chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal
Clinical narrative: heart rate went up from 83 to 103; it solved on its own; This is a spontaneous report from a contactable consumer received via Pfizer-sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 20Jan2021, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Jan2021, 2 or 2.5 hours later, her heart rate went up from 83 to 103; it solved on its own. Her HCP told her it was okay. Second dose was scheduled four weeks after the first one and enquired whether it was recommended. She enquired about the timing of the second dose of vaccine. Follow-up received on 28Jan2021 is being submitted to notify adverse events as elevated heart rate and scheduled to receive second dose 4 weeks after first dose, instead of 3 weeks. Patient measured her heart rate with an oximeter she keeps to measure oxygen levels. Even though she does not have COVID she know that decreased oxygen levels are a sign of COVID so she keeps the oximeter around. She thinks that the heart rate elevation is a much more miniscule risk as opposed to actually getting COVID. She wanted information of whether Pfizer feels that this event is normal or serious and if there is information on getting second dose after that event. She also asked if it is ok to get the second dose 4 weeks after first dose instead of 3 weeks. She has been scheduled to receive her second dose 4 weeks after first dose. She talked to her Pharmacist, Primary Care Physician and Cardiologist about the elevated heart rate event. Outcome of the event was recovered. Lot/batch number was not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable Other Health Professional (patient). A 27-Year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EL3247) via unspecified route of administration at arm left on 27Jan2021 at 09:00 AM as single dose for COVID-19 immunization. Medical history included allergies to sulfa antibiotics. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication was not reported. Previously patient received first dose of BNT162B2 for COVID-19 immunization. On an unknown date, patient experienced hives. No COVID prior vaccination. Patient has not tested COVID-19 post vaccination. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Swollen tongue, Urticaria
Clinical narrative: Red hives starting at neck and chest and radiating to arms and face; Light headed; Swollen tongue; This is a spontaneous report received from a contactable other hcp. A 48-years-old female patient received first dose of  (Solution for injection), via an unspecified route of administration, administered in Arm Left on 26 Jan 2021 18:30 as single dose for Covid-19 immunisation. The patient's medical history was not reported. Patient had no known allergies. Concomitant medications included Hydrochlorothiazide and Betahistine. It was reported that patient was not pregnant at the time event. On 26 Jan 2021, the patient experienced red hives starting at neck and chest and radiating to arms and face, lightheaded and swollen tongue. The events were non-serious. Patient received Benadryl as treatment for events. It was reported that patient was not taken any vaccine in four weeks nor had Covid and tested the same post to vaccination. Outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: breathing was labored; minor sore arm; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27Jan2021 13:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included asthma, hypertension, Immature White Blood Cells (monitored for years), heart Premature ventricular contractions, anxiety, gastrooesophageal reflux disease, drug hypersensitivity. The patient had not taken any other vaccine in four weeks, he took other medication within two weeks. The patient did not had covid-19 prior to vaccination and not tested for covid-19 post vaccination. On 27Jan2021, patient had no side effects at time of vaccination but at night of vaccination date, patient experienced minor sore arm and on the next day on 28Jan2021 at 07: 00AM breathing was labored. The patient visited to doctor or other healthcare professional office or clinic visit. The doctor put patient on Zpac and Oral Steroids as therapy for events. Outcome of events was recovering. Lot/batch number was not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Flu like symptoms 8 hours after the shot; Body aches; chills; nausea; vomiting; severe headache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received second dose of (Solution for injection, COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 28 Jan 2021 at 08:00 (at the age of 50-year-old) for COVID-19 immunization. The patient medical history included cancer survivor of 8 year. The patient had no known allergy. The patient concomitant medication included ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, Thioctic Acid, zinc ascorbate (EMERGEN C) taken within two weeks of vaccination. The patient historical vaccine included first dose of (Solution for injection, COVID-19  VACCINE; Lot Number: ELO140) via an unspecified route of administration, administered in right arm on 07 Jan 2021 at 08:00 (at the age of 50-year-old) for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether patient tested for COVID-19. On 28 Jan 2021 at 16:00, the patient experienced flu like symptoms 8 hours after the vaccination, body aches, chills, then nausea, vomiting and severe headache. Severe symptoms lasted 12 hours. The patient did not receive treatment for events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Flu like symptoms 8 hours after the shot; Body aches; chills; nausea; vomiting; severe headache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received second dose of (Solution for injection, COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 28 Jan 2021 at 08:00 (at the age of 50-year-old) for COVID-19 immunization. The patient medical history included cancer survivor of 8 year. The patient had no known allergy. The patient concomitant medication included ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, Thioctic Acid, zinc ascorbate (EMERGEN C) taken within two weeks of vaccination. The patient historical vaccine included first dose of (Solution for injection, COVID-19  VACCINE; Lot Number: ELO140) via an unspecified route of administration, administered in right arm on 07 Jan 2021 at 08:00 (at the age of 50-year-old) for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether patient tested for COVID-19. On 28 Jan 2021 at 16:00, the patient experienced flu like symptoms 8 hours after the vaccination, body aches, chills, then nausea, vomiting and severe headache. Severe symptoms lasted 12 hours. The patient did not receive treatment for events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Hypertension, Influenza like illness, Pain
Clinical narrative: Body aches/whole body was aching; Blood pressure high/Blood pressure was 174/104 and it stayed high like that all day; felt like I have flu; Chills; This is a spontaneous report received from a contactable consumer (patient). A female (Patient Age: 68 (units not mentioned)) patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: LEL3248 (that was all it said on the card she had, she assumed this was the Lot number) and expiry: not reported), via an unspecified route of administration on 26Jan2021 as single dose for covid-19 immunisation. Medical history included Covid-19 around November (unknown if ongoing). The patient's concomitant medications were not reported. On 26Jan2021 (late Tuesday) towards evening, the patient's body started to get the body aches, chills, her blood pressure went up really high and it was like that all through the night and continued running high like that (had the Pfizer COVID-19 vaccine first dose on Tuesday). On 26Jan2021, she felt like she had flu and whole body was aching. On 27Jan2021 (Wednesday) she was in bed with all the same symptoms of felt like had flu because of the body ache and the chills and the high blood pressure. She kept taking Tylenol as therapeutic measure and her blood pressure was 174/104 and it stayed high like that all day on Wednesday. On 26Jan2021 (Thursday morning) everything was gone, her blood pressure was back to normal, body ache and chills were all gone. Now, what she wanted to know was, should she be getting the second vaccine because of all the side effects that she had with the first one and she was wondering of should she get the 2nd vaccine again as she was very concerned her blood pressure was 174/104.  She also had covid around November and wanted to know if she was supposed to wait 90 days before getting the vaccine and was that normal for it to affect her blood pressure. The outcome of felt like I have flu was unknown and it was recovered for rest all the events on 28JAN2021. Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Throat tightness
Clinical narrative: The left side of my face felt numb starting after the first hour and for the whole day. Also, my throat was slightly tightening; The left side of my face felt numb starting after the first hour and for the whole day. Also, my throat was slightly tightening; This is a spontaneous report from a contactable Nurse (Patient, self-reported). A 39-years-old not pregnant female patient received first dose of ( COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29 Jan 2021 09:15AM as an unspecified dose for covid-19 immunisation. Medical history included hypothyroid, known allergies was No. Concomitant medications included levothyroxine sodium (SYNTHROID); aspirin [acetylsalicylic acid], vitamins. On 29 Jan 2021 10:00, the patient experienced the left side of my face felt numb starting after the first hour and for the whole day. also, my throat was slightly tightening. Treatment received for the evets was unknown. The clinical outcome of the event was recovered on unspecified date of 2021. Information about lot/batch number has been requested. Follow-up (16 Apr 2021): 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Constant headache/migraine; Constant headache/migraine; Panic; Trouble sleeping; Chest pain; Fatigue; Trouble breathing; Feeling of doom; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported) via intramuscular, in left arm on 18Jan2021 as single dose for COVID-19 immunization (at the age 37 years). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on left arm on 28Dec2020 as single dose for COVID-19 immunization (at the age 37 years). The patient medical history and concomitant medications were not reported. Most recent COVID-19 vaccine was administered in Hospital. No other vaccine was received 4 weeks prior and no medication was received prior 2 weeks. Patient was not diagnosed with covid-19, prior to vaccination and since the vaccination the patient was not been tested for COVID-19. Patient did not have allergies to medications, food, or other products. On 19Jan2021, patient experienced constant headache/migraine, panic, trouble sleeping, chest pain, fatigue, trouble breathing and feeling of doom. Patient visited Physician's office for the treatment. No treatment was received in response to events. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.  Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Panic disorder, Sleep disorder
Clinical narrative: Constant headache/migraine; Constant headache/migraine; Panic; Trouble sleeping; Chest pain; Fatigue; Trouble breathing; Feeling of doom; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported) via intramuscular, in left arm on 18Jan2021 as single dose for COVID-19 immunization (at the age 37 years). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on left arm on 28Dec2020 as single dose for COVID-19 immunization (at the age 37 years). The patient medical history and concomitant medications were not reported. Most recent COVID-19 vaccine was administered in Hospital. No other vaccine was received 4 weeks prior and no medication was received prior 2 weeks. Patient was not diagnosed with covid-19, prior to vaccination and since the vaccination the patient was not been tested for COVID-19. Patient did not have allergies to medications, food, or other products. On 19Jan2021, patient experienced constant headache/migraine, panic, trouble sleeping, chest pain, fatigue, trouble breathing and feeling of doom. Patient visited Physician's office for the treatment. No treatment was received in response to events. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.  Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the 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: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fever (100.5 F) all day and night; pain at the injection site; chills; headache; fatigue; This is a spontaneous report from a non-contactable consumer via medical information team. A female patient of unspecified age received of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number and expiry date: unknown), via unspecified route at unknown date at single dose for COVID-19 immunization. Relevant medical history included: The patient had a serious case of Covid-19 in unspecified date in Mar2020. Concomitant medication was not reported. On an unspecified date in Jan2021, after receiving the vaccine, the patient had fever (100.5 F) all day and night, chills, headache, fatigue, and pain at the injection site. She had antibodies 2 weeks ago on 15Jan2021. The patient did not need information and just wanted to help other people by reporting the side effects she experienced. The patient did not receive any treatment. 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: Vaccination site pain
Clinical narrative: fever (100.5 F) all day and night; pain at the injection site; chills; headache; fatigue; This is a spontaneous report from a non-contactable consumer via medical information team. A female patient of unspecified age received of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number and expiry date: unknown), via unspecified route at unknown date at single dose for COVID-19 immunization. Relevant medical history included: The patient had a serious case of Covid-19 in unspecified date in Mar2020. Concomitant medication was not reported. On an unspecified date in Jan2021, after receiving the vaccine, the patient had fever (100.5 F) all day and night, chills, headache, fatigue, and pain at the injection site. She had antibodies 2 weeks ago on 15Jan2021. The patient did not need information and just wanted to help other people by reporting the side effects she experienced. The patient did not receive any treatment. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Gait disturbance, Headache, SARS-CoV-2 test
Clinical narrative: 14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, wobbly and tired, every day got a bit better, but I'm still feeling it as of today; 14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, wobbly and tired, every day got a bit better, but I'm still feeling it as of today; 7 days after my first Pfizer Covid vaccine I developed severe fatigue and moderate headache,14 days after the vaccine I am feeling a bit better but still unusually tired; 7 days after my first Pfizer Covid vaccine I developed severe fatigue and moderate headache; This is a spontaneous report from a contactable consumer (Patient). A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was unknown), dose 1 via an unspecified route of administration, in left arm (shoulder) on 16Jan2021 09:15 (at 45-years age) as single dose for covid-19 immunisation. Medical history was and concomitant medications were not reported. Patient was not allergic to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 06:00 7 days after first Pfizer Covid vaccine patient developed severe fatigue and moderate headache. 14 days after the vaccine he was feeling a bit better but still unusually tired. At first, he was weak, wobbly and tired, every day got a bit better, but he was still feeling it as of today. On 24Jan2021 patient underwent laboratory test that include post vaccination COVID-19 nasal swab test which results negative. The patient did not receive any treatment for the events. The event outcome was reported as resolving.  Information on the lot/batch number has been requested.  Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Peripheral swelling, SARS-CoV-2 test, Urticaria
Clinical narrative: Severe Hives; Severe swelling on eye and lip; Severe swelling on eye and lip; severe swelling arthritic feeling in hands; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:  ENS318) via unspecified route administered in Arm Left on 26Jan2021 09:30 via an unspecified route of administration, as single dose for an unspecified indication. Historical vaccine included first dose of bnt162b2. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D COLECALCIFEROL). No other medication taken four weeks prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test with unknown date. The patient experienced severe hives on, severe swelling on eye, severe swelling on lip, Started roughly 10 hours after the vaccine and are still lasting 4 days later. Also severe swelling arthritic feeling in hands(could not grip anything on day 2) all these on 26Jan2021 19:00. The patient was currently using prednisone, Zyrtec, benedryl, and Pepcid AC and said nothing was helping. The patient said she had no known allergies and have never had hives before. She had to miss two days of work. The outcome of the event was not resolved.  Follow-up (02Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Query:  Dear Manufacturer, Kindly see the attached document received by Pfizer Inc. containing a product in which you have been identified as the manufacturer. Response:  Email received. Case created #. Dear Colleagues,  Would you kindly address the query below and copy it to the mailbox with your reply.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lethargy, Paraesthesia, Pyrexia
Clinical narrative: Headache; tingling in arms and hand; severe lethargy; fever 101.8; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non pregnant female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247),via unspecified route of administration, administered in left arm on 21Jan2021 at 13:00 (at the age of 53 years) as single dose for COVID-19 immunization. The patient medical history included vertigo, migraine, asthma. The patient had an unknown allergy to medications, food, or other. The concomitant medication that the patient received within 2 weeks of vaccination included pseudoephedrine hydrochloride (SUDAFED) and ibuprofen (ADVIL). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 the patient experienced headache, tingling in arms and hand, severe lethargy and fever 101.8. The patient did not receive treatment for the events. On 22Jan2021 the patient underwent lab tests and procedures which included body temperature was 101.8. fever. The outcome of event was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Dyspnoea, Heart rate, Muscle tightness
Clinical narrative: slight shortness of breath in the next few minutes; chest and back tightness began; chest and back tightness began; rash and hives across my face; rash and hives across my face; This is a spontaneous report from a contactable Nurse (patient). A 24-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262 and expiration date was not reported), via unspecified route of administration in left arm on 26Jan2021 at 05:00 PM, as single dose for COVID-19 immunisation. The patient's medical history included GERD, migraines, depression, anxiety and allergy to peanuts and codeine. The concomitant medication included Amitriptyline, lansoprazole, Zyrtec and multivitamin. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142 and expiration date was not reported), in left arm on 03Jan2021 at 03:30 PM for COVID-19 immunisation. On 26Jan2021 at 17:05 patient experienced chest and back tightness began and slight shortness of breath in the next few minutes. Reported symptoms to on duty nurses who immediately laid down and checked vitals. BP 138/98, P 102, O2 98. On 26Jan2021 at 17:00 Nurses reported that she had broken out into a rash and hives across her face and chest. Given O2 at 2 Liters per minute. She was taken to the ER and given a steroid nebulizer, benadryl and claritin. Discharged and prescribed 20mg prednisone QD (every day) for 5 days, and a pro-air albuterol inhaler prn (as needed). Facility type vaccine: Doctor's office/urgent care. The patient did not other vaccine in four weeks. The adverse event resulted in emergency room/department or urgent care visit. The patient received corrective treatment for the adverse events. No COVID prior vaccination and no covid tested post vaccination. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Rash, Urticaria
Clinical narrative: slight shortness of breath in the next few minutes; chest and back tightness began; chest and back tightness began; rash and hives across my face; rash and hives across my face; This is a spontaneous report from a contactable Nurse (patient). A 24-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262 and expiration date was not reported), via unspecified route of administration in left arm on 26Jan2021 at 05:00 PM, as single dose for COVID-19 immunisation. The patient's medical history included GERD, migraines, depression, anxiety and allergy to peanuts and codeine. The concomitant medication included Amitriptyline, lansoprazole, Zyrtec and multivitamin. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142 and expiration date was not reported), in left arm on 03Jan2021 at 03:30 PM for COVID-19 immunisation. On 26Jan2021 at 17:05 patient experienced chest and back tightness began and slight shortness of breath in the next few minutes. Reported symptoms to on duty nurses who immediately laid down and checked vitals. BP 138/98, P 102, O2 98. On 26Jan2021 at 17:00 Nurses reported that she had broken out into a rash and hives across her face and chest. Given O2 at 2 Liters per minute. She was taken to the ER and given a steroid nebulizer, benadryl and claritin. Discharged and prescribed 20mg prednisone QD (every day) for 5 days, and a pro-air albuterol inhaler prn (as needed). Facility type vaccine: Doctor's office/urgent care. The patient did not other vaccine in four weeks. The adverse event resulted in emergency room/department or urgent care visit. The patient received corrective treatment for the adverse events. No COVID prior vaccination and no covid tested post vaccination. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Headache, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pt (Patient) started feeling confused; She had numbness and tingling on R side; She had numbness and tingling on R side; pain in R leg; headache; This is a spontaneous report from a contactable Physician. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration in left arm on 27Jan2021 at 10:45 AM as single dose for COVID-19 immunisation. The patient was not pregnant. 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 to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was allergic to penicillin. The patient medical history included TIA, angina, and restless leg syndrome. Concomitant medication included Asprin 81mg daily. On 29Jan2021 at 09:00 PM, the patient started feeling confused, had numbness, and tingling on right side, pain in R leg and headache. AE resulted in emergency room/department or urgent care. Treatment was received for AE. The outcome of the events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Severe dizziness; Nausea; Severe headache; This is a spontaneous report from a contactable Other-HCP (patient). A 35-year-old female patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EK9231), via intramuscular route of administration on arm right on 05Jan2021 15:15 and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9265), via intramuscular route of administration on arm right on 26Jan2021 16:30 at single dose for COVID-19 immunization. The patient medical history included Immune thrombocytopenia, Cold, urticaria, diabetes and had no known allergies. 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 concomitant medications included OMEPRAZOLE MAGNESIUM (PRILOSEC), Zzquil. The patient had not received any other vaccines in 4 weeks. On 26Jan2021 20:00, the patient experienced severe dizziness-2 days, Severe headache-2 days, Nausea-2 days. The patient experienced severe muscle aches, bone aches, joint aches, high fever, head ache, loss of appetite, all lasting a full 24 hours and new chronic symptoms like cough, chest tightness, shortness of breath started on day 2 post second shot and are still present. The patient did not receive any treatment for the events. The outcome of the events was reported as recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Hypoaesthesia
Clinical narrative: developed pain in the left side of cheek, feels as if someone has slapped in the face. there is mild numbness as well. eating/talking or touching my face reproduces the pain.; developed pain in the left side of cheek, feels as if someone has slapped in the face. there is mild numbness as well. eating/talking or touching my face reproduces the pain.; This is a spontaneous report from a contactable physician reported for herself. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 26Jan2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history was none. Patient was not pregnant. The patient's concomitant medications were not reported.  On 30Jan2021 at 19:00, patient developed pain in the left side of cheek, it felt as if someone had slapped her in the face. There was mild numbness as well. It got worse towards the end of the night. Eating/talking or touching face reproduced the pain. Patient had not been ill or taken any medications since the vaccine and was in good health. No prior symptoms such as this. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events was reported as unknown. Outcome of the events was not resolved. This case was reported as non-serious.  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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy
Clinical narrative: Lymph node swelling in right armpit; Also experienced flu like symptoms; This is a spontaneous report from a contactable consumer reported for himself. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 28Jan2021 08:45 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS) and allergy to eggs, fish and tree nuts. Concomitant medication was received (patient received other medications within 2 weeks). The patient experienced lymph node swelling in right armpit. It was about the size of a half-dollar four days after vaccination. Also experienced flu like symptoms. The events onset on 30Jan2021 at 7:00. No treatment was received. Outcome of the events was not resolved. This case was reported as non-serious.  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: Arthralgia, Bone pain, Chest discomfort, Cough, Decreased appetite
Clinical narrative: Cough; Shortness of Breath; Chest Tightness; Bone aches; Joint aches; High fever; Loss of appetite; Muscle aches; Headache; This is a spontaneous report from a contactable healthcare professional. A 35-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265), via intramuscular route of administration on 26Jan2021 at 16:30 (at the age of 35-year-old) as single dose in right arm for COVID-19 immunization at workplace clinic. The patient's medical history included immune thrombocytopenia, cold urticaria and diabetes. There was no known allergies. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK9231), via intramuscular route of administration on 05Jan2021 at 15:15 (at the age of 35-year-old) as single dose in right arm for COVID-19 immunisation and experienced sever dizziness, severe headache and nausea, all lasted for 2 days. Patient was not pregnant at the time of vaccination. Concomitant medications included prilosec, zzquil. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jan2021 at 20:00, the patient experienced severe muscle aches, bone aches, joint aches, high fever, headaches and loss of appetite, all lasted a full 24 hours. On 28Jan2021, day 2 post second shot, the patient experienced new chronic symptoms like cough, chest tightness and shortness of breath, all still present. There was no treatment received for the events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all events was recovered with sequel.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Myalgia, Pyrexia
Clinical narrative: Cough; Shortness of Breath; Chest Tightness; Bone aches; Joint aches; High fever; Loss of appetite; Muscle aches; Headache; This is a spontaneous report from a contactable healthcare professional. A 35-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265), via intramuscular route of administration on 26Jan2021 at 16:30 (at the age of 35-year-old) as single dose in right arm for COVID-19 immunization at workplace clinic. The patient's medical history included immune thrombocytopenia, cold urticaria and diabetes. There was no known allergies. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK9231), via intramuscular route of administration on 05Jan2021 at 15:15 (at the age of 35-year-old) as single dose in right arm for COVID-19 immunisation and experienced sever dizziness, severe headache and nausea, all lasted for 2 days. Patient was not pregnant at the time of vaccination. Concomitant medications included prilosec, zzquil. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jan2021 at 20:00, the patient experienced severe muscle aches, bone aches, joint aches, high fever, headaches and loss of appetite, all lasted a full 24 hours. On 28Jan2021, day 2 post second shot, the patient experienced new chronic symptoms like cough, chest tightness and shortness of breath, all still present. There was no treatment received for the events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all events was recovered with sequel.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Hypoaesthesia, Neuralgia, Skin burning sensation
Clinical narrative: Developed unilateral neuropathic pain in one thigh, progressing to both thighs; posterior arm numbness; skin feels sunburned but no skin findings; lower abdominal burning sensation; This is a spontaneous report from a contactable physician. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 11Jan2021 (Batch/Lot Number: EL3248) as single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, allergies: shellfish. Historical vaccine included 1st dose of BNT162B2 (lot number=59267-1000-1 Lot EJ1685) via intramuscular on left arm on 21Dec2020 for COVID-19 immunization. Concomitant medications included semaglutide (OZEMPIC), atorvastatin, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and enalapril, all taken for an unspecified indication, start and stop date were not reported. Patient developed unilateral neuropathic pain in one thigh, progressing to both thighs. Patient also had posterior arm numbness, skin feels sunburned but no skin findings, also now with lower abdominal burning sensation. The events onset on 22Jan2021. Patient received treatment for the events included prednisone. The events result in doctor or other healthcare professional office/clinic visit. Outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness to the right of my face and body; numbness to the right of my face and body; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Batch/Lot Number: EN5318 via an unspecified route of administration in left arm on 28Jan2021 02:45 as single dose for covid-19 immunization. The patient was 47-years-old at the time of vaccination. The patient was not pregnant. Patient relevant medical history included prior to the vaccine about a month ago experienced the numbness in face and in body and currently consulting a neurologist. The patient's concomitant medications were not reported. Patient haven't taken other vaccine in four weeks and no other medications in two weeks. Patient have no known allergies. Patient was not tested to covid prior to vaccination and not tested post vaccination. On30Jan2021 at 19:00 the patient experienced numbness to the right of her face and body. AE resulted in emergency room/department or urgent care. No treatment taken for resulted adverse events. Outcome of the event was recovering.  Information about Lot/Batch number is requested.  Follow-up (08Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: [Query]:  Dear Colleague, Please see attached which was submitted by you. Please kindly confirm the date you first aware of the info reported in the attached source, as this date was considered as PRD (Pfizer receipt date). This date provided as 01Feb2021 on the report, while the adverse event start date provided as 30Jan2021 [Response]: Yes, the adverse event occurred on 30Jan. Here's the lot #EN5318.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache
Clinical narrative: Felt uncomfortable; headache; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29Jan2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got Covid-19 2nd vaccination yesterday (29Jan2021) at 3 o clock in the afternoon. After, she felt uncomfortable, not that severe headache but she took Tylenol. She researched online for 2 hours and read that they shouldn't be taking Tylenol after the vaccine. The patient wanted to know if this will affect the efficacy of the vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Rash
Clinical narrative: A lot of headache; Little bit nauseous; Rash on face; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247; Expiration Date: 31May2021), via an unspecified route of administration on 27Jan2021 at SINGLE DOSE for covid-19 immunisation. The same day, which was a Wednesday, the patient was having a couple of symptoms., kind of have like a headache and then a little bit nauseous but then this morning woke up with the rash on my face. The patient hasn't read anything about that being kind of a side effect and it was just a little bit strange to me that happened a few days to me after being already vaccinated. So, was enquiring what was to be done.  The outcome of the events was unknown.   Follow-up (30Jan2021): This is a Follow-up spontaneous report from a contactable consumer. Limited information was obtained.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: tiredness; Body ache; Just general body aches all over/pain; weakness; a very low temperature fever; This is a spontaneous report received from a contactable consumer via Pfizer Sponsored Program. A female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9263) via an unspecified route of administration on 29Jan2021 as single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. Reporter stated that her mom developed lots of side effects of tiredness, body ache, just general body aches all over/pain, weakness, very low temperature fever after she received the 2nd dose of vaccine on an unspecified date in Jan2021 (reported as last night) and was wondering is it okay to give Tylenol or Advil something for her symptoms. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: however she was prescribed by her doctor with Enbrel for her Arthritis; This is an initial spontaneous report received from contactable consumer (patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received first 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 a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced arthritis on an unspecified date. It was reported that patient was about to schedule her second dose however she was prescribed by her doctor with Enbrel for her Arthritis. The outcome of the event was unknown.   Information about 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: Vaccination site pain
Clinical narrative: Soreness above the injection site; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer Sponsored Program. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. It was reported that Initially wanted to ask if her fiance can take a vaccine since he is allergic to mangoes, then mentioned she had her vaccine and having soreness above the injection site. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: sore arm; Muscle aches; Chills; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (15Mar2021), this case now contains all required information to be considered valid.   This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that a 73-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266/EL8982), via an unspecified route of administration in the left arm on an unspecified date at 9:45 am, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162b2 on an unspecified date and experienced sore arm. The patient experienced sore arm, muscle aches and chills on an unspecified date. The seriousness criteria of the events were reported as non-serious by the health authority. The outcome of the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.