chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; achiness; Fever; tiredness; Sore throat; This is a follow up spontaneous report from a Pfizer-sponsored program. A contactable 91-Year-old female consumer reported.  A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9264), dose 1 via an unspecified route of administration, administered in Arm Right on 31Jan2021 10:38 as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. No additional vaccines administered on same date of the Pfizer suspect. No adverse event following prior vaccinations. It was reported that the patient reported some side effects after receiving the first dose of the vaccine. The side effects included Chills, achiness, Fever, tiredness and Sore throat on 01Feb2021. The patient reported that the fever was sporadic and low grade. The patient asked if the patient could take Benadryl or Tylenol before the second shot, because she had reaction to most medication and usually took Benadryl, mostly before antibiotics. The second shot is due on 22Feb2021 at 1:45pm. The events did not result in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. Therapeutic measures included Tylenol after a week for the reported events. Outcome of the events Chills, achiness, Fever, tiredness and Sore throat was reported as recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Faeces discoloured
Clinical narrative: lower back pain; Diarrhea not liquid but with stools that don't have color; Diarrhea not liquid but with stools that don't have color; This is a spontaneous report from a contactable consumer.    A female patient of an unspecified age (Age:71; Unit:Unknown) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 15Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, The patient experienced lower back pain and diarrhea not liquid but with stools that don't have color. Outcome of events were reported as unknown.   Information about lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Reported a strange taste in her mouth that started a few days after receiving the vaccine.  It continues as of yesterday (almost 3 weeks after receiving first dose).; This is a spontaneous report from a non-contactable consumer. This 76-year-old female consumer reported that.  A 76-years-old non pregnant female consumer received bnt162b2 (COVID 19, brand Pfizer, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Jan2021 as dose 1, single for covid-19 immunisation (age at Vaccination was 76). The patient's medical history and concomitant medications were not reported. The patient experienced a strange taste in her mouth that started a few days after receiving the vaccine. Onset date of event was reported as 31Jan2021. It continued almost 3 weeks after receiving first dose till 1 day before the day of report. Facility type of vaccine was reported as hospital. Other vaccine received in four weeks was reported as unknown. Patient was not Covid prior vaccination and not tested Covid post vaccination. The reason for lot unknown was reported as not available or provided to reporter at the time of report completion. The patient had not received treatment for the reported event. Outcome of event was report as unknown.  No follow-up attempts are possible and information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Severe Pain; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not available), via an unspecified route of administration, administered in left arm on 17Feb2021 at 09:30 AM (age at vaccination was 57 years) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not received other vaccine in four weeks. On 18Feb2021 at 09:45 AM, the patient was experienced severe pain. No treatment received for adverse event. No COVID prior vaccination and patient was not COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab resulted negative on 01Feb2021. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This is a spontaneous report from a contactable nurse. A female patient of unspecified age received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on unknown date as DOSE Number UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had experienced flu-like symptoms. The clinical outcome of the event was unknown.  Information on lot number/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Somnolence
Clinical narrative: headache; weakness; dizziness; sleepy; This is a spontaneous report from a contactable consumer. This consumer reported that, an 89-Year-old male patient that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated her father who received the first dose of the Pfizer covid vaccine and on an unspecified date (yesterday) he was experiencing headache, weakness, dizziness, sleepy. He was given Tylenol. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.  Follow-up (03Apr2021): Follow-up activities closed no further information expected
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation
Clinical narrative: Very intense burning in both eyes; This is a spontaneous report from a contactable consumer. A 89-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 18Feb2021 11:45 (at the age of 89-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included known allergies to opioids and metal/jewelry from an unknown date and unknown if ongoing. Concomitant medication included sertraline, ascorbic acid/betacarotene/cupric oxide/tocopheryl acetate/zinc oxide (PRESERVISION), macrogol 400/propylene glycol (SYSTANE), tacrolimus and latanoprost all drugs were taken for an unspecified indication, start and stop date were not reported. The patient experienced very intense burning in both eyes on 18Feb2021 13:00. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Treatment included cold compress and Advil for the event. Outcome of the event was recovering.   Information about the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Dull headache; This is a spontaneous report from a contactable consumer or other non HCP (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 formulation; Solution for injection), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included surgery (she takes aspirin 81 mg daily for a surgery she had in the past) from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for surgery from an unspecified start date and ongoing. The patient stated that she began to experience a dull headache on 18Feb2021 and asking if it was good to take Tylenol. The patient also wanted to know if she should stop taking the aspirin. The patient scheduled to get her second dose on 25Feb2021. The outcome of the event was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Vomiting; diarrhoea; aches; chills; headache; tired; muscle pain; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EM9809 and expiration date was not reported) via an unspecified route of administration, administered in Right Arm on 14Feb2021 08:30 (Age at vaccination was 68 years) as dose 1, single for covid-19 immunization. Medical history included hypertension, pneumonia. The patient didn't have COVID prior to vaccination. The patient's concomitant medications were not reported. Patient did not took any other vaccine in four weeks. The patient previously took codeine and experienced hypersensitivity. On 17Feb2021 04:00 hours the patient experienced vomiting, diarrhoea, aches , chills , headache, tired, muscle pain, injection site pain. The patient was not tested COVID after vaccination. The treatment was not received. The patient was recovered from all the events in 2021.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain, Vomiting
Clinical narrative: Vomiting; diarrhoea; aches; chills; headache; tired; muscle pain; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EM9809 and expiration date was not reported) via an unspecified route of administration, administered in Right Arm on 14Feb2021 08:30 (Age at vaccination was 68 years) as dose 1, single for covid-19 immunization. Medical history included hypertension, pneumonia. The patient didn't have COVID prior to vaccination. The patient's concomitant medications were not reported. Patient did not took any other vaccine in four weeks. The patient previously took codeine and experienced hypersensitivity. On 17Feb2021 04:00 hours the patient experienced vomiting, diarrhoea, aches , chills , headache, tired, muscle pain, injection site pain. The patient was not tested COVID after vaccination. The treatment was not received. The patient was recovered from all the events in 2021.  Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Pain in extremity
Clinical narrative: Sore arm; fatigue; trouble sleeping; mild headache; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non pregnant female patient received BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 08:45AM (Age at vaccination 31-years-old) as DOSE 2, SINGLE and also received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3247, Expiry date was not reported) via an unspecified route of administration on 26Jan2021 01:30 PM, administered in Left arm as dose 1, single for covid-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included no known allergies. The patient's concomitant medications were not reported. On 10Feb2021 09:30AM the patient experienced sore arm, fatigue, trouble sleeping, mild headache. The patient had not received any other vaccine within 4 weeks and also other medications in two weeks also. Patient had received no treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The clinical outcome of the events was recovering.     Follow-up (11May2021): Follow-up attempts completed. No further information expected
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Photophobia
Clinical narrative: body aches; Achy sickly feeling; light sensitive behind the eyes; headache; This is a spontaneous report from a contactable consumer (patient). A 63 years old male patient received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated he took the Pfizer covid vaccine a week ago (on an unspecified date in 2021) and experienced headache and body aches, they went away but he still had light sensitive behind the eyes, achy sickly feeling. Caller wanted to know was that normal, how long they last. The outcome of the events headache and body aches were recovered on an unspecified date in 2021. The outcome of the events achy sickly feeling and light sensitive behind the eyes were not recovered.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Slight headache; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. Before the vaccination, the patient was exposed to someone who tested positive. It was reported that they both had masked and the "contact was not very long from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After getting the vaccine, on an unspecified date in Feb2021, the patient experienced sore arm and slight headache and patient was asking how long it would last. Patient was asking if there would be some protection after getting a single dose of the vaccine. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Pfizer Sponsored Program. A 95-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Her arm hurted for a few hours after the first shot. Patient got her second shot yesterday (17Feb2021). Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunization. She had no side effects at all with the second dose. She had heard if you have side effects it meant your immune system was working. She did not have any side effects and wanted to know if it was working. The outcome of the event was unknown.   Information about Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vertigo, Vomiting
Clinical narrative: extreme vertigo; nausea; vomited; chills but no fever; This is a spontaneous report from a contactable nurse. A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), intramuscular, administered in left arm on 12Feb2021 at 10:45 (at the age of 76-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The medical history included essential hypertension, irregular heartbeat, chronic superficial gastritis, GERD with esophagitis, hypercholesterolemia, subclinical hypothyroidism, moderate obstructive sleep apnea, hypopnea syndrome, eczema, osteoarthritis, nephrolithiasis, and stage 3 CKD. The patient had known allergies to amoxicillin, sulfa and fragrance. The Concomitant medication(s) included amlodipine, acetylsalicylic acid (ASPIRIN (E.C.), biotin, clobetasol (CLOBETASOL), fish oil, losartan, lovastatin, metoprolol, omeprazole, and tramadol (TRAMADOL). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), intramuscular, administered in left arm on 24Jan2021 at 10:30 (at the age of 76-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 13Feb2021, the day after the second dose of the Pfizer vaccine, patient experienced extreme vertigo. History of same, but this was worse than her usual. It has improved over time but not resolved. Then, two-three days later on Feb2021, she experienced nausea and vomited x1. On Feb2021, She also experienced chills but no fever. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient had no Covid prior vaccination and not Covid tested post vaccination. The treatment was unknown. The outcome of vertigo was not resolved and other events outcome were unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a Pfizer-sponsored program. A contactable female patient of unspecified age reported for herself that she was received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number-not reported), via an unspecified route of administration, on an unspecified date in Jan2021 as dose 1, single for COVID-19 immunisation. Medical history includes routine multiple health issues from an unknown date and unknown if ongoing. The patient routinely sees a neurologist and a rheumatologist for her multiple health issues. Concomitant medications were not reported. The patient states side effects were nothing from the first dose just some arm soreness, which was experienced on an unspecified date in 2021. The patient was never asked about medications or HX at vaccination location. Outcome of the event was unknown.  Information about Lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Menstruation delayed, Pain in extremity
Clinical narrative: Sore left arm x3 days after 1st injection. Fatigue and uncontrollable sleep attacks; 1 hour after 1st injection slept 4 hours, 10 hours after second injection slept 1 hour. Period delayed by 4 days af; Fatigue; Uncontrollable sleep attacks; 1 hour after 1st injection slept 4 hours; Period delayed by 4 days after 1st injection; This is a spontaneous report from a non-contactable nurse (patient herself). A 25 years-old non-pregnant female patient received bnt162b2 (BNT162B2, formulation: solution for injection, Lot Number: EL 8982, expiry date: unknown), via an unspecified route of administration in Arm Left on 25Jan2021 13:45 as dose 1, single (at the age of 25 years) for COVID-19 immunization. Medical history included Idiopathic hypersomnia, anemia, vitamin D deficiency, HSV1, HPV, bilateral sciatica, mononucleosis in adult, GERD with possible sliding hiatal hernia, PTSD, latex allergy. Concomitant medications included modafinil (MODAFINIL) 100 mg; famotidine (FAMOTIDINE); vitamin d3 (VITAMIN D3) 2000 iU all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. On 25Jan2021 at 02:45PM, the patient experienced sore left arm x3 days after 1st injection, Fatigue and uncontrollable sleep attacks; 1 hour after 1st injection slept 4 hours, period delayed by 4 days after 1st injection. No therapeutic measures were taken as a result of events. The outcome of the events was reported as recovering.   No Follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes on left collarbone; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 44-years-old female (non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3249 and expiration date was not reported), via an unspecified route of administration, administered in Left Arm on 12Feb2021 (Age at vaccination was 44 years) as dose 2 single for COVID-19 immunization. The patient medical history was not reported. The patient did not have known allergies and other medical history were none. The patient did not have COVID prior to vaccination. Concomitant medication(s) included bupropion hydrochloride; ibuprofen; melatonin all taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number EL9263 and expiration date was not reported), via an unspecified route of administration, administered in Left Arm on 22Jan2021 at 18:00 (at the age of 44 years ) hours as dose 1, single for COVID-19 immunization. The patient did not take any other vaccine in four weeks. On 16Feb2021 the patient experienced swollen lymph nodes on left collarbone. The patient was not tested covid after the vaccination. The patient did not receive the treatment. The outcome of the event was not recovered.  No follow-up attempts needed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hot flush, Musculoskeletal stiffness
Clinical narrative: flashes / About 20 hours post injection chills ended and were replaced by hot flashes; About 12 hours post injection, chills started with body aches and while body shakes from chills; aches / body aches; headache worsened; Soreness/muscle stiffness around injection site; Soreness/muscle stiffness around injection site; headache; tiredness / whole body fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in left arm on 17Feb2021 at 11:00 AM (age at vaccination was 42 years) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported.Patient had no known allergies.The patient was not received other vaccine in four weeks and not received other medications in two weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EN9581) administered in right arm on 27Jan2021 (age at vaccination was 42 years) as dose 1, single for COVID-19 immunisation. On 17Feb2021 at 02:00 PM, the patient was experienced soreness/muscle stiffness around injection site. About 3 hours post injection (on 17Feb2021 at 02:00 PM), headache tiredness, whole body fatigue. About 12 hours post injection (On 17Feb2021 at 11:00 PM), chills started with body aches and while body shakes from chills, headache worsened. About 20 hours post injection (On 18Feb2021 at 07:00 AM) chills ended and were replaced by hot flashes, severe headache persisted. The patient did not received any treatment for adverse events. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: flashes / About 20 hours post injection chills ended and were replaced by hot flashes; About 12 hours post injection, chills started with body aches and while body shakes from chills; aches / body aches; headache worsened; Soreness/muscle stiffness around injection site; Soreness/muscle stiffness around injection site; headache; tiredness / whole body fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in left arm on 17Feb2021 at 11:00 AM (age at vaccination was 42 years) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported.Patient had no known allergies.The patient was not received other vaccine in four weeks and not received other medications in two weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EN9581) administered in right arm on 27Jan2021 (age at vaccination was 42 years) as dose 1, single for COVID-19 immunisation. On 17Feb2021 at 02:00 PM, the patient was experienced soreness/muscle stiffness around injection site. About 3 hours post injection (on 17Feb2021 at 02:00 PM), headache tiredness, whole body fatigue. About 12 hours post injection (On 17Feb2021 at 11:00 PM), chills started with body aches and while body shakes from chills, headache worsened. About 20 hours post injection (On 18Feb2021 at 07:00 AM) chills ended and were replaced by hot flashes, severe headache persisted. The patient did not received any treatment for adverse events. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: neck stiffness on left side, since day after injection and continues as of todays date 18Feb; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non pregnant female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injec-tion, Lot Number: el3247) via an unspecified route of administration, administered in arm left on 27Jan2021 12:00 (age at vaccination 66 years) as dose number unknown, single for COVID-19 immun-ization. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. Concomitant medications included loratadine, pseudoephedrine sulfate (CLARITIND), fluticasone propionate, salmeterol xinafoate (ADVAIR), ascorbic acid, ergocalciferol, nic-otinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID; ERGOCALCIFEROL; NICOTINAMIDE; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE]) all taken for an unspecified indication, start and stop date were not reported. Patient has not received other vaccine in four weeks. The patient previously took amoxicillin and experienced allergies. The patient experienced neck stiffness on left side, since day after injection and continues as of todays date 18feb on 28Jan2021. The patient was not received any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for covid post vaccination. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: twitching of left hand and foot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 21-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL9266) via an unspecified route of administration, administered in left arm on 23Jan2021 (at the age of 21-years-old) as single dose for covid-19 immunisation and patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; Batch/Lot Number: EL9266) via an unspecified route of administration, administered in left arm on 17Feb2021 16:30 (at the age of 21-years-old) as single dose for covid-19 immunisation. The patient's medical history included penicillin allergy from an unknown date and unknown if ongoing. On 07Feb2021, the patient experienced twitching of left hand and foot. Patient stated that no side effects initially experienced after first vaccine. Two weeks after first vaccine noticed twitching of left hand and foot which continued. After receiving 2nd vaccine yesterday, the twitching of left hand and left foot has increased throughout day or night and lasts between 2 to 5 seconds. For example, in the last hour I have had 5 such episodes to left foot. The twitching started in the arm of my left foot only but has now progressed to the entire left side of foot as well. No treatment received for the event. Patient's other medication included multivitamin in two weeks from vaccination. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness s after first dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received both doses of vaccine and had soreness s after first dose on an unspecified date. She preventatively took Advil before second dose because she heard that the second dose caused more side effects, therefore she wanted to be ahead of the side effects. The patient mentions that she later received notice from a friend that she was not supposed to do that. The patient would like to know if she has made the vaccine less effective o and she has not heard Dr. said anything against this. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Myalgia, Vaccination site pain
Clinical narrative: pain at the shot site of the arm; some other muscle pain; felt lethargic; Aches in forehead and temples 2 hrs; This is a spontaneous report from a non-contactable consumer or other non hcp. A adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 17Feb2021 (Batch/Lot number and expiry date was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient pregnancy information was unknown at the time of vaccination. The patient was previously received bnt162b2 (PFIZER BIONTECH Covid 19, Solution for injection), dose 1, via unknown route on an unknown date (Lot Number: unknown) as dose 1, single for covid-19 immunisation. On 17Feb2021, the patient experienced aches in forehead and temples 2 hrs after shot, the events were alleviated after taking a Tylenol but she still felt lethargic. On 18Feb2021, the patient experienced pain at the shot site of the arm, and some other muscle pain and events were alleviated with a Tylenol. The patient not received treatment for the event lethargic. The clinical outcome of the event lethargic was not recovered whereas other events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: This is a spontaneous report from a noncontactable consumer or other non-HCP (patient). A 23-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported, expiry date not reported), at the age of 23, via an unspecified route of administration, administered in left arm, on Feb 10, 2021, at 12:30, single dose, for COVID-19 immunisation. Medical history included penicillin drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient has not received any other vaccine within 4 weeks. The patient received birth control medications in two weeks. On Feb 11, 2021, patient stated lymph node in left armpit was swollen and very sore 5 days following vaccine (starting day after injection). Normal soreness at injection point for about 48 hours following injection. Soreness decreased on days 6 and 7 but still present. The patient did not receive treatment for event. The outcome for the events: recovering. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; fatigue; This is a spontaneous report from a non-contactable nurse. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose unknown via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. It was unknown if covid prior vaccination and covid tested post vaccination. The patient experienced headache and fatigue on an unspecified date. Outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Muscular weakness, Pain in extremity
Clinical narrative: Pain in left arm and have trouble sleeping arm feels weak also having issues gripping at times.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Myalgia, Nausea, Vomiting
Clinical narrative: Chills, nausea, vomiting, more muscles pain and back pain
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Electrocardiogram normal, Fatigue, Palpitations, Pyrexia
Clinical narrative: HEART RACING, FEVER, CHILLS, FATIGUE
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm only. No treatment.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient).  A 60-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9267) (at the age of 60-years-old), via an unspecified route of administration, administered in left leg on 18Feb2021 10.45 AM as dose 1, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. The patient was not pregnant. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had sore arm on 18Feb2021 at 10.45 AM. The patient treatment received no. The outcome of event was recovering.     Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age received BNT162B2 (BNT162B2, PFIZER-BIONTECH, Covid-19 vaccine, solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date: was not reported) as DOSE 1 SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced sore arm. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021184095 Same reporter, drug, event/different patient
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling
Clinical narrative: swelling described as "being in the front part of the ear in front of where the hole is"; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Wife) that:   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Formulation: Solution for injection, lot number was not reported, via an unspecified route of administration on 16Feb2021 as Dose 2, single for covid-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Formulation: Solution for injection, lot number was not reported, via an unspecified route of administration as Dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. After this second injection, his wife is experiencing some swelling described as "being in the front part of the ear in front of where the hole is" and the swelling on this part of the ear is continuing. At the time of reporting, the outcome of the event was not recovered.    Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: extreme hand and fingers began red and swell on the side where he received the Covid Pfizer vaccine; extreme hand and fingers began red and swell on the side where he received the Covid Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: 59367) via an unspecified route of administration in Right arm on 05Feb2021 01:00 as dose 1, single for COVID- 19 Immunisation. Relevant medical history included atrial fibrillation. The patient had known allergies. Concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, patient was not diagnosed with covid. Since the vaccination, the patient has not been tested for COVID-19. On 12Feb2021, the patient experienced extreme hand and fingers began red and swell on the side where he received the COVID Pfizer vaccine. Patient did not receive any treatment for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Vision blurred
Clinical narrative: sore arm; My vision was fuzzy for a few days after receiving first and second dose of vaccine; nausea; headache; This is a spontaneous report from a contactable nurse (patient, self-reported). A 62-year-old female patient (age at vaccination: 62 years) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 14Jan2021 at 14:30 PM, as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9264 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 03Feb2021 at 15:30 PM as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included hypertension and Sulfa allergies. Past drug included z pak (allergies). The patient did not received any other vaccine in four weeks. The patient received any other medications in two weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 14Jan2021 at 16:00 PM, the patient had sore arm and she had visual changes. Her vision was fuzzy for a few days after receiving first and second dose of vaccine. First dose it was 2 days before vision was back to nor-mal. After second dose, it was on the 4th day when her vision was back to normal. It took about 3-4 days before she was able to focus her vision like nor-mal. She was normally near sighted and wear glasses. Her vision has now re-turned to normal also for both shots and had nausea and headache. The patient did not received any treatment for the events. Outcome of the events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Malaise, Pain
Clinical narrative: felt some liquid drip down his shoulder; felt some liquid drip down his shoulder; nurse said she measured a little extra; patient couldn't be certain he received the correct amount; nurse said she measured a little extra; patient couldn't be certain he received the correct amount; Fever; Malaise; Body aches; This is a spontaneous report from a contactable pharmacist (patient himself) via a regulatory authority. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 21Feb2021 at 07:00 at the age of 42 years old (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. Relevant medical history indicated that the patient was diagnosed with COVID-19 prior to vaccination on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient had no family medical history relevant to the adverse events (AEs). Concomitant medication received within 2 weeks of vaccination included omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At the time of administration on 21Feb2021 at 07:00, the patient felt some liquid drip down his shoulder. The nurse said she measured a little extra; the patient couldn't be certain he received the correct amount. At night on 21Feb2021, the patient experienced fever, malaise, and body aches, which were considered non-serious. The patient further stated that he did not report an overdose with the Covid vaccine. He just felt a little drop on his shoulder and he was now wondering if the nurse dropped some of the product, but he cannot know. The patient was not taking any treatment and did not require any visit to the emergency room (ER) or physician's office for the events "fever, malaise and body aches." The patient had no relevant tests. The patient did not receive any treatment for the adverse events. The patient was not recovered from fever, malaise, and body aches at the time of the report.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue, Pyrexia
Clinical narrative: felt some liquid drip down his shoulder; felt some liquid drip down his shoulder; nurse said she measured a little extra; patient couldn't be certain he received the correct amount; nurse said she measured a little extra; patient couldn't be certain he received the correct amount; Fever; Malaise; Body aches; This is a spontaneous report from a contactable pharmacist (patient himself) via a regulatory authority. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 21Feb2021 at 07:00 at the age of 42 years old (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. Relevant medical history indicated that the patient was diagnosed with COVID-19 prior to vaccination on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient had no family medical history relevant to the adverse events (AEs). Concomitant medication received within 2 weeks of vaccination included omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At the time of administration on 21Feb2021 at 07:00, the patient felt some liquid drip down his shoulder. The nurse said she measured a little extra; the patient couldn't be certain he received the correct amount. At night on 21Feb2021, the patient experienced fever, malaise, and body aches, which were considered non-serious. The patient further stated that he did not report an overdose with the Covid vaccine. He just felt a little drop on his shoulder and he was now wondering if the nurse dropped some of the product, but he cannot know. The patient was not taking any treatment and did not require any visit to the emergency room (ER) or physician's office for the events "fever, malaise and body aches." The patient had no relevant tests. The patient did not receive any treatment for the adverse events. The patient was not recovered from fever, malaise, and body aches at the time of the report.  Follow-up attempts are completed. No further information is expected.