chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Full body tremors; bones/body contracturing; felt like a parasites was moving from injection site; headache; fever; fatigue; This is a spontaneous report from a contactable Nurse (Patient), who reported for herself.  A 54-years-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL9262) via an intramuscular route of administration on 20Janl2021 (at 20:45), administered in right arm (age at the time of vaccination was 54-years-old) as a DOSE 2, SINGLE dose for COVID-19 immunization. The patient's medical history included Hashimotos Thyroiditis, vit D deficiency, Attention deficit hyperactivity disorder, pet dander allergy, HLD, acne, hormone replacements and Medals, no, but so food intolerance from an unspecified date. The patient's concomitant medications included LEVOTHYROXINE SODIUM, Ambien (ZOLPIDEM TARTRATE), Adderall (AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE), Vitamin B2 (RIBOFLAVIN), Vitamin B3 (NICOTINAMIDE) and Vitamin B12 (CYANOCOBALAMIN) taken for an unspecified indication. The patient had no other vaccine in 4 weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post the vaccination. Previously, the patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL1685) via an unspecified route of administration on 29Dec2020 (at 18:30), administered in right arm (age at the time of vaccination was 54-years-old) as a DOSE 1, SINGLE dose for COVID-19 immunization. On 20Jan2021 (at 22:15), the patient experienced Full body tremors, bones/body contracturing, felt like a parasites was moving from injection site, headache, fever and fatigue. The clinical outcome of all the events was recovered with sequel.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. .
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Cold-like symptoms; Congestion; Headache; Sore throat; This is a spontaneous report from contactable other HCP (patient's mother) and physician from a Pfizer sponsored program via medical information team. A 19-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Jul2021 at 14:00 (at the age of 19-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medications were not reported. The patient had no other products. The patient received his first dose 28 days ago. On 24Aug2021, the patient experienced cold-like symptoms, congestion, headache and sore throat. Reporter called on behalf of her son (19-year-old) who received the first dose of the Pfizer COVID-19 vaccine last 30Jul2021 and is due to get his second dose of the vaccine but has cold-like symptoms with congestion, headache, and sore throat. Reporter wanted to know if it is contraindicated to get the vaccine while having these symptoms. The transferring agent stated that she has a patient's mom on the line that was calling about the Covid-19 Vaccine and reported that her son's second dose is scheduled for today, he is experiencing cold symptoms. Can her son take the second dose today. The caller verified the information provided by the transferring agent and clarified that she is a registered nurse. The clinical outcome of all the events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Weight
Clinical narrative: Headache; she has environmental allergies like pollen and has noticed, after the vaccines, they get severe; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was BNT162B2 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 18May2021 at 11:00 (at the age of 40 year) as dose 2, single for covid-19 immunization. Medical history included pollen allergy. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EWU175 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 29Apr2021 at 01:00 pm (at the age of 40 year) as dose 1, single for COVID-19 immunization and experienced Arm pain, Chills, really tired and really hungry the next day too which is not normal. On 18May2021, the headache started an hour after the second dose and lasted most of the day, until that evening. Patient took Tylenol, it was not a severe headache. The patient also explained that she has environmental allergies like pollen and has noticed, after the vaccines, they get severe on an unspecified date in 2021. They have stopped but there are times she feels they more severe now when she does get them, where they were light before the vaccines. The patient underwent lab tests and procedures which included weight with result 127-130 lbs. The outcome of event headache was recovered on an unspecified date in 2021 while for allergy aggravated was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101116643 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: little fatigue; pain in arm of vaccination; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 12Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine includes bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient reported sore arm and fatigue after the first dose. After second dose, the patient experienced little fatigue and pain in arm of vaccination on an unspecified date. Reporter asked a question about the second dose and reported sore arm and fatigue for the first dose, she asked about the reported adverse events, but she said she never talked about chills or headache, just sore arm and fatigue, and she never called for the second dose. But in the second dose, received on 12Aug2 021, she had a little fatigue, pain in arm of vaccination and no other adverse events. The events outcome was reported as unknown.  information about lot/batch number has been requested  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Paraesthesia oral, Swelling face
Clinical narrative: L side of my face swelled; I could feel my tongue tingling; Tightness in my chest; This is a spontaneous report from a contactable consumer (patient) and other healthcare profession. A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and also received complement c1 esterase inhibitor (HAEGARDA), subcutaneous from 14May2021 (Batch/Lot number was not reported) and ongoing, at 5182 iU (q 3-4 days) for hereditary angioedema. The patient medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant. On 26Aug2021, the patient experienced L side of her face swelled due to which the patient had to use Firazyr, she could feel her tongue tingling, and tightness in chest in the context of indication hereditary angioedema prophylactic dosing problems cause by Covid-19 vaccine. The reporter assessed the case seriousness as non-serious. Outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain
Clinical narrative: diarrhea; pain; nausea; This is a spontaneous case from a contactable pharmacist via Support. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported) via an unspecified route of administration on 24Aug2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 25Aug2021, the patient experienced pain, nausea and on 26Aug2021, experienced diarrhea. The seriousness of the events was reported as non-serious. The outcome of pain and nausea was recovered on an unspecified date in Aug2021 and event (diarrhea) was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: son experienced arm soreness.; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced arm soreness (pain in extremity) on an unspecified date with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular disorder
Clinical narrative: cardiovascular symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously patient took first dose of bnt162b2 (batch/lot number: unknown) via unspecified route on an unknown date for covid-19 immunization. On an unspecified date, the patient experienced cardiovascular symptoms after my 2nd dose of his COVID vaccine. The outcome of event was unknown.    Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Hypertrophic scar, Inflammation, Scar
Clinical narrative: I got it an inch from my old small pox vaccine scar and the spot where the covid vaccine is is fine but  my small pox scar is slightly inflamed and raised and red; I got it an inch from my old small pox vaccine scar and the spot where the covid vaccine is is fine but  my small pox scar is slightly inflamed and raised and red; I got it an inch from my old small pox vaccine scar and the spot where the covid vaccine is is fine but  my small pox scar is slightly inflamed and raised and red; I got it an inch from my old small pox vaccine scar and the spot where the covid vaccine is is fine but  my small pox scar is slightly inflamed and raised and red; This is a spontaneous report from a contactable consumer. A 25-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 26Aug2021 16:45 (Batch/Lot number was not reported, expiry date: unknown) as dose 1, single for COVID-19 immunisation from Pharmacy or Drug Store. Medical history included bipolar, epilepsy and covid-19. Concomitant medications included levetiracetam (KEPPRA), lamotrigine, and quetiapine fumarate (SEROQUEL). All were taken for an unspecified indication, start and stop date were not reported. No known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had received other medications within 2 weeks prior to the vaccination includes Keppra, Lamotrigine, and Seroquel. Prior to the vaccination, the patient was diagnosed with COVID-19, and post the vaccination, the patient had not been tested for COVID-19. On 28Aug2021 at 12:00, the patient experienced i got it an inch from my old small pox vaccine scar and the spot where the covid vaccine is is fine but my small pox scar is slightly inflamed and raised and red. The patient had not received treatment for all the events. The outcome of the events was not recovered.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Lymphadenopathy, Pain, SARS-CoV-2 test
Clinical narrative: Body aches; Pain on left side from upper lower back all the way to top of head that included injection site, under armpit, left upper shoulder neck radiating to lower mid back; Pain on left side from upper lower back all the way to top of head that included injection site, under armpit, left upper shoulder neck radiating to lower mid back; swelling under armpit; swelling on left upper chest; This is a spontaneous report from a contactable nurse. A 44-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunization (at the age of 44-year-old). Medical history included migraine, ongoing asthma, recently vitamin d deficiency and known allergies. Concomitant medication included ibuprofen. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 09Jul2021 as dose 1, single for COVID-19 immunization (at the age of 44-year-old) which led to nausea, body aches, heat sensation on chest, mouth blisters, fever, sore throat, headaches and migraines. No other vaccine in four weeks. The patient did not had COVID prior vaccination. On an unspecified date in 2021, the patient experienced body aches swelling under armpit, swelling on left upper chest, pain on left side from upper lower back all the way to top of head that included injection site, under armpit, left upper shoulder neck radiating to lower mid back. Seriousness of the events reported as non serious. On 09Jul2021, the patient underwent lab tests and procedures which included fever: unknown results and on 20Jul2021, nasal swab: negative. The patient was treated with oxycodone, toradol, muscle relaxer and otc ibuprop as a therapeutic measure of body aches swelling under armpit, swelling on left upper chest, pain on left side from upper lower back all the way to top of head that included injection site, under armpit, left upper shoulder neck radiating to lower mid back. On an unspecified date in 2021, the patient recovered with sequelae from body aches, swelling under armpit, swelling on left upper chest. The outcome of the other events was not recovered.  Follow-up attempts completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: Body aches; Pain on left side from upper lower back all the way to top of head that included injection site, under armpit, left upper shoulder neck radiating to lower mid back; Pain on left side from upper lower back all the way to top of head that included injection site, under armpit, left upper shoulder neck radiating to lower mid back; swelling under armpit; swelling on left upper chest; This is a spontaneous report from a contactable nurse. A 44-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunization (at the age of 44-year-old). Medical history included migraine, ongoing asthma, recently vitamin d deficiency and known allergies. Concomitant medication included ibuprofen. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 09Jul2021 as dose 1, single for COVID-19 immunization (at the age of 44-year-old) which led to nausea, body aches, heat sensation on chest, mouth blisters, fever, sore throat, headaches and migraines. No other vaccine in four weeks. The patient did not had COVID prior vaccination. On an unspecified date in 2021, the patient experienced body aches swelling under armpit, swelling on left upper chest, pain on left side from upper lower back all the way to top of head that included injection site, under armpit, left upper shoulder neck radiating to lower mid back. Seriousness of the events reported as non serious. On 09Jul2021, the patient underwent lab tests and procedures which included fever: unknown results and on 20Jul2021, nasal swab: negative. The patient was treated with oxycodone, toradol, muscle relaxer and otc ibuprop as a therapeutic measure of body aches swelling under armpit, swelling on left upper chest, pain on left side from upper lower back all the way to top of head that included injection site, under armpit, left upper shoulder neck radiating to lower mid back. On an unspecified date in 2021, the patient recovered with sequelae from body aches, swelling under armpit, swelling on left upper chest. The outcome of the other events was not recovered.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Pyrexia, Vaccination site pain
Clinical narrative: arm felt feverish; flu symptoms; sore arm on the injection arm; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced arm felt feverish, flu symptoms, sore arm on the injection arm on an unspecified date. It was reported that after the first shot had flu symptoms for a week, and a sore arm on the injection arm. From the second dose had pain at the injection site. Arm felt feverish after both vaccines. The clinical outcome of the event was recovered for influenza on unspecified date in 2021; unknown for vaccination site pain and pyrexia.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site mass, Vaccination site pain
Clinical narrative: had a knot where shot was given; it has my shoulder an upper arm hurting; it has my shoulder an upper arm hurting; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 53 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 30Aug2021 (Batch/Lot Number: FC3180) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 30Aug2021 (Batch/Lot Number: FF2588) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included nerve injury from an unknown date and unknown if ongoing, allergy to arthropod sting from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took sulphur and experienced allergy to chemicals. The patient experienced had a knot where shot was given causing vaccination site mass on 30Aug2021 19:30 with outcome of recovering, it has his shoulder and upper arm hurting causing arthralgia on 30Aug2021 19:30 with outcome of recovering and vaccination site pain on 30Aug2021 19:30 with outcome of recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cleft lip and palate, Tremor
Clinical narrative: Cleft lip and palate; My baby thrashed violently in my stomach most of the night; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus/baby. This is a baby report.   The mother received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 17Sep2021 13:00 (Batch/Lot Number: FF2587, expiration date: 30Dec2021) as dose 2, single for COVID-19 immunization. The patient received the drug via transplacental. The patient's medical history and concomitant medications were not reported. The baby thrashed violently in the mother's stomach most of the night on Sep2021. The patient had cleft lip and palate. The patient's father was 40 years old. No history of smoking, alcohol drinking and use of illicit drugs during the mother's pregnancy. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101227227 Mother/baby case
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site bruising, Vaccination site mass, Vaccination site swelling
Clinical narrative: a large red swollen warm bump at injection site; a large red swollen warm bump at injection site; Painful to touch and to move arm; Large bruise noted at injection site painful to touch a week later; This is a spontaneous report from a non-contactable consumer reported for herself that:   A 24-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), via an unspecified route of administration, administered in Arm Left on 13Sep2021 at (Batch/Lot Number: FF2588) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization (Age at vaccination 24 years). Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient medical history None. There were no allergies reported. There were no concomitant medications were reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 was unknown. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. on 13Sep2021 at 19:30, the patient noticed a large red swollen warm bump at injection site. Painful to touch and to move arm. Persisted for approximately 3 days and Large bruise noted at injection site painful to touch a week later on unspecified date in Sep2021. No treatment was received. The event outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: needing to change a super tampon every three hours (very severe bleeding for me on day 7); a slight fever on the first day of my period; period cramps were so severe she collapsed to the floor and couldn't move for thirty minutes until patient managed to get pain medicine; period came 10 days early; period cramps were so severe; boobs were sore and grew a full cup size; boobs were sore and grew a full cup size; nausea; body aches; This is a spontaneous report from a contactable female consumer (Patient) or other non-HCP who reported for herself. A 22-years-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0180) via an unspecified route of administration, administered in Left arm on 19Jun2021 (age at the time of vaccination was 22-years-old) as a dose 2, single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications/ medications the patient received within 2 weeks of vaccination included Vitamin D NOS and Vitamin C (ASCORBIC ACID) taken for an unspecified indication. The patient had no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Previously, the patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0178) via an unspecified route of administration, administered in Left arm on 22May2021 (age at the time of vaccination was 22-years-old) as a dose 1, single dose for COVID-19 immunization. The patient stated that she got her first period at 10 years old, and in 12 years, it has NEVER been early. On 02Jul2021, (two weeks) after her second dose, patient's period came 10 days early, a slight fever on the first day of her period. Normally, she was done bleeding after 4 days, but at day 7, was needing to change a super tampon every three hours (very severe bleeding for me on day 7) on 08Jul2021. Patient developed a slight fever on the first day of her period (patient stated she had already gone through the side effects of the vaccine two weeks prior- body aches, nausea, fever- so it was weird to get the fever again) unspecified date in Jun2021. On 02Jul2021 the patient's period cramps were so severe she collapsed to the floor and couldn't move for thirty minutes until patient managed to get pain medicine, which again, has never happened before. Patient reported her boobs were sore and grew a full cup size. The patient received treatment for the adverse events. The patient underwent lab tests and medical procedure which included PCR (SARS-CoV-2 test) Nasal Swab on an unspecified date in Jul2021, which showed Negative results. Since the vaccination, the patient had been tested for COVID-19. Patient brought it up to Primary Care Physician (Physician Office Visit). The clinical outcome of all the events was recovered with sequel (recovered with lasting effects) on an unspecified date.   Follow-up attempts are completed. No further information is expected.  Follow-Up (19Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 24Jul2021 11:00 (Batch/Lot Number: EW0181) age at vaccination of 38-years-old, as single dose, for covid-19 immunisation.  Medical history included was none. No known allergies. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in on an unspecified date (Batch/Lot Number: EW0181) age at vaccination of 38-years-old, as single dose, for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that her period did not come as usual on 11Aug2021, she period is always regular. She had intermittent spotting, but continued to be irregular for 2 months and ongoing. The patient confirmed that she is not pregnant (she has been checked); this is not emotional. Since she took vaccine her once regular period for 25 years is now spotty and gone. No treatments give for the event. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.  Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a contactable 66-year-old male consumer (patient) or other non-health care professional from Pfizer-sponsored program, Support (NCSP: 159558). A 66-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL9264, Expiry date: unknown), via an unspecified route of administration in the right arm on 05Feb2021 and second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EN9809, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 26Feb2021 (at the age of 66-year-old) both as a single dose for covid-19 immunization. Patient switched vaccination arms purposely. Medical history included prostate issues. Concomitant medications included finasteride 5 mg for prostate (ongoing) and morniflumate (FLOMAX) 4 mg for prostate (ongoing). On 17Sep2021, the patient experienced UTI (urinary tract infection). He has shrunk of two inches because his age. He did not have a prescribing doctor. Therapeutic measures taken as a result of the events included antibiotic Cefdinir (manufacturer: Unspecified, Lot number: unknown, Expiry date: unknown) 300 mg to treat UTI. Patient wanted to get his third dose and asking if he can get his third dose 7 months after his second dose. He also wanted to know if it will impact the effectivity of the vaccine as he was on antibiotic, Cefdinir. He heard in Israel they were given the third dose 6 months after the second dose. He was inquiring about getting the third dose after seven months. He knows was given the third dose after 8 months. The clinical outcome of the event UTI was not resolved.  No follow up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Ear discomfort, Fatigue, Headache
Clinical narrative: Unilateral numbness; migraine; headaches; pressure behind eyes; pressure in one ear; pain in left chest; cramps legs, feet, side-noted well hydration; short/sharp pain in side; forgetfulness; body aches; tired; rash; pressure in chest with deep breaths; pounding heart (yet normal heart rate); This is a spontaneous report from a contactable consumer or other non-HCP. A 31-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 17Apr2021 as dose 1, single (at the age of 31-years-old) for COVID-19 immunization. Medical history included Allergic reaction to yellow jacket (bees) (Allergy to arthropod sting), gluten (intolerance). Concomitant medications/other medications within 2 weeks of vaccination included ibuprofen; paracetamol (TYLENOL); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). Facility where the most recent COVID-19 vaccine was administered as Doctor's office-urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 17Apr2021 the patient experienced unilateral numbness(entire left side of body for 3 days), migraine, headaches, pressure behind eyes, pressure in one ear, pounding heart (yet normal heart rate), pain in left chest, cramps legs, feet, side-noted well hydration, short/sharp pain in side, forgetfulness, body aches, tired, rash, pressure in chest with deep breaths. A few more days of unilateral numbness even during prednisone treatment. Lab test includes normal heart rate (unspecified date). Therapeutic measures were taken as prednisone as a result of unilateral numbness, migraine, headaches, pressure behind eyes, pressure in one ear, pain in left chest, cramps legs, feet, side-noted well hydration, short/sharp pain inside, forgetfulness, body aches, tired, rash, pressure in chest with deep breaths. Device Date mentioned as 27Sep2021. The outcome of all events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate normal, Hypoaesthesia, Memory impairment, Migraine, Muscle spasms
Clinical narrative: Unilateral numbness; migraine; headaches; pressure behind eyes; pressure in one ear; pain in left chest; cramps legs, feet, side-noted well hydration; short/sharp pain in side; forgetfulness; body aches; tired; rash; pressure in chest with deep breaths; pounding heart (yet normal heart rate); This is a spontaneous report from a contactable consumer or other non-HCP. A 31-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 17Apr2021 as dose 1, single (at the age of 31-years-old) for COVID-19 immunization. Medical history included Allergic reaction to yellow jacket (bees) (Allergy to arthropod sting), gluten (intolerance). Concomitant medications/other medications within 2 weeks of vaccination included ibuprofen; paracetamol (TYLENOL); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). Facility where the most recent COVID-19 vaccine was administered as Doctor's office-urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 17Apr2021 the patient experienced unilateral numbness(entire left side of body for 3 days), migraine, headaches, pressure behind eyes, pressure in one ear, pounding heart (yet normal heart rate), pain in left chest, cramps legs, feet, side-noted well hydration, short/sharp pain in side, forgetfulness, body aches, tired, rash, pressure in chest with deep breaths. A few more days of unilateral numbness even during prednisone treatment. Lab test includes normal heart rate (unspecified date). Therapeutic measures were taken as prednisone as a result of unilateral numbness, migraine, headaches, pressure behind eyes, pressure in one ear, pain in left chest, cramps legs, feet, side-noted well hydration, short/sharp pain inside, forgetfulness, body aches, tired, rash, pressure in chest with deep breaths. Device Date mentioned as 27Sep2021. The outcome of all events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular discomfort, Pain, Palpitations, Rash
Clinical narrative: Unilateral numbness; migraine; headaches; pressure behind eyes; pressure in one ear; pain in left chest; cramps legs, feet, side-noted well hydration; short/sharp pain in side; forgetfulness; body aches; tired; rash; pressure in chest with deep breaths; pounding heart (yet normal heart rate); This is a spontaneous report from a contactable consumer or other non-HCP. A 31-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 17Apr2021 as dose 1, single (at the age of 31-years-old) for COVID-19 immunization. Medical history included Allergic reaction to yellow jacket (bees) (Allergy to arthropod sting), gluten (intolerance). Concomitant medications/other medications within 2 weeks of vaccination included ibuprofen; paracetamol (TYLENOL); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). Facility where the most recent COVID-19 vaccine was administered as Doctor's office-urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 17Apr2021 the patient experienced unilateral numbness(entire left side of body for 3 days), migraine, headaches, pressure behind eyes, pressure in one ear, pounding heart (yet normal heart rate), pain in left chest, cramps legs, feet, side-noted well hydration, short/sharp pain in side, forgetfulness, body aches, tired, rash, pressure in chest with deep breaths. A few more days of unilateral numbness even during prednisone treatment. Lab test includes normal heart rate (unspecified date). Therapeutic measures were taken as prednisone as a result of unilateral numbness, migraine, headaches, pressure behind eyes, pressure in one ear, pain in left chest, cramps legs, feet, side-noted well hydration, short/sharp pain inside, forgetfulness, body aches, tired, rash, pressure in chest with deep breaths. Device Date mentioned as 27Sep2021. The outcome of all events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Fatigue, Headache, Lymphadenopathy
Clinical narrative: sore bones in arms & legs; achy sore; Weak; nausea; swollen lymph glands in right breast; "baseball"  swollen right arm pit; Tired; Headache; Shot sight large red inflamed lump; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 66-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 24Sep2021 11:00 (Age at vaccination: 66-years-old) as dose number unknown, single for covid-19 immunization. (Vaccination facility: Pharmacy or Drug Store). Medical history included diabetes, high blood pressure, allergies all from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (BAYER ASPIRIN), mometasone furoate (FLONASE [MOMETASONE FUROATE]), atenolol (ATENOLOL), famotidine (FAMO) all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included Flu shot in Left arm on 21Sep2021 (Age at vaccination: 66-years-old) for immunization. Patient not had covid prior vaccination. On 25Sep2021 04:00 Headache, sore bones in arms & legs, nausea, achy sore, swollen lymph glands in right breast and baseball swollen right arm pit, Tired. Weak. Shot sight large red inflamed lump. Patient was not tested for covid post vaccination. The outcome for the events was reported as resolving at the time of this report.   The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Peripheral swelling, Vaccination site mass
Clinical narrative: sore bones in arms & legs; achy sore; Weak; nausea; swollen lymph glands in right breast; "baseball"  swollen right arm pit; Tired; Headache; Shot sight large red inflamed lump; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 66-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 24Sep2021 11:00 (Age at vaccination: 66-years-old) as dose number unknown, single for covid-19 immunization. (Vaccination facility: Pharmacy or Drug Store). Medical history included diabetes, high blood pressure, allergies all from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (BAYER ASPIRIN), mometasone furoate (FLONASE [MOMETASONE FUROATE]), atenolol (ATENOLOL), famotidine (FAMO) all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included Flu shot in Left arm on 21Sep2021 (Age at vaccination: 66-years-old) for immunization. Patient not had covid prior vaccination. On 25Sep2021 04:00 Headache, sore bones in arms & legs, nausea, achy sore, swollen lymph glands in right breast and baseball swollen right arm pit, Tired. Weak. Shot sight large red inflamed lump. Patient was not tested for covid post vaccination. The outcome for the events was reported as resolving at the time of this report.   The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe vertigo; This is a spontaneous report from a contactable other hcp (patient herself). A 60-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FA7485), via an unspecified route of administration, administered in left deltoid on 13Aug2021 (age at vaccination: 60 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history included hypotension and depression. The patient's concomitant medications were not reported. The patient was administered the vaccine in a pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took metronidazole (FLAGYL) and scopolamine aminoxide and experienced drug hypersensitivity. On 16Sep2021, the patient experienced severe vertigo lasting over 1 and 1/2 weeks. The adverse event resulted in emergency room visit. The patient received Meclizine as treatment for the adverse event. The patient was not diagnosed with covid-19 prior to vaccination nor was tested since the vaccination. The outcome of the event was not recovered. The device date was 28Sep2021.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: I experienced a significant headache; sore injection site; This is a spontaneous report from a contactable other hcp (Patient). A 27-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: FC3183), via an unspecified route of administration, administered in Arm Right on 07Sep2021 15:15 (at the age of 27-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. known allergies was reported as No. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as no. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Within the first 24 hours, on 07Sep2021 21:00 patient experienced a significant headache. Upon waking the next morning, it was gone. No sore arm, but sore injection site for 24-48 hrs afterwards. Treatment received for events was reported as no. The outcome of event significant headache recovered on 08Sep2021 and outcome of sore injection site was recovered on unspecified date in Sep2021. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: an infection; This is a spontaneous report from a Pfizer sponsored program Support. A Non-contactable Pharmacist reported that, A 91-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced an infection. Reporter was asking if that would affect the dosing schedule. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: Swollen, sore, red lump injection sight larger than silver dollar; Swollen, sore, red lump injection sight larger than silver dollar; Swollen, sore, red lump injection sight larger than silver dollar; Swollen, sore, red lump injection sight larger than silver dollar; Fatigue; achy joints; This is a spontaneous report from a non-contactable consumer (patient). A 69-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FF2589, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 30Sep2021 at 01:15 PM (at the age of 69-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks, no Covid prior vaccination, no Covid tested post vaccination. On 30Sep2021, the patient experienced swollen, sore, red lump injection sight larger than silver dollar, fatigue, achy joints. No treatment received for reported events. The outcomes of all reported events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swollen, sore, red lump injection sight larger than silver dollar; Swollen, sore, red lump injection sight larger than silver dollar; Swollen, sore, red lump injection sight larger than silver dollar; Swollen, sore, red lump injection sight larger than silver dollar; Fatigue; achy joints; This is a spontaneous report from a non-contactable consumer (patient). A 69-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FF2589, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 30Sep2021 at 01:15 PM (at the age of 69-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks, no Covid prior vaccination, no Covid tested post vaccination. On 30Sep2021, the patient experienced swollen, sore, red lump injection sight larger than silver dollar, fatigue, achy joints. No treatment received for reported events. The outcomes of all reported events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.