chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Arm pain; Chills; Mild fever; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Jul2021 at 10:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 21Jul2021 at 19:30, the patient experienced arm pain, chills and mild fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 15Aug2021, the patient underwent SARS-COV-2 test via nasal swab and the result was negative. The clinical outcome of the events arm pain, chills and mild fever were resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Migraine
Clinical narrative: Migraine; Extreme fatigue; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Nov2021 at 19:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks of vaccination which included tetanus vaccine (MANUFACTURER UNKNOWN) on an unknown date in 2021 for immunization. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 03Nov2021, the patient experienced migraine and extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine and extreme fatigue were unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Lymphadenopathy, Muscle fatigue, Nausea
Clinical narrative: Muscle fatigue; Body aches; Chills; Nausea; Injection site pain; Swollen axillary lymph nodes on left side; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via intramuscular route of administration in the left arm on 03Nov2021 at 09:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included IgA nephropathy. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received hydrocodone bitartrate; paracetamol (VICODIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 25Mar2021 at 15:00 (at the age of 31-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 19Apr2021 at 15:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 03Nov2021 at 15:00, the patient experienced muscle fatigue, body aches, chills, nausea, injection site pain and swollen axillary lymph nodes on the left side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle fatigue, body aches, chills, nausea, injection site pain and swollen axillary lymph nodes on the left side were not resolved at the time of this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Muscle fatigue; Body aches; Chills; Nausea; Injection site pain; Swollen axillary lymph nodes on left side; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via intramuscular route of administration in the left arm on 03Nov2021 at 09:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included IgA nephropathy. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received hydrocodone bitartrate; paracetamol (VICODIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 25Mar2021 at 15:00 (at the age of 31-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 19Apr2021 at 15:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 03Nov2021 at 15:00, the patient experienced muscle fatigue, body aches, chills, nausea, injection site pain and swollen axillary lymph nodes on the left side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle fatigue, body aches, chills, nausea, injection site pain and swollen axillary lymph nodes on the left side were not resolved at the time of this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood glucose, Coagulation time, Fatigue, Glomerular filtration rate
Clinical narrative: severe fatigue; nausea; sweats; tinnitus; This is a spontaneous report from a contactable other hcp.  A 76-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), dose 1 intramuscular, administered in Deltoid Left on 09Feb2021 (Age at vaccination: 76 years) as DOSE 1 SINGLE, dose 2 intramuscular, administered in Deltoid Left on 04Mar2021 (Batch/Lot Number: EN6205) as DOSE 2 SINGLE for covid-19 immunisation. Medical history included HTN from 20Jun2018 and was ongoing, Afib from 07Jun2021 and was ongoing, PVC, PVD, DM (Diabetes) from 14Jan2019 and was Ongoing, cataracts, diverticulosis, depression was Ongoing, polyneuropahty, COPD, insomnia, Chronic kidney disease (CKD - 3) from 24Feb2021 and was Ongoing . Patient was known to allergies which included amlodipine, codeine, cipro, losartan, MS, PCN, ACE inhibitors. It is unknown whether the patient tested for covid prior to vaccination. Post vaccination, patient was not tested for covid. It is unknown whether the patient taken any medication within four weeks prior to vaccination. Concomitant medication(s) included asa (ASA) taken for an unspecified indication from 12Jun2018 and ongoing; Duloxetine; evolocumab (REPATHA) taken for an unspecified indication from 02Jun2020 and ongoing; gliclazide (MICROZIDE [GLICLAZIDE]); metoprolol tartrate (LOPRESSOR); omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) taken for an unspecified indication from an unspecified start date and ongoing; biotin, cyanocobalamin, folic acid (MVI 3) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication from 02Jun2020 and ongoing; HCTZ taken for blood pressure measurement from Jun2020 and ongoing; metoprolol succinate (TOPROL) taken for blood pressure measurement from Jun2020 and ongoing; ondansetron (ZOFRAN [ONDANSETRON]) taken for nausea from 24Feb2021 to an un-specified stop date. On 09Feb2021, the patient experienced severe fatigue, nausea, tinnitus, sweats. Therapeutic measures were taken which included zofran, gas x labs. The patient underwent lab tests and procedures which included blood creatinine: 1.10 on 24Feb2021 High , blood glucose: 148 on 24Feb2021 High , coagulation time: 34  on 24Feb2021 High , glomerular filtration rate: 49 on 24Feb2021 Low , haematocrit: 47.3 on 24Feb2021 High , haemoglobin: 16.3 on 24Feb2021 High. The Outcome of the events was recovered in 2021.  Follow-up (02Apr2021): This is a follow up-spontaneous report from a contactable other HCP. This other HCP reported for the patient in response to Non-HCP letter [sent to Non-HCP] via follow-up letter which included that: Updated Suspect drug(Dosing regimen),event updated, patient (RMH added, narrative amended.   No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit, Haemoglobin, Hyperhidrosis, Nausea, Tinnitus
Clinical narrative: severe fatigue; nausea; sweats; tinnitus; This is a spontaneous report from a contactable other hcp.  A 76-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), dose 1 intramuscular, administered in Deltoid Left on 09Feb2021 (Age at vaccination: 76 years) as DOSE 1 SINGLE, dose 2 intramuscular, administered in Deltoid Left on 04Mar2021 (Batch/Lot Number: EN6205) as DOSE 2 SINGLE for covid-19 immunisation. Medical history included HTN from 20Jun2018 and was ongoing, Afib from 07Jun2021 and was ongoing, PVC, PVD, DM (Diabetes) from 14Jan2019 and was Ongoing, cataracts, diverticulosis, depression was Ongoing, polyneuropahty, COPD, insomnia, Chronic kidney disease (CKD - 3) from 24Feb2021 and was Ongoing . Patient was known to allergies which included amlodipine, codeine, cipro, losartan, MS, PCN, ACE inhibitors. It is unknown whether the patient tested for covid prior to vaccination. Post vaccination, patient was not tested for covid. It is unknown whether the patient taken any medication within four weeks prior to vaccination. Concomitant medication(s) included asa (ASA) taken for an unspecified indication from 12Jun2018 and ongoing; Duloxetine; evolocumab (REPATHA) taken for an unspecified indication from 02Jun2020 and ongoing; gliclazide (MICROZIDE [GLICLAZIDE]); metoprolol tartrate (LOPRESSOR); omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) taken for an unspecified indication from an unspecified start date and ongoing; biotin, cyanocobalamin, folic acid (MVI 3) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication from 02Jun2020 and ongoing; HCTZ taken for blood pressure measurement from Jun2020 and ongoing; metoprolol succinate (TOPROL) taken for blood pressure measurement from Jun2020 and ongoing; ondansetron (ZOFRAN [ONDANSETRON]) taken for nausea from 24Feb2021 to an un-specified stop date. On 09Feb2021, the patient experienced severe fatigue, nausea, tinnitus, sweats. Therapeutic measures were taken which included zofran, gas x labs. The patient underwent lab tests and procedures which included blood creatinine: 1.10 on 24Feb2021 High , blood glucose: 148 on 24Feb2021 High , coagulation time: 34  on 24Feb2021 High , glomerular filtration rate: 49 on 24Feb2021 Low , haematocrit: 47.3 on 24Feb2021 High , haemoglobin: 16.3 on 24Feb2021 High. The Outcome of the events was recovered in 2021.  Follow-up (02Apr2021): This is a follow up-spontaneous report from a contactable other HCP. This other HCP reported for the patient in response to Non-HCP letter [sent to Non-HCP] via follow-up letter which included that: Updated Suspect drug(Dosing regimen),event updated, patient (RMH added, narrative amended.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm sore; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in the left arm on 03Feb2021, at 08:50 (at the age of 69 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing dust allergy, in which she had to use fluticasone propionate (FLONASE) sometimes; tobacco user, in which she stopped on an unknown date in 2003 (reported as 18 years ago); hepatitis C from an unknown date in 2001 (reported as 20 something years ago) and ongoing, where she had a Fibroscan of liver; some cirrhosis but not a lot; found out she had hepatitis C when she donated blood for the  at work; and pre-lesions of the vagina, where she had a colonoscopy, endoscopy, and laser surgery on an unknown date in Sep2020. She also had a recent Pap smear and everything was good, and she has had last 2 Pap smears were good. Concomitant medication included pneumococcal vaccine (PNEUMONIA BOOSTER SHOT) taken for immunisation on an unknown date in Feb2021 (reported as around 19Feb202, but also 15 days before the first Pfizer COVID-19 Vaccine). On 03Feb2021 in the evening, the patient reported left arm sore. The patient stated that the arm was still a little sore to the touch if she touched in certain areas, but not bad. The patient has not recovered from the event.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a follow-up spontaneous report from a contactable consumer.This 40-year-old female consumer reported for herself that. A 40-years-old female patient received BNT162B2 (formulation: Solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left on 06Mar2021 16:00PM (age at vaccine 40-years-old) as DOSE 1, SINGLE for covid-19 immunisation. it was reported that the patient was not a pregnant at the time of vaccination. The patient medical history included thalassaemia beta from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore throat on 07Mar2021 16:00PM with outcome of unknown. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: injection site pain; scheduled to get my 2nd dose of the Pfizer Covid vaccine today, I am currently 19 weeks pregnant; This is a spontaneous report from a contactable pharmacist (patient). This is a maternal report. A 38-year-old pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular, administered in deltoid on 12Feb2021 afternoon (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. Medical history included seasonal asthma, obstetrical history included 3 previous pregnancies and 1 other child. She had 2 miscarriages/2 live births (one of the live births was preterm). Concomitant medications included Prenatal vitamins (capsules) for pregnancy at the frequency of once a day, orally from Dec2020 and ongoing and acetylsalicylic acid (ASPIRIN) 81mg tablet taken for pregnancy from Dec2020 to Jul2021. The patient had no prior vaccination. The patient was pregnant at the time of vaccination. The last menstrual period date was on an unknown date Oct2020 and estimated date of conception was in Nov2020. On 12Feb2021, the patient experienced injection site pain. The mother reported she became pregnant while taking bnt162b2. The mother was 19 Weeks pregnant at the onset of the event. The mother was not smoking, drink alcohol or used illicit drugs during pregnancy. The mother delivered the pregnancy via cesarean delivery. The baby was delivered full-term. Gestational age at birth was 39 weeks 4 days. The baby weighed 2721grams. APGAR Score 1 was 9, APGAR Score 2 was not provided, APGAR Score 3 was not provided. The fetal outcome is normal. Neonatal Information- Infant Details: Gender: Female Weight at birth: 6 lbs 7 oz Length at birth: 19 in Head circumstance at birth: 34cm. The patient did not have any problem before delivery and during delivery (including delivery complications, fetal distress, amniotic fluid abnormal, abnormal placenta). After delivery she had high total bilirubin. No treatment was received by the patient for the event. The outcome of the injection site pain was recovered on an unknown date in 2021.   Follow-up attempts are completed. No further information is expected.  Follow-up (27Aug2021 and 14Sep2021): This is a follow up-spontaneous report from a contactable Pharmacist (patient). This Pharmacist (patient) reported in response to HCP letter via follow-up letter which included that: Age at vaccination, dose 1 details (date of vaccination, lot/batch no, dosing details), new events (injection site pain and maternal exposure during pregnancy, second trimester), medical history, pregnancy details and other clinically relevant information added and updated in narrative accordingly.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine, Nausea, Photophobia, Vertigo
Clinical narrative: Migraine; extreme sensitivity to light; dizziness; vertigo-type sensation; nausea; This is a spontaneous report from a contactable female consumer (patient). A 44-year-old non-pregnant female patient received Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: not reported), via unspecified route of administration, administered in left arm, on 23Mar2021 at 10:00 AM, (age at vaccination 44-year-old), as dose 2, single for covid-19 immunisation. The patient was not a pregnant at the time of vaccination. The patient's medical history included history of headache, occasional migraine in history. Concomitant medications included multivitamins. Allergies to medications, food, or other products was reported as none. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: not reported), as dose 1, single for covid-19 immunisation. 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 had not been tested for COVID-19. On 24Mar2021 at 08:00AM onset approximately 22 hours after administration, the patient experienced migraine, included extreme sensitivity to light, dizziness, nausea or vertigo-type sensation. The patient could not work for several hours. The patient received Sumatriptan (IMITREX) as treatment for the events. The outcome of the events were recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Magnetic resonance imaging, Pain, SARS-CoV-2 test
Clinical narrative: i had headaches minutes after first shot; extreme pain; vomiting; dizziness; This is a spontaneous report from a contactable consumer or other non hcp.     A 40-year-old (non-pregnant) female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (at the age of 40 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing, cilians (drug hypersensitivity) from an unknown date and unknown if ongoing (known allergies: cilians). Concomitant medication(s) included acetylsalicylic acid, caffeine (BC [ACETYLSALICYLIC ACID;CAFFEINE]) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid, caffeine, ergotamine tartrate, homatropine methylbromide (MIGRANE) taken for an unspecified indication, start and stop date were not reported. Patient was not Pregnant at Time of Vaccination. No other vaccine in four weeks. Patient had covid prior vaccination. covid was tested post vaccination.On 28Feb2021 at 10:30 the patient had headaches minutes after first shot, extreme pain, vomiting and dizziness. It was reported that patient had headaches minutes after first shot that then progressed in coming weeks to migranes which needed to go on medicine due to extreme pain and vomiting and dizziness. Upon second shot the headaches worsened and dizziness. Still on medicine and now receiving an MRI. Brain fogginess had increased. Getting through the day to complete work or even basic tasks was very difficult.Therapeutic measures were taken with BC, migrane medicine as a result of  had headaches minutes after first shot, extreme pain, vomiting, dizziness. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown result on unspecified date, sars-cov-2 test: negative on 24Mar2021.The outcome of events was not recovered.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: i had headaches minutes after first shot; extreme pain; vomiting; dizziness; This is a spontaneous report from a contactable consumer or other non hcp.     A 40-year-old (non-pregnant) female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (at the age of 40 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing, cilians (drug hypersensitivity) from an unknown date and unknown if ongoing (known allergies: cilians). Concomitant medication(s) included acetylsalicylic acid, caffeine (BC [ACETYLSALICYLIC ACID;CAFFEINE]) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid, caffeine, ergotamine tartrate, homatropine methylbromide (MIGRANE) taken for an unspecified indication, start and stop date were not reported. Patient was not Pregnant at Time of Vaccination. No other vaccine in four weeks. Patient had covid prior vaccination. covid was tested post vaccination.On 28Feb2021 at 10:30 the patient had headaches minutes after first shot, extreme pain, vomiting and dizziness. It was reported that patient had headaches minutes after first shot that then progressed in coming weeks to migranes which needed to go on medicine due to extreme pain and vomiting and dizziness. Upon second shot the headaches worsened and dizziness. Still on medicine and now receiving an MRI. Brain fogginess had increased. Getting through the day to complete work or even basic tasks was very difficult.Therapeutic measures were taken with BC, migrane medicine as a result of  had headaches minutes after first shot, extreme pain, vomiting, dizziness. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown result on unspecified date, sars-cov-2 test: negative on 24Mar2021.The outcome of events was not recovered.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Hypersensitivity, Pyrexia, Rash macular
Clinical narrative: had an allergic reaction to the first shot; second shot scheduled date changed; Hives; Had hard time Breathing; Face turn red; Big Blotches; Temperature spiked really bad; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 12Apr2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. On an unspecified date in 2021, after first dose of vaccination, patient had an allergic reaction. Patient broke out hives in the waiting zone and then had a hard time breathing and face turn red and had really big blotches and temperature spiked really bad [onset date: unspecified date in 2021]. Patient asked to confirm that if had an allergic reaction then is the regulatory authority recommending not to get the second shot? Reportedly, second shot scheduled date changed. It was originally scheduled on the 3rd but patient had an allergic reaction, so had to change the date to go with somebody else, so that they could actually drive patient there. Patient have already done that. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: had an allergic reaction to the first shot; second shot scheduled date changed; Hives; Had hard time Breathing; Face turn red; Big Blotches; Temperature spiked really bad; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 12Apr2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. On an unspecified date in 2021, after first dose of vaccination, patient had an allergic reaction. Patient broke out hives in the waiting zone and then had a hard time breathing and face turn red and had really big blotches and temperature spiked really bad [onset date: unspecified date in 2021]. Patient asked to confirm that if had an allergic reaction then is the regulatory authority recommending not to get the second shot? Reportedly, second shot scheduled date changed. It was originally scheduled on the 3rd but patient had an allergic reaction, so had to change the date to go with somebody else, so that they could actually drive patient there. Patient have already done that. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Erythema, Pruritus, Urticaria
Clinical narrative: itchy skin all over his body; Red hives at itching site; Red hives at itching site; Uneasiness in stomach; This is a spontaneous report from a non-contactable consumer or other non HCP. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itchy skin all over his body, red hives at itching site, and uneasiness in stomach. It was reported that, callers husband had first dose of vaccine. Shortly after husband experienced itchy skin all over his body, red hives at itching site, no high temperature and uneasiness in stomach. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Muscle spasms, Nausea
Clinical narrative: muscle spasms over her entire body; Nausea; more problems breathing; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: ER2613) via unspecified route of administration, administered in left arm on 20Mar2021 (at the age of 56 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history includes ongoing sarcoidosis from unspecified date in Jul1999. The patient's concomitant medication(s) were none reported. Family history was none reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Additional Administered Vaccines was none reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6202) in left arm on 27Feb2021 (at the age of 56 years old) for covid-19 immunisation. On 20Mar2021 the patient experienced that muscle spasms over her entire body, nausea, more problems breathing. Reporter stated the main doctor she sees is her pulmonary doctor. Reporter stated the symptoms she experienced after the second dose was muscle spasms over her entire body, nausea, and she already has problems breathing but she had more problems breathing, muscle spasms over her entire body: Reporter stated this started 40 minutes after she had the vaccines. Reporter stated her hands started doubling over and she started having spams in her hand where she pulled over and had her husband drive. Reporter stated the spasms are sporadically now and not over her entire body. Reporter stated at the same time her husband wanted to take her to the hospital, but she refused, and it might have been stupid, but she is still here. Reporter stated on 20Mar2021 and 21Mar2021 she had what started in her hands and then it was over every place her legs, thighs, stomach, back and after two days the general spasm stopped and now, she just has randomly sporadically spams. More problems breathing: Reporter stated this started around the same time as her spasms started because she has a breathing machine where she takes asthma medicine, and she was able to give herself more breathing treatments. Reporter stated the breathing has not recovered since it is not back to normal, but it has improved. The patient was not hospitalized and not visited emergency room. The outcome of the event was resolved on 23Mar2021, and other events was resolving.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pains on the left side of his body, in his knee and hip; This is a spontaneous report from a contactable consumer (patients wife). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller was calling on be-half of her husband (patient). The patient has been having pains on the left side of his body, in his knee and hip, after his second dose of the vaccine. The patient's doctor said it may be a side effect of the vaccine. The caller wanted to know if this was a reported side effect. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Dyspnoea, Nasopharyngitis
Clinical narrative: very bad cold; loses sense of smell; shortness of breath; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 21Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 03Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date the patient experienced very bad cold, loses sense of smell and shortness of breath. She was asking if these was related to covid 19 vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Sneezing multiple times in quick succession; Runny nose; This is a spontaneous report from a contactable consumer (mother) reported for her son. A 17-years-old male patient received BNT162B2 (Formulation: Solution for injection, Lot Number: EW0161, Expiry Date was not reported) via an unspecified route of administration in Arm Right on 20Apr2021, Tuesday (age at vaccination 17 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were none. History of all previous immunizations with the Pfizer vaccine considered as suspect was none. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Apr2021 the patient experienced sneezing multiple times in quick succession and runny nose. Mother was calling to report her son symptoms that he has been experiencing since he got the COVID Vaccine on Tuesday, 20Apr2021. She Stated, sneezing was started within an hour of the injection. Her son sneezes multiple times in quick succession which did not seem to be as bad today as it was yesterday and Tuesday. Runny nose was also started on the day of the injection which was ongoing at about the same pace. The patient did not require a visit to Emergency Room as well as Physician Office. The outcome of the event sneezing multiple times in quick succession was recovering while the event runny nose was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Pyrexia
Clinical narrative: Fever; Every bone is aching; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient) reported for herself. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient had been in bed, had a fever and every bone was aching. The patient underwent lab test which included body temperature: fever on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: having trouble breathing; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer reported for a patient (Reporter's wife) that.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration on 27Apr2021 as dose 2, single for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included 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. Reporter stated his wife who got second dose on 27Apr2021 (today) and was having trouble breathing. She wanted to know if it was something that he should be worried about. There were unaddressed medical questions referred or forwarded to Medical Information. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be required.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable pharmacist from a Pfizer sponsored program.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Pharmacist had a patient get hives from first covid vaccine shot. Inquiring how to proceed to second. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue
Clinical narrative: He is feeling fatigued; Pressure on his chest; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program .  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, patient experienced he is feeling fatigued, pressure on his chest. It was reported that, patient received first  with no problems but with his second  about 7 days after he is feeling fatigued and pressure on his chest. He asked if this could be a side effect to the . Informed him it could but with pressure on his chest he needs to contact his HCP immediately to make sure this is not his heart. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Movement disorder
Clinical narrative: join pain; bones were hurting; couldn't move; This is a spontaneous report from a contactable consumer (Patient) in response to Non-Health Care Professional letter sent in cross-reference case.  A 32-year-old unspecified gender patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6208) via intramuscularly, administered in left arm on 17Mar2021 at 17:00 as dose 2, single for COVID-19 immunization. The patient medical history included anxiety. The concomitant medication included sertraline (MANUFACTURER UNKNOWN) for anxiety from Mar2020 to Feb2021. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198; Expiration date: 30Jun2021), via intramuscularly, administered in left arm on 24Feb2021 as a dose 1, single for COVID-19 immunization and experienced cough, mild rash on left cheek, body ache, chills and sore throat, dizzy. On an unspecified date, the patient experienced join pain, bones were hurting and couldn't move.  The patient stated that after the second dose joint pain and bones were hurting to the point and couldn't move. No relevant tests conducted. The outcome for all the reported events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Hypertension, Rash, Swelling face
Clinical narrative: Facial swelling and problems breathing; Facial swelling and problems breathing; Blood pressure jumped up; She also did have a rash, but it was not a bad rash; This is a spontaneous report from a contactable consumer (patient).   A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 49-year-old) as dose 1, single for covid-19 immunisation. Medical history included patient has low blood pressure and some other rash for other medications. Concomitant medication was not reported. Patient stated, on an unspecified date, she end up in the Emergency Room but it was not an anaphylactic reaction. She had face swelling and problems breathing. Also anytime she would get up, her blood pressure would jump up. She does not normally have high blood pressure, she has low blood pressure. When she would get up and walk around or go up stairs, it would go up. She also did have a rash, but it was not a bad rash. Patient did not wish to provide the name of the other medications that she had the rash to. The patient underwent lab tests and procedures which included blood pressure measurement resulting jumped up BP on an unspecified date. Outcome of the events was unknown at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Swelling
Clinical narrative: Presented with an inflammation on the back; Had swollen on the back on right side and now, she has swollen on the left side; This is a spontaneous report from a contactable other hcp. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration, administered in Arm Right on 04Apr2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications was reported. On an unspecified date the patient experienced presented with an inflammation on the back, had swollen on the back on right side and now, she has swollen on the left side. Additional Context: Reporter (Nurse) stated, I am calling on behalf of my aunt who received a Pfizer vaccine on 04Apr and she got the second dose on 25Apr. After the first dose, she puts into (voice not clear), she presented with an inflammation on the back on the same side as the dose (not clear) and with the second dose she presented the same symptoms on the left arm and inflammation on the back on the same side. Is that normal. No treatment was received for the events. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed a red, non-puritic rash in axilla and neck on same side as vaccination.; This is a spontaneous report from a non contactable consumer.  A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) (age at vaccination 48-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unknown date (lot number: not reported) as dose 1, single for COVID-19 immunisation. The patient experienced developed a red, non-puritic rash in axilla and neck on same side as vaccination, the patient had no discomfort, described as 'looks a little funky' on an unknown date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.