient did not receive any treatment for the events. The clinical outcomes of heart rate increased, taste peculiar, localized feeling of warmth and shoulder pain were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: The evening of the vaccine I only had about 3 hours of generalize achiness; slight generalized joint discomfort and slight burning sensation; This is a spontaneous report from a contactable nurse (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient reported that: "the evening of the vaccine I only had about 3 hours of generalize achiness (18Dec2020) and was back to normal after that. About 3 days after the vaccine I have slight generalized joint discomfort and slight burning sensation. This is not limiting my activity". The patient outcome of generalized achiness was recovered, the outcome of slight generalized joint discomfort and slight burning sensation was unknown.   Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Coworker who received the shot is positive too; Coworker who received the shot is positive too; This is a spontaneous report from a contactable consumer. This consumer reporter similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history  concomitant medications were not reported. The reporter's coworker who received the shot was positive too. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020513735 same reporter/product, different patient, similar event
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: I have a fever that is 100; body aches; Headache; This is a spontaneous report from a contactable consumer (patient). A patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history included covid before very, very, very, very, very bad. The concomitant was not reported. The patient work in a hospital and got her shot (Covid Vaccine) on 23Dec2020, and she have all the reactions to it in Dec2020. Patient have had Covid before very, very, very, very, very bad, it seems like she was starting all over it again. She don't feel like she was going to die or anything, she already went through all of that but patient have a fever that is 100, the body aches, the headaches the whole thing, they all starting now which patient assumed this is just temporary because she don't want to have through with this thing again. A lot of people do not get it that is with patient it's like patient was the one who has everything. So, patient was calling and letting company know that she was having the side effects to it, patient don't think she would but here she was with it.The outcome of the events was unknown.  Information about Lot/batch no has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Headache, Myalgia, Rhinorrhoea
Clinical narrative: moderate myalgias; arthralgias; headaches; rhinorrhea; chest tightness; scratchy throat; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the 1st dose of the Pfizer COVID19 vaccine this week. In Dec2020, patient had 3 days of moderate myalgias, arthralgias, and headaches. Patient also experienced rhinorrhea, chest tightness, and scratchy throat (Dec2020), which were reportedly not effects associated with the vaccine. Patient did get a post vaccination COVID test (PCR) in Dec2020 because of these symptoms, which was negative. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, a contributory role of vaccination with BNT162B2 in the development of the reported events cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Throat irritation
Clinical narrative: moderate myalgias; arthralgias; headaches; rhinorrhea; chest tightness; scratchy throat; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the 1st dose of the Pfizer COVID19 vaccine this week. In Dec2020, patient had 3 days of moderate myalgias, arthralgias, and headaches. Patient also experienced rhinorrhea, chest tightness, and scratchy throat (Dec2020), which were reportedly not effects associated with the vaccine. Patient did get a post vaccination COVID test (PCR) in Dec2020 because of these symptoms, which was negative. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, a contributory role of vaccination with BNT162B2 in the development of the reported events cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Pyrexia
Clinical narrative: headache; fever; severe swelling in her lips; This is a spontaneous report from a contactable other healthcare professional. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration from 23Dec2020 16:30 at single dose for COVID-19 immunization. The patient's medical history included Crohn's disease. Concomitant medications included paroxetine hydrochloride (PAXIL) and spironolactone. The patient previously took morphine 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. It was reported that the patient was injected with hyaluronic acid lip filler 10 days prior to her vaccine. The patient developed severe swelling in her lips a few hours after she received the vaccine on 23Dec2020. The following day after her vaccine she developed headache and fever too (24Dec2020). The patient went to the Emergency room/department or urgent care and was treated with Benadryl. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  Information about lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report from a non-contactable nurse. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: Ek9231, intramuscular on Left arm from 24Dec2020 13:45 to 24Dec2020 13:45 as single dose for COVID-19 immunization. Medical history included depression, anxiety, chronic migraine. Concomitant medication included duloxetine hydrochloride (CYMBALTA), ibuprofen, topiramate (TOPAMAX), bupropion hydrochloride (WELLBUTRIN). On 5Dec2020 05:45, the patient experienced nausea and associated vomiting approximately 16 hours after vaccination administration. The outcome of the events was recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Migraine, Nausea, Vomiting
Clinical narrative: Have had headache/migraine 6-24 hours after vaccine; intermittent severe stomach cramping; nausea; severe diarrhea; vomiting; This is a spontaneous report from a contactable nurse (patient). A 37-years-old female patient, non-pregnant, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, in hospital, via an unspecified route of administration on 23Dec2020 at 10:30, at 37-years of age, at single dose in right arm for COVID-19 immunization.  Medical history included anxiety, depression and migraines, all from an unknown dates. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), topiramate (TOPAMAX), buspirone hydrochloride (BUSPAR), ibuprofen and levocabastine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache/migraine 6-24 hours after vaccine (onset reported also as 25Dec2020 at 12:00 - to be clarified) and, on 25Dec2020 at 12:00, also reported as 24-72 hours after vaccine, she experienced intermittent severe stomach cramping, nausea, severe diarrhea and vomiting. The patient didn't receive any treatment for the events. The outcome of the events was unknown at the time of the report.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, SARS-CoV-2 test
Clinical narrative: Severe nausea and lightheadedness; Severe nausea and lightheadedness; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received both 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), both via unspecified routes of administration at the right arm on unspecified dates at single doses for immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. There were no concomitant medications. On an unspecified date, the patient experienced severe nausea and lightheadedness. There was no treatment given for the events. The vaccine was administered in a hospital. The patient has not received 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 been tested for COVID-19 (Nasal swab) on an unspecified date and result was negative. The outcome of the events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Pain
Clinical narrative: Aching all over; headaches; shingles; This is a spontaneous report from a contactable Nurse (Patient). A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via an unspecified route of administration at right arm on 17Dec2020 13:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Relevant medical history and concurrent conditions was reported as "Structured information (Patient episode name): Fibromyalgia, tachycardia, shingles, breast cancer". Patient was  diagnosed with COVID prior to vaccination. Patient known allergies included Codeine, morphine sulfate (Duramorph) and Sulfa. Concomitant medication included metoprolol succinate (TOPROL), alprazolam (XANAX) and desvenlafaxine succinate (PRISTIQ) received within 2 weeks of vaccination. No other vaccine in four weeks. Adverse events were reported as "Started day after shot. Aching all over headaches. Broke out in shingles 7 days later". Adverse event start date was reported on 24Dec2020. No treatment received for the events. since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: Rapid heart beat- 2 brief instances within 15-20 minutes of vaccine administration; Light headed feeling; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm on 23Dec2020 07:30 at single dose for COVID-19 immunization. Medical history included high blood pressure (HBP), supraventricular tachycardia (h/o SVT), h/o breast cancer, and sulfa drugs allergies. The patient was not pregnant. Concomitant medication included famotidine, metoprolol succinate, and tamoxifen. The patient experienced lightheaded feeling and rapid heartbeat- 2 brief instances within 15-20 minutes of vaccine administration on 23Dec2020. No treatment was received for the events. Facility where the most recent COVID-19 vaccine was administered was at a hospital. 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 and has been tested for COVID-19 since the vaccination via nasal swab on 24Dec2020, results was pending. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Feeling abnormal, Headache
Clinical narrative: diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bit cruddy; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: paa156051), via an unspecified route of administration (arm left, dose number 1) on 17Dec2020 10:30 at single dose for COVID-19 immunisation. Medical history included Psoriatic arthritis from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL), propranolol, and curcuma longa (TURMERIC CURCUMIN). Patient is on unspecified birth control and unspecified vitamins. No other vaccines in four weeks were given. The patient previously took steroids and experienced allergies (similar reaction to steroid 1 year before), and FLONASE and experienced allergies. On 17Dec2020, It was reported that the patient was fine for the first 15 minutes, afterwards became very diaphoretic, woozy, heart rate went down to 43 and blood pressure down to 83/57. The patient recovered enough to leave about 20 minutes. After that, patient's heart rate was back into the 60's and BP stayed the same but the patient was feeling better. Patient's heart rate is usually in the 70's and his BP around 115/75 or so. The patient has no breathing problems. Other than headache and feeling a bit cruddy, the patient has been fine since. Patient mentioned she really wanted to take the second dose, but she does not know if she should. No treatment for the adverse events. No COVID prior vaccination and patient has not tested for COVID post vaccination. Event outcome was recovered on Dec2020. Events were considered non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Hyperhidrosis
Clinical narrative: diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bit cruddy; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: paa156051), via an unspecified route of administration (arm left, dose number 1) on 17Dec2020 10:30 at single dose for COVID-19 immunisation. Medical history included Psoriatic arthritis from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL), propranolol, and curcuma longa (TURMERIC CURCUMIN). Patient is on unspecified birth control and unspecified vitamins. No other vaccines in four weeks were given. The patient previously took steroids and experienced allergies (similar reaction to steroid 1 year before), and FLONASE and experienced allergies. On 17Dec2020, It was reported that the patient was fine for the first 15 minutes, afterwards became very diaphoretic, woozy, heart rate went down to 43 and blood pressure down to 83/57. The patient recovered enough to leave about 20 minutes. After that, patient's heart rate was back into the 60's and BP stayed the same but the patient was feeling better. Patient's heart rate is usually in the 70's and his BP around 115/75 or so. The patient has no breathing problems. Other than headache and feeling a bit cruddy, the patient has been fine since. Patient mentioned she really wanted to take the second dose, but she does not know if she should. No treatment for the adverse events. No COVID prior vaccination and patient has not tested for COVID post vaccination. Event outcome was recovered on Dec2020. Events were considered non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node on left side of mouth; This is a spontaneous report from a non-contactable healthcare professional. A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the right arm on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen lymph node on left side of mouth on an unspecified date. No treatment was given for the event. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Caller stated that she received covid vaccine on Tuesday and was tested positive on Friday.; Caller stated that she received covid vaccine on Tuesday and was tested positive on Friday.; This is a spontaneous report from a contactable nurse reporting for herself.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date not reported), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she received the vaccine on Tuesday (Dec2020) and was tested positive on Friday (Dec2020). The patient stated she was told that vaccine was contraindicated in people who have COVID-19. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Pain at injection site; Chills; Fever; Fatigue; Headache; This is a spontaneous report from a contactable nurse (patient herself).  This 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route, on 26Dec2020 (at 02:30 PM) at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was not pregnant. Relevant medical history included depression, endometriosis, and COVID-19 in Aug2020. The patient did not have relevant concomitant medications. No other vaccine was received in four weeks. No known allergies. No congenital anomaly/birth defect. The patient was vaccinated at hospital, age at vaccination was 44-year-old. On 27Dec2020 (at 02:00 AM) the patient woke up with chills, fever, fatigue, headache and fever 99.5. After taking 2 paracetamol (TYLENOL) (1.5hr after med temp was taken), she felt like it did when she had COVID in Aug2020. She also had pain at injection site as well (onset date not provided). Post-vaccination COVID test was not performed. Therapeutic measures were taken for fever, no treatments were given for chills, fatigue and headache. The patient had not recovered from fever, chills, fatigue and headache while the outcome from pain at injection site was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; Chills; Fever; Fatigue; Headache; This is a spontaneous report from a contactable nurse (patient herself).  This 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route, on 26Dec2020 (at 02:30 PM) at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was not pregnant. Relevant medical history included depression, endometriosis, and COVID-19 in Aug2020. The patient did not have relevant concomitant medications. No other vaccine was received in four weeks. No known allergies. No congenital anomaly/birth defect. The patient was vaccinated at hospital, age at vaccination was 44-year-old. On 27Dec2020 (at 02:00 AM) the patient woke up with chills, fever, fatigue, headache and fever 99.5. After taking 2 paracetamol (TYLENOL) (1.5hr after med temp was taken), she felt like it did when she had COVID in Aug2020. She also had pain at injection site as well (onset date not provided). Post-vaccination COVID test was not performed. Therapeutic measures were taken for fever, no treatments were given for chills, fatigue and headache. The patient had not recovered from fever, chills, fatigue and headache while the outcome from pain at injection site was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever chills; This is a spontaneous report from a contactable Nurse (patient)  A patient (demographics unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient stated, 'I received the vaccine without knowing I had COVID 19'.  After vaccination, she developed the symptoms fever chills. She performed swab and was positive.  Information on the Lot/Batch Number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Hypersensitivity, Oropharyngeal pain, Throat tightness, Urticaria
Clinical narrative: hypersensitivity reaction to COVID-19 Vaccine; throat pain that progressed to a little bit of tightness; ear pain; wheals develop on her back bilaterally; This is a spontaneous report from a contactable pharmacist. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685 and Expiry date: 31Mar2021, strength: 0.3ml) (NDC number: 59267-1000-2) via Intramuscular on 21Dec2020 12:21PM at 0.3ml single dose for COVID-19 immunization. The patient's medical history and concomitant drug was reported as none. The patient experienced a hypersensitivity reaction to COVID-19 Vaccine late last night on 21Dec2020. Hypersensitivity reaction: Further described as patient developed throat pain that progressed to a little bit of tightness; some ear pain; and had wheals develop on her back bilaterally. She was transported to the emergency room on 21Dec2020 where she received treatment and was under observation. The outcome of events was unknown. Since whether outcome recovered completely, recovered with lasting effects or just improved is unknown. She was not admitted to the hospital; she was sent home from the emergency room after 2.5 hours. Caller reported seriousness criteria as medically significant because event required medical intervention. Causality was very likely. Patient at time of this report is scheduled to receive the second dose of vaccine; they have not determined if she will receive the second scheduled dose or change/stop dose in response to this event. First dose; scheduled to receive a second dose; have not determined if will be continuing with it.; Sender's Comments: Based on the compatible time association, the hypersensitivity reactions are reasonably related to suspect BNT162B2 administration.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.; On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.; Reported soreness at injection site and some soreness which was gone by day 5 or 6. On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.; Reported soreness at injection site and some soreness which was gone by day 5 or 6; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on left arm on 17Dec2020 15:30 at single dose for COVID-19 immunization. Medical history included hypothyroid, osteoporosis, and known allergies to sulfa and tetracycline. The patient was not pregnant. The patient reported soreness at injection site and some soreness on Dec2020 which was gone by day 5 or 6. On day 8 (25Dec2020) arm again was sore and now itchy with reddened area larger than injection site 3x4 inches. No treatment was given for the events. The COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received unspecified medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event pain was recovered and not recovered for the rest of the events.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: It still hurts to abduct my left arm; This is a spontaneous report from a contactable Physician (patient).  A 37-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at single dose in left arm for COVID-19 immunisation at the age of 37-year-old. Lot number was EJ1685. Medical history was unknown and concomitant medications were unknown. Patient was not pregnant at the time of vaccination. It was reported that since 19dec2020 it did still hurt to abduct left arm.. The patient was not treated for the event. The patient did not recover from the event.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Oropharyngeal pain, Pain
Clinical narrative: Sore throat; not feeling well/general malaise; feeling tired/fatigue; Feeling achy; This is a spontaneous report from a contactable physician (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 11:00 single dose for preventive. Medical history included depression. Concomitant medication included duloxetine hydrochloride (CYMBALTA) for depression. The patient previously took flu vaccine for immunization. The patient received the Covid 19 vaccine on Wednesday. Patient stated there was a possibility of feeling achy just a general possibility of not feeling well like feeling tired, like it was she had that flu, vaccine too. But, her symptoms had persisted and she also had an isolated sore throat that started after she got her vaccine. She understood that the vaccine did not cause Covid but she was not sure like if having a sore throat was what other people have reported or this was something where she should go and get tested. Physician stated that question hadn't been answered by the previous department. When probed if the indication was a preventive measure for Covid, Physician stated "Preventive." Event (sore throat) started on 23Dec2020. The patient was given the vaccine at 11 am and her symptoms started probably at around 21:00 (9 pm). Patient further stated she received vaccine on 23Dec2020 around 11am and developed side effects of sore throat, fatigue/general malaise that evening. She couldn't find any data specifically reporting on sore throat. She was wondering if she should get tested for covid. Investigation assessment was no. The outcome of the events was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on face, neck, arms and hands.; This is a spontaneous report from a contactable other hcp (patient). A 24-year-old non-pregnant female patient first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EJ1685), via an unspecified route of administration on 21Dec2020 19:00 at Left arm at single dose for covid-19 immunization.  The COVID-19 vaccine was administered at Hospital. Medical history included eczema. No known allergies. Concomitant medication included levonorgestrel (NORTREL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Rash on face, neck, arms and hands on 21Dec2020 22:00. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.  The outcome of the event was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; This is a spontaneous report from a contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), intramuscular on the left arm on 23Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included autoimmune thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 11:00, the patient experienced mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with ibuprofen. Clinical outcome of the events was recovered on an unspecified date in Dec2020.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision that was mild in nature (but noticeable, nonetheless). Began 15 minutes after vaccine received. Lasted 10 minutes. Resolved on its own. NOT accompanied by any other effect (i.e. nausea, vertigo, lightheadedness); This is a spontaneous report from a contactable nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL0140), via an unspecified route of administration on the right arm on 23Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) on an unspecified date and Ductal carcinoma in situ (DCIS) on the left breast in 2008. Concomitant medications included omeprazole and cetirizine (CETIRIZINE). On 23Dec2020 at 10:30, the patient had a blurred vision that was mild in nature (but noticeable, nonetheless). It began 15 minutes after vaccine received and lasted for 10 minutes. It resolved on its own and not accompanied by any other effect (i.e. nausea, vertigo, lightheadedness). No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovered on 23Dec2020 at 10:40.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue; tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue; numbness and tingling progressed up my cheeks and up underneath my eyes on both sides; numbness and tingling progressed up my cheeks and up underneath my eyes on both sides; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 26Dec2020 11:30 AM at single dose for covid-19 immunization. The COVID-19 vaccine was given at nurse's hospital vaccine clinic. Medical history included narcolepsy with cataplexy. Concomitant medication in two weeks included venlafaxine hydrochloride (EFFEXOR SR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took naproxen and erythromycin; and experienced drug allergy.  On 26Dec2020, the patient stated "At about 1150 my tongue started to get a little bit of numbness and tingling. I didn't really feel nervous but I thought maybe some type of anxious reaction. So I thought I'd give it just a little time and over the next 20 minutes the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue, up my cheeks and up underneath my eyes on both sides. I was not feeling anxious about the vaccination. I didn't have any trouble breathing or difficulty swallowing. It felt like Novocain that was wearing off like after you have dental work done. I decided to take 25mg Benadryl to see if it went away. And it definitely got better about 25 minutes after I took the Benadryl. Within an hour I would say it was 95% gone. Still just like a trace numbness on my cheeks. When I woke up this morning (27Dec2020) I noticed the facial numbness had completely resolved." The adverse event start time also reported as 11:45 AM. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 27Dec2020.  Information on the Batch/Lot number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral, Swollen tongue
Clinical narrative: tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue; tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue; numbness and tingling progressed up my cheeks and up underneath my eyes on both sides; numbness and tingling progressed up my cheeks and up underneath my eyes on both sides; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 26Dec2020 11:30 AM at single dose for covid-19 immunization. The COVID-19 vaccine was given at nurse's hospital vaccine clinic. Medical history included narcolepsy with cataplexy. Concomitant medication in two weeks included venlafaxine hydrochloride (EFFEXOR SR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took naproxen and erythromycin; and experienced drug allergy.  On 26Dec2020, the patient stated "At about 1150 my tongue started to get a little bit of numbness and tingling. I didn't really feel nervous but I thought maybe some type of anxious reaction. So I thought I'd give it just a little time and over the next 20 minutes the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue, up my cheeks and up underneath my eyes on both sides. I was not feeling anxious about the vaccination. I didn't have any trouble breathing or difficulty swallowing. It felt like Novocain that was wearing off like after you have dental work done. I decided to take 25mg Benadryl to see if it went away. And it definitely got better about 25 minutes after I took the Benadryl. Within an hour I would say it was 95% gone. Still just like a trace numbness on my cheeks. When I woke up this morning (27Dec2020) I noticed the facial numbness had completely resolved." The adverse event start time also reported as 11:45 AM. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 27Dec2020.  Information on the Batch/Lot number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Swelling face
Clinical narrative: experienced swelling of the face and eyes on 24Dec2020. The swelling has progressed since 24Dec2020.; experienced swelling of the face and eyes on 24Dec2020. The swelling has progressed since 24Dec2020.; This is a spontaneous report from a contactable nurse. A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm at a single dose on 21Dec2020 14:30 for COVID-19 immunization. Medical history was not reported. Concomitant medications included multivitamins (unspecified). The patient experienced swelling of the face and eyes on 24Dec2020 at 22:00. The swelling has progressed since 24Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.