chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Flushing, Pyrexia, Vaccination site bruising
Clinical narrative: Bruised painful feeling around injection site; Bruised painful feeling around injection site; Achy joints in bilateral elbows and knees; Low fever or flushed feeling.; Low fever or flushed feeling.; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 25Feb2021 at 19:00 (Lot Number: EN6202, unknown expiration; at the age of 30 years old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications reported as none. No known allergies. No other vaccine in four weeks. On 26Feb2021 at 03:00 am, the patient experienced bruised painful feeling around injection site, achy joints in bilateral elbows and knees, and low fever or flushed feeling. The patient did not receive treatment for the events. No COVID prior to vaccination and has not been tested for COVID post vaccination. The patient recovered from the events in Feb2021.   No follow up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Bruised painful feeling around injection site; Bruised painful feeling around injection site; Achy joints in bilateral elbows and knees; Low fever or flushed feeling.; Low fever or flushed feeling.; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 25Feb2021 at 19:00 (Lot Number: EN6202, unknown expiration; at the age of 30 years old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications reported as none. No known allergies. No other vaccine in four weeks. On 26Feb2021 at 03:00 am, the patient experienced bruised painful feeling around injection site, achy joints in bilateral elbows and knees, and low fever or flushed feeling. The patient did not receive treatment for the events. No COVID prior to vaccination and has not been tested for COVID post vaccination. The patient recovered from the events in Feb2021.   No follow up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Lip blister, Rash, SARS-CoV-2 test, Scab
Clinical narrative: Severe rash; blistering all over body; blistering on lips; scabs; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received first dose of first dose of BNT162B2 (brand=Pfizer), lot number: EL9264, intramuscular in the right arm on 11Feb2021 12:00 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. On 12Feb2021, the patient experienced severe rash with blistering all over body, left scabs and blistering on lips. These resulted in doctor or other healthcare professional office/clinic visit. Treatment included steroid cream. Covid test post vaccination included nasal swab with unknown result. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Morphoea
Clinical narrative: Morphea (confirmed by skin biopsy); This is a spontaneous report from a contactable physician. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on 29Jan2021 (Lot number EL9262) (at the age of 67 years old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination.  It was unknown If other vaccine in four weeks.  Medical history included Raynauds, dermatitis and sulfa allergies. Concomitant medications included MVI (multi-vitamin injection); ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient previously took propylene glycol and experienced allergy.  The patient experienced morphea (confirmed by skin biopsy) on 09Feb2021. Event resulted in doctor or other healthcare professional office/clinic visit. Treatment included Taclonex ointment. It was unknown if patient had COVID prior vaccination and if covid tested post vaccination. The patient received the second dose via an unspecified route of administration on 19Feb2021 (Batch/Lot Number: EN6201). The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 24Feb2021 (at the age of 58-years-old) (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medication included levothyroxine. On 25Feb2021, the patient experienced having little itching on my arm and have like a little rash; little rash on both of my arms. Events were treated with Neosporin cream. The outcome of the events was not recovered/not resolved. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: red rash on my neck shortly after shaving; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 03Mar2021 at 16:45 (at the age of 67-years-old) as dose 1, single for COVID-19 immunisation. Medical history included chronic back pain and obesity from an unknown date. Concomitant medications included fentanyl (DURAGESIC); serotonin; atorvastatin and ezetimibe (EZET), all taken for an unspecified indication, start and stop dates were not reported. On 03Mar2021 at 21:30, the patient developed a red rash on his neck shortly after shaving. He does not normally have evidence of irritation after shaving. There was no treatment received for the event. The outcome of the event was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site papule, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Site of vaccine left upper arm over bicep muscle started being itchy, it was red, raised circular, warm, hard slightly swollen; Site of vaccine left upper arm over bicep muscle started being itchy, it was red, raised circular, warm, hard slightly swollen; Site of vaccine left upper arm over bicep muscle started being itchy, it was red, raised circular, warm, hard slightly swollen; Site of vaccine left upper arm over bicep muscle started being itchy, it was red, raised circular, warm, hard slightly swollen; Site of vaccine left upper arm over bicep muscle started being itchy, it was red, raised circular, warm, hard slightly swollen; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), via an unspecified route of administration, administered in the left arm on 23Feb2021 08:30 (at the age of 42-year-old) as single dose for covid-19 immunisation. Medical history included anemia, jaw trismus, anxiety, migraines, and latex allergy; all from an unspecified date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not have covid prior to vaccination. Concomitant medication included celecoxib (CELEXA [CELECOXIB]). There were no other vaccine in four weeks. On 03Mar2021 at 16:00, the patient experienced at the site of vaccine left upper arm over bicep muscle started being itchy, it was red, raised circular, warm, hard slightly swollen. The patient took unspecified over the counter antihistamine. The patient was not tested for covid post vaccination. The patient had not recovered from all the events at the time of the report.     No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling knot in her arm (in the injection site); swelling knot in her arm (in the injection site); little sore and then she felt the knot in it; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Mar2021 (Lot Number: EN6205, unknown expiration; at the age of 51 years old) as dose 2, single for COVID-19 immunisation. Medical history included diabetes in 2014, blood pressure high, and cholesterol (abnormal). Concomitant medication included unspecified pill for cholesterol. The patient previously received first dose of BNT162B2 (Lot number: EM9809; at the age of 51 years old) on 09Feb2021 for COVID-19 immunisation. The patient received the second dose of the Pfizer COVID-19 vaccine on 02Mar2021 (Tuesday). The patient experienced swelling knot in her arm (in the injection site). For treatment of the swelling knot, the patient did heat yesterday and had iced it when she got home that evening on 02Mar2021. She said it had been a little sore and then she felt the knot in it. Her knot was not bigger than nickel. The patient would like to know if she should just need to keep rubbing an ice on it or something. She is aware that swelling is a reported adverse event associated with the vaccine. She wanted to know if Pfizer has any recommendation on how to manage the swelling and if it would go down on its own. Outcome of the events was unknown.   No follow-up attempts are possible; information about batch number was already obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site pain
Clinical narrative: rash; Hives with bumps fill with fluids in his chest; sore arm (Covid arm); This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm left on 12Feb2021 10:00 (at the age of 43-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient's medical history and concomitant medications were not reported. On 22Feb2021, the patient experienced rash, hives with bumps fill with fluids in his chest, and sore arm (Covid arm). No treatment was received for the reported events. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a rash on chest and back; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, a week after receiving his Covid vaccine, the patient developed a rash on chest and back. He stated he had no other changes in medications, soaps, etc. He was scheduled to get his second shot on 09Mar2021 and wanted to know if he should get the shot. Outcome of rash was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site pain
Clinical narrative: Soreness at the injection site; I had itchiness and redness in the crook of my arm.  The left arm was worse than the right (I got my shot in my left arm); I had itchiness and redness in the crook of my arm.  The left arm was worse than the right (I got my shot in my left arm); This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Feb2021 at 18:45 (Batch/Lot Number: EN6202) (at the age of 66-years-old) as dose 1, single for COVID-19 immunisation. Medical history included osteopenia (the reason why patient took vitamin D and calcium). The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient had no known allergies. Concomitant medications included calcium and vitamin D NOS, taken for osteopenia, start and stop dates were not reported; ibuprofen, taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced itchiness and redness in the crook of her arm, the left arm was worse than the right (she got her shot in her left arm) on 23Feb2021 at 19:30. It disappeared within an hour to 1 1/2 hours. The following day, soreness at the injection site on 24Feb2021. The patient received no treatment for the events. The adverse events resulted to none. The outcome of events itchiness and redness in the crook of her arm was recovered on 23Feb2021; while event soreness at the injection site recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chest discomfort, Fatigue, Painful respiration
Clinical narrative: pressure and ground glass sensation in sternal area when breathing; pressure and ground glass sensation in sternal area when breathing; Joint pain in all major joints inc. metacarpal/metatarsal/phylangeal and interphylangeal joints; extreme fatigue; This is a spontaneous report from a non-contactable physician (Patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Jan2021 10:00 (Batch/Lot number was not reported) (at the age of 42 years) as dose 1, single for covid-19 immunisation. Medical history included drug hypersensitivity (sulfa) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no COVID prior vaccination. The patient experienced pressure and ground glass sensation in sternal area when breathing, joint pain in all major joints inc. metacarpal/metatarsal/phylangeal and interphylangeal joints, extreme fatigue, all on 26Jan2021 with outcome of recovering with no treatment. Events resulted in: Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included covid-19: negative on 05Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Skin disorder
Clinical narrative: With in 48 hrs started to develop rash on temple area of face spread throughout face with swelling and small pumps; With in 48 hrs started to develop rash on temple area of face spread throughout face with swelling and small pumps; With in 48 hrs started to develop rash on temple area of face spread throughout face with swelling and small pumps; very warm to touch and ears were very hot/red and itchy; ears were very hot/red and itchy; ears were very hot/red and itchy/Also developed itchy hives in right wrist area and around both knees.; Also developed itchy hives in right wrist area and around both knees.; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Left Arm on 19Feb2021 11:30 (at the age of 34-years-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient was not pregnant. Concomitant medications were not reported. The patient received first dose of bnt162b2 for covid-19 immunisation on 29Jan2021. There were no other vaccine in four weeks. On 21Feb2021 18:00, within 48 hours, the patient started to develop rash on temple area of face spread throughout face with swelling and small pumps (as reported), it was also very warm to touch and ears were very hot/red and itchy.  Patient also developed itchy hives in right wrist area and around both knees. The patient did not have covid prior vaccination and was not covid tested post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included steroid shot. Outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: With in 48 hrs started to develop rash on temple area of face spread throughout face with swelling and small pumps; With in 48 hrs started to develop rash on temple area of face spread throughout face with swelling and small pumps; With in 48 hrs started to develop rash on temple area of face spread throughout face with swelling and small pumps; very warm to touch and ears were very hot/red and itchy; ears were very hot/red and itchy; ears were very hot/red and itchy/Also developed itchy hives in right wrist area and around both knees.; Also developed itchy hives in right wrist area and around both knees.; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Left Arm on 19Feb2021 11:30 (at the age of 34-years-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient was not pregnant. Concomitant medications were not reported. The patient received first dose of bnt162b2 for covid-19 immunisation on 29Jan2021. There were no other vaccine in four weeks. On 21Feb2021 18:00, within 48 hours, the patient started to develop rash on temple area of face spread throughout face with swelling and small pumps (as reported), it was also very warm to touch and ears were very hot/red and itchy.  Patient also developed itchy hives in right wrist area and around both knees. The patient did not have covid prior vaccination and was not covid tested post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included steroid shot. Outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red Rash on chest and upper stomach; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm right on 02Mar2021 13:15 (at the age of 85-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included stenosis, neuropathy and lupus. Concomitant medications included simvastatin; tamsulosin hydrochloride; acetylsalicylic acid (ASP); all were taken for an unspecified indication, start and stop date were not reported. The patient experienced red rash on chest and upper stomach on 04Mar2021. No treatment was received for the reported event. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: itching; rash and blotchy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (Pfizer-Biotech COVID-19 Vaccine), via an unspecified route of administration on 19Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of the COVID vaccine on 19Feb2021. Three days ago (01Mar2021), she started itching under where you bend your neck and then this progressed bigger and became very itchy and formed into a rash and blotchy. It was on the front of her neck and went down to the upper chest a bit. She would like to know if this is a delayed reaction and if she should receive the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 24Feb2021 at 11:00 am (Lot Number: EL9263, unknown expiration; at the age of 40 years old) as dose 1, single for COVID-19 immunisation.  Medical history included high blood pressure. No known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. No history of COVID prior to vaccination and has not been tested for COVID post vaccination. On 24Feb2021 at 19:30, the patient experienced a pretty nasty bruise on arm. A week later, the patient still has bruise on arm. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the event. The patient has not yet recovered from the event. No follow-up attempts are possible; information about batch number was already obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: First nose bleed ever and it was a big one.; This is a spontaneous report from a contactable male consumer(Patient). This consumer reported similar events for 2 patients. This report is for 1st of 2 patients.   A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 11:00 (at the age of 30-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 for COVID-19 immunisation (Product: COVID 19, brand=Pfizer, Lot unknown: False, Administration date: 29Jan2021, Administration time: 05:00 PM, Vaccine location: Right arm, Dose number: 1). On 26Feb2021 02:00 it was reported the patient experienced First nose bleed ever and it was a big one. The patient did not receive treatment. The outcome of the event was recovered. The patient did not have COVID prior vaccination. The patient was not COVID tested post vaccination.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021260159 Same report/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleed from one nostril; This is a spontaneous report from a contactable consumer (patient) received via the Medical Information Team. A female patient of an unspecified age (reported as patient age: 78; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 04Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a nose bleed from one nostril (non-serious) on 04Mar2021. The patient would like to know if this is a possible side effect of the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy all over her body; 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), via an unspecified route of administration, administered in the left arm, on 03Mar2021 14:30 (Batch/lot number unknown), at age 46 years old, as dose 1, single, for COVID-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. Relevant medical history included diabetes and asthma both from unknown dates, not reported if ongoing or not. The patient has no known allergies. The patient had no COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included unspecified other medication taken in two weeks. The patient did not receive other vaccine in four weeks. On 03Mar2021 14:45, 15 minutes after the vaccination (also reported as "within 10 minutes of getting the vaccine"), the patient was itchy all over her body. Treatment for the event included an unspecified antihistamine. The patient recovered from the event in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 antibody test
Clinical narrative: Unable to breathe/Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 25Feb2021 11:30 (at the age of 53-year-old) as dose 2, single for COVID-19 immunization.  Medical history included mild egg allergy. high blood pressure, and ex-smoker. Concomitant medications included paracetamol (TYLENOL); melatonin; ibuprofen; colecalciferol (VITAMIN D).  The patient had previously received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) administered in left arm on 28Jan2021 11:30 as single dose for COVID-19 immunization. No other vaccine in four weeks. No COVID prior vaccination. On 01Mar2021, the patient was unable to breathe. She experienced Shortness of breath. Went to doctor and ER. Lungs were clear. No infection. They cannot find reason why and said it could be reaction. Can't breathe while walking short distance inside house from room to room. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Nasal Swab in emergency room: negative on 04Mar2021. The patient received no treatment for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021243170 similar report from same reporter
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash over body including waist, arms, legs upper; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Feb2021 16:15 (Batch/Lot Number: EN6202) (at the age of 67 years old) as dose 2, single for COVID-19 immunisation. The patient medical history was none. No known allergies. Concomitant medication included rosuvastatin calcium (CRESTAR) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient took the dose 1 of bnt162b2 on unknown date for COVID-19 immunisation. The patient experienced rash over body including waist, arms, legs upper on 04Mar2021 15:30. Event resulted in Emergency room/department or urgent care. Treatment included prescription for prednisone. No COVID prior vaccination and not COVID tested post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: felt like her elbows were crushed and her elbows hurt so bad that she could barely move them; felt like her elbows were crushed and her elbows hurt so bad that she could barely move them; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After she got the first vaccine, like two days later (on 12Feb2021), it felt like her elbows were crushed and her elbows hurt so bad that she could barely move them. The patient asked if that was a normal side effect and if it will continue because it was really bothersome. She also reported that she received the Pfizer vaccine on 10Feb2021, and had second appointment to get her second dose on 03Mar2021 and wanted to change it to the 08Mar2021 at a different location; she was wondering if that would be a problem. 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm hurt more when I took the bandage off.; This is a spontaneous report from a contactable other hcp (patient). A 57-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 24Dec2020 08:00 (at the age of 57 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Dec2020, the patient experienced arm hurt more when she took the bandage off. No treatment was received for the adverse event. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on an unspecified date in 2021.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Somnolence
Clinical narrative: severe arm pain and shoulder for over a week; severe arm pain and shoulder for over a week; sleeping for 7 days; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 25Feb2021 (Batch/Lot number was not reported) (at the age of 70 years old) as dose 1, single for COVID-19 immunisation in a public health clinic/ veterans administration facility. Medical history included asthma. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aminophylline on an unspecified date and experienced allergies. On 25Feb2021 at 01:00 PM, the patient experienced severe arm pain and shoulder for over a week and was sleeping for 7 days. The patient did not receive any treatment for the events. The patient did not recover from the events on the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness
Clinical narrative: Bruise; Dizziness; This is a spontaneous report from a contactable consumer (patient).     A 84-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in arm right on 24Feb2021 (at the age of 84 years old) as dose 2, single for COVID-19 immunisation. Medical history included, sickness, and believed they had COVID virus, but they were told they had flu. Concomitant medication was not reported. It was reported that the patient takes heart pills and blood pressure pill (two pills a day). The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FL9261) on 26Jan2021 (at the age of 84 years old) as dose 1, single for COVID-19 immunisation. On 24Feb2021, the patient experienced dizziness. On an unspecified date, the patient experienced bruise. There were no prior vaccinations within 4 weeks. The outcome of the dizziness was recovered; outcome for the bruise was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Pain, SARS-CoV-2 test, Sleep disorder
Clinical narrative: severe chest pressure and pain; severe chest pressure and pain; severe chest pressure and pain / it was so bad that I couldn't go back to sleep; physical pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 21Jan2021 (Batch/Lot Number: EK9231) (at the age of 70 years old) as dose 1, 0.3 mL single, COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26Jan2021 (at about 02:00 AM), the patient reported that while sleeping, she had a severe chest pressure and pain which went another way across the chest, right near the clavicle area. The patient reported that it was so bad that she couldn't go back to sleep and it stayed for a quite some time. The patient also has had some other physical pain on an unspecified date in Jan2021. The patient underwent lab tests and procedures on 27Jan2021, at about 10:00 AM, which included a negative COVID test result. The patient has not taken any treatment for the events. The patient was recovering from severe chest pressure and pain which were gradually disappearing on the time of the report. The outcome for the rest of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: itching face and neck; swelling itching welt kind of things; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: ENG198 and Expiration date: 30Jun2021) via an unspecified route of administration, administered on the left arm on 25Feb2021 16:00 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. On an unspecified date in Feb2021, the patient experienced an itching face and neck, a kind of "swelling itching welt kind of things". The patient tried not to touch it and took diphenhydramine hydrochloride (BENADRYL) as a treatment. The patient stated that the reaction was mostly on her neck, and it has gotten a little better, though she still has it. She says she has been drinking a lot of water to flush it out. The outcome of the reported events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm at the age of 78 years old on 26Feb2021 15:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history was not reported. Concomitant medications included simvastatin (SIMVASTATIN), amlodipine (AMLODIPINE), carvedilol (CARVEDILOL), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), and ergocalciferol (VIT D). The patient previously took the first dose of BNT162B2 on 05Feb2021 for covid-19 immunization. On 27Feb2021, about 24 hours after receiving the second vaccine, the patient developed a rash on her feet and about halfway up to my knee but has not appeared on any other part of her body. The patient had no other side effects and the rash does not itch. No treatment was received. The outcome of the event was recovering.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Papule, Pruritus, Rash
Clinical narrative: The patient found about 3 new bumps this morning; rash from head to foot/ rash started on her neck and back.; Itching; going crazy; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm left on 16Feb2021 (at the age of 82-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included allergy to penicillin. There were no concomitant medications. On 26Feb2021, the patient experienced broke out in a rash from head to foot. The patient said that the itching and all has slowed down but she was still breaking out all over her body. The patient found about 3 new bumps this morning (01Mar2021), the rash was quieting down, no itching or nothing. The last few days the rash has quieted down, she was going crazy. The rash started on her neck and back. Right after she received the vaccine she was feeling fine. The patient was reading the paperwork on it she was trying to figure out if she should go get the second shot, but according to the paperwork, if she had a rash she should not get the second dose. The patient mentioned that she called yesterday (28Feb2021) and she got mad and hung up. The outcome of rash and itching was recovering; outcome of going crazy was unknown.    No follow-up attempts are needed: information about lot/batch number cannot be obtained.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: he got a rash on the arm where he had the second injection and he had a rash on his legs as well; This is a spontaneous report from contactable consumer (patient). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the right arm, on 26Feb2021 (Batch/lot number: EN62NZ), at age 84 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history included diabetes and chronic obstructive pulmonary disease (COPD) both from unknown dates, not reported if ongoing or not. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the right arm, on 05Feb2021 13:00 (Batch/lot number: EL342Z), at age 83 years old, as dose 1, single, for COVID-19 immunisation after which the patient experienced rash on legs. The patient did not receive other vaccine in four weeks. After the first dose, he had a rash on his legs. Then after the second dose, on 26Feb2021, he got a rash on the arm where he had the second injection and he had a rash on his legs as well. The patient did not receive treatment for the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Dizziness, Headache, Vaccination site pain
Clinical narrative: Acute extreme dizziness came on 33 hours after the 1st shot. lasted 3 hours; preceded a headache; Injection site hurt for two days; First night my chest felt hot; Neck & back (33 hours) felt hot after my dizzyspel- similar to the shingle burning sensation; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female non-pregnant patient 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 in right arm on 26Feb2021 15:30 as dose 1, single for COVID-19 immunization. Medical history included herpes zoster, had the Shingles Virus 12 years ago and no known allergies. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks or other mediation in two weeks. Patient had no covid prior vaccination and was not covid tested post vaccination. The patient experienced acute extreme dizziness came on 33 hours after the 1st shot lasted 3 hours, preceded a headache, injection site hurt for two days, first night her chest felt hot, neck & back (33 hours) felt hot after her dizzyspel- similar to the shingle burning sensation on 28Feb2021 10:30. AE resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive treatment for the events. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: felt soreness in her arm/shoulder and nothing else; felt soreness in her arm/shoulder and nothing else; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 2, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunisation. On unspecified date, the patient felt soreness in her arm/shoulder and nothing else. The clinical course was reported as follows: Everything went well for the first COVID-19 vaccine, but with the second vaccine, she was not sure if she received it. She felt soreness in her arm and nothing else. She was not very satisfied with the center she received the vaccine at. The person administering the vaccine was very cold, almost hostile. She was concerned if she actually got it. She stated that she has documents on what the responses should be, and she did not receive response as far as the vaccine goes except for her shoulder being sore. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: slight increase in pain in large joints and ankles; slight increase in pain in feet; This is a spontaneous report from a contactable other health professional via a Pfizer-sponsored program. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included tendonitis and pain in fingers relieved with steroid injections. The patient's concomitant medications were not reported. It was reported that patient missed his one dose of medication on the day of COVID vaccine. On an unspecified date, the patient experienced adverse event of slight increase in pain in large joints, ankles, and feet. Therapeutic measures were taken because of slight increase in pain in large joints, ankles, and feet. The outcome of the events was recovered/resolved on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.