chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Electrocardiogram, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Extremely sore swollen left arm; Extremely sore swollen left arm; Intense burning on (left side primarily) upper torso front and back; At night I Experienced the burning with additional sensations of (fluttering/nerve?) impulses which lasted 2-3 days.; Fatigue lasted about 14 days; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8982, Expiry date: not reported), via an unspecified route of administration in left arm on 14Jan2021 18:00 (at age of 78-years-old) as dose 1, single for covid-19 immunisation. Medical history included thyroid and known allergy: foods. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 15Jan2021 at 09:00, the patient experienced extremely sore swollen left arm, extremely sore swollen left arm, intense burning on (left side primarily) upper torso front and back, at night I experienced the burning with additional sensations of (fluttering/nerve) impulses which lasted 2-3 days and fatigue lasted about 14 days. The patient was unable to determine if sensations were external although the patient did not seem to have any symptoms of heart related issues. The patient questioned taking 2nd dose. On 05Feb2021, the patient went to doctor and she ran an electrocardiogram (EKG) which didn't indicate any change since her lasted previous one performed. To patient's knowledge, the patient had no negative heart conditions. It was at her suggestion that the patient was submitting the information for data. The adverse events resulted in doctor's clinic visit. The patient underwent lab tests and procedures which included electrocardiogram: didn't indicate any change on 05Feb2021. No therapeutic measures were taken in response to the events. The events at night I experienced the burning with additional sensations of (fluttering/nerve) impulses which lasted 2-3 days and fatigue lasted about 14 days recovered in Jan2021 while the outcome of rest of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: Extremely sore swollen left arm; Extremely sore swollen left arm; Intense burning on (left side primarily) upper torso front and back; At night I Experienced the burning with additional sensations of (fluttering/nerve?) impulses which lasted 2-3 days.; Fatigue lasted about 14 days; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8982, Expiry date: not reported), via an unspecified route of administration in left arm on 14Jan2021 18:00 (at age of 78-years-old) as dose 1, single for covid-19 immunisation. Medical history included thyroid and known allergy: foods. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 15Jan2021 at 09:00, the patient experienced extremely sore swollen left arm, extremely sore swollen left arm, intense burning on (left side primarily) upper torso front and back, at night I experienced the burning with additional sensations of (fluttering/nerve) impulses which lasted 2-3 days and fatigue lasted about 14 days. The patient was unable to determine if sensations were external although the patient did not seem to have any symptoms of heart related issues. The patient questioned taking 2nd dose. On 05Feb2021, the patient went to doctor and she ran an electrocardiogram (EKG) which didn't indicate any change since her lasted previous one performed. To patient's knowledge, the patient had no negative heart conditions. It was at her suggestion that the patient was submitting the information for data. The adverse events resulted in doctor's clinic visit. The patient underwent lab tests and procedures which included electrocardiogram: didn't indicate any change on 05Feb2021. No therapeutic measures were taken in response to the events. The events at night I experienced the burning with additional sensations of (fluttering/nerve) impulses which lasted 2-3 days and fatigue lasted about 14 days recovered in Jan2021 while the outcome of rest of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Upper respiratory tract congestion
Clinical narrative: terrible burning; also in her 'upper respiratory tract'; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on 10Feb2021 as dose 1, single for covid-19 immunisation. Medical history included acid reflux disease, asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, Caller received the 1st dose of the Pfizer vaccine 10Feb2021, however on that night she had terrible burning also in her upper respiratory tract. Caller would like to know whether she should get the 2nd dose of the Pfizer covid vaccine and would like to know how much she is covered after 1 dose of the Pfizer covid vaccine and would like to know whether she could switch between 2 different brands of the covid vaccine. The outcome of events was unknown.  Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Influenza like illness, Pain, Vaccination site pain
Clinical narrative: arm soreness at the injection site; weakness; flu like symptoms; from her shoulder down to her hand, armpit, and shoulder blade.; upset stomach; This is a spontaneous report from a Non-contactable Consumer.   A 69 years female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 03Feb2021 as dose 1, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. It was reported that patient received her first Pfizer Covid-19 vaccine on 03Feb2021 and her second dose was due 25Feb2021. Caller stated after her first vaccination patient had experienced left arm soreness at the injection site, from her shoulder down to her hand, armpit and shoulder blade and the caller also stated she did not even pick up a piece of paper, weakness for a day or two and soreness that lasted until the next morning and she had flu like symptoms and an upset stomach. Her first Pfizer Covid-19 vaccine was given in her left arm and the caller wanted to know if she should switch getting the second vaccination to her right arm instated. At the time of reporting, the outcome of the events were unknown.  No Follow-up attempts are possible. No information is expected further.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Nausea
Clinical narrative: diarrhoea; lightheadedness; heavy feeling in stomach; Nausea; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A 72-year-old male patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 29Jan2021 as DOSE 1 and dose 2 on 19Feb2021(at the age of 72-year-old) for COVID-19 immunization. Medical history included type 2 diabetes mellitus and hypertension from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination the patient was not tested for COVID-19. Concomitant medications included metformin, furosemide, potassium chloride (LASIK), amlodipine, insulin glargine (BASAGLAR) and gabapentin (GABAPENTIN). The patient previously took tamsulosin and testosterone transdermal patch and was allergic to these medications. On 19Feb2021 the patient experienced nausea (heavy feeling in stomach, creeping up to meet the same thing in the back of my throat). On an unspecified date patient experienced diarrhea and intermittent light headedness. The patient did not receive any treatment for the adverse events. The events outcome was reported as recovering for nausea and resolved for diarrhea and intermittent light headedness. Outcome for the event heavy feeling in stomach was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Swollen limp nods on left side of neck.; Immediately my arm ached where shot was given; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 66-year-old non-pregnant female 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 17Feb2021 at 08:00 (Lot Number: EN5318) as dose 2, single (at the age of 66-year-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination.Medical history included hypertension and thyroid from an unknown date and unknown if ongoing. The patient did not have COVID prior vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), lisinopril, glucosamine and multi vitamin (all received within two weeks) all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced Known allergies. Historical vaccine included first dose of bnt162b2 on 24Jan2021 at 11.00 (Batch/lot number: Unknown, administered in right arm) (at the age of 65-year-old) for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. On 19Feb2021 at 08.00, the patient experienced swollen limp nods on left side of neck, Same side where patient was given the second vaccination. Appeared exactly 2 days later. Immediately patient arm ached where shot was given and was still achy two days later but not as much. The patient not tested for COVID post vaccination. No treatment received for events.The outcome of events reported as not recovered.  Follow-up attempts completed. No further information expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Night sweats, Pain
Clinical narrative: headache; low grade fever; chills; body ache; trouble sleeping; night sweats; The initial case was missing the following minimum criteria: Duplicate cases Upon receipt of follow-up information on 24Feb2021, this case now contains all required information to be considered valid This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number: el3247, expiry date not provided) via an unknown route of administration, administered in Arm Right on 18Feb2021 11:45 AM as DOSE 2, SINGLE (at the age of 55-year-old) for covid-19 immunisation. The patient's medical history was not provided. Historical vaccine included first dose of bnt162b2(BNT162B2) administered in Arm Right on 28Jan2021 11:45 AM as DOSE 1, SINGLE (at the age of 55-year-old) for covid-19 immunisation. Patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had no known allergies. The patient did not receive any concomitant medications within 2 weeks of vaccination with the Covid-19 vaccine. On 19Feb2021, after received the second dose of the Pfizer vaccine, patient experienced headache, low grade fever, chills, body ache, trouble sleeping and night sweats. The patient underwent lab tests which included body temperature: low grade fever on 19Feb2021 and nasal swab for sars-cov-2 antibody test: negative on 02Feb2021. The patient was not received any treatment for events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test, Sleep deficit
Clinical narrative: headache; low grade fever; chills; body ache; trouble sleeping; night sweats; The initial case was missing the following minimum criteria: Duplicate cases Upon receipt of follow-up information on 24Feb2021, this case now contains all required information to be considered valid This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number: el3247, expiry date not provided) via an unknown route of administration, administered in Arm Right on 18Feb2021 11:45 AM as DOSE 2, SINGLE (at the age of 55-year-old) for covid-19 immunisation. The patient's medical history was not provided. Historical vaccine included first dose of bnt162b2(BNT162B2) administered in Arm Right on 28Jan2021 11:45 AM as DOSE 1, SINGLE (at the age of 55-year-old) for covid-19 immunisation. Patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had no known allergies. The patient did not receive any concomitant medications within 2 weeks of vaccination with the Covid-19 vaccine. On 19Feb2021, after received the second dose of the Pfizer vaccine, patient experienced headache, low grade fever, chills, body ache, trouble sleeping and night sweats. The patient underwent lab tests which included body temperature: low grade fever on 19Feb2021 and nasal swab for sars-cov-2 antibody test: negative on 02Feb2021. The patient was not received any treatment for events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Diarrhea; she had sore arm; This is a spontaneous report received from a contactable consumer (patient). A (age: 79; Units: unknown) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not provided) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller stated her first dose for Pfizer covid vaccine was on 15Feb2021. she had sore arm for 1 and a half days. She experienced Diarrhea started today, 4 days later (19Feb2021) from the first shot. caller wanted to know about it. Outcome of events was unknown.  Information about lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Limb discomfort, Pain in extremity
Clinical narrative: Diarrhea; she had sore arm; This is a spontaneous report received from a contactable consumer (patient). A (age: 79; Units: unknown) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not provided) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller stated her first dose for Pfizer covid vaccine was on 15Feb2021. she had sore arm for 1 and a half days. She experienced Diarrhea started today, 4 days later (19Feb2021) from the first shot. caller wanted to know about it. Outcome of events was unknown.  Information about lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Screaming
Clinical narrative: bad nightmares, yelling and screaming type of nightmares; bad nightmares, yelling and screaming type of nightmares; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Feb2021 (at the age of 61-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated she received the 1st dose on Friday 12Feb2021 and starting Saturday night she's been having "bad nightmares, yelling and screaming type of nightmares and it's every night" has this been reported with the vaccine. As per caller she saw the physician assistant today and mentioned this but was not aware of nightmares as being a side effect they also discussed other products she been taking for long time has not been taking anything new. Outcome of the events was unknown.   Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Malaise, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 74 year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date not reported), at the age of 74, via an unspecified route of administration, on Feb 17, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On Feb 17, 2021, patient received the first dose of Pfizer vaccine. Two hours later, she felt dizzy for 3-4 seconds but then it went away. At 5:30-6 pm, she developed nausea, headache, chills and "felt crappy." It would come and go. Then at 10 am the next morning she developed a headache and still feeling unwell. She then took some Tylenol around 2 pm and then felt okay. She was great last night. Then this morning, she felt a little nausea, headache, had chills and still feeling rundown. Nausea still lingers, comes and goes. She wants to know how long side effects usually last. Can I take Tylenol or ibuprofen for side effects? She is due for the second vaccine on Mar 10, 2021. Will the side effects be worse with the second dose? Patient received treatment with Tylenol around 2 pm for headache and still felt unwell. Then she felt okay and was great last night. The outcome for dizzy recovered on Feb 17, 2021; and for the events nausea, headache, chills and "felt crappy" unknown. Information on the batch/lot number requested. Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: mild fatigue (same day); sore left arm at the injection site; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection and Lot Number: EL9261) via an unspecified route of administration in left arm on 22Jan2021 15:30 (age at Vaccination 44 years) as a single dose for COVID-19 immunization. Medical history included blood pressure and heart burn. Concomitant medications included she took medications in two weeks for blood pressure and heart burn. No other vaccine in four weeks, no COVID prior vaccination, no tested COVID post vaccination and none known allergies were reported. Patient stated that after the first dose she experienced with mild fatigue (same day) and sore left arm at the injection site. No treatment was received for the events. The outcome events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable physician. A 83-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 83, intramuscularly, on Feb 19, 2021, single dose, for COVID-19 immunization. Medical history included diabetes and use of a pacemaker from an unknown date and unknown if ongoing. The patient's concomitant medications not reported. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. On Feb 19, 2021, patient felt a heaviness and tingling of both arms after the injection. Treatment received for the events: water and apple juice; had normal vitals. The outcome of the events: resolving. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, SARS-CoV-2 antibody test
Clinical narrative: chill and stuff; diarrhea; nausea; This is a spontaneous report from a contactable consumer (Patient wife).  A male patient of an unspecified age received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 05Feb2021 as dose1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's wife reported that she and her husband received the first vaccine on 05Feb2021. On 10Feb2021 she got COVID-19 and her husband was negative. She stated her husband had experienced "chills and stuff, no fever, no body aches, but he had nausea and diarrhea. She asked if she should have him retested. The patient underwent lab tests and procedures which included Covid test negative. Outcome of the events was unknown.    Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: I had experienced chills about 12 hours following the injection; my upper body was extremely sore; I was extremely fatigued; This is a spontaneous report from a non-contactable consumer (patient). A 33-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in left arm on 17Feb2021 at 13:30 (at the age of 33-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included supraventricular tachycardia treated in 2013. The patient's concomitant medications were not reported. Patient had no known allergies. Patient received previously first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in left arm on 23Jan2021 at13:00 (at the age of 33-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no Covid prior to vaccination and not Covid tested post vaccination. On 18Feb2021, at 01:00 the patient experienced chills about 12 hours following the injection. By the next morning, my upper body was extremely sore and I was extremely fatigued. The soreness lasted for about 36 hours following injection. The patient had no treatment for the events. The out-come of soreness was recovered on 19Feb2021 and rest event recovered on unspecified date of Feb2021.  No follow-up attempts are possible. No further information is expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Breast tenderness
Clinical narrative: Breast tenderness with swelling and not under the armpits.; Breast tenderness with swelling and not under the armpits.; This is a spontaneous report from a contactable other hcp (patient). A 52-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Right on 05Feb2021 09:00 (age at vaccination 52-Years-old) (Lot Number: EL9265) as DOSE 2, SINGLE for covid-19 immunization. Medical history included hypertension and allergy to sulphur drugs. The patient's concomitant medications were not reported. The patient received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 14Jan2021 05:00 (age at vaccination 52-Years-old) (Lot Number: EK4176) as DOSE 1, SINGLE for covid-19 immunization. Patient was not tested for COVID prior or post vaccination. Patient did not receive any other vaccine in four weeks. Patient was not pregnant during vaccination. On 12Feb2021 07:00, the patient experienced breast tenderness with swelling and not under the armpits. No therapeutic measures were taken with respect to events. At the time of this report, the outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Nausea, Pain
Clinical narrative: Body aches; headache; nausea; elevated temperature; This is a spontaneous report from a contactable consumer (Patient). A 23-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Feb2021 12:00 PM (at the age of 23-year-old) as dose 2, single administered in right arm for COVID-19 immunisation. The patient's medical history was reported as none and had no known allergies. Concomitant medication included LORYNA for birth control, start and stop dates were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) on 28Jan2021 at 2:30 PM, as single dose in right arm for covid-19 immunisation. The patient did not receive other vaccine in four weeks. On 18Feb2021 at 16:00, the patient experienced body aches, headache, nausea, and had elevated temperature. The patient underwent lab tests and procedures which included elevated body temperature on 18Feb2021. The patient had no COVID-19 prior vaccination and was not tested for COVID post vaccination. The patient received treatment with Tylenol. The clinical outcome of events was resolving at the time of report. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report received from a non-contactable consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and batch no: not reported/lot number: not reported) via an unspecified route of administration, on an unknown date in Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient mentioned that, she received the first shot of the vaccine last week and she presented nausea recently, on an unknown date in Feb2021. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number was not reported, Expiry date was not reported) via an unspecified route of administration on 17Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date of 2021 patient reported that she has been feeling extremely tired after vaccination. Patient added that the main thing was nausea, 2 days later she still has nausea. The patient specified she had to sleep for 11.5 hours. She asked if her experience included in the reported side effects of the COVID-19 vaccine. The outcome for the event extremely tired was unknown, and for the event nausea was not recovered. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: mild headache; muscle sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 29-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 18Feb2021 (at the age of 30-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date the patient experienced mild headache and muscle sore. The patient did not receive treatment for events. The outcome for the events was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female patient of age 73 (unspecified unit) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 12Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medication was not reported. On an unspecified date, the patient experienced runny nose.The patient reported that, she received first dose of vaccine on 12Feb2021. She said she was experiencing a runny nose. The patient stated she was scheduled for second dose on 01Mar2021. The patient reported that, she noticed it isn't the 3 week mark and would like to know if this is too soon. The patient also mentioned she forgot to notify vaccination provider that she takes blood thinners. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Muscle spasms/twitches that started roughly 6 hours after administration and peaked around 12 hours; Feet, calf, thighs, abdomen, bag, shoulder, neck and roof of mouth were all twitching; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via intramuscularly in left arm on 18Feb2021 at 12:00 as dose 2 single (at the age of 20-year-old) for COVID-19 immunization. Medical history was reported as none. Patient had no Known allergies. Patient did not receive any other vaccine in four weeks. Concomitant medication in two weeks included ethinylestradiol, norgestimate (TRI LINYAH). Patient was not pregnant at the time of vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via intramuscularly in left arm on 23Jan2021 at 10:00 AM as dose 1 single (at the age of 20-year-old) for COVID-19 immunization The patient was not diagnosed with Covid prior to vaccination. On 18Feb2021 at 18:00, patient experienced muscle spasms/twitches that started roughly 6 hours after administration and peaked around 12 hours. Feet, calf, thighs, abdomen, bag, shoulder, neck and roof of mouth were all twitching. No treatment was received for the adverse events. Patient had not Covid tested post vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain
Clinical narrative: Immediate pain in left shoulder; muscle spasm to left shoulder and cervical spine,reduced range of motion to head/neck and left Shoulder that is ongoing one month following 2nd vaccine; This is a spontaneous report from a contactable nurse. A 39-year-old female nurse non-pregnant received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL1283 ), dose 2 via an unspecified route of administration, administered in the left arm on 13Jan2021 at 08:00 am as a single dose for (at the age of 39-year-old) COVID-19 immunisation. The patient previously received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL1284) dose 1 via an unspecified route of administration, administered in left arm on 23Dec2020 at 07:30 pm as a single dose for (at the age of 39 year) COVID-19 immunisation in hospital. The patient's medical history included headache. She previously took bnt162b2, amoxicillin and experienced drug hypersensitivity. Concomitant medications included sulfamethoxazole, trimethoprim (MOTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and received other medication in two weeks include motrin. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient experienced Immediate pain in left shoulder, muscle spasm to left shoulder and cervical spine. Ongoing pain, severe in nature. muscle spasm, reduced range of motion to head/neck and left Shoulder that was ongoing one month following 2nd vaccine. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events include Cervical x-ray, prescriptions and Physical therapy. The outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: little pain and itchiness by the injection site; little pain and itchiness by the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 13Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced little pain and itchiness by the injection site on an unspecified date. The outcome of the event was unknown.  Information about lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cold sweat, Dizziness, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 17Feb2021 11:45 (Lot Number: EL9264) (at the age of 63-years old) as dose 1, single for covid-19 immunisation. Medical history included hepatitis b, psoriasis, hypothyroidism. Patient had no allergies to food. Concomitant medications included apremilast; entecavir; levothyroxine sodium, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks of vaccination. The patient did not have covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 20Feb2021 15:15, the patient experienced chest pain, nausea, cold sweat and dizziness. The events resulted in emergency room/department or urgent care visit. The patient did not receive any treatment for the adverse events. The outcome of the events was recovering.  Follow-up (17May2021): Follow-up attempts were completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: Headache; fatigue; nausea; This is a spontaneous report from a contactable nurse or other hcp (patient).   A 66-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot number: EN6200, Expiration date was not reported) via an unspecified route of administration, administered in left arm on 18Feb2021 at 09:15 AM (at the age of 66-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history included hypertension from an unknown date and unknown if ongoing and patient had no known allergies. The patient's concomitant medications included lisinopril and metoprolol both taken for an unspecified indication, start and stop date were not reported. patient did not tested COVID prior vaccination. patient did not received any other vaccine within four weeks. On 19Feb2021 at 12:00PM, 1 day after first dose the patient experienced headache, nausea and fatigue. The patient underwent lab tests and procedures which included nasal swab or qualitative PCR sars-cov-2 test on 19Feb2021 which result was pending. Therapeutic measures were taken as a result of headache however not relieved by Advil and no treatment received for nausea and fatigue. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: left upper arm was warm to the touch; left upper arm has become redder; upper left arm was swollen; spotty discoloration all over her left upper arm that starts about 2" above her left elbow; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 17Feb2021 11:05 (Batch/Lot Number: EN6200) at the age of 71 years, as dose 2, single for COVID-19 immunisation. Medical history included lung cancer diagnosed about 3 years ago and has been in remission for approximately 2 years. There were no concomitant medications. The patient previously received her first dose of BNT162B2 via intramuscular route in the same arm (Arm, Left Upper) on 27Jan2021 (Lot number: EL9264). The patient had no other prior vaccinations within 4 weeksThe patient stated she seems to be having a reaction to the arm that she had received the COVID-19 Vaccine shot. On 17Feb2021, the patient experienced upper left arm was swollen and she had a spotty discoloration all over her left upper arm that starts about 2" above her left elbow. On 22Feb2021, left upper arm was warm to the touch and has become redder. The patient asked if it was common to have that type of reaction, and to have the reaction last as long as 5 days after getting the COVID-19 Vaccine. Patient declined any treatment. Events did not require emergency room or physician office visit. She clarified that her left upper arm swelling seems to have worsened. She said her left upper arm has become slightly bigger and redder. She said she noticed her left upper arm was warm to the touch. Patient had no relevant test. Reported she signed up for COVID-19 Vaccine tracker on the (smartphone based tool name). No further details were provided. Outcome of the events was not recovered. Events were reported as non-serious.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bowel movement irregularity, Chills, Diarrhoea
Clinical narrative: rashy at injection sitewent down almost to the elbow (stayed for 4 days, itchy at the site)/arm was red and rashy to her elbow; rashy at injection sitewent down almost to the elbow (stayed for 4 days, itchy at the site)/arm was red and rashy to her elbow; The injection site was swollen and hot, there was redness all the way down to her elbow, and it itched; The injection site was swollen and hot, there was redness all the way down to her elbow, and it itched; The injection site was swollen and hot, there was redness all the way down to her elbow, and it itched; She was very tired; had a headache all day long that was real bad; had muscle pain at the joints; joint pain; she still shook; she felt her head and it was hot; she had nausea and had to take a pan with her to the bathroom in case she vomited; She was dizzy; Her bowels were cleaned out, it wasn't watery but it was complete- she went about 3 times; she was not feeling well; still weak; wind pipe was mucosy/her wind pipe she felt like a big lump of phlegm; Her heart was having fast heartbeats that day; body aches and pains; chills; fever; loose stools; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer patient of unknown age reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 04Feb2021 as dose 1, single for COVID-19 immunization. The medical history of the patient included strokes. She stated later her daughter-in-law, son, and granddaughter came down with covid but the caller and her son were negative. She stated she even slept with her granddaughter during that time. They tested 7 days later and were still negative. The concomitant medications were not reported. On an unknown date the post vaccination patient had all the side effects. The injection site was swollen and hot, there was redness all the way down to her elbow, and it itched. She was very tired, had a headache all day long that was real bad, had muscle pain at the joints, joint pain, and chills all day long. Even with a blanket over her and thick pants, socks, and shoes she still shook. She did not take her temperature but she felt her head and it was hot, she had nausea and had to take a pan with her to the bathroom in case she vomited. She was dizzy when she got up to bathroom. Her bowels were cleaned out, it was not watery but it was complete- she went about 3 times. She does not know about her lymph nodes but she was not feeling well. She went from the couch to the bed at 10:00 to sleep and got up the next morning and was okay but still weak. She stated over her windpipe she felt like a big lump of phlegm. Her heart was having fast heartbeats that day. She asked if she should she go back for the second dose of the vaccine given all of these symptoms. The event outcome was unknown.   No follow-up attempts were possible, information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: rashy at injection sitewent down almost to the elbow (stayed for 4 days, itchy at the site)/arm was red and rashy to her elbow; rashy at injection sitewent down almost to the elbow (stayed for 4 days, itchy at the site)/arm was red and rashy to her elbow; The injection site was swollen and hot, there was redness all the way down to her elbow, and it itched; The injection site was swollen and hot, there was redness all the way down to her elbow, and it itched; The injection site was swollen and hot, there was redness all the way down to her elbow, and it itched; She was very tired; had a headache all day long that was real bad; had muscle pain at the joints; joint pain; she still shook; she felt her head and it was hot; she had nausea and had to take a pan with her to the bathroom in case she vomited; She was dizzy; Her bowels were cleaned out, it wasn't watery but it was complete- she went about 3 times; she was not feeling well; still weak; wind pipe was mucosy/her wind pipe she felt like a big lump of phlegm; Her heart was having fast heartbeats that day; body aches and pains; chills; fever; loose stools; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer patient of unknown age reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 04Feb2021 as dose 1, single for COVID-19 immunization. The medical history of the patient included strokes. She stated later her daughter-in-law, son, and granddaughter came down with covid but the caller and her son were negative. She stated she even slept with her granddaughter during that time. They tested 7 days later and were still negative. The concomitant medications were not reported. On an unknown date the post vaccination patient had all the side effects. The injection site was swollen and hot, there was redness all the way down to her elbow, and it itched. She was very tired, had a headache all day long that was real bad, had muscle pain at the joints, joint pain, and chills all day long. Even with a blanket over her and thick pants, socks, and shoes she still shook. She did not take her temperature but she felt her head and it was hot, she had nausea and had to take a pan with her to the bathroom in case she vomited. She was dizzy when she got up to bathroom. Her bowels were cleaned out, it was not watery but it was complete- she went about 3 times. She does not know about her lymph nodes but she was not feeling well. She went from the couch to the bed at 10:00 to sleep and got up the next morning and was okay but still weak. She stated over her windpipe she felt like a big lump of phlegm. Her heart was having fast heartbeats that day. She asked if she should she go back for the second dose of the vaccine given all of these symptoms. The event outcome was unknown.   No follow-up attempts were possible, information about lot/batch number could not be obtained.