chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood count, Chills, Cough, Headache, Lethargy
Clinical narrative: headache; minor aches; heart attack; kidneys were compromised; chills; had a cough; muscles were tightening, could hardly walk; lethargic; This is a spontaneous report from a contactable consumer or other non hcp.   A 80-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration on 14Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included bypass surgery. The patient's concomitant medications were not reported. On 16Jan2021, the patient experienced headache, minor aches, had a cough, muscles were tightening, could hardly walk, lethargic, chills and heart attack on an unspecified date. Caller states that on 14Jan2021 she and her husband had the 1st Pfizer vaccine dose. 2nd dose was scheduled on 04Feb2021. Caller reporter that 2 days after the 1st dose, her husband's muscles were tightening, could hardly walk, had a cough, was lethargic, had chills and was c/o having reflux in his chest. Caller stated they had appointments that day with their Internist and their Cardiologist. Both HCPs felt all his symptoms were probably from the vaccine. That night she took him to the ER and he had had a heart attack. They did a cardiac Cath and had one of two stents put in. His kidneys were compromised and the HCP couldn't give the amount of dye needed to add another stent. So he still needs another stent. Also the blood count went down. Caller states her husband had cardiac bypass surgery years ago. The caller also mentioned her son is a surgeon and had bad flu like symptoms after second shot and only had a headache and minor aches after the first dose. She was concerned about her husband as he had a heart attack and if he should get the 2nd dose. The patient underwent lab tests and procedures which included blood count: went down. Outcome of the events were unknown.  Upon follow-up on 16Apr2021: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Myocardial infarction, Pain, Renal impairment
Clinical narrative: headache; minor aches; heart attack; kidneys were compromised; chills; had a cough; muscles were tightening, could hardly walk; lethargic; This is a spontaneous report from a contactable consumer or other non hcp.   A 80-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration on 14Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included bypass surgery. The patient's concomitant medications were not reported. On 16Jan2021, the patient experienced headache, minor aches, had a cough, muscles were tightening, could hardly walk, lethargic, chills and heart attack on an unspecified date. Caller states that on 14Jan2021 she and her husband had the 1st Pfizer vaccine dose. 2nd dose was scheduled on 04Feb2021. Caller reporter that 2 days after the 1st dose, her husband's muscles were tightening, could hardly walk, had a cough, was lethargic, had chills and was c/o having reflux in his chest. Caller stated they had appointments that day with their Internist and their Cardiologist. Both HCPs felt all his symptoms were probably from the vaccine. That night she took him to the ER and he had had a heart attack. They did a cardiac Cath and had one of two stents put in. His kidneys were compromised and the HCP couldn't give the amount of dye needed to add another stent. So he still needs another stent. Also the blood count went down. Caller states her husband had cardiac bypass surgery years ago. The caller also mentioned her son is a surgeon and had bad flu like symptoms after second shot and only had a headache and minor aches after the first dose. She was concerned about her husband as he had a heart attack and if he should get the 2nd dose. The patient underwent lab tests and procedures which included blood count: went down. Outcome of the events were unknown.  Upon follow-up on 16Apr2021: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Vomiting; Headache; This is a spontaneous report from a contactable consumer. A 63-years-old male consumer (patient) reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 28Jan2021 at 09:30 in left arm as a single dose for covid-19 immunization. Medical history included hypothyroidism, restless leg, high blood pressure and stroke all from an unknown date and unknown if ongoing. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin, clopidogrel and tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]); all start and stop date were not reported and used for unspecified indication. The patient experienced headache, vomiting on 28Jan2021 at 15:00. The events were reported as non serious. The outcome of both events was recovering/resolving.  Information on the lot/batch number has been requested.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Chills, Influenza like illness, Pyrexia, Sinus congestion
Clinical narrative: 12 hours after taking the second dose I experienced Chills, headache, fever flue like symptoms. 2 weeks after taking the second shot I am still experiencing  permanent flu like symptoms. burning sensation at both breading channels, and sinus has worsen clogging both nostrils making impossible to bread thru nose. have been using flu medication and overcounter sinus spry medicine. burning sensation makes impossible to stop snizing.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sneezing
Clinical narrative: 12 hours after taking the second dose I experienced Chills, headache, fever flue like symptoms. 2 weeks after taking the second shot I am still experiencing  permanent flu like symptoms. burning sensation at both breading channels, and sinus has worsen clogging both nostrils making impossible to bread thru nose. have been using flu medication and overcounter sinus spry medicine. burning sensation makes impossible to stop snizing.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Myalgia, Nausea, Pain
Clinical narrative: Severe body aches; muscle pain and fatigue in legs; muscle pain and fatigue in legs; nausea; lack of appetite; This is a spontaneous report from a contactable Other Health Professional (patient). A 34-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, COVID 19 Pfizer vaccine, Lot number: EL1284) on 28Jan2021 at 01:45 PM, via Intramuscular route on left arm as 2ND DOSE, SINGLE (Age at vaccination 34 Years) for covid-19 immunization. The patient did not had allergies to medications, food, or other products. Other medical history includes type 1 diabetes, hypothyroid, UTI (Urinary track infection). The historical vaccine included BNT162B2 (COVID 19 pfizer vaccine) via Intramuscular route on Left arm on 07Jan2021 at 01:15 PM as 1 ST DOSE, SINGLE for covid-19 immunization (age at vaccination was 34 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The other medications the patient received within 2 weeks of vaccination include novolog, synthroid, vyvanse, nitrofurantoin mono. The patient had severe body aches, muscle pain and fatigue in legs, nausea, lack of appetite on 29Jan2021 at 03:30 AM. No treatment was received for the adverse event. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Computerised tomogram normal, Head discomfort, Headache
Clinical narrative: Severe sudden headache squeezing and vibrating of the brain, spikes blood pressure,dibilitizing headache. Gets headache when doing anything even peeing and ejaculating and just sleeping l. Tried two medications from doctor nothing helping. Please advise what to do.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Palpitations, Pyrexia
Clinical narrative: I went to the ER because I had a fever of 103 and my blood pressure was 153/111 and it felt like my heart was racing. At the ER I stayed until 8am was given fluids.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Formication, Pain, Sleep disorder
Clinical narrative: Woke up in the middle of the night with some common side effects like chills and aches, but the part that worries me is that I feel like there are bugs crawling all over my skin and I?m really scare. I can?t get comfortable and although I?m exhausted, I can?t sleep because of this feeling.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache, Nausea and Vomiting .
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: headaches, stiffness, dizzyness, fatigue, loss of appetite pnuemonia including a stay in hospital- antibiotics x 3 types, oxygen, steroids
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: headaches, stiffness, dizzyness, fatigue, loss of appetite pnuemonia including a stay in hospital- antibiotics x 3 types, oxygen, steroids
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This is a spontaneous report from a non-contactable other hcp (patient). A 28-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 13:30 (Batch/Lot Number: unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown that the patient tested for COVID-19. The patient experienced pain at injection site on an unspecified date in Jan2021. The seriousness of the event was reported as non-serious. 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: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore upper right arm which is where the injection took place; This is a spontaneous report from a contactable consumer (patient). A 28-year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number and expiry dates were UNKNOWN), via an unspecified route of administration in the right arm on 28Jan2021 at 13:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. On 28Jan2021 at 18:15, the patient experienced sore upper right arm which was where the injection took place. The patient did not receive any treatment for the event. The outcome of event the sore upper right arm which is where the injection took place was unknown.  Follow-up attempts have been completed and no further information is expected.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea; This is a spontaneous report received from a contactable consumer reported for herself. A 91-year-old female patient (non-pregnant) received first dose bnt162b2 (batch/lot number: unknown, brand: Pfizer, Solution for injection) via unspecified route of administration in left arm on 27Jan2021 at 12:15 PM at single for covid-19 immunisation at hospital facility. The patient did not have any allergies to food or other products and relevant medical history was reported as none. The patient concomitant medications were not reported. The patient did not receive any other vaccines 4 weeks prior to administration of COVID vaccine and any other medications within 2 weeks of administration of 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 28Jan2021 at 17:00, the patient experienced severe diarrhea. The patient did not receive any treatment for the same. No seriousness criteria reported. Outcome of the event diarrhea was reported as recovering.   Information about batch/lot number is not available. Follow-up attempts have been completed and no further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Inflammation, Swelling
Clinical narrative: Eczema side of mouth; Inflammation size of baseball under right armpit; Inflammation size of baseball under right armpit; This is a spontaneous report from a contactable reporter.   A 49-year-old non pregnant female nurse reported for herself that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiry date: UNKNOWN), via an unspecified route of administration at right arm on 27Jan2021 07:00 at hospital as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination the patient did not receive any other vaccines within 4 weeks and did not received any other medications with in two weeks of vaccination. On an unspecified date in Jan2021 patient experienced Eczema side of mouth after first dose of vaccine, Inflammation size of baseball under right armpit, Same arm as vaccine. The patient did not receive any treatment for the events. Patient visited doctor or other healthcare professional office/clinic visit due to events. The outcome of the events Eczema side of mouth and Inflammation size of baseball under right armpit were not recovered.  Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Fatigue
Clinical narrative: Dull, depressed feeling; Like tired; This is a spontaneous report from a non-contactable nurse. A 6-decade-old (Age: Fifties) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dull, depressed feeling and reporter asked if a dull, depressed feeling was reported as a side effect of the COVID-19 vaccine. On an unspecified date the patient was  tired after the first dose of the COVID-19 vaccine. She declined to be transferred to the hospital and expressed her refusal to have the AE reported. She explained she will wait to see after the second dose. The outcome for both the events was unknown.   No follow up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: a low grade fever; feeling exhausted/feel regular tired; nausea/ slightly nauseous; arm pain/ arm is only sore now to the touch; This is a spontaneous report from a contactable consumer reported for a patient. A 36-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 26Jan2021 (age at vaccination was 36 years) as a 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 05Jan2021 (age at vaccination was 36 years) as a 1ST DOSE, SINGLE for COVID-19 immunization. On 27Jan2021, the patient experienced nausea, arm pain and a low-grade fever. About 12 hours after feeling exhausted and slightly nauseous, fever was gone, arm was only sore now to the touch (almost better), just felt regular tired not exhausted. Nausea was gone. The facility where the most recent COVID-19 vaccine was administered was unknown. It was unknown if the patient received 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, it was unknown if the patient has been tested for COVID-19. It was unknown if the patient received treatment for the adverse events. The events were reported as non-serious. The outcome of the events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Just a sore arm in are of injection but was very mild; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262, Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 28Jan2021 at 13:45 pm (age at vaccination was 74 years) as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications the patient received within 2 weeks of vaccination included gabapentin and furosemide (LASIX). On 29Jan2021, the patient experienced just a sore arm in are of injection but was very mild. The facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The event was reported as non-serious. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Stomatitis
Clinical narrative: Sores in mouth and tongue after 1st injection. Still have them; Sores in mouth and tongue after 1st injection. Still have them; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: El1284, Expiry date: unknown), via an unspecified route of administration, administered in left arm on 01Jan2021 at 16:45 pm (age at vaccination was 45 years) as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history included high blood pressure, diabetes and chf (congestive heart failure). The patient's allergies to medications, food, or other products included sulfa allergy. The patient received concomitant medications within 2 weeks of vaccination and the details were unknown. On 03Jan2021 at 16:00 pm, the patient experienced sores in mouth and tongue after 1st injection, still have them. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/ Administration facility. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Ek9231, Expiry date: unknown), via an unspecified route of administration, administered in left arm on 21Jan2021 (age at vaccination was unknown) as a 2ND DOSE, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The event was reported as non-serious. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: fatigue; myalgias; Mild nasal congestion; Headache; This is a spontaneous report was received from a contactable physician (patient). A 61-years-old male patient received 2nd dose bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3246), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 as single dose for COVID-19 immunization. The patient medical history included BPH. The patient had received unspecified concomitant medications. The patient had no history of allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 in right arm on 18Dec2021 at 8:00 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications the patient received within 2 weeks of vaccination. On 09Jan2021 at 11:00, 28 hours after injection, the patient developed fatigue, then myalgias, lasted about 44 hours, mild nasal congestion, and headache briefly. The patient did not take treatment for the adverse events. The outcome of the fatigue and myalgia was recovered on 11Jan2021 while for the events headache and mild nasal congestion was recovered on an unspecified date in Jan2021.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test, Tinnitus
Clinical narrative: MODERATE TO SEVERE HEADACHES AND RINGING IN THE EARS; MODERATE TO SEVERE HEADACHES AND RINGING IN THE EARS; This is a spontaneous report from a non-contactable other hcp. A 72-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL3248), dose 2 intramuscular, administered in Arm Left on 18Jan2021 08:00 at 2ND DOSE, SINGLE (at the age of 72-year-old) for covid-19 immunisation. Medical history included Allergies: LATEX, allergies: METALS EXCEPT GOLD AND TITANIUM from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination, Patient had not tested positive for COVID-19 since having the vaccine. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 28Dec2021 08:00 (lot number=EL1284) at 1 ST DOSE, SINGLE (at the age of 72-year-old) for covid-19 immunisation. The patient experienced moderate to severe headaches and ringing in the ears on 18Jan2021 16:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jan2021. The outcome of the event was not recovered  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Generalized pruritus; rash on left deltoid; This is a spontaneous report from a contactable other HCP (patient). A 40-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection) dose 2, via an unspecified route of administration on 16Jan2021 at 12:45 PM on right arm (Batch/Lot Number: EL3246) as SINGLE DOSE for COVID-19 immunization. Medical history included Sjogren's syndrome, osteoporosis, renal tubular acidosis and lactose allergy. The patient previously took bnt162b2 (BNT162B2) dose 1, via unspecified route of administration on 28Dec2020 at 02:45 PM on left arm (Batch/Lot Number: EK5730) as single dose for COVID-19 immunization. Concomitant medication received within 2 weeks of vaccination. The patient experienced generalized pruritus and rash on left deltoid on 18Jan2021. The events were reported as non-serious. COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not tested for COVID-19. The patient did not receive treatment for the events. Outcome of the events was not recovered.   Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pain in jaw, Smear test, Toothache
Clinical narrative: Right jaw and lower teeth hurt for 3 days; Right jaw and lower teeth hurt for 3 days; chills; sore arm; This is a spontaneous report from a contactable Other Health Professional (Patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 44 years of age), via intramuscular administered in Arm Left on 13Jan2021 19:30 (Batch/Lot Number: EK9231) as Unknown, single for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not have any other vaccine within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, has the patient been tested for COVID-19 test. The patient's concomitant medications were not reported. The patient experienced right jaw and lower teeth hurt for 3 days, chills and sore arm on 14Jan2021 03:00. The patient underwent lab tests and procedures which included smear test: negative, on 19Jun2020 Covid test. The seriousness criteria of the events were reported as non-serious by the health authority. No treatment and or medical procedure was performed for all events. The outcome of the events were right jaw and lower teeth hurt for 3 days recovered on 17Jan2021, chills and sore arm recovered on an unspecified date.   Follow-up attempts are completed. No further information is expected. .
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Nausea, Pain in extremity, Pyrexia
Clinical narrative: diarrhea; woke up nauseous; vomiting; a low grade fever 99.5; Right arm started hurting; This is a spontaneous report from a contactable other hcp (Patient). A 35-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 25Jan2021 17:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Right on 31Dec2020 09:15 AM (Batch/Lot number was unknown) for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the right arm started hurting on Thursday 28Jan2021 then on Friday 29Jan2021 at 05:15 AM woke up nauseous and ended up vomiting (29Jan2021 at 05:15 AM) and with a low grade fever 99.5 (29Jan2021 at 05:15 AM) then on Saturday 30Jan2021 she no longer had fever and vomiting but did have diarrhea (30Jan2021) which stopped on 31Jan2021 in total she missed 3 days of work. No treatment was received for the events. The events were assessed as non- serious by reporter. The outcome of the events right arm started hurting, woke up nauseous were recovered on an unspecified date; events vomiting, a low grade fever 99.5 were recovered on 30Jan2021 and diarrhea was recovered on 31Jan2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: diarrhea; woke up nauseous; vomiting; a low grade fever 99.5; Right arm started hurting; This is a spontaneous report from a contactable other hcp (Patient). A 35-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 25Jan2021 17:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Right on 31Dec2020 09:15 AM (Batch/Lot number was unknown) for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the right arm started hurting on Thursday 28Jan2021 then on Friday 29Jan2021 at 05:15 AM woke up nauseous and ended up vomiting (29Jan2021 at 05:15 AM) and with a low grade fever 99.5 (29Jan2021 at 05:15 AM) then on Saturday 30Jan2021 she no longer had fever and vomiting but did have diarrhea (30Jan2021) which stopped on 31Jan2021 in total she missed 3 days of work. No treatment was received for the events. The events were assessed as non- serious by reporter. The outcome of the events right arm started hurting, woke up nauseous were recovered on an unspecified date; events vomiting, a low grade fever 99.5 were recovered on 30Jan2021 and diarrhea was recovered on 31Jan2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Lower back and lower extremity pain; Lower back and lower extremity pain; Stiff neck; This is a spontaneous report from a contactable consumer (patient reported herself). A non-pregnant 72-year-old female received BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her left arm on 25Jan2021 08.30 AM (Lot number: EL9261) as single dose for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient's medical history included bilateral knee replacement in 2008 and transient ischaemic attack (TIA) in 2017. Allergies to medications, food, or other products: SULFA. Concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior or post to vaccination. On 26Jan2021 05:00 PM, lower back and lower extremity pain, and stiff neck. The events were reported as non-serious. She did not receive any treatment in response to the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Lite nausea and tired the next day; Lite nausea and tired the next day; This is a spontaneous report from a contactable consumer.  An 82-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration in right arm on 29Jan2021 01:45 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not on other medications. The patient was not diagnosed with COVID-19, prior to vaccination. On 29Jan2021 at 7:00 pm, the patient experienced Lite nausea and tired the next day. The patient has not been tested for COVID-19 Since the vaccination. There was no treatment received for adverse events. The outcome of events was recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate, Heart rate increased, Nausea
Clinical narrative: heart rate increased; felt nauseous; flushed; This is a spontaneous report from a contactable consumer. A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 12:00 (Batch/Lot Number: EL3247) as 1st dose, single for covid-19 immunization.  The patient's medical history included rheumatoid arthritis, Hashimoto's Thyroiditis, allergies: Sulfa based drugs, shortlived anesthesia. There were no concomitant medications.  The patient previously took codeine and experienced allergies, humira and experienced allergies.  The patient experienced heart rate increased, felt nauseous, flushed on 26Jan2021 12:00 PM. The patient right after shot,her heart rate increased and she felt nauseous and very flushed. No treatment received for the adverse event. The Facility where the most recent COVID-19 vaccine was administered was Hospital.The patient underwent lab tests and procedures which included heart rate: increased on 26Jan2021 12:00 PM. The outcome of the events was recovered on unspecified date  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching; having a rash; This is a spontaneous report from a contactable 65-year-old male consumer reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; unknown, unable to locate or read the details) via an unspecified route of administration on 25Jan2021 at 02:00 pm at 1st dose, single on left arm for covid-19 immunisation. Patient was 6years-old at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Doctor's office/urgent care. Patient's medical history was not reported; Allergies to medications, food, or other products was reported as none that i am aware of. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient's concomitant medications (other medications the patient received within 2 weeks of vaccination) included atorvastatin, metformin and lisinopril (dates, indication and dosage unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced itching and having a rash starting on 25Jan2021. The reported events were not considered as serious and did not fall under any seriousness criteria. No treatment was received for the adverse events. On follow-up received on 16Apr2021, it was reported that the lot/batch number is not available despite the follow-up attempts made. The outcome of events was not recovered.   Follow-up attempts have been completed and no further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site mass
Clinical narrative: red raised; painful lump at site of shot about the size of a quarter; itchy; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 10:00 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. Medical history included, Slight asthma and high blood pressure (Slight asthma and high blood pressure) from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (LEVOTHYROX), bupropion hydrochloride (WELLBUTRIN), liothyronine sodium (CYTOMEL), olmesartan medoxomil (BENICAR) and silicon taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine, nitrofurantoin, Silvadene and varenicline and experienced drug hypersensitivity (Allergies to medications, food, or other products: Codeine, nitrofurantoin, silvadene, varenicline). The patient experienced red raised, painful lump at site of shot about the size of a quarter and itchy on 30Jan2021 16:00. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was recovering.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy
Clinical narrative: Swollen lymph nodes hard to swallow; Swollen lymph nodes hard to swallow; This is a spontaneous report from a non-contactable consumer (patient).  A 23-year-old non pregnant female 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, at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. The patient was not diagnosed with COVID-19 and was not tested for COVID-19 Prior to vaccination. The patient experienced Swollen lymph nodes and hard to swallow on an unspecified date. The outcome of events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Malaise, Nausea, Pain in extremity
Clinical narrative: diarrhea on 5th day; malaise; Slightly sore arm for 3 days; nausea on 3rd day; fatigue on 3rd day; This is a spontaneous report from a contactable 64-year-old female consumer reported for herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 10:15 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing sporadic migraines. Concomitant medication included betacarotene, sitosterols (CHOLESTEROL HEALTH) taken for an unspecified indication, start and stop date were not reported. The patient previously took tylenol and experienced drug intolerance. The patient experienced slightly sore arm for 3 days on 30Jan2021 12:15, nausea on 3rd day on 30Jan2021 12:15, fatigue on 3rd day on 30Jan2021 12:15, diarrhea on 5th day on 01Feb2021, malaise on 30Jan2021 12:15. The action taken in response to the events for bnt162b2 was not applicable. Therapeutic measures were taken as a result of slightly sore arm for 3 days (pain in extremity), nausea on 3rd day (nausea), fatigue on 3rd day (fatigue), diarrhea on 5th day (diarrhoea), malaise (malaise). The outcome of the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Ear discomfort, Flushing
Clinical narrative: throat tightness; body tingles; itching; eye and ear pressure; eye and ear pressure; dizziness; weakness; chest tightness; sweating; feeling flushed; This is a spontaneous report from a non-contactable other health professional. A 73-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL9264) as 1st dose, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.The patient experienced throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness, chest tightness, sweating, feeling flushed on 29Jan2021. During her 15 minute waiting period after the injection, the patient began to experience throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness, chest tightness, sweating, and feeling flushed. She denied hives, loss of sensation, SOB. Therapeutic measures were taken as a result of the events. Treatment included: antihistamines, Benadryl 25 mg, Pepcid 10 mg. Follow up response to treatment was good. Patient was discharged and was Stable to go home and follow up with PCP. The outcome of all the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Ocular discomfort, Paraesthesia, Pruritus, Throat tightness
Clinical narrative: throat tightness; body tingles; itching; eye and ear pressure; eye and ear pressure; dizziness; weakness; chest tightness; sweating; feeling flushed; This is a spontaneous report from a non-contactable other health professional. A 73-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL9264) as 1st dose, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.The patient experienced throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness, chest tightness, sweating, feeling flushed on 29Jan2021. During her 15 minute waiting period after the injection, the patient began to experience throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness, chest tightness, sweating, and feeling flushed. She denied hives, loss of sensation, SOB. Therapeutic measures were taken as a result of the events. Treatment included: antihistamines, Benadryl 25 mg, Pepcid 10 mg. Follow up response to treatment was good. Patient was discharged and was Stable to go home and follow up with PCP. The outcome of all the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: minor sore throat; This is a spontaneous report from a contactable 72-year-old (age at vaccination) male consumer reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; unknown, Not available/provided to reporter at the time of report completion) on 22Jan2021 at 11:15 am at 1st dose single on right arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as hospital. Patient's medical history was not reported (other medical history no health issues, allergies to medications, food, or other products; no). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient was experiencing minor sore throat for past three days beginning day 9 (30Jan2021). No treatment was received for the adverse event. The reported events were not considered as serious and did not fall under any seriousness criteria. The outcome of event was not recovered.   Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Illness, Lymphadenopathy
Clinical narrative: injection site pain; tiredness; feeling unwell; swollen lymph nodes; sore throat; My tonsil stones have returned; my normal with this thermometer has been about 97.4, and today my temperature was 99.1; I am a little sick; cough; This is a spontaneous report from a contactable 24-year-old Other HCP reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264, administration time-11:30 AM, vaccine location-Left arm, dose number-1), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. The patient medical history included anxiety, low vitamin D and eczema. Concomitant medications were not reported. On 30Jan2021, the patient experienced injection site pain, tiredness, feeling unwell, swollen lymph nodes, cough, sore throat, tonsil stones have returned, my normal with this thermometer has been about 97.4, and today my temperature was 99.1 and little sick. The patient laboratory details included temperature on 30Jan2021 with 99.1 (my normal with this thermometer has been about 97.4, and today my temperature was 99.1). The patient did not take the treatment for the adverse event. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Pyrexia, Tonsillolith, Vaccination site pain
Clinical narrative: injection site pain; tiredness; feeling unwell; swollen lymph nodes; sore throat; My tonsil stones have returned; my normal with this thermometer has been about 97.4, and today my temperature was 99.1; I am a little sick; cough; This is a spontaneous report from a contactable 24-year-old Other HCP reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264, administration time-11:30 AM, vaccine location-Left arm, dose number-1), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. The patient medical history included anxiety, low vitamin D and eczema. Concomitant medications were not reported. On 30Jan2021, the patient experienced injection site pain, tiredness, feeling unwell, swollen lymph nodes, cough, sore throat, tonsil stones have returned, my normal with this thermometer has been about 97.4, and today my temperature was 99.1 and little sick. The patient laboratory details included temperature on 30Jan2021 with 99.1 (my normal with this thermometer has been about 97.4, and today my temperature was 99.1). The patient did not take the treatment for the adverse event. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.