chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Heart rate increased, Hot flush
Clinical narrative: nausea; Dry heaves; really bad headache, Headache/pain felt like worst migraine; variable muscle pains; chills; increased heart rate; no appetite.; Head felt hot; This is a spontaneous report from a contactable nurse. This 75 year reported female nurse (patient) reported.  A 75-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiration date: unknown), via unspecified route, administered in left arm on 17Feb2021 (at the age of 75-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 27Jan2021 (at the age of 75-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Hypertension, Hyperparathyroidism, Drug hypersensitivity, Past drug event includes Candesartan induced unspecified reaction and metoprolol induced unspecified reaction. concomitant medications include Paracetamol (TYLENOL) from an unspecified date to unknown ongoing. On 18Feb2021 05:00 AM, after the vaccination, the patient experienced nausea, dry heaves, bad headache, variable muscle pains, chills, head felt hot, increased heart rate from usual 64 to 80 per minute, no appetite. Headache/pain felt like worst migraine ever - couldn't stop groaning. Ice packs on head all day. Woke midnight and headache gone but felt like migraine postdrome next day but by noon was free of all symptoms. The outcome of the events was recovered.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (03Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Retching
Clinical narrative: nausea; Dry heaves; really bad headache, Headache/pain felt like worst migraine; variable muscle pains; chills; increased heart rate; no appetite.; Head felt hot; This is a spontaneous report from a contactable nurse. This 75 year reported female nurse (patient) reported.  A 75-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiration date: unknown), via unspecified route, administered in left arm on 17Feb2021 (at the age of 75-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 27Jan2021 (at the age of 75-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Hypertension, Hyperparathyroidism, Drug hypersensitivity, Past drug event includes Candesartan induced unspecified reaction and metoprolol induced unspecified reaction. concomitant medications include Paracetamol (TYLENOL) from an unspecified date to unknown ongoing. On 18Feb2021 05:00 AM, after the vaccination, the patient experienced nausea, dry heaves, bad headache, variable muscle pains, chills, head felt hot, increased heart rate from usual 64 to 80 per minute, no appetite. Headache/pain felt like worst migraine ever - couldn't stop groaning. Ice packs on head all day. Woke midnight and headache gone but felt like migraine postdrome next day but by noon was free of all symptoms. The outcome of the events was recovered.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (03Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomited x 1 6 hours after vaccine administrationDiarrhea x 1 - 6 hours after vaccine administration; Diarrhea x 1 - 6 hours after vaccine administration; This is a spontaneous report from a contactable other hcp. A 35-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6203), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 19:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ 10) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; vitamin b2 [riboflavin] (VITAMIN B2 [RIBOFLAVIN]) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 for covid-19 immunisation, amoxicillin and experienced drug hypersensitivity, aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, ibuprofen and experienced drug hypersensitivity. The patient experienced vomited x 1 6 hours after vaccine administration diarrhea x 1 - 6 hours after vaccine administration on 19Feb2021 01:30, diarrhea x 1 - 6 hours after vaccine administration. The outcome of the events were recovered. Follow-up (20May2021): Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph Node under left axillary swelled to size of baseball approximately 24 hours after injection.; This is a spontaneous report from a contactable other HCP. A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3248), dose 2 intramuscular, administered in Arm Left on 23Jan2021 (at the age of 34 year) as dose 2, single for COVID-19 immunisation at clinic. Patient had known allergies. No covid prior vaccination. No covid tested post vaccination. No If other vaccine in four weeks. Patient received other medications in two weeks. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 02Jan2021 (at the age of 34 year) for COVID-19 immunisation at clinic. On 24Jan2021, patient experienced Lymph Node under left axillary swelled to size of baseball approximately 24 hours after injection. It was reported that no therapeutic measures were taken for the events experienced. The outcome of event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Vaccination site discomfort
Clinical narrative: Mild discomfort at injection site; mild fatigue; mild muscular pain; lymphadenopathy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN62B1) via an unspecified route of administration in left arm on 21Feb2021 at 09:00 (at the age of 58-year-old) as single dose for COVID-19 immunization at Hospital. Medical history of the patient was not reported. Patient had no known allergies. Concomitant/other medications in two weeks included Atenolol 25mg once daily, Pravastatin 20mg once daily both taken for unspecified indications. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. On 22Feb2021 at 01:00, patient experienced mild discomfort at injection site, mild fatigue, mild muscular pain, lymphadenopathy. Patient did not receive any treatment for adverse events. Outcome of the events were resolved on an unspecified date in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: sore arm at the injection site; very vague / mild headache; This is a spontaneous report from a contactable other hcp (patient). A 75-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 31Jan2021 10:15 (at the age of 75-year-old) as dose 1, single for covid-19 immunisation.  Medical history included arteriosclerosis from an unknown date and unknown if ongoing. Patient was allergic to penicillin, cephalosporin. Concomitant medications included atorvastatin calcium taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; vitamin d3 taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced sore arm at the injection site, very vague / mild headache. No treatment was taken as a result of events. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Mild Pain And Itching At Injection Site; Mild Pain And Itching At Injection Site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Jan2021 17:30 (at the age of 66-year-old) as dose 1, single for covid-19 immunisation. Medical history included high blood pressure, Pre diabetes, High cholesterol. Patient did not have any known allergies. Concomitant medication(s) included amlodipine besilate, olmesartan medoxomil (AMLODIPINE AND OLMESARTAN MEDOXOMIL) taken for an unspecified indication, start and stop date were not reported; metformin 500 mg taken for an unspecified indication, start and stop date were not reported; famotidine taken for an unspecified indication, start and stop date were not reported. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient experienced mild pain and itching at injection site on 31Jan2021 21:00. Patient did not receive treatment for adverse events. The outcome of mild pain and itching at injection site was recovered on an unspecified date of 2021.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: my arm was sore and red; I had a slight headache after the first vaccine, which resolved quickly; This is a spontaneous report received from a contactable consumer or other non hcp. A 67-years-old male patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 29Jan2021,at the age of 67 years old, as Dose 1,single for covid-19 immunization.Medical history included cardiovascular disorder, asthma, hypertension and drug hypersensitivity from an unknown date and unknown if ongoing.Concomitant medication(s) included metoprolol; rosuvastatin,tamsulosin and acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication,start and stop date were not reported.The patient experienced my arm was sore and red on an unspecified date, he had a slight headache after the first vaccine, which resolved quickly on an unspecified date.The patient received his 2nd dose of Pfizer covid19 vaccine on 19 feb2021,11:15 am.The patient had not received any other vaccine in 4 weeks.The patient was not diagnosed with covid prior to vaccination and not tested post vaccination.The patient had not received any treatment for the event.The outcome of the event was recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pruritus
Clinical narrative: headache; Pain; Itching at Injection Site; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 17:30 (Batch/Lot number was not reported) as dose 2, single (age at vaccination 68-year-old) for covid-19 immunisation. Medical history included diabetes mellitus and High cholesterol from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 30Jan2021, administration site (Left arm), administered at 05:45 PM (age at vaccination 68-year-old) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 21Feb2021 06:00, the patient experienced headache, pain, itching at injection site (vaccination site pruritus). Therapeutic measures were taken as a result of events includes TYLENOL. The outcome for all events was recovering.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 83-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number 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 experienced he got a little tired after the 2nd dose on an unspecified date. Therapeutic measures were taken as a result of he got a little tired after the 2nd dose was Tylenol. The outcome of the event fatigue was recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: Brain fog; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in Arm Left on 22Feb2021 13:30 as dose 1, single for COVID-19 immunisation (Age at vaccination was 31 years). The patient medical history was none and no known allergies. The patient concomitant medications were not reported. It was reported that, she did not receive any other vaccine in four weeks and no other medications in two weeks prior COVID vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. She was not a pregnant at the time of vaccination. On 22Feb2021 14:00, the patient experienced brain fog, headache, and fatigue. No therapeutic measures were taken as a result of events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient's mother). This is 2nd of 2 reports.  A female patient of an unspecified age received 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 single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm. The patient recovered from the event on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Limb discomfort
Clinical narrative: fatigue; chills; headache; very heavy/dead legs; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue, chills, headache, and very heavy/dead legs. The outcome for all the events was unknown.  Information about lot/ batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering
Clinical narrative: she had a large blister in her mouth; This is a spontaneous report from a Pfizer-sponsored program SUPPORT. A contactable consumer (Mother) reported for a female consumer (Daughter).   A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 19Feb2021 as single dose for COVID-19 immunization. Medical history, concomitant medications of the patient were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date in Feb2021, patient had a large blister in her mouth. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Musculoskeletal discomfort, Pain assessment, Sluggishness
Clinical narrative: Pain (7/10) in his arm (presumably at the injection site); Discomfort on the left side of his neck; Headache; Overall feeling sluggish; Chills; This is a spontaneous report from contactable consumer (patient) via Pfizer Sales Representative. A male patient of age 45 (Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Pain (7/10) in his arm (presumably at the injection site), Discomfort on the left side of his neck, Headache, Overall feeling sluggish and Chills (although unsure whether that is due to his house being kept cool). The patient underwent lab tests and procedures which included Pain (pain assessment): 7/10 on an unspecified date. The outcome of events was unknown.  Information about lot/ batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain (7/10) in his arm (presumably at the injection site); Discomfort on the left side of his neck; Headache; Overall feeling sluggish; Chills; This is a spontaneous report from contactable consumer (patient) via Pfizer Sales Representative. A male patient of age 45 (Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Pain (7/10) in his arm (presumably at the injection site), Discomfort on the left side of his neck, Headache, Overall feeling sluggish and Chills (although unsure whether that is due to his house being kept cool). The patient underwent lab tests and procedures which included Pain (pain assessment): 7/10 on an unspecified date. The outcome of events was unknown.  Information about lot/ batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: his son's arm will be swollen; This is a spontaneous report from a contactable consumer (parent) from a Pfizer-sponsored program. A male patient of age 16 (unit reported as unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), second dose 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 experienced arm was swollen on an unspecified date. Reporter wanted to know how many days that his son's arm will be swollen, because every day the pain was increasing. Clinical outcome of event was unknown.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Headache, Weight decreased
Clinical narrative: Headache; Dizziness; This is a spontaneous case from a contactable consumer or other non-health professional. A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EH9899), via Intramuscular route of administration, administrated in left arm on an unspecified date (age at the time of vaccination 68-years-old), as a single dose for COVID-19 immunization. The patient medical history included I am border line diabetic, High blood pressure taken medication for that, Overweight, heart condition, and lost my sense of smell 10 years ago. The patient concomitant medications included LISINOPRIL as 10mg a day, ROSUVASTATIN as 5mg, and Vitamins. On an unspecified date, the patient experienced Headache, and Dizziness. On an unspecified date, the patient underwent lab tests and procedures which included Blood test: unknown; and Weight decreased: 60lbs, I have lost 60 pounds in the last 10 years. Patient took an Ibuprofen for the treatment of adverse events. The outcome for all the events was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Swollen glands in neck; Headache; This is a spontaneous report from a contactable Consumer. This 75-year-old Female consumer (patient) reported that.  A 75-years-old female patient received 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 (At the age of 75-years) dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swollen glands in neck, and headache on an unspecified date. Consumer stated, she just wanted to check on some reactions she had his shot, second shot yesterday at about 1 o'clock and she was 75 years old. she had some swollen glands in his neck and some headache. Is that normal. Product details and further details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done and limited information available over the call. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Malaise, Nausea, Pain
Clinical narrative: Feeling sick; Diarrhea; Nauseated; Threw up; Aches and hurt all over; Feeling miserable; This is a spontaneous report from a contactable consumer or other non health care professional. A female patient (wife) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 20Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, reporter was calling for his wife, she is the one who got the shot yesterday and she is not feeling (incomplete sentence). She got the shot yesterday about 2 o'clock here in (withheld) at the health department and she is feeling sick this morning (21Feb2021), she had diarrhea, nauseated and she threw up and just aches and hurt all over and just feels miserable, he want to know is this something she is going to experience very long. He want to know if we need to seek professional help from the hospital or somewhere. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Feeling sick; Diarrhea; Nauseated; Threw up; Aches and hurt all over; Feeling miserable; This is a spontaneous report from a contactable consumer or other non health care professional. A female patient (wife) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 20Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, reporter was calling for his wife, she is the one who got the shot yesterday and she is not feeling (incomplete sentence). She got the shot yesterday about 2 o'clock here in (withheld) at the health department and she is feeling sick this morning (21Feb2021), she had diarrhea, nauseated and she threw up and just aches and hurt all over and just feels miserable, he want to know is this something she is going to experience very long. He want to know if we need to seek professional help from the hospital or somewhere. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 92 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 20Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced diarrhoea on an unspecified date with outcome of unknown.    Information of lot and batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: super tired; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 20Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on 20Feb2021, the patient experienced super tired. It was reported that the 2nd dose was scheduled earlier (03Mar2021) than 21 days. Outcome of the event was unknown. Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: red rash at injection site; This is a spontaneous report from a contactable Consumer. This 35-year-old female consumer (patient) reported. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Right on 13Feb2021 12:00 (at the age of 35-years-old) as a single dose for covid-19 immunization. Medical history included hypothyroidism, dermatitis contact, food allergy. Concomitant medication(s) in two weeks included levothyroxine. The patient had allergies shellfish, adhesive. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Feb2021 16:45, the patient experienced red rash at injection site 8 days after receiving vaccine "COVID Arm". The patient did not receive any treatment. Outcome of the event was unknown, at the time of this report. Information on the batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site bruising
Clinical narrative: big bruise appeared below the injection site; This is a spontaneous report from a contactable other health professional (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the right arm, on 29Jan2021 (Batch/lot number: EL8982), at age 62 years old, as dose 2, single, for COVID-19 immunisation, at a hospital. The patient was not pregnant at the time of vaccination. Relevant medical history included high cholesterol (above 200) and known allergies to earlier generations of penicillins both from unknown dates, not reported if ongoing or not. The patient did not have COVID-19 prior to the vaccination. There were no concomitant medications in two weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the left arm, on 04Jan2021 (Batch/lot number: Ek92310), at age 62 years old, as dose 1, single, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 05Feb2021 (also reported as 7-8 days after the second dose), a big bruise appeared below the injection site. The patient did not feel any pain. She just noticed it on her arm. The patient did not receive treatment for the event. The patient was tested for COVID-19 post vaccination thru PCR nasal swab on 25Feb2021 and was negative. The patient recovered from the events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle tightness, Myalgia, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 44-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL3248), via an unspecified route of administration, on Mar 8, 2021, at 12:45 pm, left arm, single dose, for COVID-19 immunization. The patient medical history and concomitant medications not reported. Other vaccine administered in four weeks: unknown. Patient has no known allergies. Other medications administered in two weeks: unknown. It was unknown if prior to vaccination patient was diagnosed with COVID-19. Since the vaccination, patient has tested for COVID-19. On Mar 9, 2021, patient experienced sore arm, muscle tightness/aches, nausea, headache, chills, fever and heart palpitations. Therapeutic measures taken included Tylenol and ibuprofen. The outcome of events recovered. No follow-up attempts possible. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 44-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL3248), via an unspecified route of administration, on Mar 8, 2021, at 12:45 pm, left arm, single dose, for COVID-19 immunization. The patient medical history and concomitant medications not reported. Other vaccine administered in four weeks: unknown. Patient has no known allergies. Other medications administered in two weeks: unknown. It was unknown if prior to vaccination patient was diagnosed with COVID-19. Since the vaccination, patient has tested for COVID-19. On Mar 9, 2021, patient experienced sore arm, muscle tightness/aches, nausea, headache, chills, fever and heart palpitations. Therapeutic measures taken included Tylenol and ibuprofen. The outcome of events recovered. No follow-up attempts possible. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Fatigue, Headache, Limb discomfort
Clinical narrative: tiredness; weakness; headache; her arm blew up; she got terrible itching all over her body; I had my arm blew up very badly; swollen arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3302, Expiry date: Unknown, NDC and UPC number: Unknown) dose 1 via an unspecified route of administration on 07Mar2021 (at the age of 74-years-ago) as dose 1, single for COVID-19 immunisation. Medical history included Diabetic type 1, Kidney transplant. Concomitant medication(s) included insulin and immunosuppressants medication. On Mar2021 the patient experienced tiredness, weakness, headache, her arm blew up, she got terrible itching all over her body, I had my arm blew up very badly, swollen arm. It was reported that patient got the First Pfizer Covid vaccine and she had tiredness and weakness, she had a headache, her arm blew up and she had terrible itching all over her body, which went away and now has come back and she had her first vaccine on Sunday (07Mar2021) she had not had the second obviously. "When paraphrased the above concern, Consumer stated, "Right, my main reason for call was to find out if I could have the second one." consumer stated, "I told all of them to the lady , you repeating them that's it, didn't the lady told you who I was speaking to I think she repeated all the things I had my arm blew up very badly, swollen arm." Yeah I have to keep taking blood tests for my kidney. The patient underwent lab tests and procedures which included blood test unknown results on an unknown date for kidney. Patient stated that I called doctor and he said to put ice on my arm so put an Ice pack on as treatment. Patient stated that I called doctor and he said to put ice on my arm so put an Ice pack on as treatment. The clinical outcome of the events tiredness, weakness, headache, her arm blew up, I had my arm blew up very badly; swollen arm was reported as unknown, and she got terrible itching all over her body was reported as recovered with sequelae.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: tiredness; weakness; headache; her arm blew up; she got terrible itching all over her body; I had my arm blew up very badly; swollen arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3302, Expiry date: Unknown, NDC and UPC number: Unknown) dose 1 via an unspecified route of administration on 07Mar2021 (at the age of 74-years-ago) as dose 1, single for COVID-19 immunisation. Medical history included Diabetic type 1, Kidney transplant. Concomitant medication(s) included insulin and immunosuppressants medication. On Mar2021 the patient experienced tiredness, weakness, headache, her arm blew up, she got terrible itching all over her body, I had my arm blew up very badly, swollen arm. It was reported that patient got the First Pfizer Covid vaccine and she had tiredness and weakness, she had a headache, her arm blew up and she had terrible itching all over her body, which went away and now has come back and she had her first vaccine on Sunday (07Mar2021) she had not had the second obviously. "When paraphrased the above concern, Consumer stated, "Right, my main reason for call was to find out if I could have the second one." consumer stated, "I told all of them to the lady , you repeating them that's it, didn't the lady told you who I was speaking to I think she repeated all the things I had my arm blew up very badly, swollen arm." Yeah I have to keep taking blood tests for my kidney. The patient underwent lab tests and procedures which included blood test unknown results on an unknown date for kidney. Patient stated that I called doctor and he said to put ice on my arm so put an Ice pack on as treatment. Patient stated that I called doctor and he said to put ice on my arm so put an Ice pack on as treatment. The clinical outcome of the events tiredness, weakness, headache, her arm blew up, I had my arm blew up very badly; swollen arm was reported as unknown, and she got terrible itching all over her body was reported as recovered with sequelae.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Influenza like illness, Rash pruritic
Clinical narrative: rash all over her body/itchy rash all over her; feeling flu-ish; joint pain/sore and joint issues; fatigue/tired; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EL9266 and Expiration date: May2021) via unknown route of administration, administered in left arm on 02Mar2021 as dose 1, single (age at vaccination 66-year-old) for COVID-19 immunisation. Patient medical history included seasonal allergies (since child) from an unknown date and unknown if ongoing. Patient received no concomitant medications. On 03Mar2021, patient experienced a rash all over her body/ itchy rash all over, joint pain/sore and joint issues, feeling flu-ish/ feeling like she had the flu, and fatigue/tired. Patient stated that she had shoulder surgery on 19Mar2021, and the second dose was scheduled for 30Mar2021. Patient wanted to know what to do about the second dose of the vaccine. Patient mentioned that she might take prednisone to treat her rash. The outcome of feeling flu-ish was unknown and not recovered for rest of the events.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Discomfort
Clinical narrative: swollen left arm; was tired, felt fatigue; I felt weak, unbalanced; sore throat; sneezing; chills; I had trouble walking; I didn't have an appetite; stuffed nose; dizzy; coughing; body discomfort; malaise; his voice changed, it sounds a little lower; his throat is stuffy; he has a cold now but he does not really have a cold; This is a spontaneous report from a contactable consumer or other non hcp.    A 79-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 07Mar2021 15:09 (Batch/Lot Number: EN6205) as 2nd dose, single for covid-19 immunisation. Medical history included glaucoma, he is 79 years old and he was diagnosed with that when he was 15, He has high blood pressure and that is under control, he is on one medication for high blood pressure. Caller reported that had a swollen left arm where got the vaccine and then no symptoms on Monday and then yesterday I was shopping and felt like I can't stand up anymore. I was tired, felt fatigue coming on me. I sleep normally and don't get tired in the middle of the day. At 3-4:00 in the afternoon I felt weak, unbalanced, sore throat, sneezing, chills. I still have sore throat now. I had trouble walking. I laid down when I got home and knocked out right away. I didn't have an appetite. I forced myself to eat because I know I have to eat. I had a stuffed nose like a regular head cold , Caller is calling about the Vaccine second dose. He has his card in front of him. He confirms the Pfizer COVID 19 vaccine. He got the vaccine in (city withheld) City on Sunday at about 2:30PM and now it is about 1:30, Monday Tuesday Wednesday. This started on Tuesday afternoon about 24 hours after the vaccine, initially he only felt like his arm was swollen, he didn't have any bodily effect until Tuesday which was about 24 hours later, he started having sore throat, feeling weak, fatigue, dizzy, and coughing and sneezing, general body fatigue. That was all yesterday which was about 24 hours after the shot and today is the third day today he still has a sore throat, fatigue, loss of appetite, body discomfort, dizziness. What he is calling about is he teaches online from his home, so he is normally on a computer but he has this vague feeling of discomfort in terms of concentration and he wants to know when can he expect this feeling to go away. The outcome of the events was unknown on 09Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysphonia, Fatigue, Gait disturbance, Malaise
Clinical narrative: swollen left arm; was tired, felt fatigue; I felt weak, unbalanced; sore throat; sneezing; chills; I had trouble walking; I didn't have an appetite; stuffed nose; dizzy; coughing; body discomfort; malaise; his voice changed, it sounds a little lower; his throat is stuffy; he has a cold now but he does not really have a cold; This is a spontaneous report from a contactable consumer or other non hcp.    A 79-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 07Mar2021 15:09 (Batch/Lot Number: EN6205) as 2nd dose, single for covid-19 immunisation. Medical history included glaucoma, he is 79 years old and he was diagnosed with that when he was 15, He has high blood pressure and that is under control, he is on one medication for high blood pressure. Caller reported that had a swollen left arm where got the vaccine and then no symptoms on Monday and then yesterday I was shopping and felt like I can't stand up anymore. I was tired, felt fatigue coming on me. I sleep normally and don't get tired in the middle of the day. At 3-4:00 in the afternoon I felt weak, unbalanced, sore throat, sneezing, chills. I still have sore throat now. I had trouble walking. I laid down when I got home and knocked out right away. I didn't have an appetite. I forced myself to eat because I know I have to eat. I had a stuffed nose like a regular head cold , Caller is calling about the Vaccine second dose. He has his card in front of him. He confirms the Pfizer COVID 19 vaccine. He got the vaccine in (city withheld) City on Sunday at about 2:30PM and now it is about 1:30, Monday Tuesday Wednesday. This started on Tuesday afternoon about 24 hours after the vaccine, initially he only felt like his arm was swollen, he didn't have any bodily effect until Tuesday which was about 24 hours later, he started having sore throat, feeling weak, fatigue, dizzy, and coughing and sneezing, general body fatigue. That was all yesterday which was about 24 hours after the shot and today is the third day today he still has a sore throat, fatigue, loss of appetite, body discomfort, dizziness. What he is calling about is he teaches online from his home, so he is normally on a computer but he has this vague feeling of discomfort in terms of concentration and he wants to know when can he expect this feeling to go away. The outcome of the events was unknown on 09Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Peripheral swelling, Sneezing
Clinical narrative: swollen left arm; was tired, felt fatigue; I felt weak, unbalanced; sore throat; sneezing; chills; I had trouble walking; I didn't have an appetite; stuffed nose; dizzy; coughing; body discomfort; malaise; his voice changed, it sounds a little lower; his throat is stuffy; he has a cold now but he does not really have a cold; This is a spontaneous report from a contactable consumer or other non hcp.    A 79-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 07Mar2021 15:09 (Batch/Lot Number: EN6205) as 2nd dose, single for covid-19 immunisation. Medical history included glaucoma, he is 79 years old and he was diagnosed with that when he was 15, He has high blood pressure and that is under control, he is on one medication for high blood pressure. Caller reported that had a swollen left arm where got the vaccine and then no symptoms on Monday and then yesterday I was shopping and felt like I can't stand up anymore. I was tired, felt fatigue coming on me. I sleep normally and don't get tired in the middle of the day. At 3-4:00 in the afternoon I felt weak, unbalanced, sore throat, sneezing, chills. I still have sore throat now. I had trouble walking. I laid down when I got home and knocked out right away. I didn't have an appetite. I forced myself to eat because I know I have to eat. I had a stuffed nose like a regular head cold , Caller is calling about the Vaccine second dose. He has his card in front of him. He confirms the Pfizer COVID 19 vaccine. He got the vaccine in (city withheld) City on Sunday at about 2:30PM and now it is about 1:30, Monday Tuesday Wednesday. This started on Tuesday afternoon about 24 hours after the vaccine, initially he only felt like his arm was swollen, he didn't have any bodily effect until Tuesday which was about 24 hours later, he started having sore throat, feeling weak, fatigue, dizzy, and coughing and sneezing, general body fatigue. That was all yesterday which was about 24 hours after the shot and today is the third day today he still has a sore throat, fatigue, loss of appetite, body discomfort, dizziness. What he is calling about is he teaches online from his home, so he is normally on a computer but he has this vague feeling of discomfort in terms of concentration and he wants to know when can he expect this feeling to go away. The outcome of the events was unknown on 09Mar2021.  No follow-up attempts are possible. No further information is expected.