chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Fever of 101.1 degrees Fahrenheit; rigors; body and joint aches; body and joint aches; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: Ek4176), via Intramuscular on right arm on 16Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient previously received first dose of BNT162B2 at the age of 29 years old on 25Dec2020 (first dose, Lot number=EH9899, 10:00 AM, Intramuscular on Right arm) for covid-19 immunisation. The patient experienced fever of 101.1 degrees Fahrenheit, rigors, body and joint aches, headache, fatigue 12 hours after vaccination on 16Jan2021 at 10:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination. The patient underwent lab test included COVID 19 PCR on 17Jan2021 (covid test result: Pending). The outcome of the events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever of 101.1 degrees Fahrenheit; rigors; body and joint aches; body and joint aches; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: Ek4176), via Intramuscular on right arm on 16Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient previously received first dose of BNT162B2 at the age of 29 years old on 25Dec2020 (first dose, Lot number=EH9899, 10:00 AM, Intramuscular on Right arm) for covid-19 immunisation. The patient experienced fever of 101.1 degrees Fahrenheit, rigors, body and joint aches, headache, fatigue 12 hours after vaccination on 16Jan2021 at 10:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination. The patient underwent lab test included COVID 19 PCR on 17Jan2021 (covid test result: Pending). The outcome of the events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Constipation, Diarrhoea, Fatigue, Headache
Clinical narrative: Fatigue; headache; constipation; then extremely loose stools and 1 event of loss of bowel control.; then extremely loose stools and 1 event of loss of bowel control.; This is a spontaneous report from a contactable Other healthcare professional (patient). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration on 13Jan2021 16:00 at single dose in Left Arm for COVID-19 immunization. The patient medical history was not reported. There were no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). There were no other vaccines received in four weeks. The patient did not have COVID-19 prior vaccination and COVID-19 was not tested post vaccination. The patient experienced Fatigue, headache, constipation, then extremely loose stools and 1 event of loss of bowel control on 13Jan2021 17:00, no treatment received for these events. The outcome of the events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Dizziness, Dry mouth, Gait disturbance, Headache
Clinical narrative: feeling a little woozy/dizzy; My head was sideways and every time I would raise my head the room was spinning; there is not enough spit in my mouth. It's very dry; I walked very slowly; slight headache; My blood pressure now is 137/93. It was high this morning; felt lousy like I had the flu; felt like I was fainting; This is a spontaneous report from a contactable consumer.  A 68-years-old female patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included transient ischaemic attack (I had a TIA prior). The patient's concomitant medications were not reported. The patient experienced "feeling a little woozy/dizzy" on an unspecified date with outcome of unknown, "my head was sideways and every time I would raise my head the room was spinning" on an unspecified date with outcome of unknown, "there is not enough spit in my mouth, it is very dry" on an unspecified date with outcome of unknown, I" walked very slowly" on an unspecified date with outcome of unknown, "slight headache" on an unspecified date with outcome of unknown, "my blood pressure now is 137/93. it was high this morning" on an unspecified date with outcome of unknown, "feelt lousy like I had the flu" on an unspecified date with outcome of unknown, "felt like I was fainting" on an unspecified date with outcome of unknown. Reaction description by the reporter:" I had no pain, slight headache. My blood pressure now is 137/93. It was high this morning when I talked with the triage nurse. I had the shot/vaccine (first dose) on Friday. I feel better today than yesterday. Friday I felt fine. I got symptoms yesterday. When I woke up yesterday. I was feeling a little woozy, I always stretch slowly in bed. I slowly raised myself on the bed but before I got up my torso fell backwards. I felt like I was fainting. The room was spinning. All day yesterday I did not drive. I walked very slowly. I was holding onto the wall. I felt lousy like I had the flu. I would lay down for 20 minutes, watching tv. My head was sideways and every time I would raise my head the room was spinning. Also there is not enough spit in my mouth. It is very dry. I had a slight headache. So I did not bother but no headache today. I supposed to get my 2nd dose on 02Feb2021. The action taken was not applicable. Information on the Lot/Batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Malaise, Presyncope, Vertigo
Clinical narrative: feeling a little woozy/dizzy; My head was sideways and every time I would raise my head the room was spinning; there is not enough spit in my mouth. It's very dry; I walked very slowly; slight headache; My blood pressure now is 137/93. It was high this morning; felt lousy like I had the flu; felt like I was fainting; This is a spontaneous report from a contactable consumer.  A 68-years-old female patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included transient ischaemic attack (I had a TIA prior). The patient's concomitant medications were not reported. The patient experienced "feeling a little woozy/dizzy" on an unspecified date with outcome of unknown, "my head was sideways and every time I would raise my head the room was spinning" on an unspecified date with outcome of unknown, "there is not enough spit in my mouth, it is very dry" on an unspecified date with outcome of unknown, I" walked very slowly" on an unspecified date with outcome of unknown, "slight headache" on an unspecified date with outcome of unknown, "my blood pressure now is 137/93. it was high this morning" on an unspecified date with outcome of unknown, "feelt lousy like I had the flu" on an unspecified date with outcome of unknown, "felt like I was fainting" on an unspecified date with outcome of unknown. Reaction description by the reporter:" I had no pain, slight headache. My blood pressure now is 137/93. It was high this morning when I talked with the triage nurse. I had the shot/vaccine (first dose) on Friday. I feel better today than yesterday. Friday I felt fine. I got symptoms yesterday. When I woke up yesterday. I was feeling a little woozy, I always stretch slowly in bed. I slowly raised myself on the bed but before I got up my torso fell backwards. I felt like I was fainting. The room was spinning. All day yesterday I did not drive. I walked very slowly. I was holding onto the wall. I felt lousy like I had the flu. I would lay down for 20 minutes, watching tv. My head was sideways and every time I would raise my head the room was spinning. Also there is not enough spit in my mouth. It is very dry. I had a slight headache. So I did not bother but no headache today. I supposed to get my 2nd dose on 02Feb2021. The action taken was not applicable. Information on the Lot/Batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Hyperhidrosis, Pyrexia, Vertigo
Clinical narrative: feeling a little woozy/dizzy; My head was sideways and every time I would raise my head the room was spinning; there is not enough spit in my mouth. It's very dry; I walked very slowly; slight headache; My blood pressure now is 137/93. It was high this morning; felt lousy like I had the flu; felt like I was fainting; This is a spontaneous report from a contactable consumer.  A 68-years-old female patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included transient ischaemic attack (I had a TIA prior). The patient's concomitant medications were not reported. The patient experienced "feeling a little woozy/dizzy" on an unspecified date with outcome of unknown, "my head was sideways and every time I would raise my head the room was spinning" on an unspecified date with outcome of unknown, "there is not enough spit in my mouth, it is very dry" on an unspecified date with outcome of unknown, I" walked very slowly" on an unspecified date with outcome of unknown, "slight headache" on an unspecified date with outcome of unknown, "my blood pressure now is 137/93. it was high this morning" on an unspecified date with outcome of unknown, "feelt lousy like I had the flu" on an unspecified date with outcome of unknown, "felt like I was fainting" on an unspecified date with outcome of unknown. Reaction description by the reporter:" I had no pain, slight headache. My blood pressure now is 137/93. It was high this morning when I talked with the triage nurse. I had the shot/vaccine (first dose) on Friday. I feel better today than yesterday. Friday I felt fine. I got symptoms yesterday. When I woke up yesterday. I was feeling a little woozy, I always stretch slowly in bed. I slowly raised myself on the bed but before I got up my torso fell backwards. I felt like I was fainting. The room was spinning. All day yesterday I did not drive. I walked very slowly. I was holding onto the wall. I felt lousy like I had the flu. I would lay down for 20 minutes, watching tv. My head was sideways and every time I would raise my head the room was spinning. Also there is not enough spit in my mouth. It is very dry. I had a slight headache. So I did not bother but no headache today. I supposed to get my 2nd dose on 02Feb2021. The action taken was not applicable. Information on the Lot/Batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Stated that he received the first dose then took the test and it came out positive/got vaccinated 29Dec2020/took the Covid test on 30Dec2020/found out that he was positive on Friday (01Jan2021); Stated that he received the first dose then took the test and it came out positive/got vaccinated 29Dec2020/took the Covid test on 30Dec2020/found out that he was positive on Friday (01Jan2021); This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose then took the test and it came out positive. He was scheduled to take the second dose next Tuesday 19Jan2021 and wanted to confirm if he has to wait 90 days or still stick with the second dose since he has already had the first dose. Patient stated that he had got vaccinated on 29Dec2020. Stated that he took the Covid test on 30Dec2020 because someone tested positive and found out that he was positive on Friday (01Jan2021). He was cleared to return to work and he will tomorrow. He wanted to know if this will impede the vaccination process and wanted to know if he will have to redo the vaccination. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, SARS-CoV-2 test
Clinical narrative: last night had a violent bout of chills; slight headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 85; Unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. Medical history included sars-coV-2 virus. The patient's concomitant medications were not reported. Reporter wanted to know if her side effects are normal. Vaccine received at a community center. Patient had been infected with the sars-coV-2 virus several months ago, this past Saturday (Jan2021) she got the first dose of the COVID vaccine series at about 10 AM and last night (Jan2021) had a violent bout of chills which was 6-8 hours after the shot. Also reported a slight headache for which she took 2 ibuprofen, 3 hours later, it struck her like a ton of bricks. She wanted to know if the timeframe for which her side effects appeared is a long time or not. She wanted to know if she should get the second dose of the covid vaccine. She stated "I'm not docking your product, I'm thankful that we have it." She would like to know if her history of being positve for covid infection reacted with her first dose of Covid vaccine. The outcome of the events was unknown.    Information on the batch/lot number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctival irritation, Conjunctival oedema
Clinical narrative: Transient focal swelling of the medial right conjunctiva associated with mild irritation.; Transient focal swelling of the medial right conjunctiva associated with mild irritation.; This is a spontaneous report from a contactable physician (reporting for himself).  A 35-year-old male patient  received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283: expiration date unknown), via an unspecified route of administration in the left arm on 15Jan2021 at 17:00 at a single dose for COVID-19 immunization.  Medical history included seasonal allergies and no allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included acetaminophen on unspecified date for unspecified indication. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 26Dec2020 at 07:00 PM in the right arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17Jan2021 at 18:00, the patient experienced transient focal swelling of the medial right conjunctiva associated with mild irritation. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included diphenhydramine. The events were considered non-serious by the reporter. The outcome of the events was recovered on unspecified date in Jan2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Severe lower back pain; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number Cc3248), via an unspecified route of administration in the left arm on 15Jan2021 at 13:15 at a single dose for COVID-19 immunization. Medical history included being tested for arthritis and allergies (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included prednisone. The patient experienced severe lower back pain on 16Jan2021. The patient did not receive treatment for the event. The patient has not been tested for COVID-19 since the vaccination. Outcome of the event was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: nausea; chills; I had a headache within 24 hrs of vaccine; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL0140), intramuscular in the right arm on 05Jan2021 at 11:00 AM as a single dose for COVID-19 immunization. Medical history included allergies to penicillin. The patient's concomitant medications were not reported. The patient previously took morphine sulfate and experienced allergies. The patient was not pregnant at the time of vaccination, did not receive any other vaccines within four weeks prior to the COVID vaccine, did not have any other medications within 2 weeks of the vaccination, and was not diagnosed with COVID-19 prior to vaccination. The patient had a headache within 24 hours of the vaccine and then she had nausea and chills on 09Jan2021 at 15:30. The patient underwent lab tests and procedures which included nasal swab for SARS-CoV-2 (COVID-19) test: negative on 13Jan2021. No treatment was given for the events. Outcome of the events was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache for over a week; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), 1st dose on 19Dec2020 14:45 and 2nd dose on 11Jan2021 08:45; both via unspecified route of administration via the left arm at a single dose for COVID-19 immunization. Medical history included asthma, allergies and COVID-19 (prior to vaccination). The patient is not pregnant at the time of vaccination. Concomitant medication included azelastine hydrochloride (ASTELIN), fluticasone propionate, salmeterol xinafoate (ADVAIR), zafirlukast (ACCOLATE) and omeprazole (PRILOSEC). The patient previously took motelukast (SINGULAIR), dimeticone, glycerol (CETAPHIL) and budesonide, formoterol (SYMBICORT); all for allergy. The patient experienced headache for over a week on 11Jan2021 08:45. No treatment was received for the evet. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Neck pain, Rash erythematous, Swelling
Clinical narrative: Left Axilla/Underarm pain; Left Axilla/Underarm swelling; lymph node swelling; pain in neck.; Red rash on both arms, chest.; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 26Dec2020 14:00 at single dose in left arm for COVID-19 immunization. Medical history included complete thyroidectomy in 2000 and known allergies included Sulfa. Concomitant medications included losartan, levothyroxine, thyroid (ARMOUR THYROID). The patient didn't receive other vaccine in four weeks. The patient had no covid prior vaccination and no covid tested post vaccination. The patient experienced left axilla/underarm swelling/pain, lymph node swelling/pain in neck. Red rash on both arms, chest on 27Dec2020. The patient did not receive the treatment for events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Patient has a red, warm, hard spot in her arm where the second dose was administered; Patient has a red, warm, hard spot in her arm where the second dose was administered; Patient has a red, warm, hard spot in her arm where the second dose was administered; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included overweight. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient has a red, warm, hard spot in her arm where the second dose was administered on unspecified date. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Nausea, Vertigo
Clinical narrative: Bouts of vertigo; Dizziness; Weakness; Nausea; This is a spontaneous report from a contactable nurse (patient). A 52-years-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: e10142) via an unspecified route of administration on 13Jan2021 09:15 at single dose in left arm for COVID-19 immunisation. She received the first dose (Lot number: Ej1658) in left arm on 23Dec2020 06:30 PM for COVID-19 immunisation. Medical history included diabetes, hypertension. The patient was not allergic to medications, food, or other products. Concomitant medication included metformin, metoprolol tartrate (METPROLOL), triamterene, rosuvastatin, pyrvinium (TRU). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the 2nd dose on 13Jan2021, experienced weakness, dizziness and nausea at around noon next day (14Jan2021 12:00 PM) then at around 6:00 pm bouts of vertigo. Up to now 5 day after the onset dizziness and vertigo still present. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for events. Events outcome was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: first dose 23Dec2020, arm sore; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 23Dec2020 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm sore after the first dose on 23Dec2020.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Influenza like illness, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: flu like symptoms for 36-48 hours; injection site pain; pain on the left side, at the armpit; pain in the swollen lymph nodes; pain in the swollen lymph nodes; This is a spontaneous report from a contactable consumer reported for himself. This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 15Jan2021 night at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine on 15Jan2021 night and had a pretty severe reaction (in Jan2021) that were described as flu like symptoms for 36-48 hours. He felt like that's over with now. He got the vaccine on his left arm. The injection site pain lasted for 24 hours. After 34 hours, he had a pain on the left side, at the armpit. He said it got better 36 hours ago. He was wondering if pain in the arm where the shot was administered in the armpits were reported as a side effect and how long will the pain in the swollen lymph nodes last. The outcome of "flu like symptoms" and "injection site pain" was recovered, of "armpit pain" was recovering, of other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Influenza like illness, Vaccination site pain
Clinical narrative: flu like symptoms for 36-48 hours; injection site pain; pain on the left side, at the armpit; pain in the swollen lymph nodes; pain in the swollen lymph nodes; This is a spontaneous report from a contactable consumer reported for himself. This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 15Jan2021 night at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine on 15Jan2021 night and had a pretty severe reaction (in Jan2021) that were described as flu like symptoms for 36-48 hours. He felt like that's over with now. He got the vaccine on his left arm. The injection site pain lasted for 24 hours. After 34 hours, he had a pain on the left side, at the armpit. He said it got better 36 hours ago. He was wondering if pain in the arm where the shot was administered in the armpits were reported as a side effect and how long will the pain in the swollen lymph nodes last. The outcome of "flu like symptoms" and "injection site pain" was recovered, of "armpit pain" was recovering, of other events was unknown.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Influenza like illness, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: got shot in left arm, it was very sore for about 24 hours; sore in his arm pit on the left side; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient).   A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) via an unspecified route of administration at left arm on 15Jan2021 18:00 at single dose for COVID -19 immunisation. Medical history was none. There were no concomitant medications. Patient had a question about side effects of the COVID vaccine, took the vaccine last Friday night (15Jan2021 around 18:00), stated having the normal side effects, started with flu like symptoms for first 24 -36 hours in Jan2021, felt much better then, clarified those effects have resolved completely, exact day they resolved is unknown. Stated he had one lingering side effect, wanted to ask if we have heard of this before. Stated he got shot in left arm, it was very sore for about 24 hours on 15Jan2021, at about the 24 hour mark, he noticed it got really sore in his arm pit on the left side, stated it had been over 48-60 hours since he got the shot. Wanted to know if this is something we have heard of. Outcome of flu like symptoms recovered in Jan2021, outcome of got shot in left arm, it was very sore was recovering, outcome of other event was not recovered.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Influenza like illness, Vaccination site pain
Clinical narrative: got shot in left arm, it was very sore for about 24 hours; sore in his arm pit on the left side; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient).   A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) via an unspecified route of administration at left arm on 15Jan2021 18:00 at single dose for COVID -19 immunisation. Medical history was none. There were no concomitant medications. Patient had a question about side effects of the COVID vaccine, took the vaccine last Friday night (15Jan2021 around 18:00), stated having the normal side effects, started with flu like symptoms for first 24 -36 hours in Jan2021, felt much better then, clarified those effects have resolved completely, exact day they resolved is unknown. Stated he had one lingering side effect, wanted to ask if we have heard of this before. Stated he got shot in left arm, it was very sore for about 24 hours on 15Jan2021, at about the 24 hour mark, he noticed it got really sore in his arm pit on the left side, stated it had been over 48-60 hours since he got the shot. Wanted to know if this is something we have heard of. Outcome of flu like symptoms recovered in Jan2021, outcome of got shot in left arm, it was very sore was recovering, outcome of other event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Hyperaesthesia, Myalgia
Clinical narrative: pain/ uppper body is very sensitive, sore; skin that is sensitive to touch; blotches on the back and chest; general feeling of tiredness; Headache; muscle aches; Red rash; uncomfortable; This is a spontaneous report from a contactable consumer (patient).  A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiration date unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient experienced pain/ upper body is very sensitive, sore, headache, skin that is sensitive to touch, blotches on the back and chest, general feeling of tiredness. On an unspecified dates in Jan2021, the patient experienced muscle aches, red rash, and uncomfortable. The patient reported that he did not have any symptoms of the COVID when he got the vaccine shot. He mentioned that he made an appointment to get a test. The outcome of the events skin that is sensitive to touch, muscle aches, red rash was not recovered; while the outcome of the rest of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash erythematous, Rash macular
Clinical narrative: pain/ uppper body is very sensitive, sore; skin that is sensitive to touch; blotches on the back and chest; general feeling of tiredness; Headache; muscle aches; Red rash; uncomfortable; This is a spontaneous report from a contactable consumer (patient).  A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiration date unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient experienced pain/ upper body is very sensitive, sore, headache, skin that is sensitive to touch, blotches on the back and chest, general feeling of tiredness. On an unspecified dates in Jan2021, the patient experienced muscle aches, red rash, and uncomfortable. The patient reported that he did not have any symptoms of the COVID when he got the vaccine shot. He mentioned that he made an appointment to get a test. The outcome of the events skin that is sensitive to touch, muscle aches, red rash was not recovered; while the outcome of the rest of the events was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration at the right arm on 16Jan2021 at single dose for Covid-19 immunization in a hospital and not in military facility. The patient's medical history included sinus headache and headaches; both ongoing. The patient informed that he usually gets the sinus headache but wanted to know if this was normal. The patient was getting sinus headaches this time of the year. The patient was taking different medication but was taking sinus medication daily due to the chronic sinus condition. The patient informed that he was seeing an ENT regularly for the headaches and sinus condition. The patient informed that with the flu vaccine he normally has mild flu symptoms for a day. He got the shingles vaccine this fall and he had a more severe reaction with it in terms of flu symptoms. The patient thinks that shingles vaccine was called Shingrix. The patient has no prior vaccinations within 4 weeks. The patient had a headache after the COVID vaccine on Saturday. The patient informed that he got the vaccine on 16Jan2021 at about 10 am or 10:15 am and about 3 pm the headache started, it lasted about 2 hours. The patient had nothing other than the headache and for that he can't say that wasn't his normal sinus headaches he gets normally during this time of the year. The patient explained that the headache occurred later in the day but he can't say it wasn't his normal sinus headaches. The patient informed that the headache wasn't severe, not even a Tylenol was needed, there was no treatment. The patient was scheduled for the second dose on day 20 instead of the 21st day. The patient explained when he got his first shot he was given a window of days to choose from for the second dose. He picked one day which happened to be day 20 after the first dose. The patient informed that he wanted to know if that was ok but was told to check with his physician. The patient didn't want to get it the next day which would be day 21 as he was working that day and didn't want to risk feeling bad, in case there was a side effect. The event did not require a visit to emergency room and physician office. The outcome of the event headache was recovered on 16Jan2021 17:00.  Follow-up activities are possible, information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: developed a sore red spot with  a burning sensation in the administration site of the vaccine; she developed a sore red spot with  a burning sensation in the administration site of the vaccine; This is a spontaneous report from a non-contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient was concomitantly taking  valsartan (manufacturer unknown) for the management of her blood pressure, ibandronate sodium (BONIVA) for her bones, levothyroxine sodium (SYNTHROID) for an unspecified indication and gabapentin (manufacturer unknown) for neuropathy.  The patient was also taking dietary supplements (unspecified) to improve her immune system. The patient reported that she developed a sore red spot with a burning sensation in the administration site of the vaccine on an unspecified date. The patient reported that this sore spot does not compromise the movement or her normal activities. The patient expressed her satisfaction with vaccine because it is a grace to have a vaccine that is saving the world. She also wanted to know if it would be appropriate to take Tylenol and if it would be appropriate to attend her therapy of the neck appointment. The patient also wanted information if the  COVID-19 vaccine would interact with her medications. The outcome of the events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Contusion, Feeling hot, Nausea, Rash erythematous
Clinical narrative: red rash; bruise; slight nausea; slight feeling of fever but temp registered normal; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number BNT162b2), at age of 59-year-old via an unspecified route of administration in left arm on 31Dec2020 11:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID), valsartan, rosuvastatin (ROSUVASTATIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient was not pregnant at Time of Vaccination. The patient experienced red rash, bruise, slight nausea, slight feeling of fever but temp registered normal on 12Jan2021 01:00 with outcome of recovering. The patient received topical antibiotic, diphenhydramine (BENADRYL) for treatment. The events resulted in doctor or other healthcare professional office/clinic visit.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm at injection site; Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL1284), via an unspecified route of administration in the left arm on 13Jan2021 at 18:30 as a single dose for COVID-19 immunization. Medical history included Sjogren's Syndrome, connective tissue disorder, high blood pressure, was pre-diabetic, and had a known allergy to penicillin. The patient had other medications in two weeks (unspecified). The patient was not pregnant, had no other vaccines in four weeks, and did not have COVID prior to the vaccination. The patient experienced sore arm at injection site on 13Jan2021 at 21:00. The patient did not receive any treatment for the events. She was not COVID tested post-vaccination. Outcome of the event was recovered.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: had 5 nosebleeds in the past 2 weeks; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Dec2020 10:00 at a single dose for COVID-19 immunization. Medical history included asthma and hypertension. Concomitant medication included acetylsalicylic acid (ASPIRIN), atorvastatin, benazepril hydrochloride, hydrochlorothiazide (LOTENSIN HCT), and verapamil. The patient previously took cefuroxime axetil (CEFTIN) and experienced allergy. Patient had 5 nosebleeds in the past 2 weeks on 29Dec2020 12:00, after not having a single one for 10+ years. Nasal saline and Afrin was given as treatment for the event. Outcome of the event was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Ear pain, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Diarrhea; She felt really bad; She experienced what felt like "a very bad cold"; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3302), via an unspecified route of administration at site of right arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included fibromyalgia from 2018 and ongoing, borderline diabetes from Feb2020 and ongoing. Concomitant medication included ongoing duloxetine for fibromyalgia, ongoing meloxicam for fibromyalgia, ongoing semaglutide (OZEMPIC) for borderline diabetes. Clinical course: After vaccination, Patient felt fine the first couple of days. On 15Jan2021, she experienced what felt like "a very bad cold", she had a severe headache. She also had diarrhea, a sore throat and she felt really bad on 16Jan2021. It was controlled with taking paracetamol (TYLENOL). Paracetamol made her headache better when she took it. On 18Jan2021, she felt a bit of congestion, an earache and really bad fatigue. She didn't know if these are side effects from the vaccines and if so, how long will last. The episodes of diarrhea came and went. Her sore throat is not as bad. She also had a runny nose and body aches on 17Jan2021. She received the vaccine because she worked as a front-line worker as a dental assistant. She felt like she has the symptoms of COVID. The outcome of event a very bad cold, felt really bad, body aches and earache was unknown; of events fatigue and runny nose was not recovered; of rest events was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Diarrhea; She felt really bad; She experienced what felt like "a very bad cold"; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3302), via an unspecified route of administration at site of right arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included fibromyalgia from 2018 and ongoing, borderline diabetes from Feb2020 and ongoing. Concomitant medication included ongoing duloxetine for fibromyalgia, ongoing meloxicam for fibromyalgia, ongoing semaglutide (OZEMPIC) for borderline diabetes. Clinical course: After vaccination, Patient felt fine the first couple of days. On 15Jan2021, she experienced what felt like "a very bad cold", she had a severe headache. She also had diarrhea, a sore throat and she felt really bad on 16Jan2021. It was controlled with taking paracetamol (TYLENOL). Paracetamol made her headache better when she took it. On 18Jan2021, she felt a bit of congestion, an earache and really bad fatigue. She didn't know if these are side effects from the vaccines and if so, how long will last. The episodes of diarrhea came and went. Her sore throat is not as bad. She also had a runny nose and body aches on 17Jan2021. She received the vaccine because she worked as a front-line worker as a dental assistant. She felt like she has the symptoms of COVID. The outcome of event a very bad cold, felt really bad, body aches and earache was unknown; of events fatigue and runny nose was not recovered; of rest events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Rash, Rash erythematous, Rash macular
Clinical narrative: my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across my chest; red splotchy rash; right side of my head was tingling; I was mildly tachycardic; This is a spontaneous report from a contactable other Health Professional (patient). A 47-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via an unspecified route of administration on 06Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included allergies to adhesive and nickel. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. There were no concomitant medications. It was reported that the day after vaccination, patient's right arm started to feel like it was on fire. This feeling quickly spread up neck and across chest and this area had a red splotchy rash. The right side of head was tingling. Patient took 50 mg diphenhydramine hydrochloride (BENADRYL) and headed to ER (Emergency Room) where patient received Dexamethasone. Patient was mildly tachycardic. Above events started on 07Jan2021 at 12:30. Outcome of the events was resolved.; Sender's Comments: The events are considered related to the suspect product based on the strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across my chest; red splotchy rash; right side of my head was tingling; I was mildly tachycardic; This is a spontaneous report from a contactable other Health Professional (patient). A 47-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via an unspecified route of administration on 06Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included allergies to adhesive and nickel. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. There were no concomitant medications. It was reported that the day after vaccination, patient's right arm started to feel like it was on fire. This feeling quickly spread up neck and across chest and this area had a red splotchy rash. The right side of head was tingling. Patient took 50 mg diphenhydramine hydrochloride (BENADRYL) and headed to ER (Emergency Room) where patient received Dexamethasone. Patient was mildly tachycardic. Above events started on 07Jan2021 at 12:30. Outcome of the events was resolved.; Sender's Comments: The events are considered related to the suspect product based on the strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product 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: Abnormal sensation in eye, Hypoaesthesia, Paraesthesia
Clinical narrative: left eye pulsating intermittently; 1st left side of face numb in spots. Now experiencing entire face with 'pins and needles' numbness intermittently; 1st left side of face numb in spots. Now experiencing entire face with 'pins and needles' numbness intermittently; This is a spontaneous report from a contactable nurse (patient). An adult female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL32495121), via an unspecified route of administration in the left arm on 14Jan2021 07:00 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 15Jan2021 09:30, the patient experienced her left eye was pulsating intermittently. First, the left side of face was numb in spots. Now, she experiencing entire face with pins and needles and numbness intermittently. No treatment was received for the adverse events. Outcome of the events was not recovered.