chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Sciatica, Seasonal allergy
Clinical narrative: Cannot extend arm outward or upward without cringing in pain; Cannot extend arm outward or upward without cringing in pain; Muscle in arm that took injection aches; Inflammation like the vaccine "flipped a switch" triggering re-emergence of sciatica & heightened arthritic pain in toes, ankles and fingers; Worst seasonal allergies ever; acute sinus infection; urinary tract infection; Elevated HA1C; Extreme muscular ache & burning; joint pain; chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731) via an unspecified route of administration, administered in arm left on13Apr2021 at 01:30 PM (age at vaccination 58 years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included diagnosed with type 2 diabetes 3 month after vaccine, nonalcoholic fatty liver since 2005, seasonal allergies, arthritis, and allergic to penicillin & sulfa drugs. Concomitant medications included atorvastatin (ATORVASTATIN); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); montelukast sodium (SINGULAIR); azelastine (AZELASTINE) nasal all taken for an unspecified indication, start and stop date were not reported. No covid prior vaccination. No other vaccine in four weeks. On 14Apr2021 at 01:30 PM the patient experienced Extreme muscular ache & burning, joint pain, chills & nausea, 2 incidents each lasting 4-5 hours, both day after shot. Chills & nausea continued for 35 days until relief came with sinus infection medication. Muscle in arm that took injection aches 3 months later (Jul2021) cannot extend arm outward or upward without cringing in pain. Inflammation like the vaccine flipped a switch triggering reemergence of sciatica & heightened arthritic pain in toes, ankles and fingers. Worst seasonal allergies ever - culminated in acute sinus infection & urinary tract infection from antibiotic. Elevated HA1C not previously an issue (3 month look-back of test overlapped with 3 months post vaccine). The patient visits Doctor or other healthcare professional office/clinic. No treatment was received for the events. No covid was tested post vaccination. The patient underwent lab tests and procedures which included glycosylated haemoglobin: elevated on Not previously an issue (3 month look-back of test overlapped with 3 months post vaccine). Therapeutic measures were taken as a result of nausea. The outcome of the event nausea was recovered 19May2021 and other events not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Urinary tract infection, Vaccination site pain
Clinical narrative: Cannot extend arm outward or upward without cringing in pain; Cannot extend arm outward or upward without cringing in pain; Muscle in arm that took injection aches; Inflammation like the vaccine "flipped a switch" triggering re-emergence of sciatica & heightened arthritic pain in toes, ankles and fingers; Worst seasonal allergies ever; acute sinus infection; urinary tract infection; Elevated HA1C; Extreme muscular ache & burning; joint pain; chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731) via an unspecified route of administration, administered in arm left on13Apr2021 at 01:30 PM (age at vaccination 58 years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included diagnosed with type 2 diabetes 3 month after vaccine, nonalcoholic fatty liver since 2005, seasonal allergies, arthritis, and allergic to penicillin & sulfa drugs. Concomitant medications included atorvastatin (ATORVASTATIN); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); montelukast sodium (SINGULAIR); azelastine (AZELASTINE) nasal all taken for an unspecified indication, start and stop date were not reported. No covid prior vaccination. No other vaccine in four weeks. On 14Apr2021 at 01:30 PM the patient experienced Extreme muscular ache & burning, joint pain, chills & nausea, 2 incidents each lasting 4-5 hours, both day after shot. Chills & nausea continued for 35 days until relief came with sinus infection medication. Muscle in arm that took injection aches 3 months later (Jul2021) cannot extend arm outward or upward without cringing in pain. Inflammation like the vaccine flipped a switch triggering reemergence of sciatica & heightened arthritic pain in toes, ankles and fingers. Worst seasonal allergies ever - culminated in acute sinus infection & urinary tract infection from antibiotic. Elevated HA1C not previously an issue (3 month look-back of test overlapped with 3 months post vaccine). The patient visits Doctor or other healthcare professional office/clinic. No treatment was received for the events. No covid was tested post vaccination. The patient underwent lab tests and procedures which included glycosylated haemoglobin: elevated on Not previously an issue (3 month look-back of test overlapped with 3 months post vaccine). Therapeutic measures were taken as a result of nausea. The outcome of the event nausea was recovered 19May2021 and other events not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Jaw disorder, Mass, Pain in jaw
Clinical narrative: under his jaw felt a similar lump / Lump under jaw; lump on their collar bone / Bump on collar bone; Pain under jaw; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0179, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 29Apr2021 14:00 (at the age of 23-year-old) as dose 2, single for COVID-19 immunization, at arena. The patient medical history and concomitant medications were not reported. family medical history relevant to adverse events was none. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. No investigation assessment. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0162, and Expiration date: Jul2021), via an unspecified route of administration, administered in left arm on 08Apr2021 (at the age of 23-year-old) as dose 1, single for COVID-19 immunization. The patient received no additional vaccines administered on same date of the Pfizer suspect. The patient reported he had received both doses of the Pfizer-BioNTech COVID-19 Vaccine back in April2021. He knew other people had "lump on their collar bone, which he had as well". Today, "he had a pain under jaw and felt a similar lump". The patient was asking if this was normal or if other people had it as well. On 06May2021, the patient had "lump on their collar bone / Bump on collar bone". The patient said he had been aware of a possible side effect of having a "bump on the collar bone" after vaccination. On an unspecified date, the patient experienced pain under jaw (started 2-3 months ago from the time of report), stated it was not consistent it will be on and off a couple of days at a time; and had been going on for a few weeks. On 30Jul2021, the patient noticed under his jaw felt a similar lump / Lump under jaw (was feeling around on his jaw and noticed what seems to be a lump similar to the one he had on his collar bone under his jaw) and lump was around the same area as where he experienced the pain. The patient stated that the lump on their collar bone / Bump on collar bone became smaller at the time of this report. No relevant tests were performed. The events did not result in Emergency Room or Physician Office visit. The patient denied any medical conditions, medications, labs, testing, or treatments relevant to events. The outcome of the event lump on their collar bone / Bump on collar bone was reported as resolving. The outcome of the event Pain under jaw and "under his jaw felt a similar lump / Lump under jaw" was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pruritus
Clinical narrative: About 24 hours after vaccinated, my entire right arm started itching like mad; I have bruising all over my arm; This is a spontaneous report from a contactable consumer reported for herself. A 50-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, solution for injection, Lot number: not available), via an unspecified route on 11Aug2021 at 15:45 (age at vaccination: 50-year-old), as a single dose for covid-19 immunization. Medical history included covid and patient allergic to the antibiotic given for covid in Jan2021. The patient concomitant medications were not reported. Patient took unknown medication in last two weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Aug2021, about 24 hours after vaccinated, patient entire right arm started itching like mad. She has bruising all over her arm from itching so badly and all the time since then. Patient did not receive any treatment for the events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Post vaccination, patient has not been tested for COVID-19. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Overdose
Clinical narrative: dose number=2 vaccine date=18May2021/ Dose number=1 Administration date=18May2021; Hypertension hard to control/Was on one pill now have to take 5 and it's still high; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 18May2021 at 13:30 (at the age of 48-years-old) in left arm as a single dose for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0217) via an unspecified route of administration on 18May2021 (at the age of 48-years-old) in left arm as a single dose for covid-19 immunization. Medical history included borderline high blood pressure (never triple digits top and bottom) from an unknown date and unknown if ongoing. The patient previously took codeine and experienced allergies. The patient did not receive any other vaccine in four weeks or any other medications in two weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. The patient's concomitant medications included unspecified pill for hypertension. The patient received both doses 1 and 2 on 18May2021 (coded to overdose). The patient experienced hypertension which was hard to control on an unknown date in 2021. She was on one pill and had to take 5 and still it was high. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was treated with a lot of hypertensive medication. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date in 2021. The outcome of the event hypertension was not recovered and for overdose was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vein disorder
Clinical narrative: Vein that goes up in his neck has a little knot in it; Vein is really puffed up andhave that knot in it where he got the shot, well same side he got the shot on; This is a spontaneous report from a contactable consumer. This female consumer reported for a 52-year-old male patient (fiance) that received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on 18Aug2021 (at the age of 52-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Aug2021, the patient experienced vein that goes up in his neck had a little knot in it; vein is really puffed up and have that knot in it where he got the shot, well same side he got the shot on. Reporter assessed the event as non-serious. Patient did not receive any treatment for the event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Angiogram, Computerised tomogram, Condition aggravated, Hangover, Headache
Clinical narrative: Headache; I wake with what feels like a hangover and typically it gets worse from there.; I wake with what feels like a hangover and typically it gets worse from there; Progressing to what may be a tension level headache; Maybe finishing with what l can only imagine is what a migraine may feel like.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of unknown age and gender received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history included covid-19 from Jan2021 to Jan2021 and was hospitalized from 18Jan to 23Jan. Received the remdesivir injections for 5 days and was discharged. The patient concomitant medications were not reported. The patient previously received first dose of vaccine BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number- not reported) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunization and experienced flu like symptoms, headache and feeling abnormal. On an unknown date in 2021, the patient experienced headache (It's now 6 months later and he still have daily headaches), Many days the headache was almost debilitating, he wake with what feels like a hangover and typically it gets worse from there, At best many of the hours in a day it felt like a bad hangover, progressing to what may be a tension level headache and maybe finishing with what patient could only imagine is what a migraine may feel like. The patient underwent lab tests and procedures which included angiogram (MRA) showed unknown result, computerised tomogram (TMJ CT scan) with unknown result, magnetic resonance imaging (MRI of neck and spine) with unknown result, magnetic resonance imaging head (MRV of Brain) showed unknown result on an unknown date. The treatment medications included Nortriptyline at bedtime, Nurtec, Zipsor, Ubrelvy and Ajovy injections. Zipsor when Nurtec or Ubrelvy did not help. Seeing a neurologist but to date still had issues and did not see any light at the end of a very dark tunnel. Reporter wanted to know anyone that is actively studying covid related headaches. The clinical outcome of the events headache, it gets worse from there was not recovered while that of other events was unknown.  The Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Migraine, Tension headache
Clinical narrative: Headache; I wake with what feels like a hangover and typically it gets worse from there.; I wake with what feels like a hangover and typically it gets worse from there; Progressing to what may be a tension level headache; Maybe finishing with what l can only imagine is what a migraine may feel like.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of unknown age and gender received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history included covid-19 from Jan2021 to Jan2021 and was hospitalized from 18Jan to 23Jan. Received the remdesivir injections for 5 days and was discharged. The patient concomitant medications were not reported. The patient previously received first dose of vaccine BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number- not reported) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunization and experienced flu like symptoms, headache and feeling abnormal. On an unknown date in 2021, the patient experienced headache (It's now 6 months later and he still have daily headaches), Many days the headache was almost debilitating, he wake with what feels like a hangover and typically it gets worse from there, At best many of the hours in a day it felt like a bad hangover, progressing to what may be a tension level headache and maybe finishing with what patient could only imagine is what a migraine may feel like. The patient underwent lab tests and procedures which included angiogram (MRA) showed unknown result, computerised tomogram (TMJ CT scan) with unknown result, magnetic resonance imaging (MRI of neck and spine) with unknown result, magnetic resonance imaging head (MRV of Brain) showed unknown result on an unknown date. The treatment medications included Nortriptyline at bedtime, Nurtec, Zipsor, Ubrelvy and Ajovy injections. Zipsor when Nurtec or Ubrelvy did not help. Seeing a neurologist but to date still had issues and did not see any light at the end of a very dark tunnel. Reporter wanted to know anyone that is actively studying covid related headaches. The clinical outcome of the events headache, it gets worse from there was not recovered while that of other events was unknown.  The Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pain, Paranasal sinus discomfort
Clinical narrative: Fever; chills; aches; headache; sinus pressure; diarrhea that lasted 5 days; This is a spontaneous report from a contactable other HCP (patient). A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration, administrated in Right arm on 20Aug2021 11:15 (age at the time of vaccination 29-years-old), as a single dose for COVID-19 immunization. The patient's medical history included COVID, covid prior vaccination. The patient's concomitant medications included gabapentin, Metformin, Effexor xr, and Birth control. No other vaccine in four weeks. No covid tested post vaccination. No known allergies. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administrated in Right arm on 30Jul2021 14:00 (age at the time of vaccination 29-years-old), as a single dose for COVID-19 immunization. On 21Aug2021 12:00, the patient experienced Fever, chills, aches, headache, sinus pressure, and diarrhea that lasted 5 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient took Tylenol and immodium for the treatment of adverse events. The outcome for all the event was not recovered.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; aches; headache; sinus pressure; diarrhea that lasted 5 days; This is a spontaneous report from a contactable other HCP (patient). A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration, administrated in Right arm on 20Aug2021 11:15 (age at the time of vaccination 29-years-old), as a single dose for COVID-19 immunization. The patient's medical history included COVID, covid prior vaccination. The patient's concomitant medications included gabapentin, Metformin, Effexor xr, and Birth control. No other vaccine in four weeks. No covid tested post vaccination. No known allergies. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administrated in Right arm on 30Jul2021 14:00 (age at the time of vaccination 29-years-old), as a single dose for COVID-19 immunization. On 21Aug2021 12:00, the patient experienced Fever, chills, aches, headache, sinus pressure, and diarrhea that lasted 5 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient took Tylenol and immodium for the treatment of adverse events. The outcome for all the event was not recovered.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Bradykinesia, Decreased appetite, Depressed mood, Insomnia
Clinical narrative: Difficulty sleeping; Generally feel gloomy, down; in slow motion; some loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Aug2021 10:00 (Batch/Lot Number: FC3182) (at the age of 66 years old) as single dose for Covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), via an unspecified route of administration on 26Aug2021 (as reported) (Batch/Lot Number: UJ689AA) dose 1, single for immunization. The patient medical history was not reported. The patient has no known allergies. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 05Aug2021 10:45 (lot number: FA7485) (at the age of 66 years old) via an unspecified route of administration in left arm for Covid-19 immunisation and the patient experienced dull headache across front lobe forehead including right and left side temples. Concomitant medications included simvastatin (SIMVASTATIN); ezetimibe, simvastatin (VYTORIN); both taken for an unspecified indication, start and stop date were not reported. After the second jab on 26Aug2021, the patient experienced difficulty sleeping, generally feel gloomy and down, in slow motion, and some loss of appetite. The patient did not receive any treatment for the adverse events. The patient was not tested for Covid-19 post vaccination. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: losing appetite; This is a spontaneous report from a contactable consumer or other non health care professional. A male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Medical history included diabetes mellitus from an unknown date. Prior to vaccination patient diagnosed with COVID-19. Patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient reported losing appetite on an unspecified date after second dose. It was unknown if the patient received vaccine in four weeks. It was unknown if the patient was tested post vaccination. No treatment received for the event. The outcome of event was recovered.  Follow-up attempts have been completed and no further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: diarrhea for 36 hours; severe chills with fever that lasted about 3 hours; severe chills with fever that lasted about 3 hours; body aches, headache, and fatigue which lasted about 24 hours; body aches, headache, and fatigue which lasted about 24 hours; body aches, headache, and fatigue which lasted about 24 hours; This is a spontaneous report from a contactable Nurse (patient) reporting for self. A 56-year-old non- pregnant female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3812) via an unspecified route of administration in arm left on 19Aug2021 at 09:45 as single dose for COVID-19 immunisation. Medical history included COVID-19, hypertension, depression, factor V leiden mutation, Sulfonamide allergy and Latex allergy, all from an unknown date and unknown if ongoing. Concomitant medications included propranolol, hydrochlorothiazide and bupropion all taken for an unspecified indication, start and stop date were not reported. The patient previously took Rocephin, Vioxx and experienced allergy. Patient had not taken any other vaccines in four weeks and not taken other medications. Patient had COVID-19 prior to vaccination and not been tested post vaccination. On 20Aug2021 at 12:00 pm, 14 hours after vaccination patient experienced severe chills with fever that lasted about 3 hours body aches, headache, and fatigue which lasted about 24 hours. Then 3 days after the vaccination, had diarrhea for 36 hours on 22Aug2021. Therapeutic measures were taken as result of events included acetaminophen, and Imodium. The outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: diarrhea for 36 hours; severe chills with fever that lasted about 3 hours; severe chills with fever that lasted about 3 hours; body aches, headache, and fatigue which lasted about 24 hours; body aches, headache, and fatigue which lasted about 24 hours; body aches, headache, and fatigue which lasted about 24 hours; This is a spontaneous report from a contactable Nurse (patient) reporting for self. A 56-year-old non- pregnant female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3812) via an unspecified route of administration in arm left on 19Aug2021 at 09:45 as single dose for COVID-19 immunisation. Medical history included COVID-19, hypertension, depression, factor V leiden mutation, Sulfonamide allergy and Latex allergy, all from an unknown date and unknown if ongoing. Concomitant medications included propranolol, hydrochlorothiazide and bupropion all taken for an unspecified indication, start and stop date were not reported. The patient previously took Rocephin, Vioxx and experienced allergy. Patient had not taken any other vaccines in four weeks and not taken other medications. Patient had COVID-19 prior to vaccination and not been tested post vaccination. On 20Aug2021 at 12:00 pm, 14 hours after vaccination patient experienced severe chills with fever that lasted about 3 hours body aches, headache, and fatigue which lasted about 24 hours. Then 3 days after the vaccination, had diarrhea for 36 hours on 22Aug2021. Therapeutic measures were taken as result of events included acetaminophen, and Imodium. The outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Paraesthesia
Clinical narrative: no feeling in her right ring and right pinkie finger; started having complaints in her right arm that day of her arm feeling hot and tingling as if it had fallen asleep and it stayed like that all night; started having complaints in her right arm that day of her arm feeling hot and tingling as if it had fallen asleep and it stayed like that all night; This is a spontaneous report from a contactable consumer.  A 36 years old female patient received bnt162b2 (Comirnaty,Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 01Sep2021 as dose 2, single (At the age of 36 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) dose 1 via an unspecified route of administration, administered in unspecified date as dose 1,single for covid-19 immunization. On 01Sep2021, in her left arm and started having complaints in her right arm that day of her arm feeling hot and tingling as if it had fallen asleep and it stayed like that all night, but now she has no feeling in her right ring and right pinkie finger. On 02Sep2021, the event started having complaints in her right arm that day of her arm feeling hot and tingling as if it had fallen asleep and it stayed like that all night was resolved. At the time of reporting, the outcome of the event no feeling in her right ring and right pinkie finger was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional disorder, Fatigue, Injury
Clinical narrative: Too injured to notice anything else; Overly tired; very emotional; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 59-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EWO185), via an unspecified route of administration (at the age of 59-years), administered in arm right on 26Aug2021 at 11:45 as dose 1, single for COVID-19 immunization. Medical history included refractory epilepsy, asthma, sleep apnea, injury back, injured knee, neuropathy in left thigh and known allergies with latex, penicillin, soy, sulfa from an unknown date and unknown if ongoing. Concomitant medications included eslicarbazepine acetate (APTIOM), clobazam (ONFI), gabapentin (GABAPENTIN), buspirone hydrochlo-ride (BUSPAR), ascorbic acid (VIT C), colecalciferol (VIT D [COLECALCIFEROL]), zinc (ZINC) taken for an unspecified indication, start and stop date were not reported. The patient previously took polyethylene glycol and experienced known allergies. The facility where the most recent COVID-19 vaccine was administered was reported as unknown. The patient did not receive any other within 4 weeks pri-or to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Aug2021, the patient experienced too injured to notice anything else, overly tired, very emotional. It was further reported that after dose 1, I was overly tired and very emotional. Too injured to notice anything else. The treatment was not received for all the adverse events. The clinical outcome for all the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness; She experienced vertigo (badly) which lead to depth perception being off and she ran over her grand daughter; This is a spontaneous report from a contactable consumer (reporter's mother). A 69-years-old non pregnant female patient received bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 19Aug2021 (at the age of 69-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included kidney transplant. Patient had no known allergy. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Patient previously received first and second dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unspecified date, patient experienced vertigo (badly) which lead to depth perception being off and she ran over her granddaughter her doctors believe that her dizziness was from 3 vaccine. Therapeutic measures were taken as a result of dizziness and she experienced vertigo (badly) which lead to depth perception being off and she ran over her granddaughter and she received medication for vertigo. The outcome of al the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Body temperature, Chills, Decreased appetite
Clinical narrative: not feeling well; she could not sleep; had no energy; no appetite; had a little bit of a headache; upset stomach; tiredness; chills; nausea; diarrhea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. An 84-year-old female patient received BNT162B2 (COMINARTY), via an unspecified route of administration in Aug2021 (reported as almost 3 weeks ago) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient is scheduled for her second dose on 23Sep2021. She reported this past Saturday (18Sep2021) and Sunday (19Sep2021), she was not feeling well and yesterday (20Sep2021) she was fine. And today (21Sep2021) or last night could not sleep and felt the same signs again this morning and last night. In addition she reported she she had no fever and takes her temperature every morning, had no energy, no appetite, had a little bit of a headache, upset stomach. Stated she experienced tiredness, chills, nausea, and diarrhea. She was asking if those are side effects from the vaccine that could occur this late. She heard that it is worse on the second, so is scared. The outcome of the event not feeling well was resolved on 20Sep2021, while the outcome of the other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Insomnia, Malaise
Clinical narrative: not feeling well; she could not sleep; had no energy; no appetite; had a little bit of a headache; upset stomach; tiredness; chills; nausea; diarrhea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. An 84-year-old female patient received BNT162B2 (COMINARTY), via an unspecified route of administration in Aug2021 (reported as almost 3 weeks ago) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient is scheduled for her second dose on 23Sep2021. She reported this past Saturday (18Sep2021) and Sunday (19Sep2021), she was not feeling well and yesterday (20Sep2021) she was fine. And today (21Sep2021) or last night could not sleep and felt the same signs again this morning and last night. In addition she reported she she had no fever and takes her temperature every morning, had no energy, no appetite, had a little bit of a headache, upset stomach. Stated she experienced tiredness, chills, nausea, and diarrhea. She was asking if those are side effects from the vaccine that could occur this late. She heard that it is worse on the second, so is scared. The outcome of the event not feeling well was resolved on 20Sep2021, while the outcome of the other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: not feeling well; she could not sleep; had no energy; no appetite; had a little bit of a headache; upset stomach; tiredness; chills; nausea; diarrhea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. An 84-year-old female patient received BNT162B2 (COMINARTY), via an unspecified route of administration in Aug2021 (reported as almost 3 weeks ago) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient is scheduled for her second dose on 23Sep2021. She reported this past Saturday (18Sep2021) and Sunday (19Sep2021), she was not feeling well and yesterday (20Sep2021) she was fine. And today (21Sep2021) or last night could not sleep and felt the same signs again this morning and last night. In addition she reported she she had no fever and takes her temperature every morning, had no energy, no appetite, had a little bit of a headache, upset stomach. Stated she experienced tiredness, chills, nausea, and diarrhea. She was asking if those are side effects from the vaccine that could occur this late. She heard that it is worse on the second, so is scared. The outcome of the event not feeling well was resolved on 20Sep2021, while the outcome of the other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Hypoaesthesia oral, Muscle tightness, Pain in jaw
Clinical narrative: electrical jolt in her jaw; numbness in her lips; tightening in neck area; tingling in lips; slight chills; Her nerves felt on fire / neck and jaw felt like it was on fire; slight ache in her jaw and teeth; This is a spontaneous report received from Pfizer medical information team from a contactable consumer or other non hcp (patient).  A 69-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot No, NDC number, Expiry date: was not reported), via an unspecified route of administration on Feb2021 as 2nddose, single for covid-19 immunisation. Historical vaccine was a 69-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot No: was not reported), via an unspecified route of administration on unspecified date as 1stdose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced electrical jolt in her jaw, numbness in her lips, tightening in neck area, tingling in lips, slight chills, her nerves felt on fire / neck and jaw felt like it was on fire, slight ache in her jaw and teeth in 2021. Patient was planning to get her 3rd dose. Upon follow-up on 23Sep2021new information was updated. This is a follow-up spontaneous report received a contactable consumer (patient) that reported about adverse event, dates for COVID vaccine (Start: Unspecified Stop: Unspecified), reason for no lot number of COVID vaccine patient was unwilling to complete the report. Other products not provided; patient history was not provided. Investigation assessment was not provided. There is no information out there for the general public about side effects. She is turning 70. It felt like she had received Novocain at the dentist, and it was wearing off, and there was tingling in her lips. She had a very slight lip tingle on and off for a couple of days. The clinical outcome of the events was recovered.  Follow-up (23Sep2021). This is a follow-up spontaneous report received a contactable consumer (patient) that reported about adverse event, dates for COVID vaccine (Start: Unspecified Stop: Unspecified), reason for no lot number of COVID vaccine patient was unwilling to complete the report. Other products were not provided, patient history was not provided. Investigation assessment was not provided. There is no information out there for the general public about side effects. She is turning 70. It felt like she had received Novocain at the dentist, and it was wearing off, and there was tingling in her lips. She had a very slight lip tingle on and off for a couple of days.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Toothache
Clinical narrative: electrical jolt in her jaw; numbness in her lips; tightening in neck area; tingling in lips; slight chills; Her nerves felt on fire / neck and jaw felt like it was on fire; slight ache in her jaw and teeth; This is a spontaneous report received from Pfizer medical information team from a contactable consumer or other non hcp (patient).  A 69-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot No, NDC number, Expiry date: was not reported), via an unspecified route of administration on Feb2021 as 2nddose, single for covid-19 immunisation. Historical vaccine was a 69-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot No: was not reported), via an unspecified route of administration on unspecified date as 1stdose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced electrical jolt in her jaw, numbness in her lips, tightening in neck area, tingling in lips, slight chills, her nerves felt on fire / neck and jaw felt like it was on fire, slight ache in her jaw and teeth in 2021. Patient was planning to get her 3rd dose. Upon follow-up on 23Sep2021new information was updated. This is a follow-up spontaneous report received a contactable consumer (patient) that reported about adverse event, dates for COVID vaccine (Start: Unspecified Stop: Unspecified), reason for no lot number of COVID vaccine patient was unwilling to complete the report. Other products not provided; patient history was not provided. Investigation assessment was not provided. There is no information out there for the general public about side effects. She is turning 70. It felt like she had received Novocain at the dentist, and it was wearing off, and there was tingling in her lips. She had a very slight lip tingle on and off for a couple of days. The clinical outcome of the events was recovered.  Follow-up (23Sep2021). This is a follow-up spontaneous report received a contactable consumer (patient) that reported about adverse event, dates for COVID vaccine (Start: Unspecified Stop: Unspecified), reason for no lot number of COVID vaccine patient was unwilling to complete the report. Other products were not provided, patient history was not provided. Investigation assessment was not provided. There is no information out there for the general public about side effects. She is turning 70. It felt like she had received Novocain at the dentist, and it was wearing off, and there was tingling in her lips. She had a very slight lip tingle on and off for a couple of days.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Auditory disorder
Clinical narrative: during the call he also mentioned that sometimes he can not understand words because he has hearing problems; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) as dose 2, single and as dose 1, single, both via an unspecified route of administration on an unspecified date for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (COPD), ongoing emphysema, both were underlying conditions. The patient's concomitant medications were not reported. The patient wants to know if he should receive a third booster dose of the Pfizers COVID-19 vaccine, he saw on the news that adults who are 65 years of age can receive the vaccine, he also stated that he saw that patients with aids and undergoing certain procedures could be eligible as well. He was a patient with certain underlying conditions: he has Chronic obstructive pulmonary disease and emphysema. During the call he also mentioned that sometimes he can not understand words because he has hearing problems on an unknown date. He already received two doses of the Pfizer COVID-19 vaccine and wants to know if he requires a prescription from his doctor to receive the booster dose. Response received like a single dose of the booster dose may be administered to individuals who are 65 years of age and older. The outcome for the event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced shingles. Reporter stated, I have caller on the other line. She is calling from a medical institute and she said that they receive questionnaire from Pfizer regarding the patient that they need to fill up this questionnaire because the patient received, I mean had shingles. I think it's in between the vaccine the Pfizer COVID 19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Swelling face
Clinical narrative: Got swelling on the right side of my face.; Pregnant now 38 weeks.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 28-years-old pregnant female patient received BNT162B2 (Solution for injection, Lot number: EW0187), via an unknown route of administration in right arm on 22Sep2021 (at the age of 28-years-old) as dose number unknown, single for COVID-19 immunization at pharmacy and received other vaccine on same date was influenza vaccine (FLU VACCINE) in right arm on 22Sep2021 as dose number unknown, single. The patient's medical history included vaso vagal syncope and allergic to Latex. She had 38 weeks of prospective pregnancy. Due date was 01Oct2021. Concomitant medication was not reported. On 22Sep2021, the patient experienced got swelling on the right side of her face. Non-serious case. Event resulted in emergency room/department or urgent care. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment for event. The outcome of the event was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.