chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic
Clinical narrative: Rash on my arm, itching very badly; arm was sore; This is a spontaneous report from a contactable consumer(Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 06Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on my arm, itching very badly on Mar2021, arm was sore on Mar2021.Reporter stated, Scheduled date for second shot was on the 3Apr, they told patient to come the first week can come on the 1st or 2nd or third. At first arm was sore. Thinks the rash side only on the 10th. (The 10 of march). The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pruritus, Rash
Clinical narrative: After 2nd dose about 10 hours later was feeling sick; had terrible itching on feet and rash is back on chest; had terrible itching on feet and rash is back on chest; This is a spontaneous report from a contactable consumer or other non hcp (Patient) via Pfizer Sponsored Program COVAX US Support.  A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, Lot Number: Unknown, expiration date: unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (BNT162B2, formulation: solution for injection, Lot Number: Unknown, expiration date: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization and experienced small rash on his chest but did go away. On an unknown date, patient reported After 2nd dose about 10 hours later was feeling sick. Got up next morning had terrible itching on feet and rash is back on chest. Wondering if anyone else reported these symptoms. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pyrexia
Clinical narrative: a bit nauseous; 99 fever; Feeling a bit fatigued; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 17Mar2021 at 16:45 (at the age of 67-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included COVID-19 from an unknown date and unknown if ongoing. The patient had no known allergies. The concomitant medications of the patient were not reported. The patient previously received first dose of bnt162b2 (BNT162B2 solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on an unspecified date as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 18Mar2021 at 08:00, the patient experienced a bit nauseous, 99 fever, feeling a bit fatigued. The patient underwent lab tests and procedures which included body temperature: 99 on 18Mar2021. The patient received no treatment for the events. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching in the arm; This is a spontaneous report from a contactable Physician (patient reported for self). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itching in the arm on an unspecified date. The patient outcome of the event was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Feeling abnormal, Feeling hot, Hypersensitivity
Clinical narrative: swollen fingers and feet; Felt in chest like she had been beaten or hit herself heavily; chest area was sore; Sensation like she had applied vapor rub in the inside; allergic reaction; it was irritated right in the center from throat down lower; circle of warmth in the chest; This is a spontaneous report from a non-contactable consumer (patient herself). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left (upper part) on 05Mar2021 09:30 (age at vaccination: 67 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were none. The patient did not receive any vaccinations prior to four weeks. On an unknown date, the patient experienced swollen fingers and feet on the third day and then it cleared, it was not drastic just a lit bit of swelling; felt in chest like she had been beaten or hit herself heavily, chest area was sore, sensation like she had applied vapor rub in the inside also referred to sensation as if she applied hot pepper, it was irritated right in the center from throat down lower. Caller stated this started after she first noticed the warmth. Caller stated it came on gradually; she stated what remains in the tiny spot in the stomach between chest in the solar plexus. It was just a tiny spot. Reporter clarified that this was at the end of the bone which is what she thinks is called the hypothesis just under the bone in the center in that area. She recovered but has occasional sensation, felt it could have been an irritation of the lining or tissues and that she does not know but it is pretty much cleared by this morning. She clarified that the little tiny spot that still remains warmth is just the remnants that she experience down the entire tube and only that spot in the bottom of the tube. She felt much more back to normal. On 12Mar2021, 8 days after the shot, the patient experienced circle of warmth in the chest. She is still only experiencing a little tiny bit in the pleural sac area not but it is much less, it seemed to stay the same for a while and gradually started to get better and felt better two weeks after she received the shot. She was back to normal. The patient believes is an allergic reaction. The patient did not receive any treatment for the adverse events. The patient did not visit physician's or emergency room. The outcome of peripheral swelling, chest discomfort, chest pain was recovered on an unknown date in 2021; feeling hot, feeling abnormal, throat irritation was recovering; hypersensitivity was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Throat irritation
Clinical narrative: swollen fingers and feet; Felt in chest like she had been beaten or hit herself heavily; chest area was sore; Sensation like she had applied vapor rub in the inside; allergic reaction; it was irritated right in the center from throat down lower; circle of warmth in the chest; This is a spontaneous report from a non-contactable consumer (patient herself). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left (upper part) on 05Mar2021 09:30 (age at vaccination: 67 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were none. The patient did not receive any vaccinations prior to four weeks. On an unknown date, the patient experienced swollen fingers and feet on the third day and then it cleared, it was not drastic just a lit bit of swelling; felt in chest like she had been beaten or hit herself heavily, chest area was sore, sensation like she had applied vapor rub in the inside also referred to sensation as if she applied hot pepper, it was irritated right in the center from throat down lower. Caller stated this started after she first noticed the warmth. Caller stated it came on gradually; she stated what remains in the tiny spot in the stomach between chest in the solar plexus. It was just a tiny spot. Reporter clarified that this was at the end of the bone which is what she thinks is called the hypothesis just under the bone in the center in that area. She recovered but has occasional sensation, felt it could have been an irritation of the lining or tissues and that she does not know but it is pretty much cleared by this morning. She clarified that the little tiny spot that still remains warmth is just the remnants that she experience down the entire tube and only that spot in the bottom of the tube. She felt much more back to normal. On 12Mar2021, 8 days after the shot, the patient experienced circle of warmth in the chest. She is still only experiencing a little tiny bit in the pleural sac area not but it is much less, it seemed to stay the same for a while and gradually started to get better and felt better two weeks after she received the shot. She was back to normal. The patient believes is an allergic reaction. The patient did not receive any treatment for the adverse events. The patient did not visit physician's or emergency room. The outcome of peripheral swelling, chest discomfort, chest pain was recovered on an unknown date in 2021; feeling hot, feeling abnormal, throat irritation was recovering; hypersensitivity was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Experiencing mild flu-like symptoms; Chills; muscle aches; slight fever; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 42-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient stated, I had my 2nd COVID vaccine shot yesterday at 10am. On an unspecified date experiencing mild flu-like symptoms, chills, muscle aches, slight fever. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Blister, Eyelid margin crusting, Pyrexia, Rash
Clinical narrative: Rash; real bad fever; real bad fever blister around mouth; eyes crusting over at night like mucus; it swells up at night real bad gets swollen and crusty; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Left shoulder on 09Mar2021 14:45 (at the age of 63 year old) as dose 1, single for COVID-19 immunisation.  Medical history included ongoing meniere's disease from 2015, stroke from 08Jan2019 and Heart attack from 08Jan2021, cholesterol , diabetes mellitus from an unknown date. Patient had done heart valve replacement on an unspecified date. Concomitant medications included warfarin that been taking for 10 1/2 years as blood thinner for Heart valve replaced; pravastatin been taking for 10 years, for cholesterol; metformin for diabetes mellitus, physician just increased the dose last year, before he was taking 750 mg twice a day for 10 years; liraglutide (VICTOZA) been taking for about 5 years for diabetes mellitus; insulin glargine (BASAGLAR) been taking for about 3 years for diabetes mellitus; zaleplon (ZALEPLON) been taking for several years, probably 5 years for sleep aid; acetylsalicylic acid (BABY ASPIRIN) been taking for 2 years for preventive measure. Patient received vaccine on 09Mar2021 (Tuesday), and on 11Mar2021, he developed a rash, real bad fever blister around mouth, and eyes crusting over at night like mucus, and got swollen. He had been to his primary care doctor, dermatologist, and ophthalmologist. It was reported that no one knows what it might be and stated that the only thing that changed during this time was that he had received the COVID vaccine. Relevant tests included, on an unspecified date in Mar2021, skin biopsy, result found to be no skin cancer. Therapeutic measures included steroid eye drop with antibacterial for the event eyes crusting over at night, where at the time of report, it is not as bad, has gotten better. The outcome of the events it swells up at night real bad gets swollen and crusty was recovering and of other events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Rash; real bad fever; real bad fever blister around mouth; eyes crusting over at night like mucus; it swells up at night real bad gets swollen and crusty; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Left shoulder on 09Mar2021 14:45 (at the age of 63 year old) as dose 1, single for COVID-19 immunisation.  Medical history included ongoing meniere's disease from 2015, stroke from 08Jan2019 and Heart attack from 08Jan2021, cholesterol , diabetes mellitus from an unknown date. Patient had done heart valve replacement on an unspecified date. Concomitant medications included warfarin that been taking for 10 1/2 years as blood thinner for Heart valve replaced; pravastatin been taking for 10 years, for cholesterol; metformin for diabetes mellitus, physician just increased the dose last year, before he was taking 750 mg twice a day for 10 years; liraglutide (VICTOZA) been taking for about 5 years for diabetes mellitus; insulin glargine (BASAGLAR) been taking for about 3 years for diabetes mellitus; zaleplon (ZALEPLON) been taking for several years, probably 5 years for sleep aid; acetylsalicylic acid (BABY ASPIRIN) been taking for 2 years for preventive measure. Patient received vaccine on 09Mar2021 (Tuesday), and on 11Mar2021, he developed a rash, real bad fever blister around mouth, and eyes crusting over at night like mucus, and got swollen. He had been to his primary care doctor, dermatologist, and ophthalmologist. It was reported that no one knows what it might be and stated that the only thing that changed during this time was that he had received the COVID vaccine. Relevant tests included, on an unspecified date in Mar2021, skin biopsy, result found to be no skin cancer. Therapeutic measures included steroid eye drop with antibacterial for the event eyes crusting over at night, where at the time of report, it is not as bad, has gotten better. The outcome of the events it swells up at night real bad gets swollen and crusty was recovering and of other events was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: 10/10 pain in right knee/spread to thigh and buttocks area; 10/10 pain in right knee/spread to thigh and buttocks area; spread to thigh and buttocks area/ pain has gotten slightly better in right leg; This is a spontaneous report from a non-contactable consumer via Pfizer. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that after the first injection of the Pfizer covid vaccine, patient had 10/10 pain in right knee. Two days later pain was still 10 and had spread to thigh and buttocks area. The patient went to urgent care and was given pain meds. Pain was slightly better in right leg about a 7-8. Events took place after use of product. He was due for second injection on 18Mar2021. He had appointment with orthopaedic on 22Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Illness, Pyrexia
Clinical narrative: sick; fever; back pains; This is a spontaneous report from a Pfizer sponsored Program. A contactable female consumer reported that:  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 16Mar2021 as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The caller stated received first CoVax yesterday and experienced sick, fever, back pains on an unspecified date . Caller asked if that was normal. Medical Information: No unaddressed medical questions referred or forwarded to Medical Information. The outcome of event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: generalized rash (not just at injection site) without anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced generalized rash (not just at injection site) without anaphylaxis after first covid vacc on an unspecified date. Patient tried to clarify if was safe for her to get second shot. The outcome of the event was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: fever; sore muscles and joints; sore muscles and joints; This is a spontaneous report from a non-contactable consumer. A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 16:00  as dose number unknown, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced fever, sore muscles and joints on 17Mar2021. The treatment given for the events was unknown. The outcome of the events was recovering.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Nausea, Pyrexia
Clinical narrative: Felt stoned; Headache; Chills; Fever; Nausea; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old, non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6201 and expiry date not reported) via an unspecified route of administration, on 18Feb2021 14:00 (at the age of 69-year-old), as dose 1, single, for COVID-19 immunisation. Medical history included allergy to Barium. Concomitant medication included alprazolam (manufacturer unknown) for unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had felt stoned, experienced a bad headache for 3 days, felt chills, fever and nausea on 18Feb2021 at 14:15 which lasted one week. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events felt stoned, headache, chills, fever, and nausea were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling of eyelid
Clinical narrative: Itching around eyes; swelling of eyelids; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208 and expiration date: not reported), via an unspecified route of administration, in the left arm, on 16Mar2021 at 12:00 (at the age of 48-year-old) as dose 2, single dose for COVID-19 immunization. Medical history included allergy to sulfur containing antibiotics. Concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number and expiration date: not reported ) via an unspecified route of administration, in the left arm, on 23Feb2021 at 17:00 (at the age of 48-year-old) as dose 1, single dose for COVID-19 immunization and experienced Itching around eyes. The patient was not pregnant at time of vaccination.  The patient had not received any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 17Mar2021, the patient experienced itching around eyes and swelling of eyelids. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events itching around eyes and swelling of eyelids which included self-treatment with antihistamine on an unknown date in 2021 and Doctor rx'ed Benadryl and cortisone cream. The outcome of events itching around eyes and swelling of eyelids was recovering at time of report  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone swelling, Neck pain
Clinical narrative: Collarbone off to side of neck is swollen; felt like back of neck was sore; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6205, expiration date: 30Jul2021) via intramuscular route, in right arm, on 18Mar2021 10:00 (at the age of 56-years-old), at dose 1, single for covid-19 immunization from clinic through hospital system. Family medical history included mother allergic to iodine dyes for MRI's and CT scans. Concomitant medications included ibuprofen, vitamins. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient experienced felt like back of neck was sore on 18Mar2021, collarbone off to side of neck is swollen on 19Mar2021 08:00. There were no relevant test results. The outcome of the events was not recovered.  Follow-up (31May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: high fever; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable Physician reported for a patient that:  This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced high fever and headache. The outcome of the events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Rash, Urticaria
Clinical narrative: after the second dose of the vaccine, the rashes and welts got bigger; after the second dose of the vaccine, the rashes and welts got bigger; after the second dose of the vaccine, the rashes and welts got bigger; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 06Mar2021 as dose 2, single for covid-19 immunisation. Medical history included Anuric from 2020, allergy to hydrocodone/Tylenol 3. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 13Feb2021 as dose 1, single for covid-19 immunisation and had Whelps, rash, itching, bumps on upper boy near chest and under arm, swelling of ear lobes, mouth, and eyes, pealing of ears, lines on body. concomitant medication included tamsulosin hydrochloride (FLOMAX) taken for prostatic disorder, start and stop date were not reported. The patient experienced after the second dose of the vaccine, the rashes and welts got bigger. Patient trying to eliminate hygiene products because he thought that was the cause of his reaction. He has been using a cream called Larisa for the symptoms. Patient saw his primary HCP about his symptoms and she advised him not to get the vaccine again due to fear that he may have a anaphylactic reaction and want to know would like to know if he should not get the vaccine if it is ever a need to get it again in the future considering his reaction. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Rash papular, Rash pruritic
Clinical narrative: rash above mammary region; it was red, itchy and bumpy; it was red, itchy and bumpy; it was red, itchy and bumpy; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 17Mar2021 15:00 (Batch/Lot Number: EN6204) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA), chlorphenamine maleate (CHLOR) taken for hypersensitivity, start and stop date were not reported. on 17Mar2021 Consumer states she took the Pfizer COVID 19 vaccine yesterday at the (Name), in (Place) at 1500PM and had a reaction. She had a rash above the mammary region; it has subsided, but she is asking how can she provide a sample of the rash to get it tested? or what should she do about it? Mentions she went online to the FDA and completed a report, but she felt really weak doing that without lab tests to back up; to validate it. Mentions she first called in on her cell phone but now she is on her landline and is concerned about long distance charges. Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 17Mar2021 at 1500PM in unspecified site. She noticed the rash that day; it was red, itchy and bumpy. It is improved today. Outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Condition aggravated, Cough, Dyspnoea
Clinical narrative: Full on flu; 101.4 temperature/fever at 99.0; Body ache; Continued sniffing; neck pain; dry chest cough; shortness of breath; shortness of breath; Bad headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN9581 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 16Feb2021 14:15 (at the age of 62-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included some disc issues; had shortness of breath and tightening in throat that had been going on all year with different intensities; had anxiety/panic disorder that came on from shortness of breath after had a cold in Dec2019. Concomitant medications included fish oil; ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin B NOS (MULTIPLE VITAMINS) and herbs all taken for unspecified indication within 2 weeks of vaccination. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL330 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 26Jan2021 14:30 (at the age of 62-year-old), as dose 1, single, for COVID-19 immunisation and experienced dry cough. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The evening after the 2nd shot the patient woke up with a bad headache and chills. By the morning (17Feb2021 02:00), he felt like he had full on flu. The patient had a 101.4 temperature (the patient was in the high 97 range), a really bad head ache also in his neck where he had some disc issues, full on body aches, continued sniffling and dry cough (that started with the initial shot when he received 1st dose). On day two still achy though after taking Tylenol every 4-6 hours his headache was gone and fever at 99.0. On day three (18Feb2021), everything seemed to settle down. Still dry chest cough (could be allergies but started when he received the first shot). The patient undergone both the antibody and swab test that were negative, but he was never having a shortness of breath like this. The patient received Tylenol for the events of headache and fever and did not receive any treatment for the other events. The clinical outcome of the events sniffling, dry cough, headache, chills, fever, body ache and flu like symptoms was recovered with lasting effects.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza, Neck pain, Pain, Pyrexia
Clinical narrative: Full on flu; 101.4 temperature/fever at 99.0; Body ache; Continued sniffing; neck pain; dry chest cough; shortness of breath; shortness of breath; Bad headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN9581 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 16Feb2021 14:15 (at the age of 62-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included some disc issues; had shortness of breath and tightening in throat that had been going on all year with different intensities; had anxiety/panic disorder that came on from shortness of breath after had a cold in Dec2019. Concomitant medications included fish oil; ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin B NOS (MULTIPLE VITAMINS) and herbs all taken for unspecified indication within 2 weeks of vaccination. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL330 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 26Jan2021 14:30 (at the age of 62-year-old), as dose 1, single, for COVID-19 immunisation and experienced dry cough. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The evening after the 2nd shot the patient woke up with a bad headache and chills. By the morning (17Feb2021 02:00), he felt like he had full on flu. The patient had a 101.4 temperature (the patient was in the high 97 range), a really bad head ache also in his neck where he had some disc issues, full on body aches, continued sniffling and dry cough (that started with the initial shot when he received 1st dose). On day two still achy though after taking Tylenol every 4-6 hours his headache was gone and fever at 99.0. On day three (18Feb2021), everything seemed to settle down. Still dry chest cough (could be allergies but started when he received the first shot). The patient undergone both the antibody and swab test that were negative, but he was never having a shortness of breath like this. The patient received Tylenol for the events of headache and fever and did not receive any treatment for the other events. The clinical outcome of the events sniffling, dry cough, headache, chills, fever, body ache and flu like symptoms was recovered with lasting effects.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Full on flu; 101.4 temperature/fever at 99.0; Body ache; Continued sniffing; neck pain; dry chest cough; shortness of breath; shortness of breath; Bad headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN9581 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 16Feb2021 14:15 (at the age of 62-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included some disc issues; had shortness of breath and tightening in throat that had been going on all year with different intensities; had anxiety/panic disorder that came on from shortness of breath after had a cold in Dec2019. Concomitant medications included fish oil; ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin B NOS (MULTIPLE VITAMINS) and herbs all taken for unspecified indication within 2 weeks of vaccination. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL330 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 26Jan2021 14:30 (at the age of 62-year-old), as dose 1, single, for COVID-19 immunisation and experienced dry cough. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The evening after the 2nd shot the patient woke up with a bad headache and chills. By the morning (17Feb2021 02:00), he felt like he had full on flu. The patient had a 101.4 temperature (the patient was in the high 97 range), a really bad head ache also in his neck where he had some disc issues, full on body aches, continued sniffling and dry cough (that started with the initial shot when he received 1st dose). On day two still achy though after taking Tylenol every 4-6 hours his headache was gone and fever at 99.0. On day three (18Feb2021), everything seemed to settle down. Still dry chest cough (could be allergies but started when he received the first shot). The patient undergone both the antibody and swab test that were negative, but he was never having a shortness of breath like this. The patient received Tylenol for the events of headache and fever and did not receive any treatment for the other events. The clinical outcome of the events sniffling, dry cough, headache, chills, fever, body ache and flu like symptoms was recovered with lasting effects.  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Vaccination site erythema
Clinical narrative: Arm got red/Consumer confirmed redness is at site of injection; This is a spontaneous report from a contactable consumer (patient). A 81-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201), via an unspecified route of administration in arm on 06Mar2021 (at the age of 81 years old) as single for covid-19 immunisation. Medical history included patient was very sensitive. When patient got the pneumonia shot, patient also got redness but it run away. The patient's concomitant medications were not reported. The patient previously received pneumonia shot and experienced redness. The patient wanted to say patient got the Pfizer shot a week ago and patient was fine. Patient had no side effect at all. Then on 06Mar2021, Saturday, a week later all of sudden arm got red. Patient don't have any pain. Patient don' t have any side effects. It feels fine but the redness would not go away. The concern was redness would not go away. Patient had no pain. Patient tried to take the temperature at it, it does not have the temperature but just the redness would not go away and the next Saturday, not this week but 27th of March, patient due for another injection and patient don't know whether patient should have it or not. Patient don't know whether this redness doesn't mean anything because patient didn't get any effect when patient first got the shot. Patient don't know what to do? The next day patient had no redness. The first day that patient had the vaccine patient had redness and then the next patient took a Tylenol(treatment) and the next day on 07Mar2021, patient had no reaction at all. Redness and everything were fine. Then on the 13th, the following Saturday from the vaccination arm started to get red. Patient confirmed redness was at site of injection. The patient underwent lab tests and procedures which included body temperature: it does not have the temperature. Therapeutic measures were taken as a result of Arm got red/Consumer confirmed redness is at site of injection with tylenol. The outcome of event was recovered on 07Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 50 year old female patient reported significant rash on her back after receiving vaccine. Rash lasted several days.; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Pfizer sales representative.   A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. On an unspecified date patient experienced significant rash on her back after receiving vaccine and rash lasted several days. The outcome of the event was unknown .   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Lacrimation increased, Rash pruritic, Urticaria
Clinical narrative: Itchy rash/hives on both forearms away from the injection site; Itchy rash/hives on both forearms away from the injection site; Itchy watery eyes; Itchy watery eyes; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration, in the left arm, on 17Mar2021 at 14:00 (at the age of 46-years-old) at dose 1 single dose for COVID-19 immunization. Medical history included asthma. No known allergies were reported for the patient. Concomitant medications included effexor (VENLAFAXINE HYDROCHLORIDE), wellbutrin (BUPROPION HYDROCHLORIDE), lisinopril and plexus (AMBROXOL HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE). The patient did not receive any other vaccines four weeks prior to COVID-19 vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 19Mar2021, the patient had itchy rash, hives on both forearms away from the injection site and had itchy watery eyes. The events did not result in doctor or other healthcare professional office or clinic visit, or emergency room visit. The patient did not receive any treatment for the events. The clinical outcome of the events was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: she is currently experiencing itchy eyes and she said that it looks like its swelling.; she is currently experiencing itchy eyes and she said that it looks like its swelling.; This is a spontaneous report from a Pfizer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 17Mar2021 as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced she is currently experiencing itchy eyes and she said that it looks like its swelling. on an unspecified date. She wanted to know if it is part of the reactions of the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Swelling
Clinical narrative: Swollen neck; Swollen glands or lymph nodes; Discomfort swallowing; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 12Mar2021 12:45 (at the age of 46-year-old), as dose 1, single, for COVID-19 immunisation.Paient was not pregnant at the time of vaccination. Medical history included acid reflux, hypothyroidism, anxiety, blood pressure high, obesity. Concomitant medications included sertraline hydrochloride (ZOLOFT); levothyroxine sodium (SYNTHROID); pantoprazole sodium sesquihydrate (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]); verapamil; triamterene all for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 15Mar2021 at 07:00, the patient experienced swollen neck, swollen glands or lymph nodes, discomfort swallowing, it was not like strep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The outcomes of the events not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Euphoric mood, Fatigue, Headache
Clinical narrative: feverish; chills; throbbing headache; nausea; restlessness; insomnia; tired feeling; Loss of appetite.; felt high immediately afterreceiving the dose; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration in the right arm on 22Mar2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included redundant colon. The patient was allergic to penicillin and erythromycin. The patient did not have any concomitant medications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via unspecified route of administration in the right arm on 01Mar2021 at 08:45 as a single dose for COVID-19 immunization and the patient felt high immediately after receiving the first dose. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 22Mar2021 at 08:15, the patient felt high immediately after receiving the vaccine. On 22Mar2021 at 20:15, the patient experienced feverish, chills, throbbing headache, nausea, restlessness, insomnia, overall tired feeling and loss of appetite. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pyrexia, Restlessness
Clinical narrative: feverish; chills; throbbing headache; nausea; restlessness; insomnia; tired feeling; Loss of appetite.; felt high immediately afterreceiving the dose; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration in the right arm on 22Mar2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included redundant colon. The patient was allergic to penicillin and erythromycin. The patient did not have any concomitant medications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via unspecified route of administration in the right arm on 01Mar2021 at 08:45 as a single dose for COVID-19 immunization and the patient felt high immediately after receiving the first dose. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 22Mar2021 at 08:15, the patient felt high immediately after receiving the vaccine. On 22Mar2021 at 20:15, the patient experienced feverish, chills, throbbing headache, nausea, restlessness, insomnia, overall tired feeling and loss of appetite. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.