chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Sleep disorder
Clinical narrative: Fever; Chills; I couldn't Sleep; This is a spontaneous report received from a contactable consumer (Patietn). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: May2021), Solution for injection, via an unspecified route of administration, administered in Arm Left on 23Feb2021 11:00 (at the age of 48-year-old) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for blood pressure abnormal. Patient historic vaccine included first dose of BNT162B0 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot: Not reported), Solution for injection, via unspecified route of administration, via unknown route on an unspecified date as single dose for COVID-19 immunization. On 23Feb2021, the patient experienced fever, chills and couldn't sleep. The patient underwent lab tests and procedures which included body temperature: 103, 102 and 101 on 23Feb2021. It was reported that, yesterday she received her second dosage of Pfizer vaccine. First one was okay for her, it was a little arm pain, but yesterday was terrible for her. She got the shot at 11 O'clock at the daytime, she was fine she was able to work. She worked from 3 to 11 but when she came at night like 11 in the evening, she came home took her shower yesterday started to chill and whole night she couldn't sleep. She had fever 103; 102; 101 and she couldn't even sleep. Her complaint was chills and fever whole night today. At that moment, at the night time she didn't take anything (did not take any treatment) she took a shower thought it is going to help her. The events were recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Skin burning sensation, Vaccination site pain
Clinical narrative: Intense pain at injection sight. Almost felt like it was burning at some points. Received the vaccine at 7:30am. ~9:30pm I started running a fever and had a mild fever all night. The fever has gone; Burning at some point; Fever; Headach; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 07:30 (at the age of 27years), (Batch/Lot Number: EN 5318) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021, (Batch/Lot Number: EN 5318) as DOSE 1, SINGLE for covid-19 immunisation. Patient stated, on 16Feb2021 9:30PM experienced, Intense pain at injection sight. Almost felt like it was burning at some points. Received the vaccine at 7:30am., 9:30pm started running a fever and had a mild fever all night. The fever has gone away, but now he was left with a headache. The patient did not receive any treatment for the events. The clinical outcome of the event fever was recovered in 2021 and all other events were recovering at the time of report.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Caller was prescribed antibiotics for sinus infection after the 1st dose; This is a spontaneous report from contactable consumer (Patient) via Pfizer Sponsored Program COVAX US Support. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot: number: unknown) via an unspecified route of administration on 30Jan2021 as DOSE 1 SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sinus infection. She stated that she was prescribed antibiotics for sinus infection after the 1st dose. 1st dose received last 30Jan and scheduled to receive the 2nd dose on 20Feb. Asking if she could still receive the 2nd dose? Therapeutic measures were taken as a result of sinus infection and included treatment with antibiotics. The outcome of event was unknown.   Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Retching
Clinical narrative: nauseas; dry heaves; fever; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer reported for a female patient (mom) that. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Calling for mom Just had 1st dose of covid vaccine. Has normal symptoms of vaccine. Said she has nauseas, dry heaves and fever on an unspecified date. Wants to know if we recommend anything. He is concerned if he should stay with her. Advised to reach out to HCP. The event outcome was Unknown.  Information for lot number/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A male patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL9269, expiry date: unknown), via an unspecified route of administration, on Feb 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Feb 7, 2021, patient experienced pain in the arm and shoulder. His arm got better, with outcome of recovering. Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Insomnia, Pain, Pyrexia
Clinical narrative: Fever (highest of 102 degrees); severe body aches; severe chills; unable to sleep; This is a spontaneous report from a contactable consumer. This consumer reported for a 24-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9267; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at age of 24-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at time of vaccination. Patient's medical history was none. Patient had not other medical history nor any known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO) and levothyroxine sodium (SYNTHROID) taken for an unspecified indication. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3249; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 26Jan2021 (at age of 23-years-old) for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not COVID prior vaccination. On 24Feb2021 12:00 the patient experienced fever, severe body aches, severe chills and unable to sleep. Patient did not receive any treatment for AEs. Patient had not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: highest of 102 degrees on unspecified date. The outcome of all events was recovering.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blood pressure measurement, Heart rate, Heart rate increased, Investigation
Clinical narrative: increased HR; This is a spontaneous report from a contactable Other Health Care Professional. A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3302) via intramuscular route of administration, on 09Feb2021 at 11:00 (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. Medical history included hashimoto's disease, hypotension and depression. Concomitant medications included duloxetine, bupropion and pregabalin. The patient allergies were unknown. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) as dose 1, single for COVID-19 Immunization. It was unknown if the patient was pregnant. On 09Feb2021 at 11:05, the patient complained of increased heart rate approximately 15-20 minutes after vaccine was given. Facility type vaccine: Public Health Clinic/Administration facility. Patient notified observer, and medical called to area. Patient taken to the first aid area for assessment. At 11:10 the patient's blood pressure was 116/76, heart rate 88, Respiratory rate 18, oxygen saturation was 98 percent on right arterial (RA). The patient alert and oriented (A & O) was x3, Skin assessment (pink, warm and dry) P/W/D, moves all extremities well (MAEW) was x4. Radial pulses 3+. It was reported that the patient reassessed by provider on duty nurse and emergency medical services (EMS) includes: blood pressure 112/72, heart rate 82, respiratory rate 16, oxygen saturation was 99 precent on RA. The patient did not received treatment. It was unknown if the patient received other vaccine in four weeks. It was unknown if covid prior vaccination and it was unknown if tested for covid post vaccination. No further symptoms noted at that time and provider cleared patient for discharge home. Patient was monitored until approximately 11:40 and the outcome of the event was recovered on 09Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Radial pulse, Respiratory rate
Clinical narrative: increased HR; This is a spontaneous report from a contactable Other Health Care Professional. A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3302) via intramuscular route of administration, on 09Feb2021 at 11:00 (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. Medical history included hashimoto's disease, hypotension and depression. Concomitant medications included duloxetine, bupropion and pregabalin. The patient allergies were unknown. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) as dose 1, single for COVID-19 Immunization. It was unknown if the patient was pregnant. On 09Feb2021 at 11:05, the patient complained of increased heart rate approximately 15-20 minutes after vaccine was given. Facility type vaccine: Public Health Clinic/Administration facility. Patient notified observer, and medical called to area. Patient taken to the first aid area for assessment. At 11:10 the patient's blood pressure was 116/76, heart rate 88, Respiratory rate 18, oxygen saturation was 98 percent on right arterial (RA). The patient alert and oriented (A & O) was x3, Skin assessment (pink, warm and dry) P/W/D, moves all extremities well (MAEW) was x4. Radial pulses 3+. It was reported that the patient reassessed by provider on duty nurse and emergency medical services (EMS) includes: blood pressure 112/72, heart rate 82, respiratory rate 16, oxygen saturation was 99 precent on RA. The patient did not received treatment. It was unknown if the patient received other vaccine in four weeks. It was unknown if covid prior vaccination and it was unknown if tested for covid post vaccination. No further symptoms noted at that time and provider cleared patient for discharge home. Patient was monitored until approximately 11:40 and the outcome of the event was recovered on 09Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Daughter said arm hurt for 2 days; injection site was red and hot; injection site was red and hot; This is a spontaneous report from a non-contactable consumer (parent) via Pfizer sponsored program COVAX US Support. A 24-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing autistic. Concomitant medication was not reported. On an unspecified date of 2021 the patient experienced daughter said arm hurt for 2 days, injection site was red and hot. Patient was rubbing or itching but injection site was red and hot. Want to know what we recommend. Not clarified if daughter was Autistic before or after vaccine and for side effect. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: Can't properly move her feet within the past hour after receiving the first dose; Numbness in toes and bottoms of feet; This is a spontaneous report from a contactable consumer or other non hcp.     A 45-year-old female (non-pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered on 24Feb2021 08:45  (at the age of 45-years-old)  as SINGLE DOSE for covid-19 immunisation.  Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, OCD (obsessive-compulsive disorder) from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, Allergy to drug from an unknown date and unknown if ongoing (Most pain medications). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was yes. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. The patient stated received first dose of vaccine today at 8:45am. Caller said her toes become numb on 24Feb2021 15:45 and can't properly move her feet within the past hour after receiving the first dose on an unspecified date. Therapeutic measure were taken as no for events. The outcome of event numbness in toes and bottoms of feet was not recovered and outcome of event can't properly move her feet within the past hour after receiving the first dose was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 29-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 29, via an unspecified route of administration, left arm, on Feb 24, 2021, at 11:00, single dose, for COVID-19 immunization.  Medical history not reported. The patient's concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On Feb 24, 2021, patient experienced numbness in the face (primarily on left-side including lips). The outcome of the events: not recovered. This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nausea, Pain
Clinical narrative: fever up to 100.6 F; nausea; a major headache; Fatigue; body aches; This is a spontaneous report from a contactable consumer. This 26-year-old non pregnant female consumer reported for herself. A 26-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number EN5318) via an unspecified route of administration in arm left on 16Feb2021 09:15 as dose 2, single (age at vaccination: 26 years) for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included sertraline hydrochloride (ZOLOFT) 50 mg, daily taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number EN5318) via an unspecified route of administration in arm left on 26Jan2021 09:15 as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. No covid prior vaccination and did not test covid post vaccination. No known allergies. On 16Feb2021, 09:00 PM, after 12 hours of second dose the patient experienced nausea and a major headache then developed a fever up to 100.6 F, fatigue and body aches as well. No treatment was received. The patient underwent lab tests and procedures which included fever resulted as 100.6 fahrenheit on 16Feb2021. The clinical outcome of the events was resolving.  Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever up to 100.6 F; nausea; a major headache; Fatigue; body aches; This is a spontaneous report from a contactable consumer. This 26-year-old non pregnant female consumer reported for herself. A 26-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number EN5318) via an unspecified route of administration in arm left on 16Feb2021 09:15 as dose 2, single (age at vaccination: 26 years) for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included sertraline hydrochloride (ZOLOFT) 50 mg, daily taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number EN5318) via an unspecified route of administration in arm left on 26Jan2021 09:15 as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. No covid prior vaccination and did not test covid post vaccination. No known allergies. On 16Feb2021, 09:00 PM, after 12 hours of second dose the patient experienced nausea and a major headache then developed a fever up to 100.6 F, fatigue and body aches as well. No treatment was received. The patient underwent lab tests and procedures which included fever resulted as 100.6 fahrenheit on 16Feb2021. The clinical outcome of the events was resolving.  Follow-up attempts completed. No further information expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Low grade fever; chills; body aches; This is a spontaneous report from a Non contactable Consumer. This consumer reported for a 22-Years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration on 03Feb2021 (at age of 22-Years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Patient had not other medical history. Patient had not known allergies. There was no any other vaccine in four weeks. Patient had not COVID prior vaccination. The patient experienced low grade fever, chills and body aches on 03Feb2021. Patient did not receive any treatment for AEs. Patient had not COVID tested post the vaccination. The outcome of all events was resolved on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Pain, Pain in extremity
Clinical narrative: Weakness; I am still lot tired and achy; I am still lot tired and achy; Arm hurt really bad; Rash all over my stomach and back; Exhaust; Dizziness; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 49-years-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 15Feb2021 (Batch/Lot Number: EL9267) (at the age of 49-years-old) as SINGLE for covid-19 immunisation. Medical history included blood pressure high and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication(s) included atenolol; levothyroxine sodium (SYNTHROID); omeprazole (PROTONIX [OMEPRAZOLE]), metoclopramide and lisinopril; all taken for an unspecified indication, start and stop date were not reported. The patient got vaccine 3 days ago and the first night the patient had the dizziness (Voice feeble) but it went away and second day arm hurt really bad. Then yesterday was exhaust and now today the patient got rash all over abdomen (Voice break) and back when woken up. The patient was extremely tired and should get the second shot or not. Now, rash all over stomach and back. When probed for the outcome of the event, the dizziness and weakness improved but, still lot tired and achy, just not feeling well and rash is concerning at this point. The outcome of events dizziness and weakness was recovering, whereas, still lot tired and achy was not recovered. Other events was unknown.  Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Weakness; I am still lot tired and achy; I am still lot tired and achy; Arm hurt really bad; Rash all over my stomach and back; Exhaust; Dizziness; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 49-years-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 15Feb2021 (Batch/Lot Number: EL9267) (at the age of 49-years-old) as SINGLE for covid-19 immunisation. Medical history included blood pressure high and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication(s) included atenolol; levothyroxine sodium (SYNTHROID); omeprazole (PROTONIX [OMEPRAZOLE]), metoclopramide and lisinopril; all taken for an unspecified indication, start and stop date were not reported. The patient got vaccine 3 days ago and the first night the patient had the dizziness (Voice feeble) but it went away and second day arm hurt really bad. Then yesterday was exhaust and now today the patient got rash all over abdomen (Voice break) and back when woken up. The patient was extremely tired and should get the second shot or not. Now, rash all over stomach and back. When probed for the outcome of the event, the dizziness and weakness improved but, still lot tired and achy, just not feeling well and rash is concerning at this point. The outcome of events dizziness and weakness was recovering, whereas, still lot tired and achy was not recovered. Other events was unknown.  Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: rash the next day, 16Feb2021, where the vaccine was administered; itchy; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported for a patient (wife).   A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6201, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 15Feb2021 at 13:20 (at the age of 72-years-old) as a DOSE 1, SINGLE for covid-19 immunization. The patient medical history included ongoing parkinson's disease. Concomitant medications reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Prior Vaccinations within 4 weeks were None. events following prior vaccinations was reported as, she usually gets a rash following vaccinations where she gets the rash. It usually goes away as it is one of the side effects. On 16Feb2021, 10 hrs 40 min, the patient experienced rash the next day, 16Feb2021, where the vaccine was administered and itchy. he reported that she had the vaccine on 15Feb2021, and she had a reaction after the vaccine. she had a rash the next day, 16Feb2021, where the vaccine was administered it seems to be getting better, but it was still itchy. she did not have a reaction right away (date unspecified). Patient had Parkinson's and wanted to know if she could put a cream on there or what. It was reported that, the rash looks like a little light red, not as red now as it was. the caller said that his wife has Parkinson's and said that she takes a lot of different medications when queried. The reporter said that was covering her upper arm where she got the vaccination. The reporter clarified that the rash is on his wife's right arm. next vaccination was planned on 08Mar2021. family Medical History relevant to AE was none. relevant tests done were None. Events did not require a visit to, emergency Room or Physician Office. Outcome of both the events were recovering.  Follow-up attempts completed. No further information expected
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in his right hip and shoulder.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported for male patient(husband) of an unknown age received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration in left arm on 16Feb2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced pain in his right hip and shoulder. It was reported that No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Both caller and her husband got their 1st doses on Tuesday. The patient's HCP scheduled him out 4 weeks instead of 3. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts were completed. No further information was expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills throughout the night and following day; low grade fever (never reaching higher than 101); This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 25-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:45 (age at the vaccination 25-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes first dose of COVID vaccine (COMIRNATY, solution for injection, lot number: EL3247) on 27Jan2021 02:45 PM as DOSE 1, SINGLE for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills throughout the night and following day, low grade fever (never reaching higher than 101) on 17Feb2021 23:30. The patient underwent lab tests and procedures which included body temperature never reaching higher than 101 on 17Feb2021. The patient did not receive any other treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Chills, Cough, Diarrhoea
Clinical narrative: coughing; diarrhea; headaches; weak/no energy; no taste; chilling; Neither of us felt very well; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection Lot Number: UNKNOWN), via an unspecified route of administration on 10Feb2021 17:15 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient Medical history included hypertension, inflammation and blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included (VERAPAMIL) taken for hypertension, (PROBENECID) taken for an unspecified indication, start and stop date were not reported; (MELOXICAM) taken for inflammation. The patient concomitant medication also included several meds for high BP and medication for cholesterol. On 10Feb2021, the patient did not feel very well on the day he took the shot. On 11Feb2021, the patient had been coughing, was weak, no taste, chilling, diarrhea, no energy and headaches. The patient had no fever. The patient was not hungry but food was tasteless. The patient did not receive any treatment for the adverse events. The clinical outcome of events was not recovered.  Information about Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171112 Same drug/ reporter, different patient/ AE
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: coughing; diarrhea; headaches; weak/no energy; no taste; chilling; Neither of us felt very well; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection Lot Number: UNKNOWN), via an unspecified route of administration on 10Feb2021 17:15 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient Medical history included hypertension, inflammation and blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included (VERAPAMIL) taken for hypertension, (PROBENECID) taken for an unspecified indication, start and stop date were not reported; (MELOXICAM) taken for inflammation. The patient concomitant medication also included several meds for high BP and medication for cholesterol. On 10Feb2021, the patient did not feel very well on the day he took the shot. On 11Feb2021, the patient had been coughing, was weak, no taste, chilling, diarrhea, no energy and headaches. The patient had no fever. The patient was not hungry but food was tasteless. The patient did not receive any treatment for the adverse events. The clinical outcome of events was not recovered.  Information about Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171112 Same drug/ reporter, different patient/ AE
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Joint pain; swollen lymph nodes; headache; tiredness; fever; nausea; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jan2021 at 14:00 hours (Batch/Lot Number: EL9262) as DOSE 2, SINGLE (at the age of 36-years-old) for COVID-19 immunisation. The patient's medical history included HIV on treatment from an unknown date and unknown if ongoing. The patient's concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY). The patient had known allergies with acetaminophen, dipyrone, and aspirin. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jan2021 at 12:00 PM (Batch/Lot Number: PAA156051) as DOSE 1, SINGLE (at the age of 36-years-old) for COVID-19 immunisation. On 23Jan2021 at 23:00 hours, the patient experienced joint pain, headache, tiredness, fever, swollen lymph nodes, and nausea. Therapeutic measures were taken as a result of the adverse events. The patient underwent lab tests and procedures which included body temperature: fever on 23Jan2021. The patient received treatment with Piroxicam 20 mg, one dose for the adverse events. The patient did not have any other vaccine in four weeks. The patient did not have COVID prior vaccination and had not got COVID tested post vaccination. The patient recovered from the events on an unspecified date in 2021.  Follow-up (14Jun2021): Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Joint pain; swollen lymph nodes; headache; tiredness; fever; nausea; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jan2021 at 14:00 hours (Batch/Lot Number: EL9262) as DOSE 2, SINGLE (at the age of 36-years-old) for COVID-19 immunisation. The patient's medical history included HIV on treatment from an unknown date and unknown if ongoing. The patient's concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY). The patient had known allergies with acetaminophen, dipyrone, and aspirin. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jan2021 at 12:00 PM (Batch/Lot Number: PAA156051) as DOSE 1, SINGLE (at the age of 36-years-old) for COVID-19 immunisation. On 23Jan2021 at 23:00 hours, the patient experienced joint pain, headache, tiredness, fever, swollen lymph nodes, and nausea. Therapeutic measures were taken as a result of the adverse events. The patient underwent lab tests and procedures which included body temperature: fever on 23Jan2021. The patient received treatment with Piroxicam 20 mg, one dose for the adverse events. The patient did not have any other vaccine in four weeks. The patient did not have COVID prior vaccination and had not got COVID tested post vaccination. The patient recovered from the events on an unspecified date in 2021.  Follow-up (14Jun2021): Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Neck pain, Pain, Vaccination site pain
Clinical narrative: There is some residual pain today; headache; Sore left arm within first 24 hours of injection; body pains especially in the neck and armpit area; body pains especially in the neck and armpit area; This is a spontaneous report from a non-contactable consumer or other non-HCP. A 37-years old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration in Left arm on 17Feb2021 09:30 (age at the time of vaccination 37-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccine in four weeks. No Other medications in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration in Left Arm on 26Jan2021 11:45 (age at the time of vaccination 37-years-old), as a single dose for COVID-19 immunization. On 18Feb2021 09:30, the patient experienced headache, Sore left arm within first 24 hours of injection, body pains especially in the neck and armpit area, and There is some residual pain today. No treatment received for adverse events. No covid prior vaccination. No covid tested post vaccination. The outcome of all the events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: Fever starting 14-16 hours after. Fever lasting 50-60 hours. Mostly around 100 degress, but topped out at 102.5; shakes; Minimal pain at injection site; Aches and pains starting about 12 hours after; This is a spontaneous report from a contactable consumer (Patient). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 16:00 (at the age of 35 year) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration in right arm on 22Jan2021 at 18:00 as dose 1, single (at the age of 35 year) for COVID-19 immunisation. On 13Feb2021 at 06:00, patient experienced minimal pain at injection site. Aches and pains started about 12 hours after. Aches, pains, shakes lasted about 36 hours. On 15Feb2021, 14-16 hours after, patient experienced fever. Fever lasting 50-60 hours. Mostly around 100 degrees but topped out at 102.5. The patient underwent lab tests and procedures on 15Feb2021 which included body temperature: 100 centigrade and 102.5 centigrade. It was reported that no therapeutic measures were taken for the events experienced. The outcome of event fever was recovered on 17Feb2021, for shaking and ache was recovered on 14Feb2021 at 18:00 and for Vaccination site pain was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Headache, Pain, Pyrexia
Clinical narrative: chest tightness; Chills; Fever; Body Aches; Headache; This is a spontaneous report from a contactable nurse (patient). A 33-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Feb2021 at 12:00 hours as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) in two weeks included nebivolol hydrochloride (Bystolic) and fluoxetine hydrochloride (Prozac) (both taken for an unspecified indication, start and stop date were not reported). Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination. On 17Feb2021, at 15:45 hours, patient had fever, chills, body aches, headache, and chest tightness. On 17Feb2021, patient had been tested for COVID-19 (qualitative polymerase chain reaction) post vaccination using nasal swab, rapid test and result was negative. Patient received no treatment for the events. Patient had doctor or other healthcare professional office/clinic visit for the events. The outcome of all the events was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: chest tightness; Chills; Fever; Body Aches; Headache; This is a spontaneous report from a contactable nurse (patient). A 33-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Feb2021 at 12:00 hours as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) in two weeks included nebivolol hydrochloride (Bystolic) and fluoxetine hydrochloride (Prozac) (both taken for an unspecified indication, start and stop date were not reported). Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination. On 17Feb2021, at 15:45 hours, patient had fever, chills, body aches, headache, and chest tightness. On 17Feb2021, patient had been tested for COVID-19 (qualitative polymerase chain reaction) post vaccination using nasal swab, rapid test and result was negative. Patient received no treatment for the events. Patient had doctor or other healthcare professional office/clinic visit for the events. The outcome of all the events was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: after 24 hours small redness and itchy; Sore arm up to 48 hours; after 24 hours small redness and itchy; This is a spontaneous report from a contactable consumer or other non health care professional (Patient). A 32-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Feb2021 12:00 as unknown single dose for covid-19 immunization. (Vaccination facility: Pharmacy or Drug Store). The patient medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within four weeks. Patient was not diagnosed with covid prior to vaccination. Had no allergies. On 17Feb2021 19:00 patient experienced Sore arm up to 48 hours and after 24 hours small redness and itchy. Patient was not tested for covid post vaccination. Patient did not receive any treatment for the events. The outcome for the events was reported as resolving at the time of this report.  Follow-up (12May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Pain
Clinical narrative: Fever; Chills; Chatter; Fatigue; Aches; Headache; This is a spontaneous report received from a contactable consumer (patient himself). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at (upper) right arm on 16Feb2021 (Lot Number: EL9266) as single dose for COVID-19 immunisation. Medical history included patient had COVID-19 in the year of 2020 to 2020 (that's why he had such severe reactions). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at deltoid right on 26Jan2021 14:00 (Lot number: EL9262) for COVID-19 immunization and patient experienced chatter, fever, chills, fatigue, ache, headache, myalgia, malaise, asthenia, nausea, arthralgia, injection site pain, musculoskeletal stiffness, gait disturbance and feeling abnormal. The patient wants to report an adverse reaction to the COVID Vaccine and he had fever, chills, chatter, fatigue, aches, and headache on 16Feb2021. It happened with the first shot on 26Jan2021 and then it subsided after 4 days and then it happened again 16Feb2021 with the second shot. They are milder no more fever but some headache and some aches. The patient received just Tylenol for the treatment of events. Outcome of event fever was recovered on an unspecified date in 2021, for chills, chatter and fatigue was unknown and for aches and headache was not recovered.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Chatter; Fatigue; Aches; Headache; This is a spontaneous report received from a contactable consumer (patient himself). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at (upper) right arm on 16Feb2021 (Lot Number: EL9266) as single dose for COVID-19 immunisation. Medical history included patient had COVID-19 in the year of 2020 to 2020 (that's why he had such severe reactions). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at deltoid right on 26Jan2021 14:00 (Lot number: EL9262) for COVID-19 immunization and patient experienced chatter, fever, chills, fatigue, ache, headache, myalgia, malaise, asthenia, nausea, arthralgia, injection site pain, musculoskeletal stiffness, gait disturbance and feeling abnormal. The patient wants to report an adverse reaction to the COVID Vaccine and he had fever, chills, chatter, fatigue, aches, and headache on 16Feb2021. It happened with the first shot on 26Jan2021 and then it subsided after 4 days and then it happened again 16Feb2021 with the second shot. They are milder no more fever but some headache and some aches. The patient received just Tylenol for the treatment of events. Outcome of event fever was recovered on an unspecified date in 2021, for chills, chatter and fatigue was unknown and for aches and headache was not recovered.  Follow-up attempts completed. No further information expected.