chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Illness, Nausea
Clinical narrative: Nauseous; I was definitely sick; I throw up like 6 times and I had a pain in my stomach by that; Headache; This is a spontaneous report from a contactable consumer. This 70-years-old (at the time of vaccination) female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EN5318) NDC, UPC number, expiry date; unknown via an unspecified route of administration on 12Feb2021 at single dose on right arm for covid-19 immunisation. Patient's weight was 52.62 kg and height 163 cm. Patient's medical history included cirrhosis of liver and blood thinner (dates unspecified). Concomitant medications included unspecified medication, lot number; unknown, Reason for no lot number; suspect was captured for query, expiry Date of Unspecified Medication; Not Supplied, Unspecified Medication manufacturer; Moderna from an unspecified date to an unspecified date at unspecified dose and frequency for unknown indication (Other Products: Yes). Consumer stated, "I wanted to tell you about the side effects I have had from the Pfizer Shot, I had it on 12Feb2021 and next day on 13Feb2021 I have just slight headache and that was fine that went away and then the 5th day on 17Feb2021 that night I throw up. I was definitely sick, I throw up like 6 times and I had a pain in my stomach by that threw up 6 times and then the next morning I was nauseous though I had a piece of dry toast and then I felt better when the day went on but then this week on Monday, Tuesday, Wednesday and today I feel better but I am still kind of nauseous. I want to report it but I don't know if that's common. Is that common for this shot." Treatment was not given for the AEs. When asked about lab test, consumer stated, "Yes, I did but not today, I tell you some other blood thinner." (Further clarification was unknown). Consumer added, "I was just wondering if I could have the different shots (Unspecified Medication) maybe like the Moderna one that would help." The outcome of events was recovering and for nausea was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: positive test result for covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient herself) of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 23Jan2021 (Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 26Jan2021, the patient experienced positive test result for covid-19 vaccine. The patient underwent lab tests and procedures on 26Jan2021 which included sars-cov-1 test: results positive covid-19 vaccine. The outcome of the event was unknown.  Information of lot and batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested  covid  positive 08Jan; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient (reporters' mom) of an unknown age received BNT162B2 (BNT162B2 formulation: solution for injection, Lot/batch number and expiry date: Unknown) on 04Jan2021 via an unspecified route of administration and second dose (Lot number: Unknown) on 15Feb both as a single dose for covid-19 immunization. Patient was diagnosed with cardiac infusion, fluid on heart, had difficulty breathing and paralysed vocal cords and clarified all was before covid vaccine. Concomitant medications were not reported. Patient tested positive for covid-19 on 08Jan2021. Caller confirmed that patient lives in nursing home and would like to move her from nursing home to assisted living facility. Outcome of the event was unknown.  No follow-up attempts were possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report from a contactable consumer reporting for a patient (husband). A male patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration in an unspecified anatomical location on 12Feb2021 as single dose for covid-19 immunization. It was reported that, patient tested positive yesterday (25Feb2021) and confirming if he can take the second dose on 04Mar2021. The outcome of the events was unknown.  No follow up attempts are possible. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 virus ( tested positive); Covid-19 virus ( tested positive); This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, expiration date: Not provided), via an unspecified route of administration as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 27Feb2021 patient received first dose of Covid 19 Vaccine, today the patient was scheduled for second dose of Covid 19 Vaccine, today the patient experienced Covid 19 virus. The patient laboratory data included SARS-CoV-2 test positive on 27Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: Severe headache and weakness 4 days post vaccination with the 2nd dose; Severe headache and weakness 4 days post vaccination with the 2nd dose; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe headache and weakness 4 days post vaccination with the 2nd dose. The outcome of the events were unknown.  The information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Epistaxis, Nausea
Clinical narrative: Nosebleed; Upper and lower back pain; Chest pain; Knee pain; Nausea; This is a spontaneous case received from a contactable consumer (patient).   A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: Not reported), via an unspecified route of administration on 17Mar2021 at single dose for COVID-19 immunisation. The patient's medical history included COPD, insulin dependent diabetic, past drug event allergies on lisinopril, that made her coma for 3 days, coma. Concomitant medications were not reported. On an unspecified date, the patient experienced nosebleed, upper and lower back pain, chest pain, knee pain and nausea. She had experienced nosebleed for trice on an unspecified date. Patient asked if the side-effects would be worse after taking second dose. She was informed that no information about nosebleed during the clinical study of the vaccine was seen. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: woke up very dizzy; had poor balance; This is a spontaneous report received from a contactable other HCP (Patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER8737, Expiration date was not reported) via an unspecified route of administration in left arm on 19Mar2021 15:45 as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included Obesity, seasonal allergies, asthma from allergies, high blood pressure and known allergies with Shellfish, walnuts, Bactrim. Concomitant medications included fluticasone propionate (FLONASE ALLERGY RELIEF), pantoprazole (PANTOPRAZOLE), Multivitaminum and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Covid prior to vaccination. No covid tested post vaccination. On 24Mar2021 07:00 AM, the patient woke up very dizzy and had poor balance. she had to steady herself using furniture. It lasted about 15 minutes upon wakening. The patient did not receive any treatment for the adverse event. The reporter classified the events as non-serious. The outcome of the events was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: The site of the injection is swollen still after 23 days; This is a spontaneous report received from a contactable consumer (patient reported herself). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (COVID-19, Pfizer, Formulation: Solution for injection, Batch/Lot number: EN6203) via an unspecified route of administration to her left arm on 02Mar2021 04:45 PM at single dose for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient's medical history and concomitant medications were not reported. The patient was allergic to sulfa drugs. On 02Mar2021 05:00 PM, the site of the injection was swollen still after 23 days. The patient did not receive any treatment in response to the event. Outcome of the event was recovering. Vaccine facility information, ethnicity information and race information were available.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Contusion, Diarrhoea, Flatulence, Loss of consciousness
Clinical narrative: passed out; busted head; bruised/broke elbow/dont know if it chipped elbow or just bruised; about 1 hr after shot my stomach started feeling upset; had diarrheas' and gas; had diarrheas' and gas; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old male patient received bnt162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 23Mar2021, 12:30 (Lot Number: EP7534) as single dose for Covid-19 immunisation (age at vaccination was 55 years).  Medical history included high blood pressure (controlled with RX). There were no known allergies. No other vaccine was received in four weeks. Patient received other medications in two weeks. Historical vaccine included bnt162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 02Mar2021, (Lot Number: el9266) as single dose for Covid-19 immunisation (age at vaccination was 55 years). On 23Mar2021, the patient about 1 hour after shot her stomach started feeling upset and she stopped at a rest area, had diarrhea and gas. This continued some through the evening. On 24Mar2021 (The next day), while outside with her friend, she passed out, ended up with a busted head and bruised/broke elbow/don't know if it chipped elbow or just bruised. She could feel it was coming on but then it started to pass, and the next thing was that she woke up in her driveway. No treatment received for events. No covid prior vaccination and no covid tested post vaccination was reported. The outcome for all the event(s) was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Upper limb fracture
Clinical narrative: passed out; busted head; bruised/broke elbow/dont know if it chipped elbow or just bruised; about 1 hr after shot my stomach started feeling upset; had diarrheas' and gas; had diarrheas' and gas; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old male patient received bnt162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 23Mar2021, 12:30 (Lot Number: EP7534) as single dose for Covid-19 immunisation (age at vaccination was 55 years).  Medical history included high blood pressure (controlled with RX). There were no known allergies. No other vaccine was received in four weeks. Patient received other medications in two weeks. Historical vaccine included bnt162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 02Mar2021, (Lot Number: el9266) as single dose for Covid-19 immunisation (age at vaccination was 55 years). On 23Mar2021, the patient about 1 hour after shot her stomach started feeling upset and she stopped at a rest area, had diarrhea and gas. This continued some through the evening. On 24Mar2021 (The next day), while outside with her friend, she passed out, ended up with a busted head and bruised/broke elbow/don't know if it chipped elbow or just bruised. She could feel it was coming on but then it started to pass, and the next thing was that she woke up in her driveway. No treatment received for events. No covid prior vaccination and no covid tested post vaccination was reported. The outcome for all the event(s) was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Erythema, Hypersensitivity
Clinical narrative: every day her legs they get red and allergies on her legs and arms; anaphylactic shock; every day her legs they get red and allergies on her legs and arms; This is a spontaneous report from a contactable consumer (husband) or other Non-HCP.   A 26-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an 22Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not allergic. On 22Mar2021 at 07:00 PM (same day of vaccination), the patient experienced anaphylactic shock. The patient had allergy every day. Clinical course of the event was as follows: The patient had red and allergies on her legs and arms all started after vaccination.  Patient had not got attention required where she needed an allergist, she went to the hospital, they said they don't have an allergist. And this needs to be treated. She had got appointment to see an allergist which was after 4 months. She does have a primary doctor and took appointment for next day however she did not get any solution at that moment. She was informed that that a contact would be made but not done. On an unspecified date, the patient went to the doctor and they gave her medicine but she had allergy felt like she was about to die they had to give her a shot so she could come back after the vaccine. She was taking medicine but had continuous allergy every day. The patient wanted to report the event to pharmacy and FDA. Outcome of anaphylactic shock was unknown and outcome of red and allergies on her legs and arms was not resolved.   Information on lot/batch no. has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Persistent swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself) of 36-years-old non pregnant received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Jan2021 01:15Pm in Arm Left (Batch/Lot Number: EL1284) and dose 2 via an unspecified route of administration on 24Jan2021 11:15 Am (Batch/Lot Number: EL3247) in Arm left both as single dose for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing. No Allergies to medications, food, or other products. Prior to the COVID vaccine, patient didn't receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had been tested for COVID-19. The patient's concomitant medications were not reported. On 24Jan2021 03:00, after second dose the patient experienced persistent swollen lymph nodes and were swollen for a week. Now they were frequently swollen. Event does not caused hospitalization. No treatment was received for the adverse event caused. The patient underwent lab tests and procedures which included sars-cov-2 test results negative on an unspecified date. Outcome of event was reported as not recovered.   No follow up attempts were possible. No further information was expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Pain
Clinical narrative: Headache; Body aches; Light headed; Loss of energy; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Pfizer er8730, Expiration date: unknown) via an unspecified route of administration on 22Mar2021 at 13:00 on left arm at single dose for COVID-19 Immunization. Medical history included Chrones. The concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 16:00 (24-hour clock), patient experienced headache, body aches, Lightheaded and Loss of energy. The patient did not receive any treatment for the events. The reporter assessed the event as non-serious. The events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperacusis, Migraine, Photophobia
Clinical narrative: Headaches; migraines; Light and noise sensitivity.; noise sensitivity; This is a spontaneous report from a contactable consumer or other non hcp. A 43-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 05:15 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. Medical history included hashimotos thyroid, drug hypersensitivity, food allergy unknown if ongoing, drug hypersensitivity from unknown if ongoing, allergies to medications, food, or other products Cipro, doxycycline. Concomitant medication(s) included sertraline hcl (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; alprazolam (ALPRAZOLAM) taken for an unspecified indication, start and stop date were not reported. On 09Feb2021 the patient experienced headaches, migraines, light and noise sensitivity, noise sensitivity. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive; tested positive; This is a spontaneous report reported by a contactable consumer regarding a male patient. A contactable consumer (Reporter's father) reported for an unspecified age male patient received first dose of BNT162B2 (formulation: Solution for injection, lot number: unknown, Expiration date; unknown), unspecified route of administration on unspecified date at 0.3 mL, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not have allergies. Reporter father was hospitalized and tested positive a week after taking the 1st dose of Covid-19 vaccine on unspecified date, father doesn't have an appointment also for the 2nd dose and he would like to know also how long do they need to wait to get the 2nd dose of his father. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; vomiting; This is a spontaneous report from a non-contactable consumer (Patient herself). A 38-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6203, Expiration Date: Unknown) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization in the workplace clinic. The patients medical history included colitis and IBD (Inflammatory bowel disease) from an unknown date and unknown if ongoing. The patient had no allergies to medications, food or other products. Concomitant medication included Mesalamine. The patient previous received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 for COVID-19 Immunization. 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 not tested after vaccination. The patient experienced nausea and vomiting approximately 22 hours and again 28 hours after receiving vaccine on 25Mar2021 at 08:00.   Follow-up action is closed, further information is cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted Covid; he contracted Covid in between the doses; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 08Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received his first dose of the Pfizer Covid Vaccine last 08Mar2021 and would be receiving his 2nd dose on 29Mar2021. However, he contracted Covid in between the doses and would come off from isolation on 28Mar2021 and would be released to work on 29Mar2021. Wanted to know if it's ok to get his second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, COVID-19, Drug ineffective, Fatigue, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID-19/tested positive for COVID; diagnosed with COVID-19/tested positive for COVID; she was tired; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 58-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 17Mar2021 06:40 (at the age of 58-years-old) as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (lot: EL9266) in left arm on 22Feb2021 at about 07:30 (at the age of 58-years-old) for covid-19 immunisation. The vaccination facility type was stated that was like a wellness center, an urgent care, hospital clinic and the vaccine was not administered at military facility. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). There were no primary infection site, no predisposing factors, no culture performed and no antipyretic Use (around the date of vaccination). Medical history included did not have the best immune system and has some vitamin deficiencies. Concomitant medication included bamlanivimab. The patient's second vaccine was 23 days after the first vaccine. The patient received the second dose on 17Mar2021 and tested positive 20Mar2021 for the Covid virus. The patient stated that her husband tested positive for the Covid virus as well. The patient asked if she will need to get another vaccine. This Saturday (20Mar2021 at 18:00), they were diagnosed with COVID-19 and they were currently still battling it. The patient got the result on 20Mar2021 at 18:00, and describes as it got worse, but then it plateaued. The patient wanted to know if having COVID-19 at the time of vaccination lessen the efficacy of the vaccine. The patient wanted to know if she should take another shot because she has COVID-19 at the time of vaccination. The patient was not going to fill out her husband's report, she was tired. The height reported as 5 foot 1 and a half. The events did not require emergency room visit, no hospitalization as of yet. They gave her monoclonal antibodies at the Urgent Care. They scheduled that at the Urgent Care. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021336109 same reporter/drug/event, different patient
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: allergic reaction; Rash; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Mar2021 (Batch/Lot number: EN6207) at single dose (at 20-year-old) in arm right for COVID-19 immunization. Medical history was reported as none. Ongoing concomitant medication included galcanezumab (EMGALITY injection) monthly; and ethinylestradiol/ norethisterone acetate (HAILEY) daily; both for an unspecified indication from an unspecified date. The patient got the vaccine on 23Mar2021 (Tuesday), then noticed the rash on 24Mar2021 (Wednesday) evening about 9 pm it started in chest and abdomen and over the last couple of days it spread down to some of arms and legs. It's a mild rash over a decent part of her body. She believed it's an allergic reaction frankly. She had been taking diphenhydramine hydrochloride (BENADRYL). She was taking it three times now over the last Wednesday. The rash was still there (persisting).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Paraesthesia
Clinical narrative: feeling weak; she feels like she can hardly stand/I felt weak like I couldn't even stand up; tingling in the back of her neck as well; This is a spontaneous report from a contactable consumer reported for herself. A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Mar2021 at single dose for COVID-19 immunisation. Medical history included auto-immune disorder. Concomitant medications were not reported. The patient stated she had been feeling weak, she felt weak when standing up, and she felt like she can hardly stand. She had been feeling this way for the past 2 weeks. However, it seems like it's getting better today. She felt tingling in the back of her neck as well.  She just wanted to know after the first vaccine does anybody got weak 'legs and hand overall (not clear nor clarified). Patient just wondered if she should even get the second shot, she didn't know if it had to do anything with it or 'if it's not'. Patient added she had autoimmune disease, so that's why she was wondering. The outcome of events was unknown.   Information for lot number/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: severe vertigo started Wednesday morning and still have it and can't stand up; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 16:45 (Batch/Lot Number: ER8730) at the age of 43-years-old as single dose for covid-19 immunisation. Medical history reported as none. The patient's concomitant medications were none. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She experienced side effects 3 days after the administration of the first dose of the Pfizer's COVID-19 vaccine she experienced severe vertigo started Wednesday morning and still have it and can't stand up on 24Mar2021. Adverse event result in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe vertigo included Meclazine RX. 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 not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Upset stomach 2 days after 1st COVID vaccine shot; This is a spontaneous report received from a non-contactable consumer (Patient). A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on an unknown date in  Mar2021 (Batch/Lot Number: ER2613) at the age of 33-years-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. 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 and since the vaccination, the patient was not been tested for COVID-19. The patient experienced upset stomach 2 days after 1st covid vaccine shot on an unknown date in Mar2021. The outcome of the event unknown.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Lethargy, Vaccination site pain
Clinical narrative: Pain at injection site; lightheadedness/dizzy; lethargic; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25Mar2021 12:15 (Batch/Lot Number: UNKNOWN) at the age of 65-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Public Health Clinic. Medical history included Peanut oil allergy. Concomitant medications included lisinopril taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took the first dose of bnt162b2 for covid-19 immunization on 04Mar2021 12:15 PM at Left arm. The patient experienced pain at injection site, lightheadedness/dizzy, lethargic on 26Mar2021 10:30. No treatment received for the events. 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 recovering. Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Injection site soreness; Aches and tiredness starting about 24 hours after injection; Aches and tiredness starting about 24 hours after injection.; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 11:30 (Batch/Lot Number: EK5730) at the age of 41-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Workplace clinic. Patient was not pregnant. Medical history included High Blood Pressure, Hypoparathyroidism, allergies to Penicillin, Bleach. The patient concomitant medication included unspecified medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: EJ1685) at left arm on 04Mar2021 11:00 AM for covid-19 immunisation. The patient experienced injection site soreness, aches and tiredness starting about 24 hours after injection on 26Mar2021 11:00 AM. No treatment received for the events. 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 recovering.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis
Clinical narrative: chills; sweats; tired; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:00 (Batch/Lot Number: EP6955) at the age of 54-years-old as single dose for covid-19 immunisation. Patient was not pregnant. Medical history included hypertension, osteo-arthritis. Concomitant medications included candesartan cilexetil (ATACAND) taken for an unspecified indication, start and stop date were not reported; vitamin B2 [riboflavin] taken for an unspecified indication, start and stop date were not reported; vitamin D2 taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ10) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (Lot number: EL3247) on 03Mar2021 10:00 AM at left arm for covid-19 immunization. The patient had chills and sweats and was really tired on 25Mar2021 07:30 PM. No treatment received for the events. 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 recovering.
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: having memory issues from her stroke; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included stroke. The patient's concomitant medications were not reported. On an unspecified date, the patient was having memory issues from her stroke. She had her stroke a while ago, but was still unable to recall when, only stating that it was before her vaccination. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID-19/tested positive for COVID; diagnosed with COVID-19/tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports.  A 47-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date and received the second dose on 15Mar2021 (at the age of 47-year-old), both via an unspecified route of administration at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Mar2021, the patient was diagnosed with COVID-19 and currently still battling it. The consumer further reported that her husband had his second dose last week, on Monday (15Mar2021), and hers was given on Wednesday. She reported that they both tested positive for COVID on 20Mar2021, after, and they are still trying to beat it. The consumer wanted to know if having COVID-19 at the time of vaccination lessen the efficacy of the vaccine. The patient had not yet recovered from the events.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335455 same reporter/drug/event, different patient
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Hyperhidrosis
Clinical narrative: Extreme tiredness; sweating; confusion; This is a spontaneous report received from a non-contactable consumer (patient herself). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 10:00 (lot number: unknown) as single dose for covid-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. Pregnant at the time of vaccination was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced extreme tiredness extreme tiredness, sweating and confusion on 26Mar2021 with outcome of not recovered. No treatment was received for events.  Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Vaginal haemorrhage
Clinical narrative: I began to bleed and pass blood clots from my vagina; I began to bleed and pass blood clots from my vagina; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 11Mar2021 01:15 (at the age of 32 years) (Batch/Lot Number: EN6208) as a single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medications were not reported. The patient is not pregnant. On 13Mar2021 04:00, the patient began to bleed and pass blood clots from her vagina. The event blood clots was assessed as serious (medically significant). The patient visited the doctor for the events and the events were given treatment. The outcome of the events was not recovered.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paresis, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Tiredness; headache; slight numbness of right side of face; slight loss of muscle control in right side of face; This is a spontaneous report received from a non-contactable consumer (patient). A 35-year-old male patient received first dose of bnt162b2 (Batch/Lot Number: 953738), at the age of 35-year-old via an unspecified route of administration, administered in left arm on 21Mar2021 as single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced tiredness, headache, slight numbness of right side of face, slight loss of muscle control in right side of face all on 27Mar2021 16:00. No treatment received for the adverse events. The events were reported as non-serious. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient didn't 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 hadn't been tested for COVID-19. Not allergies to medications, food, or other products. The outcome of events was not resolved.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine with aura, Paraesthesia, Seasonal allergy
Clinical narrative: severe seasonal allergy symptoms; Headache; Extended migraine. severe intermittent aural effects (loss of vision, shots of light, looks snow on a TV); tingling in limbs- hands, toes, left side of face; This is a spontaneous report received from a contactable consumer (patient).  This 39-year-old female patient (no pregnant ) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 20Mar2021 14:00 (Lot Number: ER8727) at single dose for COVID-19 immunization. Medical history included allergy: allergies to medications, food, or other products was not known. Concomitant medications included ascorbic acid, cobalt sulfate, copper sulfate, ergocalciferol, ferrous fumarate, magnesium sulfate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, vitamin b12 nos, zinc gluconate (MULTIVITAMIN (16)); oenothera biennis oil (EVENING PRIMROSE); cetirizine for allergy. The patient experienced severe seasonal allergy symptoms, headache, extended migraine with severe intermittent aural effects (loss of vision, shots of light, looks snow on a TV) tingling in limbs, hands, toes, and left side of face on 21Mar2021 at 23:45. Symptoms had come and go 10 and more times a day, but seemed to be decrease in frequency and severity lessening. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was no diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. Seriousness criteria: results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect was no. Treatment received for the adverse events included Tylenol. The outcome of the events was recovering.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test, White blood cell count
Clinical narrative: Fever/temperature was 99.6/ 99.4 /99.3; This is a spontaneous report from a contactable consumer. A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 via an unspecified route of administration on 25Mar2021 09:00 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. Medical history included heart valve replacement from 13Nov2019 to an unknown date (His heart operation was 13Nov2019 it has been 16 months that he has been inactive), chronic myeloid leukaemia from 2018 to an unknown date, accumulating fluid around the lung sack from an unknown date and unknown if ongoing aortic stenosis (from an unknown date and unknown if ongoing (They changed the heart valve because he had aortal stenosis), heart murmur from an unknown date and unknown if ongoing (He went in to see his general practitioner and a woman there said he had a heart murmur) cough from an unknown date and unknown if ongoing (Caller states he has a little cough. He quit smoking several years ago and has been coughing ever since. The cough was prior to COVID-19 vaccines) fell from Nov2020 to an unknown date (Caller fell the first week of Nov2020 and that is how long the process has taken. He has been in pain for months. Caller clarified that his hospitalizations and fall were prior to getting the vaccine). The patient previously took first dose of bnt162b2 for covid-19 immunisation and sprycel and experienced kidneys were failing. (Caller clarified that the hospitalization he had for 8 days was when he was on Sprycel and he was hospitalized because his kidneys were failing). Caller clarified that he has a fever, but he is not sure what it is because of the thermometer. Earlier today it was 99.6. It is now 2:24PM (State name) time, so it has been 5.5 hours since the vaccine on 25Mar2021. His temperature was 99.6 then 99.4 then 99.3. Frankly he doesn't trust it. He had positive experience both times he got the COVID Vaccine. The patient underwent lab tests and procedures which included body temperature: 99.6 on 25Mar2021 body temperature: 99.4 on 25Mar2021 body temperature: 99.3 on 25Mar2021 white blood cell count: unknown results on (When he went to the doctor to get checked he had unusual white blood cells running). The outcome of the event was reported as unknown.   No follow up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Inappropriate schedule of product administration, Off label use
Clinical narrative: administration date 12Feb2021/administration date 26Jan2021; administration date 12Feb2021/administration date 26Jan2021; had breakthrough bleeding for the first time ever. Periods were significantly heavier with massive clots; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249 and expiration date not provided), via an unspecified route of administration, in left arm, on 12Feb2021 10:00 (at the age of 37-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history was not reported. Patient has no known allergies to medications, food, or other products. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No concomitant medication (reported as "patient received no medications within 2 weeks of vaccination"). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 26Jan2021 (at the age of 37-year-old), at single dose, for COVID-19 immunization. In Feb2021 and Mar2021 patient had breakthrough bleeding for the first time ever. Periods were significantly heavier with massive clots. Patient saw OBGYN, but no reason found except vaccine side effect. Event result in doctor or other healthcare professional office/clinic visit. No treatment received. Patient had not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: this past Saturday, she tested positive; This is a spontaneous report from a patient reported for herself. An 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202) via unknown route first dose on 10Mar2021, at an unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the 1st dose covid vaccine on 10Mar2021. She has tested negative for covid infection every Saturday since then. However, this past Saturday (Mar2021), she tested positive. She is scheduled to receive the 2nd dose of the covid vaccine on 31Mar2021. Patient would like to know whether she can get the 2nd dose of the covid vaccine although she has tested positive for covid after the 1st dose. Patient would like to know if she still has to wait the isolation period (10 days) before returning for her second dose if she tests negative tomorrow. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.