chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea
Clinical narrative: freezing cold; nausea; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunization .The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced freezing cold and nausea. The outcome of the events was unknown.  Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: lymph nodes in her armpit; on the same side as her injection, is sore.; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 28Jan2021 as, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Jan2021 the patient experienced lymph nodes in her armpit, on the same side as her injection, is sore. She believes that she noticed the soreness a couple of days but the soreness was really apparent yesterday and today .The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever ranging to 99-101.9; This is a spontaneous report from a contactable consumer (patient, reported for self).  An unspecified age female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown; Formulation: solution for injection; Expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Feb2021 at 10:00, the patient experienced fever ranging to 99-101.9(units not reported). The patient underwent lab tests and procedures which included body temperature: 99-101.9 (units not reported) on 05Feb2021. Patient wanted to know if she can take Tylenol since she heard that it might dampen the effect of the vaccine. Patient wanted to know what was the maximum that this fever can reach, and mentioned that she was hesitant to take Tylenol and would hold back on it while she can. The outcome of the event fever ranging to 99-101.9 was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site scab
Clinical narrative: Scab on my skin at the vaccination sight; This is a spontaneous report from a contactable consumer, the patient (non-pregnant patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in right arm on 29Jan2021, at 12:30, as unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had sulfur allergy. The patient stated that, she experienced scab on her skin at the vaccination sight on 02Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test on an unspecified date in 2021, with unknown results. It was also stated that, prior to vaccination, the patient was not diagnosed with COVID-19. No treatment was received for the event. The seriousness criteria was reported as non-serious for the event. The outcome of the event was unknown.  Follow-up attempts have been completed and no further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest is sore. Right in the middle. Hurts to stretch or breathe deeply; This is a spontaneous report from a contactable Other HCP (patient). A 43-year-old female received BNT162B2 (BNT162B2, Solution for injection, Lot number: Not reported), via an unspecified route of administration in left arm on 05Feb2021 at 09:00 as first dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not provided. The patient did not have COVID-19 prior to vaccination. On 05Feb2021 at 14:00 the patient experienced chest sore right in the middle. She informed that it hurts to stretch or breathe deeply. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anisomastia, Mammogram
Clinical narrative: Lateral left breast asymmetries; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient (self-reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 14Jan2021 (Batch/Lot Number: EK 9231) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included valaciclovir taken for an un-specified indication, start and stop date were not reported. The patient previously took nickel and experienced Nickel topical allergy. The patient experienced lateral left breast asymmetries (anisomastia) on 19Jan2021. The patient underwent lab tests and procedures which included mammogram: lateral left breast asymmetries-cc view only. On 19Jan2021 BI-RADS Assessment Category 0 (Incomplete, Need additional imaging evaluation), mammogram: lateral left breast simple cyst & simple cyst cluster on 02Feb2021 benign-accounting for the mammographic appearance. BI-RADS Assessment Category. Patient did not received treatment for the adverse event. Patient was not pregnant at the time of vaccination. patient did not diagnose with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was recovered on unspecified date of 2021.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Skin laxity
Clinical narrative: the arm he had the shot in, he has loose skin under the arm; he feels numb under the bottom of his feet; numbness under his feet but today it is more pronounced; This is a spontaneous report from a contactable consumer or other non hcp. An 82-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 05Feb2021 (82-years-old at the time of vaccination) as a SINGLE DOSE for COVID-19 immunization. The reported indication was reported as that is what was offered. The patient's medical history included stents in his heart and back condition. The patient's concomitant medications were not reported. The patient reported that skin from his elbow to his armpit is more "flabby" than normal and he has "numbness under" his feet. He also reports having a prior injury, degenerative disc, in his back that sometimes causes numbness under his feet but today it is more pronounced. On 05Feb2021, the patient experienced having a problem with his arm he had the shot in, he has loose skin under the arm, he feels numb under the bottom of his feet. The outcome of the event the arm he had the shot in, he has loose skin under the arm was recovering and other events was not recovered.  Follow-up (05Feb2021): Upon follow up, new information included: Age at time of onset of reaction/event details, patient details, adverse event details, medical history details, Event onset details, Lot details.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Lymph node pain
Clinical narrative: lymph node pain; ear pain; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), first dose via an unspecified route of administration on 02Feb2021 13:00 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced lymph node and ear pain. Further patient questioned that if these symptoms are related to the vaccine and how long will they last. Reporter assessed the event as non-serious. The outcome of the events was unknown.  Information on the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection diagnosed after the administration of the first dose of the vaccine.; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that between the first and the second administration of the COVID-19 vaccine his physician diagnosed on him a urinary tract infection that needed to be attended with Keflex once a day for 14 days. The patient calls for information about if Keflex - Cephaloxin could interact with the administration of the second dose of the Pfizer's COVID-19 vaccine and about the administration of Tylenol before the administration of the COVID-19 vaccine. He asked if he could use antipyretics before or after vaccination with the COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Glossodynia, Swollen tongue, Tongue biting, Tongue discolouration, Tongue erythema
Clinical narrative: my tongue has swollen; small red sores on the sides and underneath my tongue; small red sores on the sides and underneath my tongue; bitten my tongue in 2 places which are now white; bitten my tongue in 2 places which are now white; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, Expiry date: unknown, age at vaccination: 62-year-old), via an unspecified route of administration in Arm Right on 26Jan2021 08:00 AM as dose 2, single for covid-19 immunisation administered at hospital. Medical history included hypertension, type 2 diabetes mellitus, asthma and seasonal pollen allergy. Previously the patient received first dose of bnt162b2 (Lot number EJ1686), in Arm left on 07Jan2021 07:15 AM for covid-19 immunization. Concomitant medications included terazosin hydrochloride (HYTRIN), metformin and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and since the vaccination, the patient was not tested positive for Covid-19. On 01Feb2021, the patient reported, he had his tongue swollen and had small red sores on the sides and underneath his tongue and because of the swelling he had bitten his tongue in 2 places which are now white. No corrective treatment was taken. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: has had a fever "pretty much since".; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number, Expiry date was not reported) via an unspecified route of administration on 01Feb2021 as UNKNOWN, SINGLE for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. On 01Feb2021 (Monday, this week), the patient received vaccine and had a fever pretty much since. Patient had indicates she was 37 years of age with underlying health issues. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood pressure increased, Blood pressure measurement, Vaccination site pain
Clinical narrative: her blood sugar and blood pressure is also up; her blood sugar and blood pressure is also up; Her arm is still sore where they put the shot in all the way down to the elbow; This is a spontaneous report from a contactable consumer.   A 81-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm on 01Feb2021 09:00 as 1st DOSE, SINGLE DOSE for an unspecified indication. The patient medical history and concomitant medications were not reported. On Feb2021 the patient experienced her arm was still sore where they put the shot in all the way down to the elbow, her blood sugar and blood pressure was also up and her blood sugar and blood pressure was also up. The patient underwent lab tests and procedures which included blood glucose: up, blood pressure measurement: up. Outcome of event injection site pain not recovered, and blood glucose increased, blood pressure increased was unknown. Follow-up (05Feb2021): This is a Follow-up spontaneous report from a contactable consumer. This Consumer reporter for a 81-year-old female patient added. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After her first shot of the vaccine, she had taken Advil for her arm because it hurt; This is a spontaneous report from a contactable consumer(patient). An unspecified age female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a  first dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after her first shot of the vaccine, she had taken Advil for her arm because it hurt. The next morning, it already didn't hurt. She wanted to know if the rumor was true or not. Patient had received the second shot of the Pfizer BioNTechCOVID-19 vaccine on Thursday (04Feb2021) and she had heard a rumor to not take Advil or Tylenol if you have discomfort. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic, Throat irritation
Clinical narrative: rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus.; rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus.; rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus.; This is a spontaneous report from a contactable physician (patient). An 81-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 02Feb2021((at the age of 81-years-old) as single dose for COVID-19 immunization. The patient's medical history had diabetes. He was diagnosed his first year in medical school in 1968. Concomitant medications were not reported. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EL3246) on 12Jan2021 as historical vaccination as single dose for covid-19 immunization. On 03Feb2021 patient experienced rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus. Clinical course of events: within 24 hours, after the patient had the second shot patient had no symptoms until late next day, then rash on all four extremities and trunk/ had a pruritic rash covering all 4 of his extremities and most of his trunk. It was not on his face. Then atter night, it got much worse next day. He states that he has taken a Benadryl and Pepcid which was helped with the itching but the rash has not gone away. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus.; rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus.; rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus.; This is a spontaneous report from a contactable physician (patient). An 81-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 02Feb2021((at the age of 81-years-old) as single dose for COVID-19 immunization. The patient's medical history had diabetes. He was diagnosed his first year in medical school in 1968. Concomitant medications were not reported. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EL3246) on 12Jan2021 as historical vaccination as single dose for covid-19 immunization. On 03Feb2021 patient experienced rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus. Clinical course of events: within 24 hours, after the patient had the second shot patient had no symptoms until late next day, then rash on all four extremities and trunk/ had a pruritic rash covering all 4 of his extremities and most of his trunk. It was not on his face. Then atter night, it got much worse next day. He states that he has taken a Benadryl and Pepcid which was helped with the itching but the rash has not gone away. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic, Throat irritation
Clinical narrative: started to get rash and then hives.; started to get rash and then hives.; This is a spontaneous report from contactable consumer from a Pfizer sponsored program. (Patient, reported for self)   A male patient of unspecified age received second dose of BNT162B2(PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: solution for injection, Batch/lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the second COVID shot on Tuesday no side effects, on Thursday started to get rash and then hives (after taking the vaccine). Patient was getting better after taking Benadryl. The outcome of the events rash and then hives was recovering.  Follow-up (19Apr2021): 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: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: started to get rash and then hives.; started to get rash and then hives.; This is a spontaneous report from contactable consumer from a Pfizer sponsored program. (Patient, reported for self)   A male patient of unspecified age received second dose of BNT162B2(PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: solution for injection, Batch/lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the second COVID shot on Tuesday no side effects, on Thursday started to get rash and then hives (after taking the vaccine). Patient was getting better after taking Benadryl. The outcome of the events rash and then hives was recovering.  Follow-up (19Apr2021): 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: Blepharospasm, Tremor, Vomiting
Clinical narrative: Tremors in arms; eye twitching; vomiting; This is a spontaneous report from a non-contactable consumer (the patient, reported for herself). An adult non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry dates were unknown), via unspecified route of administration in the left arm on 04Feb2021 as single dose for COVID-19 immunization. The patient's medical history included Latex allergy. Concomitant medications were not reported. On an 05Feb2021 at 03:00 PM, patient experienced tremors in arms, eye twitching and vomiting. Unknown if the patient received any treatment for the adverse events. Patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reporter assessed the events as non-serious. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash, SARS-CoV-2 test
Clinical narrative: Rash to body; Nausea; This is a spontaneous report from a contactable Nurse (reported for herself). A 49-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in right arm on 05Feb2021 at 15:00 (at the age of 49-year-old), as a single for COVID-19 immunisation in hospital. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. Since the vaccination, patient has been tested for COVID-19. On 05Feb2021 at 17:00, the patient experienced rash to body and nausea. The events had not Seriousness criteria- resulted in for death, life-threatening, caused/prolonged hospitalisation, disabling/incapacitating or congenital anomaly/birth defect. No treatment was received for the events. No covid prior vaccination. Patient tested covid post vaccination. The patient underwent lab tests and procedures post COVID-19 vaccination which included Sars-Cov-2 test (Nasal swab): negative on 04Feb2021. The outcome of the events was reported as Recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: she has phlegm in her throat without a fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration on 16Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that She received the 1st dose 3 weeks ago and is scheduled to have the 2nd dose tomorrow. She is concerned because she has phlegm in her throat without a fever and wanting to know if she can continue tomorrow with the shot or should she delay it. It was reported that she had the first dose of the vaccine and is scheduled to get the second dose of the vaccine tomorrow 06Feb2021. It was reported that today she has been clearing phlegm out of her throat and wants to know if she can get the second dose tomorrow. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Feeling abnormal
Clinical narrative: Huge bruise 50 cent dollar, did it get in the blood; Feeling like before surgery; This is a spontaneous report from a contactable consumer reporting for herself. An 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccine 80-year-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. on an unknown date, the patient experienced huge bruise 50 cent dollar, did it get in the blood; and had that feeling like before surgery. Patient questioned about what happens if administered in wrong distribution system. Clinical outcome of the events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Contusion, Feeling abnormal, Skin discolouration, Vaccination site haemorrhage
Clinical narrative: Huge bruise 50 cent dollar, did it get in the blood; Feeling like before surgery; This is a spontaneous report from a contactable consumer reporting for herself. An 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccine 80-year-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. on an unknown date, the patient experienced huge bruise 50 cent dollar, did it get in the blood; and had that feeling like before surgery. Patient questioned about what happens if administered in wrong distribution system. Clinical outcome of the events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Eye swelling, Swollen tongue
Clinical narrative: Swollen eyes and tongue; Swollen eyes and tongue; dizzy; weak; This is a spontaneous report from a contactable other hcp. A 34-years-old female patient received second dose bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 03Feb2021 10:45 as 2ND DOSE, SINGLE for covid-19 immunisation. Patient didn't received another vaccination prior to covid vaccination with in 4 weeks, Patient didn't had Covid prior to vaccination. Medical history included cardiac disorder from an unknown date and unknown if ongoing ,food allergy from an unknown date and unknown if ongoing patient had received first dose bnt162b2 (BNT162B2,Solution for injection, Batch/Lot Number:EK9231), via an unspecified route of administration, administered in Arm Left on 11Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported, patient didn't got tested prior to post vaccination. On 03Feb2021 11:00 the patient experienced swollen eyes and tongue, dizzy and weak. The outcome of the events swollen eyes and tongue, dizzy, weak was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, SARS-CoV-2 test
Clinical narrative: Metalic taste in mouth; This is a spontaneous report from a contactable Other HCP (patient). This 39-year-old non pregnant female patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: EN5318), dose 2 intramuscularly, administered in Arm Left on 29Jan2021 23:00 as 2nd dose, single for an COVID-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing, milk allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: EL0142, Expiration date: unknown), dose 1 intramuscular, administered in Arm Left on 08Jan2021 12:00 PM as 1st dose, single for an COVID-19 immunisation. The patient experienced metalic taste in mouth on 02Feb2021 12:00. No treatment was received for event. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Feb2021 Nasal swap rapid test. The outcome of the event metalic taste in mouth was recovering Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain in extremity
Clinical narrative: My arm was a little sore; 5-6 big bumps; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Jan2021 09:30 (at the age of 85-year-old) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Jan2021 17:30, the patient experienced 5-6 big bumps on the left side of her forehead, next to her eye and biggest one was the size of a milk dud. They were protruding like a gumdrop. These lasted about 3-4 days. Now she can push on the area with her hands on her forehead and feels 1 indention. The bumps have now went away for the most part. The reporter stated that she didn't know whether it was a clot or something else happened. On an unknown date, patient experienced, arm was a little sore. Patient was due for the second shot 18Feb and so worried about it. The outcome of the event bumps was recovering, however the outcome of the event arm was little sore was unknown.   Information on the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Mobility decreased, Myalgia, Night sweats
Clinical narrative: night sweats; cold feet; fatigue/tiredness; very brief sore throat; Slept poorly; Lots of a myalgias; arthralgias; Tendons were irritated of my lower extremity mobility was compromised; Tendons were irritated of my lower extremity mobility was compromised; This is a spontaneous report from a contactable physician. A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route , administered in Arm Left on 23Jan2021 08:30 (Batch/Lot Number: EL3246) as first dose, single dose (at the age of 71-years-old) for covid-19 immunisation . Medical history included plasma cell myeloma (Multiple myeloma), polycythemia vera, pneumonia (pneumonia five months earlier requiring hospitalization). Concomitant medications included bortezomib (VELCADE) ; lenalidomide (REVLIMID) ; prednisone ; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) ; levothyroxine sodium (SYNTHROID) ; febuxostat (ULORIC) ; gabapentin ; morphine sulfate (MS CONTIN) taken for an unspecified indication, start and stop date were not reported for all medications . The patient had no known allergies . The patient did not have covid prior vaccination and did not test for covid post vaccination. The patient did not take any other vaccine prior to four weeks. The patient also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular route, administered in Arm Left on an unspecified date (Batch/Lot Number: Ek9231) as second dose, SINGLE for covid-19 immunization .On 07Jan2021 09:00, On day three post vaccination fatigue for 48 hours than the development of a very brief sore throat but no temperature no hypoxemia no vital signs change out and then the development of night sweats but associated also with cold feet. Slept poorly. Lots of a myalgias some arthralgias. Tendons were irritated of my lower extremity mobility was compromised. Symptoms unfortunately occur still now 13 days later with resolution of some such as the night sweats, but the aches and pains fatigue tiredness all persist. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The outcome of the event night sweats was recovered on unknown date in 2021 and for rest all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Peripheral coldness, Poor quality sleep, Tendon pain
Clinical narrative: night sweats; cold feet; fatigue/tiredness; very brief sore throat; Slept poorly; Lots of a myalgias; arthralgias; Tendons were irritated of my lower extremity mobility was compromised; Tendons were irritated of my lower extremity mobility was compromised; This is a spontaneous report from a contactable physician. A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route , administered in Arm Left on 23Jan2021 08:30 (Batch/Lot Number: EL3246) as first dose, single dose (at the age of 71-years-old) for covid-19 immunisation . Medical history included plasma cell myeloma (Multiple myeloma), polycythemia vera, pneumonia (pneumonia five months earlier requiring hospitalization). Concomitant medications included bortezomib (VELCADE) ; lenalidomide (REVLIMID) ; prednisone ; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) ; levothyroxine sodium (SYNTHROID) ; febuxostat (ULORIC) ; gabapentin ; morphine sulfate (MS CONTIN) taken for an unspecified indication, start and stop date were not reported for all medications . The patient had no known allergies . The patient did not have covid prior vaccination and did not test for covid post vaccination. The patient did not take any other vaccine prior to four weeks. The patient also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular route, administered in Arm Left on an unspecified date (Batch/Lot Number: Ek9231) as second dose, SINGLE for covid-19 immunization .On 07Jan2021 09:00, On day three post vaccination fatigue for 48 hours than the development of a very brief sore throat but no temperature no hypoxemia no vital signs change out and then the development of night sweats but associated also with cold feet. Slept poorly. Lots of a myalgias some arthralgias. Tendons were irritated of my lower extremity mobility was compromised. Symptoms unfortunately occur still now 13 days later with resolution of some such as the night sweats, but the aches and pains fatigue tiredness all persist. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The outcome of the event night sweats was recovered on unknown date in 2021 and for rest all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Paraesthesia, Vaccination site pain
Clinical narrative: Lightheaded(mild); Fatigue(mild); muscle pain at injection site(moderate); tingling in fingertips(mild); This is a spontaneous report from a contactable consumer or other non HCP (Patient, reported for self)  A 28-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:15 as single dose for covid-19 immunization. (vaccination Facility: Other). Medical history was not reported. The patient concomitant medications were not reported. patient did not took any other vaccine in four weeks. Patient did not experience COVID prior to vaccination. No known allergies. Patient had no known allergies. Other medical history: None. On 05Feb2021 at 10:45 AM patient experienced Lightheaded(mild), Fatigue(mild) muscle pain at injection site(moderate) and tingling in fingertips(mild). Patient did not receive any treatment for the adverse events. Patient was not tested for COVID post vaccination. Outcome for the events was reported as Recovering.   Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: nausea; tired/every day since receiving the product, she has had extreme fatigue; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 02Feb2021 (at the age of 78-year-old) as 2nd dose, single, in left arm for COVID-19 immunisation. The patient's medical history included high blood pressure. Concomitant medications included unspecified high blood pressure medicine. Patient had no other vaccines on the same day as the COVID vaccine. On 03Feb2021, the next day after receiving Pfizer COVID vaccine, the patient was very tired. On the third day, the patient became even more tired. Patient also had nausea, but that comes and goes. Fatigue does not go away and every day since receiving the product, she had extreme fatigue. Patient had been on high blood pressure medications for a long time, so she thought that could have done it. The clinical outcome of the event was tired/every day since receiving the product, she has had extreme fatigue was not resolved and the clinical outcome of the event nausea was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurry vision; This is a spontaneous report from a contactable nurse (reported for himself). A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EL3247), via an unspecified route of administration in left arm on 15Jan2021 13:00 as single dose for COVID-19 immunization. The patient medical history included Hypertension, ADHD, hyperlipidemia and COVID-19. The patient concomitant drugs included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), olmesartan medoxomil (BENICAR), atorvastatin (LIPITOR) and pantoprazole sodium sesquihydrate (PROTONIX). The patient was no known allergy to medications, food, and other products. The facility where the most recent COVID-19 vaccine was administered was hospital. On 15Jan2021 13:00 the patient experienced with Blurry vision. Treatment received was reported as no. Outcome of event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; This is a spontaneous report from a non-contactable consumer or other non health care professional (wife reported for her husband). An unspecified age male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 24Jan2021 as 1ST DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had experienced nauseous 1 week after receiving the 1st dose of vaccine. Patient wife scheduled to receive the 2nd dose on 13Feb2021, which was 1 day earlier than the recommended 3-week-interval so she wants to know if this was acceptable. Reporter assessed the event as non-serious. The outcome of the event was unknown.   No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site infection
Clinical narrative: Infection in my arm at injection sight; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: Unknown), via an unspecified route of administration, administered in left arm on 25Jan2021 10:00 (at the age of 69-years-old) as single dose for covid-19 immunization at public health clinic. The patient medical history and concomitant medications were not reported. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced infection in her arm at injection site on 03Feb2021 12:00PM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated with Bactrim DS Tablets 800-160MG Orally 14. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pruritus, Rash
Clinical narrative: 5 days after receiving the second dose of the vaccine I developed a rash on my toes similar to "covid toes".; Several red bumps on my toes around the nail beds; On tips of the toes that get very itchy on both feet; This is a spontaneous report from a contactable other HCP. This 32-year-old (Non-pregnant) female received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration in Left arm on 25Jan2021 15:30 (at age of 32-years) as single dose for COVID-19 Immunization. Patient medical history was not reported. There are no known allergies. Patient concomitant medications include ethinylestradiol, norethisterone acetate(MICROGESTIN), Olly flawless complexion supplements used for unspecified indication from unknown date and unknown ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. Patient previously received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration in Left arm on 04Jan2021 15:30 as single dose for COVID-19 Immunization. On 30Jan2021, (5days after vaccination) patient developed a rash on toes like covid toes. She had several red bumps on her toes around the nail beds and on tips of the toes that got very itchy on both feet. Treating with antifungal products did not improve symptoms. Patient did not receive any treatment for adverse event. The outcome of event was not recovered.   Information about batch/lot 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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Itchy rash in both armpits, groin left and right, isolated itchiness in small areas in some parts of the body; hives in both armpits; This is a spontaneous report from a contactable consumer reported for himself. A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL8982) via an unspecified route of administration in right arm on 18Jan2021 14:00 (at the age of 73-years-old) as 1st dose, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine administered was other. The patient's medical history and concomitant medications were not reported. The patient was allergic to medications, food, or other products, shellfish and iodine in CT Scan dye were reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any vaccines within four weeks prior to the vaccination. On 23Jan2021 15:00 (5 days after the vaccine), the patient experienced developed delayed allergic reaction Itchy rash and hives in both armpits, Itchy rash in groin left and right, isolated itchiness in small areas in some parts of the body. The patient received treatment for the events was benadryl 25mg tab, 2% diphenhydramine cream, clari. Outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm near the injection site; This is a spontaneous report from a contactable consumer. A 33-years-old Non pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247,expiration date was not reported), dose 1 via an unspecified route of administration, administered in Left arm on 05Feb2021 14:00 (age at vaccination is 33 years) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included etonogestrel (NEXPLANON). The patient previously took morphine, sulfa drugs and experienced drug hypersensitivity. On 05Feb2021 18:00 the patient experienced sore arm near the injection site Soreness started approximately four hours after vaccination and has persisted at least 24 hours. Outcome of the event was recovering.    Follow-up attempts are completed. No further information is expected.