chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: felt dizzy and felt like I wanted to faint; had a strike in blood pressure and was higher than my usual BP; My heart was beating faster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 04:30 (Lot number: FC3181) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUNEL FE 1/20. The following information was reported: DIZZINESS (non-serious) with onset 23Aug2021 10:45, outcome "not recovered", described as "felt dizzy and felt like I wanted to faint"; BLOOD PRESSURE INCREASED (non-serious) with onset 23Aug2021 10:45, outcome "not recovered", described as "had a strike in blood pressure and was higher than my usual BP"; HEART RATE INCREASED (non-serious) with onset 23Aug2021 10:45, outcome "not recovered", described as "My heart was beating faster". The events "felt dizzy and felt like i wanted to faint", "had a strike in blood pressure and was higher than my usual bp" and "my heart was beating faster" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, blood pressure increased, heart rate increased.  Additional information: The patient did not receive other vaccine in four weeks. The patient stated, she received first dose on 20Aug and on the third day (23rd), she felt dizzy and felt like she wanted to faint. She had a strike in blood pressure and was higher than my usual BP. Her heart was beating faster. Today is 29Aug, and she still have the same symptoms of feeling dizzy and faint. The patient was not diagnosed with Covid-19 prior vaccination. The patient was diagnosed with Covid-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety disorder, Depression
Clinical narrative: Within the first 24 hours after receiving each dose (3 total) of the vaccine, I had a sever depressive episode along with flare ups of my anxiety disorder. These subsided each time within 72 hours.; Within the first 24 hours after receiving each dose (3 total) of the vaccine, I had a sever depressive episode along with flare ups of my anxiety disorder. These subsided each time within 72 hours.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 12:00 (Lot number: EW0196) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE; ADDERALL; SERTRALINE; FERROUS SULFATE.  The following information was reported: DEPRESSION (non-serious), ANXIETY DISORDER (non-serious) all with onset 20Mar2021 12:00, outcome "recovered" (2021) and all described as "Within the first 24 hours after receiving each dose (3 total) of the vaccine, I had a sever depressive episode along with flare ups of my anxiety disorder. These subsided each time within 72 hours.". Therapeutic measures were not taken as a result of depression, anxiety disorder.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Known allergies NKA. Within the first 24 hours after receiving each dose (3 total) of the vaccine, I had a sever depressive episode along with flare ups of my anxiety disorder. These subsided each time within 72 hours.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood test, Fatigue
Clinical narrative: she and her husband received the first Pfizer Covid 19 Vaccine on 12April2021. They both felt tired after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Lot number: EW0151) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "she and her husband received the first Pfizer Covid 19 Vaccine on 12April2021. They both felt tired after the vaccine". The patient underwent the following laboratory tests and procedures: blood cholesterol: unknown; blood test: unknown.  Additional information: Consumer reported that she and her husband received the first Pfizer Covid 19 Vaccine on 12Apr2021. They both felt tired after the vaccine. Consumer stated for lab test  her husband and she had just had a wellness or like a annual and the doctor and that's really lab like you know blood work done for like regular. You know like the Cholesterol and we haven't gone over that with them yet.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Drug ineffective, Electrocardiogram, Electrocardiogram QRS complex normal
Clinical narrative: omicron 10Dec2021; Omicron 10Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jun2021 17:00 (Lot number: EW0196) as dose 2, single and administered in arm left, administration date 29May2021 17:00 (Lot number: EW0177) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing); "Chronic migraine" (ongoing). Concomitant medication(s) included: AMBIEN taken for migraine (ongoing); FLEXERIL [CEFIXIME] taken for migraine (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Dec2021, outcome "unknown", described as "omicron 10Dec2021"; SUSPECTED COVID-19 (medically significant) with onset 10Dec2021, outcome "recovering", described as "Omicron 10Dec2021". The patient underwent the following laboratory tests and procedures: blood test: (23Jun2021) normal; chest x-ray: (23Jun2021) normal; electrocardiogram: (23Jun2021) unknown results; (23Jun2021) normal; electrocardiogram qrs complex normal: (23Jun2021) 128 ms; electrocardiogram qt interval: (23Jun2021) 370 ms; (23Jun2021) 486 ms; electrocardiogram rr interval: (23Jun2021) 164 ms; electroencephalogram: (23Jun2021) normal; troponin (normal high range 14): (23Jun2021) less than 6, notes: Troponin T interpretation: Your value normal; weight: (unspecified date) weight gain on 10 pund; (unspecified date) weight gain on 10 pound. It was unknown if therapeutic measures were taken as a result of suspected covid-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EW0196 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods: lot EW0196, fill lot EP8741, and the formulated drug product lot EP8622 and lot EW0177, fill lot EP8728, and bulk formulation lot EP8609. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram QT interval, Electrocardiogram RR interval, Electroencephalogram, Suspected COVID-19, Troponin
Clinical narrative: omicron 10Dec2021; Omicron 10Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jun2021 17:00 (Lot number: EW0196) as dose 2, single and administered in arm left, administration date 29May2021 17:00 (Lot number: EW0177) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing); "Chronic migraine" (ongoing). Concomitant medication(s) included: AMBIEN taken for migraine (ongoing); FLEXERIL [CEFIXIME] taken for migraine (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Dec2021, outcome "unknown", described as "omicron 10Dec2021"; SUSPECTED COVID-19 (medically significant) with onset 10Dec2021, outcome "recovering", described as "Omicron 10Dec2021". The patient underwent the following laboratory tests and procedures: blood test: (23Jun2021) normal; chest x-ray: (23Jun2021) normal; electrocardiogram: (23Jun2021) unknown results; (23Jun2021) normal; electrocardiogram qrs complex normal: (23Jun2021) 128 ms; electrocardiogram qt interval: (23Jun2021) 370 ms; (23Jun2021) 486 ms; electrocardiogram rr interval: (23Jun2021) 164 ms; electroencephalogram: (23Jun2021) normal; troponin (normal high range 14): (23Jun2021) less than 6, notes: Troponin T interpretation: Your value normal; weight: (unspecified date) weight gain on 10 pund; (unspecified date) weight gain on 10 pound. It was unknown if therapeutic measures were taken as a result of suspected covid-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EW0196 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods: lot EW0196, fill lot EP8741, and the formulated drug product lot EP8622 and lot EW0177, fill lot EP8728, and bulk formulation lot EP8609. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: omicron 10Dec2021; Omicron 10Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jun2021 17:00 (Lot number: EW0196) as dose 2, single and administered in arm left, administration date 29May2021 17:00 (Lot number: EW0177) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing); "Chronic migraine" (ongoing). Concomitant medication(s) included: AMBIEN taken for migraine (ongoing); FLEXERIL [CEFIXIME] taken for migraine (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Dec2021, outcome "unknown", described as "omicron 10Dec2021"; SUSPECTED COVID-19 (medically significant) with onset 10Dec2021, outcome "recovering", described as "Omicron 10Dec2021". The patient underwent the following laboratory tests and procedures: blood test: (23Jun2021) normal; chest x-ray: (23Jun2021) normal; electrocardiogram: (23Jun2021) unknown results; (23Jun2021) normal; electrocardiogram qrs complex normal: (23Jun2021) 128 ms; electrocardiogram qt interval: (23Jun2021) 370 ms; (23Jun2021) 486 ms; electrocardiogram rr interval: (23Jun2021) 164 ms; electroencephalogram: (23Jun2021) normal; troponin (normal high range 14): (23Jun2021) less than 6, notes: Troponin T interpretation: Your value normal; weight: (unspecified date) weight gain on 10 pund; (unspecified date) weight gain on 10 pound. It was unknown if therapeutic measures were taken as a result of suspected covid-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EW0196 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods: lot EW0196, fill lot EP8741, and the formulated drug product lot EP8622 and lot EW0177, fill lot EP8728, and bulk formulation lot EP8609. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pain in extremity, X-ray
Clinical narrative: arm is hurting and she can't stand for air to hit her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6204) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, Batch/lot number: EL9269 , Dosage text: left arm), administration date: 08Feb2021, when the patient was 73 years old, for COVID-19 Immunization; Small pox vaccine (Vaccine mark from the small pox vaccine), for immunization, reaction(s): "vaccine mark". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "arm is hurting and she can't stand for air to hit her arm". The event "arm is hurting and she can't stand for air to hit her arm" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101067450 same reporter/vaccine/AE different patient.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, SARS-CoV-2 test
Clinical narrative: can't sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 21Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid 19 virus", start date: 2021 (unspecified if ongoing), notes: She has a caller on the line who had the Covid 19 virus about one month ago.; "having problems sleeping" (unspecified if ongoing), notes: She was having problems sleeping before the Covid 19 vaccine. The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset Aug2021, outcome "unknown", described as "can't sleep". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Acne, Oral herpes, Skin discomfort
Clinical narrative: Pimples on the rigth side of my face; Herpes Labialis; Skin irritations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Jul2021 10:30 (Batch/Lot number: unknown) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: LYNESTRENOL taken for contraception (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Single, Time: 17:45, Anatomical site of injection:  Left arm, Route of administration: Intramuscular, Batch/Lot number: EW0181), administration date: 25Jun2021, when the patient was 36 years old, for Covid-19 Immunization, reaction(s): "I had 3 pimples in a week", "had rashes", "my skin became rough", "I was diagnosed with Herpes Labialis". The following information was reported: ACNE (non-serious) with onset 02Jul2021, outcome "recovered with sequelae" (2021), described as "Pimples on the right side of my face"; SKIN DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Skin irritations"; ORAL HERPES (non-serious) with onset 02Jul2021, outcome "recovering", described as "Herpes Labialis". The events "pimples on the right side of my face" and "herpes labialis" were evaluated at the physician office visit. Therapeutic measures were taken as a result of acne, oral herpes.  Additional Information: A few days after the 1st dose patient had 3 pimples in a week and ended up with pimples and on the left face also had rashes and skin became rough. Since it was not improving with the acne treatment. She went to the doctor on 22Jul and I was diagnosed with Herpes Labialis which I had never had before( pimples). After my second dose she got pimples on the right side of my face it has cleared up more but still got unusual pimple, skin irritation. Even if her skin not known to be sensitive. Treatment taken was Betamethasone, Adapalene clindamycin, Claricort and Acyclovir 400 mg/ 7 days. Adverse event lead to the visit to Physician office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab Test result:Positive; Nasal Swab Test result:Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 (Lot number: EW0180) at the age of 37 years as dose 2, single and administered in arm left, administration date 19May2021 (Lot number: EW0182) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: verbatim: Migraines; "Psoriasis" (unspecified if ongoing), notes: verbatim: Psoriasis. The patient took concomitant medications. Past drug history included: Wellbutrin, reaction(s): "Known allergies:Wellbutrin", notes: verbatim: Wellbutrin. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "Nasal Swab Test result:Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive, notes: Nasal Swab. No any other vaccines within 4 weeks prior to the covid vaccine, no covid-19 diagnosed prior to vaccination, covid-19 was tested positive since the vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Blood test, Diffuse alopecia
Clinical narrative: Nasal Swab Test result:Positive; Nasal Swab Test result:Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 (Lot number: EW0180) at the age of 37 years as dose 2, single and administered in arm left, administration date 19May2021 (Lot number: EW0182) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: verbatim: Migraines; "Psoriasis" (unspecified if ongoing), notes: verbatim: Psoriasis. The patient took concomitant medications. Past drug history included: Wellbutrin, reaction(s): "Known allergies:Wellbutrin", notes: verbatim: Wellbutrin. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "Nasal Swab Test result:Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive, notes: Nasal Swab. No any other vaccines within 4 weeks prior to the covid vaccine, no covid-19 diagnosed prior to vaccination, covid-19 was tested positive since the vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Telogen effluvium; rapid hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 (Lot number: EW0180) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "scalp psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Wellbutrin, reaction(s): "known allergies: Wellbutrin". Vaccination history included: Bnt162b2 (Previous dose details: product=COVID 19, dose brand=Pfizer, lot number=EW0182, dose number=1, vaccine location=Left arm), administration date: 19May2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: DIFFUSE ALOPECIA (non-serious) with onset 23Jun2021, outcome "unknown", described as "Telogen effluvium"; ALOPECIA (non-serious) with onset 23Jun2021, outcome "not recovered", described as "rapid hair loss". The events "telogen effluvium" and "rapid hair loss" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diffuse alopecia, alopecia.  Additional information: The patient was not pregnant at the time of vaccination. Other vaccine in four weeks was reported as no. Other medications in two weeks was reported as yes. No covid prior vaccination and no covid tested post vaccination. It was reported that, the patient had Telogen effluvium: rapid hair loss occurred within 2 weeks after receiving 2nd dose. Full panel of blood work was done and all was normal. Hair loss has continued. Therapeutic measures included that, the patient was currently on spironolactone as well as nutrafol.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Blood test, Diffuse alopecia
Clinical narrative: Telogen effluvium; rapid hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 (Lot number: EW0180) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "scalp psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Wellbutrin, reaction(s): "known allergies: Wellbutrin". Vaccination history included: Bnt162b2 (Previous dose details: product=COVID 19, dose brand=Pfizer, lot number=EW0182, dose number=1, vaccine location=Left arm), administration date: 19May2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: DIFFUSE ALOPECIA (non-serious) with onset 23Jun2021, outcome "unknown", described as "Telogen effluvium"; ALOPECIA (non-serious) with onset 23Jun2021, outcome "not recovered", described as "rapid hair loss". The events "telogen effluvium" and "rapid hair loss" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diffuse alopecia, alopecia.  Additional information: The patient was not pregnant at the time of vaccination. Other vaccine in four weeks was reported as no. Other medications in two weeks was reported as yes. No covid prior vaccination and no covid tested post vaccination. It was reported that, the patient had Telogen effluvium: rapid hair loss occurred within 2 weeks after receiving 2nd dose. Full panel of blood work was done and all was normal. Hair loss has continued. Therapeutic measures included that, the patient was currently on spironolactone as well as nutrafol.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure measurement, Diarrhoea, Dizziness, Fatigue
Clinical narrative: TIRED; 10 MINUTES AFTERWARDS, WEIRD TASTE IN MY MOUTH; FIRST 2 DAY DIARRIA; 3RD DAY FAST HEARTBEART (RACING HEART); HIGH BLOOD PRESSURE; UPSET STOMACH; DIZZY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: FA6780) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRAMADOL. The following information was reported: FATIGUE (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "TIRED"; TASTE DISORDER (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "10 MINUTES AFTERWARDS, WEIRD TASTE IN MY MOUTH"; DIARRHOEA (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "FIRST 2 DAY DIARRIA"; HEART RATE INCREASED (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "3RD DAY FAST HEARTBEART (RACING HEART)"; HYPERTENSION (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "HIGH BLOOD PRESSURE"; ABDOMINAL DISCOMFORT (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "UPSET STOMACH"; DIZZINESS (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "DIZZY". The events "tired", "10 minutes afterwards, weird taste in my mouth", "first 2 day diarria", "3rd day fast heartbeart (racing heart)", "high blood pressure", "upset stomach" and "dizzy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fatigue, taste disorder, diarrhoea, heart rate increased, hypertension, abdominal discomfort, dizziness.  Additional information: Facility type vaccine: Pharmacy or drug store. No other vaccine in four weeks. Went to dr. on wed following, referred to cardiologist. Dr. wants to do a stress/echo test this week. never had any issues before shot. never had high blood pressure. No covid prior vaccination. Not tested for covid post vaccination. There were no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypertension, Taste disorder
Clinical narrative: TIRED; 10 MINUTES AFTERWARDS, WEIRD TASTE IN MY MOUTH; FIRST 2 DAY DIARRIA; 3RD DAY FAST HEARTBEART (RACING HEART); HIGH BLOOD PRESSURE; UPSET STOMACH; DIZZY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: FA6780) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRAMADOL. The following information was reported: FATIGUE (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "TIRED"; TASTE DISORDER (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "10 MINUTES AFTERWARDS, WEIRD TASTE IN MY MOUTH"; DIARRHOEA (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "FIRST 2 DAY DIARRIA"; HEART RATE INCREASED (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "3RD DAY FAST HEARTBEART (RACING HEART)"; HYPERTENSION (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "HIGH BLOOD PRESSURE"; ABDOMINAL DISCOMFORT (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "UPSET STOMACH"; DIZZINESS (non-serious) with onset 06Aug2021 12:30, outcome "not recovered", described as "DIZZY". The events "tired", "10 minutes afterwards, weird taste in my mouth", "first 2 day diarria", "3rd day fast heartbeart (racing heart)", "high blood pressure", "upset stomach" and "dizzy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fatigue, taste disorder, diarrhoea, heart rate increased, hypertension, abdominal discomfort, dizziness.  Additional information: Facility type vaccine: Pharmacy or drug store. No other vaccine in four weeks. Went to dr. on wed following, referred to cardiologist. Dr. wants to do a stress/echo test this week. never had any issues before shot. never had high blood pressure. No covid prior vaccination. Not tested for covid post vaccination. There were no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Blood sodium decreased, Blood test, Hyponatraemia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 08Jul2021 (Lot number: FA6780) at the age of 77 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "aching muscle" (unspecified if ongoing), notes: it's just it's dragging and aching the aching muscle. The patient took concomitant medications. The following information was reported: HYPONATRAEMIA (non-serious) with onset 26Jul2021, outcome "unknown", described as "my sodium chloride was little on the low side"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 26Jul2021, outcome "unknown", described as "high cholesterol"; MALAISE (non-serious) with onset 09Jul2021, outcome "unknown", described as "I suffered for months, when I got first shot and I didn't feel well for three weeks". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hyponatraemia, blood cholesterol increased, malaise. Additional information: The patient later got BNT162b2 (BNT162B2), administration date 30Jul2021(Lot number: FA7484) at the age of 78 years as dose 2, single for covid-19 immunisation and was exhausted and aching and headache and weak and just feel sick. Concomitant medications included Multivitamins and Calcium. The patient had not taken any other vaccine (4 weeks prior). The patient had fibromyalgia and chronic fatigue and it made it 10 times worse. Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 08Jul2021 (Lot number: FA6780) at the age of 77 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "aching muscle" (unspecified if ongoing), notes: it's just it's dragging and aching the aching muscle. The patient took concomitant medications. The following information was reported: HYPONATRAEMIA (non-serious) with onset 26Jul2021, outcome "unknown", described as "my sodium chloride was little on the low side"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 26Jul2021, outcome "unknown", described as "high cholesterol"; MALAISE (non-serious) with onset 09Jul2021, outcome "unknown", described as "I suffered for months, when I got first shot and I didn't feel well for three weeks". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hyponatraemia, blood cholesterol increased, malaise. Additional information: The patient later got BNT162b2 (BNT162B2), administration date 30Jul2021(Lot number: FA7484) at the age of 78 years as dose 2, single for covid-19 immunisation and was exhausted and aching and headache and weak and just feel sick. Concomitant medications included Multivitamins and Calcium. The patient had not taken any other vaccine (4 weeks prior). The patient had fibromyalgia and chronic fatigue and it made it 10 times worse. Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Limb discomfort, Myalgia, Vascular pain
Clinical narrative: heavy legs, feet; Muscle/vein pain; Muscle/vein pain; Can't walk after 3 hrs on my legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Aug2021 17:00 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Soy allergy" (unspecified if ongoing); "Shrimp allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VASCULAR PAIN (non-serious), MYALGIA (non-serious) all with onset 06Aug2021 08:00, outcome "not recovered" and all described as "Muscle/vein pain"; GAIT DISTURBANCE (non-serious) with onset 06Aug2021, outcome "not recovered", described as "Can't walk after 3 hrs on my legs"; LIMB DISCOMFORT (non-serious) with onset 29Aug2021, outcome "not recovered", described as "heavy legs, feet". The events "muscle/vein pain", "can't walk after 3 hrs on my legs", "heavy legs, feet" and "muscle/vein pain" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vascular pain, gait disturbance, limb discomfort, myalgia.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination was not applicable.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Change in menstrual cycle.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 14:30 (Lot number: EW0165) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no known allergies. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 03Aug2021 15:00, outcome "not recovered", described as "Change in menstrual cycle.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Patient received most recent COVID-19 vaccine was administered at hospital. Vaccine facility information was available. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. My period had ended two days prior to my 1st dose. It started again right after my injection and lasted from the 3rd -19th, an ultra tampon was soaked right after insertion. My period finally ended on the 19th and began again right after my 2nd dose which was 24Aug2021 cramping and more discomfort than usual, as if I'm a young woman.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Illness, Pain, Pain in extremity
Clinical narrative: lightheadedness / dizzyness; chills; shootingburning pain/dull aching pain; the body aches stayed and turned into a pins and needles sensation throughout my whole body but mostly in my arns and hands, as well as feet and legs; Then after a few weeks it changed to severe arm and hand pain; I am sick of it; body aches; Then after a few weeks it changed to severe arm and hand pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Sep2021 (Lot number: 30135BA) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PCOS," (unspecified if ongoing); "penicillin" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: ATIVAN; METHYLPREDNISOLONE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0179, Location of injection: Arm Right), for COVID-19 immunization, reaction(s): "dizzyness", "lightheadedness", "brain fog". The following information was reported: DIZZINESS (non-serious) with onset 18Sep2021, outcome "not recovered", described as "lightheadedness / dizzyness"; CHILLS (non-serious) with onset 18Sep2021, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 18Sep2021, outcome "not recovered", described as "shootingburning pain/dull aching pain"; PARAESTHESIA (non-serious) with onset 18Sep2021, outcome "not recovered", described as "the body aches stayed and turned into a pins and needles sensation throughout my whole body but mostly in my arns and hands, as well as feet and legs"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "not recovered" and all described as "Then after a few weeks it changed to severe arm and hand pain"; ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "I am sick of it"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "body aches". The events "lightheadedness / dizzyness", "chills", "shootingburning pain/dull aching pain", "the body aches stayed and turned into a pins and needles sensation throughout my whole body but mostly in my arns and hands, as well as feet and legs", "then after a few weeks it changed to severe arm and hand pain", "i am sick of it", "body aches" and "then after a few weeks it changed to severe arm and hand pain" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, chills, pain, paraesthesia, pain in extremity, illness, pain, pain in extremity.  No follow-up attempts are possible. No further information is expected.  Follow-Up#01 (30Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: lightheadedness / dizzyness; chills; shootingburning pain/dull aching pain; the body aches stayed and turned into a pins and needles sensation throughout my whole body but mostly in my arns and hands, as well as feet and legs; Then after a few weeks it changed to severe arm and hand pain; I am sick of it; body aches; Then after a few weeks it changed to severe arm and hand pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Sep2021 (Lot number: 30135BA) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PCOS," (unspecified if ongoing); "penicillin" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: ATIVAN; METHYLPREDNISOLONE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0179, Location of injection: Arm Right), for COVID-19 immunization, reaction(s): "dizzyness", "lightheadedness", "brain fog". The following information was reported: DIZZINESS (non-serious) with onset 18Sep2021, outcome "not recovered", described as "lightheadedness / dizzyness"; CHILLS (non-serious) with onset 18Sep2021, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 18Sep2021, outcome "not recovered", described as "shootingburning pain/dull aching pain"; PARAESTHESIA (non-serious) with onset 18Sep2021, outcome "not recovered", described as "the body aches stayed and turned into a pins and needles sensation throughout my whole body but mostly in my arns and hands, as well as feet and legs"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "not recovered" and all described as "Then after a few weeks it changed to severe arm and hand pain"; ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "I am sick of it"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "body aches". The events "lightheadedness / dizzyness", "chills", "shootingburning pain/dull aching pain", "the body aches stayed and turned into a pins and needles sensation throughout my whole body but mostly in my arns and hands, as well as feet and legs", "then after a few weeks it changed to severe arm and hand pain", "i am sick of it", "body aches" and "then after a few weeks it changed to severe arm and hand pain" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, chills, pain, paraesthesia, pain in extremity, illness, pain, pain in extremity.  No follow-up attempts are possible. No further information is expected.  Follow-Up#01 (30Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure increased, Blood pressure measurement, Burning sensation, Fatigue
Clinical narrative: The next day she felt completely exhausted and all symptoms were gone; felt burning up inside like she has a slight fever; back pain; elevated blood pressure; headache; whole body was like working everything; felt burning up inside like she has a slight fever; hands and feet were all ice cold; her arm where she received the shot is heavily swollen; Lymph nodes are swollen on the armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Oct2021 (Batch/Lot number: unknown) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization; Bnt162b2 (2nd dose), for COVID-19 Immunization, reaction(s): "headache". The following information was reported: BACK PAIN (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "back pain"; BLOOD PRESSURE INCREASED (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "elevated blood pressure"; HEADACHE (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "headache"; FEELING ABNORMAL (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "whole body was like working everything"; BURNING SENSATION (non-serious), PYREXIA (non-serious) all with onset 22Oct2021, outcome "recovered" (23Oct2021) and all described as "felt burning up inside like she has a slight fever"; FEELING COLD (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "hands and feet were all ice cold"; FATIGUE (non-serious) with onset 23Oct2021, outcome "recovered" (23Oct2021), described as "The next day she felt completely exhausted and all symptoms were gone"; PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "her arm where she received the shot is heavily swollen"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "Lymph nodes are swollen on the armpit". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.