chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Pruritus, Rash
Clinical narrative: Headache; cold; slight rash; itchiness; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration in right arm on 19Feb2021 16:00 at single dose for covid-19 immunization. The patient has known allergies. The patient historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration in right arm on 29Jan2021 16:00 at single dose for covid-19 immunization. Concomitant medication was not reported. The patient received other medications within 2 weeks of vaccination. 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. The patient was not tested for COVID-19 since the vaccination. On 19Feb2021 at 20:00 patient experienced headache, cold, slight rash, and itchiness. Patient taken benadryl to help relieve the itch but it continues over 36 hours after second dose. Patient didn't received treatment for the headache, cold and slight rash. The clinical outcome of the event is not recovered.   Information on lot/ batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swollen lower lip 2nd day after vaccine; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265) dose 1 via an unspecified route of administration on 02Feb2021 01:30 PM as single dose in left arm for COVID-19 immunization. Medical history included abdominal discomfort. No other vaccine in four weeks. Patient was not pregnant. No covid prior vaccination. Other medications in two weeks was reported as yes. Known allergies was reported as yes. The patient's concomitant medications were not reported. The patient experienced swollen lower lip 2nd day after vaccine on 03Feb2021 09:00 AM. No treatment for adverse event. No covid tested post vaccination. The outcome of event was recovered in 2021  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; fatigue; This is a spontaneous report from a contactable consumer (reported for himself). A 73-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6200) administered in left arm via an unknown route of administration, on 19Feb2021 at 10:15  am as SINGLE DOSE for covid-19 immunization. Medical history included hypertension, chronic obstructive pulmonary disease. The patient previously received first dose of bnt162b2 (Lot number: EL3249) administered in left arm on 29Jan2021at 09:00 am. The patient's concomitant medications were not reported. On 19Feb2021 at 14:00, the patient experienced chills and fatigue. The patient did not received treatment for the events. In Feb2021, the patient recovered from the events. Prior to vaccination the patient was not tested for covid-19. There were no known allergies.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: he developed "a nosebleed yesterday and today.; This is a spontaneous report received from a contactable consumer (patient's wife). A 85-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, in left arm, on 18Feb2021, as single dose for COVID-19 immunisation. Patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that on 20Feb2021, the patient developed a nosebleed. It lasted about 10 min to maybe 30 min with pressure and gauze applied. He might have just blown his nose too hard, or it could be the cold weather. Patient's wife was not sure that it was from the vaccine. Outcome of the event was unknown.  Follow-up attempts are completed. Information about Lot/batch requested.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: He developed Shingles; This is a spontaneous report from a Pfizer-sponsored program through a contactable consumer. A male patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on unknown date as single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that the patient suffered from shingles. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: loss of balance; Headache; Fatigue; dizziness; nausea; pain in muscles all over body; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201, expiry date is not reported) via an unspecified route of administration, in Arm Left, on 18-FEB-2021 07:00 AM (at age of 77 years), as a single dose for COVID-19 immunisation. The Patient's medical history included Benign nerve-sheath tumor, not growing. Concomitant medications included Atorvastatin, Tamsulosin, Pepcid, Allegra. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247, expiry date is not reported) via an unspecified route of administration, in Arm Left, on 26-JAN-2021 07:30 AM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Atorvastatin, Tamsulosin, Pepcid, Allegra within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The Patient had experienced Headache, fatigue, loss of balance, dizziness, nausea, pain in muscles all over body on 18Feb2021 08:00 PM. Patient didn't receive any treatment for the event. Outcome of the event was reported as Recovered/Resolved with Sequel.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: loss of balance; Headache; Fatigue; dizziness; nausea; pain in muscles all over body; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201, expiry date is not reported) via an unspecified route of administration, in Arm Left, on 18-FEB-2021 07:00 AM (at age of 77 years), as a single dose for COVID-19 immunisation. The Patient's medical history included Benign nerve-sheath tumor, not growing. Concomitant medications included Atorvastatin, Tamsulosin, Pepcid, Allegra. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247, expiry date is not reported) via an unspecified route of administration, in Arm Left, on 26-JAN-2021 07:30 AM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Atorvastatin, Tamsulosin, Pepcid, Allegra within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The Patient had experienced Headache, fatigue, loss of balance, dizziness, nausea, pain in muscles all over body on 18Feb2021 08:00 PM. Patient didn't receive any treatment for the event. Outcome of the event was reported as Recovered/Resolved with Sequel.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills; Headache; Bodyache; This is a spontaneous case is received from a contactable consumer (patient). A 25-years-old pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm right on 10Feb2021 11:15 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 20Jan2021. The patient experienced chills, headache and bodyache on 11Feb2021. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: High blood pressure; This is a spontaneous report from a Pfizer-sponsored program and medical information team. Two contactable other healthcare professional (one of them was patient herself) reported that a female patient of an unspecified age (Age: 84; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 29Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, she was calling about the Pfizer vaccine for COVID. She has been experiencing high blood pressure on 29Jan2021. She read the article and saw that it has sodium chloride and sodium phosphate and would like to know if that could affect the blood pressure going up, since hers went up after the vaccine. Caller states that she has been sent to ER a week ago on Sunday and she had a visit to the doctor's office on Monday a week ago. Caller states that she called Pfizer yesterday but could not get through to someone, she then called Pfizer last night, and went through a safety report in which they asked her questions. She does not have a reference number. There was a medical information request about ingredient and BP. Caller asked, "was it advisable for her to take the second dose." Caller received the first dose of the COVID vaccine on 29Jan2021 and experienced "high blood pressure around the vaccine time." Caller asked if sodium chloride or sodium phosphate, that was in the vaccine, can increase her blood pressure. The patient underwent lab test and procedure which included blood pressure: High on 29Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Covid RNA Test Positive; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EM6201, Expiration date: Unknown) via an unspecified route of administration in the left arm on 15Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced covid RNA test positive on 18Feb2021. The patient stated she received the first dose last Monday, but was then diagnosed with covid on Thursday. She didn't realize she was coming down with it when getting vaccine. Her second dose is scheduled on 08Mar2021. Her First Dose was on 15Feb2021. Then on 18Feb2021 she was diagnosed positive with covid. They did a covid RNA Test, which consisted of doing a nasal swab, her result was positive. She did not express any symptoms before the first dose. She has had no positive covid test before the first dose. She took the actual covid test on thursday 18Feb2021 and got the result on Friday the next day. The patient decided to get tested because after the first dose on the 15th, she noticed on Wednesday afternoon she started to have symptoms, she was experiencing aches, fever, chills. The only things ongoing at the moment are congestion and body aches and being tired. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 18Feb2021. The outcome of event was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Dysphagia, Dyspnoea, Headache
Clinical narrative: tongue was not manageable; throat was swollen; terrible headache; arm started hurting; fever of about 99.9; Feeling sick; stomach starting throwing up and patient was throwing up; started having trouble breathing and could not breath; breathing got worse; I started having trouble breathing and I could not breath; my breathing got worse; could not swallow, could not do anything; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 15Feb2021 (at around 12:00) as single dose for COVID-19 immunization. The patient medical history included asthma (patient had bad case of asthma, patient had that forever), thyroid (patient takes thyroid pill, natural picked thyroid a 30 mg, takes in the morning) and heart. The patient previously received the first dose of bnt162b2 (COMIRNATY) for COVID-19 immunization (at the age 78 years). Concomitant medication(s) included amlodipine besilate 5mg, cortisone, fish oil, losartan potassium 50 mg, naltrexone hydrochloride 4.5mg, prednisone 5mg, rheumagel, spironolactone 25mg and simvastatin 10mg taken for heart. On 15Feb2021, patient experienced fever of about 99.9, feeling sick, stomach starting throwing up and patient was throwing up, started having trouble breathing and could not breath; breathing got worse, could not swallow, could not do anything and that continued, terrible headache, arm started hurting. On an unspecified date, the patient experienced tongue was not manageable and throat was swollen. The patient mentioned that temperature was 97.7 in the first shot and then it was just 98.2 but on 15Feb2021 it was a little higher. The patient called her primary doctor. The patient took 800 mg Ibuprofen as treatment for fever of about 99.9. The outcome of started having trouble breathing and could not breath; breathing got worse and arm started hurting was not recovered and was unknown for the rest of the events.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pharyngeal swelling, Pyrexia, Tongue movement disturbance
Clinical narrative: tongue was not manageable; throat was swollen; terrible headache; arm started hurting; fever of about 99.9; Feeling sick; stomach starting throwing up and patient was throwing up; started having trouble breathing and could not breath; breathing got worse; I started having trouble breathing and I could not breath; my breathing got worse; could not swallow, could not do anything; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 15Feb2021 (at around 12:00) as single dose for COVID-19 immunization. The patient medical history included asthma (patient had bad case of asthma, patient had that forever), thyroid (patient takes thyroid pill, natural picked thyroid a 30 mg, takes in the morning) and heart. The patient previously received the first dose of bnt162b2 (COMIRNATY) for COVID-19 immunization (at the age 78 years). Concomitant medication(s) included amlodipine besilate 5mg, cortisone, fish oil, losartan potassium 50 mg, naltrexone hydrochloride 4.5mg, prednisone 5mg, rheumagel, spironolactone 25mg and simvastatin 10mg taken for heart. On 15Feb2021, patient experienced fever of about 99.9, feeling sick, stomach starting throwing up and patient was throwing up, started having trouble breathing and could not breath; breathing got worse, could not swallow, could not do anything and that continued, terrible headache, arm started hurting. On an unspecified date, the patient experienced tongue was not manageable and throat was swollen. The patient mentioned that temperature was 97.7 in the first shot and then it was just 98.2 but on 15Feb2021 it was a little higher. The patient called her primary doctor. The patient took 800 mg Ibuprofen as treatment for fever of about 99.9. The outcome of started having trouble breathing and could not breath; breathing got worse and arm started hurting was not recovered and was unknown for the rest of the events.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: tongue was not manageable; throat was swollen; terrible headache; arm started hurting; fever of about 99.9; Feeling sick; stomach starting throwing up and patient was throwing up; started having trouble breathing and could not breath; breathing got worse; I started having trouble breathing and I could not breath; my breathing got worse; could not swallow, could not do anything; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 15Feb2021 (at around 12:00) as single dose for COVID-19 immunization. The patient medical history included asthma (patient had bad case of asthma, patient had that forever), thyroid (patient takes thyroid pill, natural picked thyroid a 30 mg, takes in the morning) and heart. The patient previously received the first dose of bnt162b2 (COMIRNATY) for COVID-19 immunization (at the age 78 years). Concomitant medication(s) included amlodipine besilate 5mg, cortisone, fish oil, losartan potassium 50 mg, naltrexone hydrochloride 4.5mg, prednisone 5mg, rheumagel, spironolactone 25mg and simvastatin 10mg taken for heart. On 15Feb2021, patient experienced fever of about 99.9, feeling sick, stomach starting throwing up and patient was throwing up, started having trouble breathing and could not breath; breathing got worse, could not swallow, could not do anything and that continued, terrible headache, arm started hurting. On an unspecified date, the patient experienced tongue was not manageable and throat was swollen. The patient mentioned that temperature was 97.7 in the first shot and then it was just 98.2 but on 15Feb2021 it was a little higher. The patient called her primary doctor. The patient took 800 mg Ibuprofen as treatment for fever of about 99.9. The outcome of started having trouble breathing and could not breath; breathing got worse and arm started hurting was not recovered and was unknown for the rest of the events.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain
Clinical narrative: Body aches; Chills; Headache; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in right arm on 16Feb2021 at 16:30 as a single dose for COVID-19 immunisation. The patient's medical history included 20-year breast cancer survivor, no chronic health conditions, COVID-19 from 26Jun2020 (when patient had COVID, 26Jun2020, patient had these same symptoms plus a low fever, but patient was sick much longer), allergy to Sulfa based meds (allergies to medications, food, or other products: Sulfa based meds), low fever, sick. Concomitant medications included clarithromycin (CLARITIN), acetylsalicylic acid (ASPRIN) at 84 mg, multi-vitamin; All received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, 24 hours after dose, on 17Feb2021, the patient experienced body aches, then chills and headache for the next 8 hours. Recovered fully. The second dose was scheduled on 09Mar2021. The patient underwent lab test and procedure which included body temperature: Low fever on an unspecified date in 2020. The events were considered as non-serious by the consumer. No treatment medications were received for the adverse events. The outcome of the events was recovered on an unspecified date in 2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: Dizziness began 10 days afterwards; received prescription for vertigo; fatigue began within a couple of days of vaccination; This is a spontaneous report from a contactable Other Health care professional (patient). A 71-year-old non pregnant female patient received (BNT162B2, Solution for injection, Lot number: EN5318,), via an unspecified route of administration on 04Feb2021 02:15 PM left arm as single dose for covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history was not reported. Concomitant medication included Glucosamine, chondroitin, fish oil, D3, Carnitine. No other vaccine was taken in four weeks. Covid was no tested prior vaccination. Covid was tested post vaccination. No Known allergies. The patient experienced fatigue began within a couple of days of vaccination, Dizziness began 10 days afterwards. Dizziness was debilitating, contacted my physician and received prescription for vertigo on an 08Feb2021 and corrective treatment included Meclizine 25 mg.1xdaily. The patient had a physician office visit. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Vaccination site lymphadenopathy
Clinical narrative: Enlarged lymph nodes on left side (vaccination side) in recent mammogram; This is a spontaneous report received from a contactable consumer reporting for himself. A 50-year-old female non-pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number: EL3247; Expiration date was not reported), via an unspecified route of administration on the left arm on 27Jan2021 12:15 as single dose for COVID-19 immunization at workplace clinic. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications included unspecified birth control pills. The patient did not receive other vaccine in four weeks. On 16Feb2021, the patient underwent mammogram which revealed enlarged lymph nodes on left side (vaccination side). No treatment was received for the event. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The outcome of the event enlarged lymph nodes was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Sunburn type rash on abdomen 3 days post vaccine. Turned into typical rash for about 4 full days; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 30Jan2021 as single dose for covid-19 immunisation. Patient did not had medical history. Concomitant medications included loperamide hcl, colecalciferol (VITAMIN D 3) , propofol (ANESTHESIA S/I 40) and calcium. On 02Feb2021 patient experienced sunburn type rash on abdomen 3 days post vaccine,turned into typical rash for about 4 full. The outcome of the event was recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Sore at injection site; headache; This is a spontaneous report received from a contactable other health care professional (Patient).  A 53-year-old female patient (non-pregnant) received first dose bnt162b2 (Solution for injection, COVID-19) via an unspecified route of administration, administered in Arm Left on 24Feb2021 10:00 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. The patient medical history Includes hypothyroid, atopic dermatitis, known allergies: sulfa drugs. Concomitant medications included escitalopram oxalate (LEXAPRO), fexofenadine hydrochloride (ALLEGRA), levothyroxine sodium (LEVOTHYROXIN), ibuprofen (ADVIL), colecalciferol (VITAMIN D), vitamin c [ascorbic acid] taken for an unspecified indication, start and stop date were not reported. No COVID prior vaccination and no COVID tested post vaccination. On an unspecified date in 2021, patient experienced sore at injection site and Headache. Outcome for these events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Investigation
Clinical narrative: Left hip and joints is bothering me and my left leg is like sore; left hip and the joints, it really hurts; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 10Feb2021 (at the age of 80-year-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included insertion of cardiac pacemaker put into his body on the left side on 04Feb. Concomitant medications were his regular medication and blood pressure pills, which included losartan 50 mg one daily, atorvastatin 80 mg one daily, aspirin 81 mg, carvedilol 12.5 taken 2 daily. The patient took first dose of BNT162B2 (Lot Number: EK4176) on via an unspecified route of administration 20Jan2021) as single dose for COVID-19 immunisation. On an unspecified date, the patient's left hip and joints bothered and his left leg was like sore, left hip and the joints, it really hurts him. The patient enquired if its natural that happens or what's going on because it comes and goes but in his left hip and the joints really hurts.. The patient went for lab work at the hospital where he was two weeks ago, but result was unknown. Outcome of the event was unknown.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: Dysphagia, difficulty swallowing medications in pill form; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient of an unspecified gender received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El9261) via an unspecified route of administration in left arm on 12Feb2021 08:15 as single dose and had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3248) administered in left arm on 22Jan2021 08:00 as single dose for covid-19 immunization. The patient was 65-years-old at the time of vaccination. The patient medical history and concomitant medications were not reported. On 14Feb2021, the patient experienced dysphagia, difficulty swallowing medications in pill form. Vaccination facility type was doctor's office/urgent care. No other vaccine in four weeks. No treatment received for adverse event. No vaccination prior to covid. No covid tested post vaccination. The outcome of event was not recovered.
Sex: U
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable Nurse. A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hives on an unspecified date. The nurse reported that  the patient developed hives after first dose of meningococcal group b rlp2086 vaccine. The doctor asked the nurse to contact the vaccine manufacturer to seek advice on whether or not this patient should receive the second dose of meningococcal group b rlp2086 or not. The outcome of the event was unknown.   No follow-up attempts are needed, Information on Lot/Batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: Having an allergic reaction; Itching; It has been slight on the back; It is down around my buttock, around my hip; Having an allergic reaction; Itching; It has been slight on the back; It is down around my buttock, around my hip; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162B2 (Pfizer Covid vaccine, Solution for injection, Lot number: EN6203) via unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Stated, he was having a, he got the Pfizer shot on Wednesday and he was having an allergic reaction, he guess but he was not sure, he was itching on an unspecified date in 2021. Treatment in response to event, stated, as No, because it has been slight on the back and this morning, it was down around his buttock, around his hip. Stated that patient was on unspecified other medications. Stated that patient got the second shot on 18Feb2021. The outcome of the events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Fatigue
Clinical narrative: 101.6 fever for 2 1/2 days; headache; joint and muscle pain; joint and muscle pain; stiff, sore neck; chills; sweating; fatigue; restlessness; lack of appetite; injection site pain; swelling in left armpit; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old female patient (non-pregnant) received second dose of bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 16Feb2021 10:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included Hay fever, known allergies to Sulfa, Penicillin. The patient's concomitant medications were not reported. Patient previously took cefalexin (KEFLEX) and had drug allergy. The patient received first dose of historical vaccine, bnt162b2 (Lot: EN5318, product: COVID19, brand: Pfizer) in left arm on 26Jan2021 10:30 for covid-19 immunisation. The patient experienced 101.6 fever for 2 1/2 days, headache, joint and muscle pain, stiff, sore neck, chills, sweating, fatigue, restlessness, lack of appetite, injection site pain, swelling in left armpit on 16Feb2021 around 19:30 and lasted until Friday (19Feb2021) 3 days later with slight injection site pain and slight neck and underarm pain still lingering. Remained in bed all Wednesday, Thursday and some of Friday. The patient underwent lab tests and procedures which included body temperature: 101.6 fever for 2 1/2 days on 16Feb2021, sars-cov-2 test via Nasal Swab the Rapid and PCR: negative on 03Feb2021. The Clinical outcome of all the events was recovered on 19Feb2021.  Information about lot/Batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Musculoskeletal stiffness, Myalgia, Peripheral swelling
Clinical narrative: 101.6 fever for 2 1/2 days; headache; joint and muscle pain; joint and muscle pain; stiff, sore neck; chills; sweating; fatigue; restlessness; lack of appetite; injection site pain; swelling in left armpit; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old female patient (non-pregnant) received second dose of bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 16Feb2021 10:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included Hay fever, known allergies to Sulfa, Penicillin. The patient's concomitant medications were not reported. Patient previously took cefalexin (KEFLEX) and had drug allergy. The patient received first dose of historical vaccine, bnt162b2 (Lot: EN5318, product: COVID19, brand: Pfizer) in left arm on 26Jan2021 10:30 for covid-19 immunisation. The patient experienced 101.6 fever for 2 1/2 days, headache, joint and muscle pain, stiff, sore neck, chills, sweating, fatigue, restlessness, lack of appetite, injection site pain, swelling in left armpit on 16Feb2021 around 19:30 and lasted until Friday (19Feb2021) 3 days later with slight injection site pain and slight neck and underarm pain still lingering. Remained in bed all Wednesday, Thursday and some of Friday. The patient underwent lab tests and procedures which included body temperature: 101.6 fever for 2 1/2 days on 16Feb2021, sars-cov-2 test via Nasal Swab the Rapid and PCR: negative on 03Feb2021. The Clinical outcome of all the events was recovered on 19Feb2021.  Information about lot/Batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Restlessness, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: 101.6 fever for 2 1/2 days; headache; joint and muscle pain; joint and muscle pain; stiff, sore neck; chills; sweating; fatigue; restlessness; lack of appetite; injection site pain; swelling in left armpit; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old female patient (non-pregnant) received second dose of bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 16Feb2021 10:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included Hay fever, known allergies to Sulfa, Penicillin. The patient's concomitant medications were not reported. Patient previously took cefalexin (KEFLEX) and had drug allergy. The patient received first dose of historical vaccine, bnt162b2 (Lot: EN5318, product: COVID19, brand: Pfizer) in left arm on 26Jan2021 10:30 for covid-19 immunisation. The patient experienced 101.6 fever for 2 1/2 days, headache, joint and muscle pain, stiff, sore neck, chills, sweating, fatigue, restlessness, lack of appetite, injection site pain, swelling in left armpit on 16Feb2021 around 19:30 and lasted until Friday (19Feb2021) 3 days later with slight injection site pain and slight neck and underarm pain still lingering. Remained in bed all Wednesday, Thursday and some of Friday. The patient underwent lab tests and procedures which included body temperature: 101.6 fever for 2 1/2 days on 16Feb2021, sars-cov-2 test via Nasal Swab the Rapid and PCR: negative on 03Feb2021. The Clinical outcome of all the events was recovered on 19Feb2021.  Information about lot/Batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Migraine, Nausea, SARS-CoV-2 test
Clinical narrative: Daily stomach aches; migraines; severe nausea; This is a spontaneous report from a contactable other-HCP (patient, self-reported). A 35-year-old female patient received dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: unknown and expiry date was not provided), via an unspecified route of administration, on 19Feb2021, as a single dose for COVID-19 immunization. The patient was 35-years-old and was not pregnant at the time of vaccination. Patient's medical history and concomitant medications were not reported. The patient did not have any known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. Prior vaccination, the patient was not diagnosed with COVID. After vaccination, the patient was tested with COVID which was nasal swab test however, result was unknown. It was reported that on 13Feb2021 at 00:00, the patient experienced daily stomach aches, migraines, and severe nausea. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash; would call it hives; very itchy; Rash; would call it hives; very itchy; Rash; would call it hives; very itchy; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 02 patients (wife and Husband). This is 1st of 02 reports. A 76-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included type 2 diabetes was diagnosed A lot of years ago, she thinks in 1995, heart problem. Concomitant medication(s) included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported. Insulin was administered via pen, once a night. The patient stated that for diabetes, she takes a lot of medications and there are several of them. Consumer further stated that she has preventives for heart problem. She has been using and is on them permanently. Consumer stated, "They are all taken orally." She thinks her weight, it's like 180 pounds somewhere around there and she was not sure. The patient experienced rash; would call it hives; very itchy in Feb2021. Consumer stated, she had a side effect but she don't know if it's a side effect that you have. It's not listed on the sheet that she got when she got her shot of our vaccination. The patient had a rash. She would call it hives. They itch like double. There were a couple of on her right shoulder, she had two on the back of her left calf, on her leg and she had on her whole left arm where the vaccination shot was put in, completely covered in hives and they were very itchy. Consumer further stated that she wants to know what to do about it. The itch was like double, and this had been day 4 and she had the last, the second vaccination on 4th Feb on left upper arm. She wanted to get rid of these hives. They were driving her nuts. Consumer stated, 4 days ago, 19Feb 2021, somewhere around that she started having the events. Consumer further stated that she wants somebody to tell her what she was supposed to do. She don't want to go through all this stuff. She enquired what to do about these hives. The patient had got Calamine lotion, it's calamine topical suppressant and she had got Wal-dryl, it's a generic for Benadryl as treatment. The patient was still experiencing the adverse events and stated otherwise she wouldn't be calling. They were still there, it's still driving her nuts. The patient has not done lab test. She has got to do it another month. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021219067 same drug/same event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: The women mentioned that since she had her second vaccine dose her eyelids have been twitching; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). An elderly non-pregnant female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Feb2021 patient experienced twitching of eyelids. It was reported that since she had her second vaccine dose her eyelids have been twitching. No treatment was taken for adverse event. It was unknown if patient had other vaccine in 4 weeks or patient had COVID prior vaccination. It was unknown if patient was tested for COVID post vaccination. The outcome of event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: The day after 2nd vaccine the patient experienced twitching of the eyelids.; This is a spontaneous report received from a non-contactable consumer (Non-healthcare Professional reporting for a patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that, on 03Feb2021, the day after 2nd vaccine the patient experienced twitching of the eyelids. The outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: Eyelids started twitching the day after 2nd dose of vaccine; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on 05Feb2021 as SINGLE DOSE for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. On 06Feb2021, the patient's eyelids started twitching the day after 2nd dose of vaccine. The patient did not receive any treatment for the event. The outcome of event unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate, Heart rate increased, Myalgia, Nausea
Clinical narrative: swelling of face/throat; tightness of heart; fever; muscle ache; nausea; pulse was 122; This is a spontaneous report from a contactable other hcp. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 29Jan2021 16:30 (Batch/Lot number UNKNOWN) as single dose for covid-19 immunisation. Medical history included, food allergy. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 29Jan2021 16:30 (Batch/Lot number UNKNOWN) as a single dose for COVID-19 immunization. The patient's concomitant medications were not reported. The patient previously took doxycycline and experienced drug hypersensitivity, caffeine and experienced drug hypersensitivity. The patient stated she had a slight tightness of heart and nausea after 1st dose. They were resolved after 48 hrs. She informed the several nurses about my tightness of heart but they said it's ok if they were gone after 48 hrs. After 2nd dose, she had fever, muscle ache, swelling of face/throat, nausea, and tightness of heart. Again, they were gone after 48 hrs. And then they came back after a week later(6Feb). She had muscle ache and stronger nausea and a racing heart. She called vaccine adverse hotline on 10Feb2021 and was told to go to a urgent care which helped me schedule with respiratory clinic. Her pulse was 122 when she was sitting down. The fast heartbeat lasted for 5-6 days until completely gone. The patient did not take any other vaccine in four weeks or any other medications in two weeks. The patient was not covid vaccinated priorly. The patient was tested covid post vaccination. The patient underwent lab tests and procedures which included heart rate: pulse was 122 on 6Feb2021, sars-cov-2 test (Covid PCR): negative on 10Feb2021, sars-cov-2 test (nasal swab): negative on 10Feb2021. The outcome of the events was recovered on an unspecified date 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: swelling of face/throat; tightness of heart; fever; muscle ache; nausea; pulse was 122; This is a spontaneous report from a contactable other hcp. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 29Jan2021 16:30 (Batch/Lot number UNKNOWN) as single dose for covid-19 immunisation. Medical history included, food allergy. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 29Jan2021 16:30 (Batch/Lot number UNKNOWN) as a single dose for COVID-19 immunization. The patient's concomitant medications were not reported. The patient previously took doxycycline and experienced drug hypersensitivity, caffeine and experienced drug hypersensitivity. The patient stated she had a slight tightness of heart and nausea after 1st dose. They were resolved after 48 hrs. She informed the several nurses about my tightness of heart but they said it's ok if they were gone after 48 hrs. After 2nd dose, she had fever, muscle ache, swelling of face/throat, nausea, and tightness of heart. Again, they were gone after 48 hrs. And then they came back after a week later(6Feb). She had muscle ache and stronger nausea and a racing heart. She called vaccine adverse hotline on 10Feb2021 and was told to go to a urgent care which helped me schedule with respiratory clinic. Her pulse was 122 when she was sitting down. The fast heartbeat lasted for 5-6 days until completely gone. The patient did not take any other vaccine in four weeks or any other medications in two weeks. The patient was not covid vaccinated priorly. The patient was tested covid post vaccination. The patient underwent lab tests and procedures which included heart rate: pulse was 122 on 6Feb2021, sars-cov-2 test (Covid PCR): negative on 10Feb2021, sars-cov-2 test (nasal swab): negative on 10Feb2021. The outcome of the events was recovered on an unspecified date 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Stingy pain in calf; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program  A female patient of an unspecified age received first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history included ongoing cancer. The patient concomitant medications included an unspecified chemotherapy medication. It was reported that the patient has a stingy pain in calf today (22Feb2021) and been going on since the first dose. It started the day after of the first dose on an unspecified date. The outcome of the event was not recovered.  Information on the lot batch number has been requested.