chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Feeling abnormal, Influenza like illness, Malaise
Clinical narrative: Injection site swollen, red, burning; injection site swollen, red, burning; Injection site swollen, red, burning; She was feeling bad; Chills; Chest pain; Flu like symptoms; She started to feel sick; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 47-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9265) via an unspecified route of administration in left arm on 06Feb2021 14:00 as dose 2, single (at the age of 47-years-old) for COVID-19 immunization. Patient medical history was not reported. The concomitant medications were  reported as none. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3249) via an unspecified route of administration in left arm on 20Jan2021 10:30 as dose 1, single for COVID-19 immunization. Vaccination Facility type was reported as School/Student Health Clinic. Vaccine was not administered at military facility. Consumer stated she was calling to report her side effects. She had the second shot on Saturday afternoon (06Feb2021 14:00) and was sick all day Sunday. She felt better on Monday and Tuesday. Added on Sunday when she was feeling bad (07Feb2021) she also noticed chest pain (07Feb2021). Clarified she received the first dose of the Pfizer COVID 19 vaccine on 20Jan2021 at 10: 30 in the left arm. Then she received the second dose of the Pfizer COVID 19 vaccine on 06Feb2021 at 14:00 in the left arm. She started to feel sick Saturday night (06Feb2021) with flu like symptoms (06Feb2021) and chills (07Feb2021). She also felt chest pain (07Feb2021) coming and going. Chest pain was one of the last symptoms. It lasted from the afternoon to the evening and went away. She was asking was this an expected side effect. Added she also had swelling, redness and burning at the injection site on 09Feb2021. She took some Benadryl at work from a co-worker but it did not help. She does not have any product or information for the Benadryl to provide UPC, lot or expiration date. The adverse events did not result in a visit to physician or ER. Description of complaint included consumer reporting an AE for the Pfizer COVID-19 vaccine mentioned she took some Benadryl at work from a co-worker but it did not help. She did not have any product or information for the Benadryl to provide UPC, lot or expiration date. The outcome of the event chills and chest pain was resolved on 07Feb2021, that of flu like symptoms was resolved on 08Feb201, that of feeling bad and feeling sick was unknown, while the outcome of the events injection site swollen, red, burning was resolving.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site swollen, red, burning; injection site swollen, red, burning; Injection site swollen, red, burning; She was feeling bad; Chills; Chest pain; Flu like symptoms; She started to feel sick; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 47-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9265) via an unspecified route of administration in left arm on 06Feb2021 14:00 as dose 2, single (at the age of 47-years-old) for COVID-19 immunization. Patient medical history was not reported. The concomitant medications were  reported as none. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3249) via an unspecified route of administration in left arm on 20Jan2021 10:30 as dose 1, single for COVID-19 immunization. Vaccination Facility type was reported as School/Student Health Clinic. Vaccine was not administered at military facility. Consumer stated she was calling to report her side effects. She had the second shot on Saturday afternoon (06Feb2021 14:00) and was sick all day Sunday. She felt better on Monday and Tuesday. Added on Sunday when she was feeling bad (07Feb2021) she also noticed chest pain (07Feb2021). Clarified she received the first dose of the Pfizer COVID 19 vaccine on 20Jan2021 at 10: 30 in the left arm. Then she received the second dose of the Pfizer COVID 19 vaccine on 06Feb2021 at 14:00 in the left arm. She started to feel sick Saturday night (06Feb2021) with flu like symptoms (06Feb2021) and chills (07Feb2021). She also felt chest pain (07Feb2021) coming and going. Chest pain was one of the last symptoms. It lasted from the afternoon to the evening and went away. She was asking was this an expected side effect. Added she also had swelling, redness and burning at the injection site on 09Feb2021. She took some Benadryl at work from a co-worker but it did not help. She does not have any product or information for the Benadryl to provide UPC, lot or expiration date. The adverse events did not result in a visit to physician or ER. Description of complaint included consumer reporting an AE for the Pfizer COVID-19 vaccine mentioned she took some Benadryl at work from a co-worker but it did not help. She did not have any product or information for the Benadryl to provide UPC, lot or expiration date. The outcome of the event chills and chest pain was resolved on 07Feb2021, that of flu like symptoms was resolved on 08Feb201, that of feeling bad and feeling sick was unknown, while the outcome of the events injection site swollen, red, burning was resolving.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: dark round 4 inches bruise at the injection  location lasting 3 weeks; This is a spontaneous report from a contactable Other-HCP (patient). A 45-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration in left arm on 27Jan2021 as a single dose for COVID 19 immunization. The patient medical history was None. Patient had no Known allergies. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks and other medications in 2 weeks. Patient had no COVID prior vaccination and no COVID tested post vaccination. On 27Jan2021 10:00 AM, the patient experienced dark round 4 inches bruise at the injection location lasting 3 weeks. Patient did not received treatment. Outcome of the event was recovered in 2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: My arm swelled and it is still swelled; This was more like a tingling like needle tingling in my hands and it was also like went through my body; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient 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 dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, my arm swelled and it is still swelled, this was more like a tingling like needle tingling in my hands and it was also like went through my body on an unspecified date. Reported as, "I had the Pfizer shot on Saturday and I had some, a little bit side effects from it, of course my arm swelled and it is still swelled this morning, but last night I had like tingling in my hand, and in my (incomplete sentence), and in one of my down one of my legs and it was like a tingling through my body and I read and read everything they gave me the information on the vaccine for Pfizer and that was not in there but it could be, it says it's some kind of muscle, you could have some muscle sore or muscle pains but this was more like a tingling like needle tingling in my hands and it was also like went through my body last night, and then it went down my leg so". Outcome of the event swelling arm was not recovered and unknown for paraesthesia.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Bad headache over left temple; Arm pain all the way down to fingertips; Nausea; muscle aches in both shoulders; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration in the upper left arm on 12Feb2021 02:00 PM (at the age of 48-years-old) as dose 1, single for COVID-19 immunisation at a workplace clinic. Medical history included hypertension and high cholesterol; both from an unknown date and unknown if ongoing. Concomitant medications included chlorthalidone, atorvastatin (LIPITOR), potassium chloride and magnesium; all taken for an unspecified indication, start and stop dates were not reported. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. The patient experienced bad headache over left temple and arm pain all the way down to fingertips, nausea, muscle aches in both shoulders and fatigue on 13Feb2021 04:00 AM. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Palpitations, Pyrexia
Clinical narrative: Feverish; Chills; Heart racing; Tightening in my chest; This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age and unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 15Feb2021 13:03 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the Covid 2nd vaccination this afternoon at 1:03 PM (15Feb2021 13:03) and about 25 minutes ago, the patient started to feel feverish and had chills and a racing heart and about 5 minutes, the patient started to feel tightening in chest. The patient wanted to know whether this was standard reaction from the second vaccination or the patient should call the ambulance. The patient did not want to go to the hospital because the patient did not want to catch it before the second vaccine ticks in. The patient did not consider it a bad experience, the patient just want to know if this was a normal reaction, or the patient should just lay out. The patient stated, it's a good thing, the patient was not dying. Outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: 100 degree fever overnight after dose 1; sore arm at injection; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration in right arm on 13Feb2021 12:00 (at the age of 67-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Feb2021, the patient experienced sore arm at injection and 100 degree fever overnight after dose 1. The outcome of the events was recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Nausea, Pain
Clinical narrative: a mild rash under the injected arm; Tenderness at the injection site; slight fever; mild nausea; mild head/body aches; mild head/body aches; mild pain in the injection shoulder; This is a spontaneous report from a non-contactable consumer or other non HCP (patient). A 48-year-old male patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 12Feb2021 at 11:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 48-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient had Known allergies. It was unknown if patient received other medication in two weeks prior to the COVID vaccine or not. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Historical vaccine included first dose of bnt162b2 on unspecified date for covid-19 immunisation and experienced mild pain in the injection shoulder which was more painful and more widespread than dose 1. The patient experienced tenderness at the injection site and a mild rash under the injected arm, 3 to 4 hours post vaccination, he had mild pain in the injection shoulder which was more painful and more widespread than dose 1. After 6 to 8 hours post vaccination, patient had slight fever and mild nausea. Fever resolved within the hour and nausea persisted until bedtime. After 8 to 10 hours post vaccination, he had mild head/body aches. After 18 hours post vaccination, he had still rash under the injection arm. It was reported that through the next 24 hours, most side effects had faded. The patient underwent lab tests and procedures which included Nasal Swab which was negative on Feb2021. No treatment was received for the events. The outcome of events slight fever recovered on 12Feb2021 and all other events recovered on unknown date of Feb2021.  Information on the lot/batch number has been requested
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: a mild rash under the injected arm; Tenderness at the injection site; slight fever; mild nausea; mild head/body aches; mild head/body aches; mild pain in the injection shoulder; This is a spontaneous report from a non-contactable consumer or other non HCP (patient). A 48-year-old male patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 12Feb2021 at 11:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 48-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient had Known allergies. It was unknown if patient received other medication in two weeks prior to the COVID vaccine or not. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Historical vaccine included first dose of bnt162b2 on unspecified date for covid-19 immunisation and experienced mild pain in the injection shoulder which was more painful and more widespread than dose 1. The patient experienced tenderness at the injection site and a mild rash under the injected arm, 3 to 4 hours post vaccination, he had mild pain in the injection shoulder which was more painful and more widespread than dose 1. After 6 to 8 hours post vaccination, patient had slight fever and mild nausea. Fever resolved within the hour and nausea persisted until bedtime. After 8 to 10 hours post vaccination, he had mild head/body aches. After 18 hours post vaccination, he had still rash under the injection arm. It was reported that through the next 24 hours, most side effects had faded. The patient underwent lab tests and procedures which included Nasal Swab which was negative on Feb2021. No treatment was received for the events. The outcome of events slight fever recovered on 12Feb2021 and all other events recovered on unknown date of Feb2021.  Information on the lot/batch number has been requested
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Dyspepsia, Feeling abnormal, Pain assessment
Clinical narrative: sour stomach; stated that she did not feel right; had stomach cramps on a medium pain scale; did not get much sleep; only ate 1/3 of meal/Stated ate less breakfast than usually does; This is a spontaneous report from a contactable consumer(patient). A 66-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Feb2021(at the age of 66-year-old) as dose 2, single for Covid-19 immunisation.The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 as dose 1, single for Covid-19 immunisation and stated had no problems with the first one. The patient had her second vaccine on 09Feb2021 (reported as yesterday). She had no problems with the first one. Stated that she got supper after the vaccine and about halfway through the meal noticed that she did not feel right and only ate 1/3 of meal. She tossed and turned all night did not get much sleep. The patient ate less breakfast than usually does. It was reported that with lunch she got sour stomach or stomach cramps medium scale pain. The patient wanted to know if there were any over the counter medication that she could take for her problems or if she should speak with her doctor about a prescription. On Feb2021, the patient experienced sour stomach and stated that she did not feel right, had stomach cramps on a medium pain scale, did not get much sleep, only ate 1/3 of meal/stated ate less breakfast than usually does. The patient underwent lab tests which included stomach cramps: medium on unknown date in Feb2021. Outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: sour stomach; stated that she did not feel right; had stomach cramps on a medium pain scale; did not get much sleep; only ate 1/3 of meal/Stated ate less breakfast than usually does; This is a spontaneous report from a contactable consumer(patient). A 66-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Feb2021(at the age of 66-year-old) as dose 2, single for Covid-19 immunisation.The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 as dose 1, single for Covid-19 immunisation and stated had no problems with the first one. The patient had her second vaccine on 09Feb2021 (reported as yesterday). She had no problems with the first one. Stated that she got supper after the vaccine and about halfway through the meal noticed that she did not feel right and only ate 1/3 of meal. She tossed and turned all night did not get much sleep. The patient ate less breakfast than usually does. It was reported that with lunch she got sour stomach or stomach cramps medium scale pain. The patient wanted to know if there were any over the counter medication that she could take for her problems or if she should speak with her doctor about a prescription. On Feb2021, the patient experienced sour stomach and stated that she did not feel right, had stomach cramps on a medium pain scale, did not get much sleep, only ate 1/3 of meal/stated ate less breakfast than usually does. The patient underwent lab tests which included stomach cramps: medium on unknown date in Feb2021. Outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swollen tongue, Taste disorder, Tongue discolouration
Clinical narrative: Acid taste in mouth that won't go away.; White layer in tongue that won't brush away (similar to thrush); scalloped looking tongue with ridges around perimeter of tongue from swelling; This is a spontaneous report from a non-contactable consumer or other non hcp reported for herself. A 32-year-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration, administered in Arm Right on 12Feb2021  as dose number unknown, single (age at vaccination 32-year-old) for covid-19 immunisation. Medical history included known allergies: Sulfa from an unknown date. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient experienced acid taste in mouth that won't go away, white layer in tongue that won't brush away, scalloped looking tongue with ridges around perimeter of tongue from swelling on 12Feb2021 21:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Feb2021 (covid test result=Negative). Therapeutic measures were taken as a result of events. The outcome for all events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Pyrexia, Rash erythematous, SARS-CoV-2 test
Clinical narrative: burning sensation; A febrile with no other symptoms; tingling in the fingertips; Red rash at tips of toes; This is a spontaneous report from a contactable physician. A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9262), via intramuscular route of administration, administered in arm left on 28Jan2021 at 18:00 (06:00 PM) (at the age of 56-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included estradiol, progesterone, both drugs taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within four weeks. Patient was diagnosed with COVID prior vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EK9231), via intramuscular route of administration, administered in arm left on 07Jan2021 at 06:00 PM (at the age of 56-year-old) as dose 1, single for COVID-19 immunization. On 14Feb2021 at 15:00 (03:00 PM), the patient experienced burning sensation, a febrile with no other symptoms, tingling in the fingertips, red rash at tips of toes. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse event: Red rash at tips of toes, with burning sensation. Also, some tingling in the fingertips. A febrile with no other symptoms. COVID PCR test pending. The patient underwent lab tests and procedures which included COVID PCR test was pending on 02Feb2021. Patient was COVID tested post vaccination. The patient received topical hydrocortisone as treatment medication for the events. Outcome of the events was not recovered.  Follow-up (PRD/SRD 14May2021): Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Underarm started hurting really bad and to the point where it really hurt even bad now; Started to get like a little bit lethargic; Low grade fever like 99.3 or 99.5; My arm was getting sore; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 13Feb2021 (at the age of 52-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included patient take it for stomach and surgery, stated that, no, she just had a surgery, actually, tomorrow makes 3 months. So, she was not able to take pills form because of surgery (further clarification unknown). The patient's concomitant medication included omeprazole, the patient taken it for stomach. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration on 23Jan2021 (at the age of 52-year-old) as a dose 1, single for COVID-19 immunization. Stated that, the patient got the second shot on 13Feb2021. When she got the shot, she felt like her arm was getting sore on 13Feb2021 and then the next day, on 14Feb2021, she started to get like a little bit lethargic and a low grade fever like 99.3 or 99.5 which was fine, so nothing big. But then, her underarm started hurting really bad and to the point where it really hurt even bad now, like today. Stated that, today it was like 15 and it got worse (not clarified further). Was it harming and something on her armpit. The patient was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department. The patient was informed that, Pfizer medical information was the concerned department for all queries. Stated that, the patient don't have the card with her right now. She had the picture of card for the first shot. Stated that, for second shot, it was in her bag which she left at her sister's. It was EN5318, this was for first shot, for the second one she don't have. (Consumer had Lot# for the first shot, however consumer was experiencing events after the second shot, hence Lot# not captured in tab). The consumer stated that, first one was on 23Jan2021 and second shot was on 13Feb2021 (hence, date for second shot captured in tab as consumer was experiencing events after the second shot). Stated that, treatment received for the events was reported as no, she did not. On 14Feb2021, the patient underwent lab tests and procedures which included low grade fever (body temperature), resulted as low grade fever like 99.3 or 99.5 which was fine, so nothing big. The outcome of the events for started to get like a little bit lethargic and low grade fever like 99.3 or 99.5 was recovered on an unspecified date in 2021 and for my arm was getting sore was unknown while for the other event was not recovered.  Information about Lot/batch number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Asthenia, Hypoaesthesia, Illness, Insomnia
Clinical narrative: sick to stomach; Nausea; legs felt numb; muscle pain in legs; felt bloated and was close to throwing up; sleepless evening; legs felt weak; This is a spontaneous report from a contactable consumer (patient) reported that. A 79-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 09:00 (Batch/Lot Number: EL9266) as DOSE 1 SINGLE for covid-19 immunization (Age at vaccination 79 years). The patient past Medical history included cataract surgery from 26Jan2021 to an unknown date. Concomitant medication(s) included loteprednol etabonate (LOTEMAX, Dosage text: .39%, 1 drop left twice daily) taken for cataract from Jan2021 to 09Feb2021. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 09Feb2021, Tuesday the patient was sick to his stomach. He had nausea. That evening his legs felt numb. He had muscle pain his legs from the waist down. He was bloated and was close to throwing up. He had a sleepless evening until 3:00am. He must go today to have a test. He legs also felt weak. He fell asleep last night at 2:00am and woke at 4:00am. He was feeling better. When he woke at 6:00am he felt normal. The event outcome was recovered on 10Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: sick to stomach; Nausea; legs felt numb; muscle pain in legs; felt bloated and was close to throwing up; sleepless evening; legs felt weak; This is a spontaneous report from a contactable consumer (patient) reported that. A 79-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 09:00 (Batch/Lot Number: EL9266) as DOSE 1 SINGLE for covid-19 immunization (Age at vaccination 79 years). The patient past Medical history included cataract surgery from 26Jan2021 to an unknown date. Concomitant medication(s) included loteprednol etabonate (LOTEMAX, Dosage text: .39%, 1 drop left twice daily) taken for cataract from Jan2021 to 09Feb2021. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 09Feb2021, Tuesday the patient was sick to his stomach. He had nausea. That evening his legs felt numb. He had muscle pain his legs from the waist down. He was bloated and was close to throwing up. He had a sleepless evening until 3:00am. He must go today to have a test. He legs also felt weak. He fell asleep last night at 2:00am and woke at 4:00am. He was feeling better. When he woke at 6:00am he felt normal. The event outcome was recovered on 10Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain from the elbow to shoulder; This is a spontaneous report from a contactable consumer or other non-health care professional. A 09-decade-old (80's) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 30Jan2021 14:00 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date of Jan2021 the patient experienced pain from the elbow to shoulder. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: an itchy, burning rash on my arms, legs and face.; an itchy, burning rash on my arms, legs and face.; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL8983) via an unspecified route of administration on 08Feb2021 at 14:30 (at the age of 66-years-old) in left arm as a single dose for covid-19 immunization. Medical history included known allergies to sulfa and gluten both from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included lisinopril (LISINOPRIL) and atorvastatin calcium (ATORVASTIN) both taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: EL9899) on 18Jan2021 at 14:30 in left arm for covid-19 immunization and developed minor rash on arms and legs. On the second injection, he was given a dose of benedryal beforehand. He had no immediate reaction. About a week later, as the vaccine was taking its full effect, he had an itchy, burning rash on his arms, legs, and face. He took 2 benedryal and it went away in about 30 minutes. The outcome of both the events was resolved in Feb2021.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: aches; fever; This is a spontaneous report from a contactable consumer. An unspecified age and gender patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had fever, and aches. She said she did not have the same side effects and did not have any severe reaction after her 1st dose of the vaccine. She wants to know if not having side effects mean that there is a problem with her immune response. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Date started (or best estimated period): 24Jan2021, 10Feb2021; sore arm; fever; chills; headache; hot flashes; This is a spontaneous report from a contactable consumer reported in response to Non-HCP letter sent in a cross-reference case. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9269) via an unspecified route of administration in left arm on 10Feb2021 at 10:30 (at the age of 37-year-old) as single dose for COVID-19 immunization at Hospital. Medical history included bad reaction to eggs. Concomitant medications of the patient were not reported. Patient previously had MMR vaccine in 1999 that resulted in facial swelling and blotches on her face. When she was admitted to the hospital, the MD told her to never receive a flu vaccine because she had a bad reaction to eggs. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262) via an unspecified route of administration in left arm on 24Jan2021 at 12:00 as single dose for COVID-19 immunization and experienced only a sore arm. On an unspecified date in 2021, after receiving second dose of vaccination patient experienced sore arm, fever, chills, headache, and hot flashes. Outcome of the events were resolved as events were gone within 24 hours on an unspecified date in 2021 and patient was fine now.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Date started (or best estimated period): 24Jan2021, 10Feb2021; sore arm; fever; chills; headache; hot flashes; This is a spontaneous report from a contactable consumer reported in response to Non-HCP letter sent in a cross-reference case. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9269) via an unspecified route of administration in left arm on 10Feb2021 at 10:30 (at the age of 37-year-old) as single dose for COVID-19 immunization at Hospital. Medical history included bad reaction to eggs. Concomitant medications of the patient were not reported. Patient previously had MMR vaccine in 1999 that resulted in facial swelling and blotches on her face. When she was admitted to the hospital, the MD told her to never receive a flu vaccine because she had a bad reaction to eggs. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262) via an unspecified route of administration in left arm on 24Jan2021 at 12:00 as single dose for COVID-19 immunization and experienced only a sore arm. On an unspecified date in 2021, after receiving second dose of vaccination patient experienced sore arm, fever, chills, headache, and hot flashes. Outcome of the events were resolved as events were gone within 24 hours on an unspecified date in 2021 and patient was fine now.  Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: felt like a lightening bolt was trying to escape her head; shooting pain in her head and heart; her arm was on fire; Fever; aches and pain/ shooting pain in her head and heart; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in upper right arm on 02Feb2021 16:00 (at the age of 53-year-old) (Batch/Lot Number: EN5318) as dose 1, single for covid-19 immunisation. Medical history included lymphoedema from an unknown date and unknown if ongoing In the left arm. That was the same arm that had the shooting pains to her heart, but it could have been related to the high fever , cellulitis from an unknown date and unknown if ongoing it was two years ago and almost killed her , breast cancer from an unknown date and unknown if ongoing , covid-19 from Nov2020 to an unknown date She did have COVID virus in Nov2020. Concomitant medication(s) included tamoxifen 10mg taken for an unspecified indication, start and stop date were not reported. She was told she was supposed to report negative side effects with COVID19 Vaccine. 24 hours after the shot she had bad side effects and they lasted for 24 hours. She has illness at time of vaccination. The patient experienced felt like a lightening bolt was trying to escape her head, shooting pain in her head and heart, her arm was on fire, fever and aches and pain on 03Feb2021 15:15. The clinical outcome of the events were recovered on 04Feb2021 16:00.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Pyrexia
Clinical narrative: Fever; Dizziness; Upset stomach; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 2 patients. This is 1st of two reports. This consumer reported for a female patient (Mother i.e., is a friend of my mother's). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number were not reported), via unspecified route on Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Fever, dizziness, upset stomach on an unspecified date. The patient did not received any treatment for the events. The clinical outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021161215 same reporter/SD/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: mild pain in the injection shoulder; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced mild pain in the injection shoulder. On an unknown date in Feb2021, the patient performed the nasal swab test which showed negative result. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior to vaccination. The patient had tested for covid post vaccination. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Numbness in her mouth and tongue; Numbness in her mouth and tongue; This is a spontaneous report from a Pfizer. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was experiencing numbness in her mouth and tongue after she received the first dose of Covid-19 Vaccine. Outcome of the events was unknown.  Information about Lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy, Headache
Clinical narrative: Severe muscles spasms that were epileptic in scope; severe, very severe, headache; This is a spontaneous report from a contactable other health care professional (Patient). A 76-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 21Feb2021 09:45 as a single dose for covid-19 immunisation. Medical history included ongoing glaucoma from an unknown date and unknown if ongoing. Concomitant medication included sertraline taken for an unspecified indication, start and stop date were not reported and eye drops for glaucoma. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9263 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 30Jan2021 09:45 (at the age of 76-year-old) as single dose for covid-19 immunisation. Patient had no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 22Feb2021 01:00 the patient experienced Severe muscles spasms that were epileptic in scope. And severe, very severe, headache Took place 12 hrs after shot. spasms lasted 24 hours, with after effects another 12. Headache lasted 48 hours. The patient did not receive treatment for the events. The outcome of the events was recovered on unspecified date of 2021.  Follow-up attempts completed. No further information expected; Sender's Comments: As there is limited information in the case provided, the causal association between the events Epilepsy and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, Throat tightness
Clinical narrative: Swelling of lips; Tightness of her throat after receiving the 2nd dose; after receiving the 2nd dose, allergic reaction; This is a spontaneous report from a contactable nurse. The nurse reported for a female patient in response to the HCP letter sent in a cross-referenced case via telephonic. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, lot number: EL9261; expiration date: May2021) dose 2 via an unspecified route of administration on 10Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included asthma. The patient's concomitant medications was not reported. Historical vaccine included BNT162B2, lot number: EL9261; expiration date: May2021 dose 1 on 27Jan2021 as dose 1 single, for COVID-19 immunisation with injection site pain and slight redness. On an unspecified date in 2021 the patient experienced swelling of lips, tightness of her throat after receiving the 2nd dose, allergic reaction. She was feeling a little bit better now but has taken the week off of work to recover. The clinical outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone swelling, Joint range of motion decreased
Clinical narrative: left Sub clavicle swelling, limited range of motion in neck; left Sub clavicle swelling, limited range of motion in neck; This is a spontaneous report from a contactable other health care professional, the patient. An adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 12Feb2021 as dose number unknown, single for covid-19 immunization. Medical history reported as none. The patient concomitant medications were not reported. On 12Feb2021 21:45, the patient experienced left sub clavicle swelling and limited range of motion in neck. The therapeutic measures were not taken for the reported events. The patient did not receive any other vaccine in four weeks and also did not receive other medications in two weeks. The did not have covid prior to vaccination and not tested for covid post vaccination. There possible known allergies were present, but it was unspecified. The patient visited the doctor or other healthcare professional office for the events. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: reporter's friend who received the vaccine and afterwards his "BP went up so high; This is a spontaneous report from a contactable Consumer or other non-HCP. This consumer reported for a male patient (reporter friend). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced his BP (blood pressure) went up so high. The reporter stated that she had a friend who received the vaccine and afterwards his BP went up so high, it went to 190. The patient outcome of the event was unknown at the time of this report.   Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.