chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Chills, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 07Feb2021 as SINGLE DOSE for Covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. Patient got the vaccine, the first one, she got the shot on Sunday night and had the chills and the join ache, just little time and thing like that. Now in the last about a day she feel like she loosing a little bit of taste and smell. 07Feb and about a day later she started experiencing the joint pain and she does not feel great in general. That's how she described it feeling unwell, but she said it's not enough that she cannot deal with that. On Feb2021 the patient experienced joint pain, joint ache, i don't feel great/i don't feel real good/does not feel great in general, i had the chills, i started to lose a little bit of my taste and smell/i am loosing a little bit of taste and smell/started to lose a little bit of her taste and smell; taste is different. Therapeutic measures were taken as a result of joint pain ,joint ache , i don't feel great/i don't feel real good/does not feel great in general , i had the chills , i started to lose a little bit of my taste and smell/i am loosing a little bit of taste and smell/started to lose a little bit of her taste and smell; taste is different, i started to lose a little bit of my taste and smell/i am loosing a little bit of taste and smell/started to lose a little bit of her taste and smell; taste is different,. Treatment included Last night she took some Ibuprofen. The outcome of events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Muscle Ache on injection site; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 47-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an intramuscular route of administration, administered in Arm Left on 19Jan2021 16:00 (at the age of 47-years-old) as dose 1, single for COVID-19 immunisation. Medical history included uterine leiomyoma from 03Oct2013 to 03Nov2013 (myomectomy Nov2013), gallbladder disorder from 03Jan2001 to 03Feb2001 (gallbladder removed Feb2001), uterine leiomyoma from 03Mar2018 to Dec2018 (myomectomy Dec2018), myomectomy from Nov2013 to an unknown date, myomectomy from Dec2018 to an unknown date, diabetes mellitus (grandparent- diabetes) and pancreatic carcinoma from an unknown date and unknown if ongoing (father-pancreatic cancer). The patient concomitant medications were not reported. Patient received vaccine facility in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810) , via an intramuscular route of administration, administered in Arm Left on 09Feb2021 16:00 as dose 1, single for COVID-19 immunisation and experienced muscle aches, headache, sore throat, chills, low grade fever and fatigue on 10Feb2021. Short term side effects after seconds dose, Less than 24 hours. The patient experienced muscle ache on injection site on Jan2021. No treatment was received for the events. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Investigation, Pain, Pyrexia
Clinical narrative: headache; low grade fever; sweats; body aches; hive like rash on both arms in the crevices of my elbow; hive like rash on both arms in the crevices of my elbow; This is a spontaneous report from a contactable Other HCP. This 38-year-old female Other HCP (Patient) reported that:  A 38-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 04Feb2021 13:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Hypothyroid/hoshimotos, rheumatoid arthritis, asthma, seasonal allergies, IBS, Known allergies: Penicillin. Concomitant medication(s) included ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) taken for an unspecified indication, from unknown start date; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, from unknown start date; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, from unknown start date, in two weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered in Arm Left on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient previously took amoxicillin and experienced drug hypersensitivity. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. No prior to vaccination. The patient was not tested for COVID-19. On 06Feb2021 23:00, the patient experienced headache, low grade fever, sweats, body aches, hive like rash on both arms in the crevices of my elbow. About 55 hours after receiving vaccination and feeling better from the normal side effects.The patient underwent lab tests and procedures which included investigation: low grade on an unspecified date. No treatment received for the events. The clinical outcome of events were recovered on unspecified date on 2021.  Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: headache; low grade fever; sweats; body aches; hive like rash on both arms in the crevices of my elbow; hive like rash on both arms in the crevices of my elbow; This is a spontaneous report from a contactable Other HCP. This 38-year-old female Other HCP (Patient) reported that:  A 38-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 04Feb2021 13:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Hypothyroid/hoshimotos, rheumatoid arthritis, asthma, seasonal allergies, IBS, Known allergies: Penicillin. Concomitant medication(s) included ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) taken for an unspecified indication, from unknown start date; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, from unknown start date; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, from unknown start date, in two weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered in Arm Left on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient previously took amoxicillin and experienced drug hypersensitivity. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. No prior to vaccination. The patient was not tested for COVID-19. On 06Feb2021 23:00, the patient experienced headache, low grade fever, sweats, body aches, hive like rash on both arms in the crevices of my elbow. About 55 hours after receiving vaccination and feeling better from the normal side effects.The patient underwent lab tests and procedures which included investigation: low grade on an unspecified date. No treatment received for the events. The clinical outcome of events were recovered on unspecified date on 2021.  Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Nausea
Clinical narrative: received the second and final dose of the Pfizer BioNTech vaccine on 09Feb/receive the first dose of the Pfizer BioNTech vaccine on 17Jan2021; fever; body aches; chills; severe nausea; even vomited a few times; overall weakness and fatigue; overall weakness and fatigue; This is a spontaneous report from a contactable Consumer. This 29-year-old female consumer reported for herself. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EK9231) via an unspecified route of administration in arm Left on 09Feb2021 18:30 as dose 2, single (age at vaccination: 29 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EL9261) via intramuscularly in arm Left on 17Jan2021 18:30 as dose 1, single (age at vaccination: 29 years) for COVID-19 immunisation. No other vaccines given the same day and no problems with vaccines in past. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. On 10Feb2021, the patient experienced fever, other symptoms associated with after the vaccine were body aches, chills, severe nausea, even vomited a few times, overall weakness and fatigue and this was reported as worsened. The patient received vaccine doses, reported post vaccination experience with DSU. On 11Feb2021, stated that she was out of work today for fever. It was queried that will the vaccine cause a false positive on covid-19 rapid test. Her workplace is wanting her to get a rapid Covid test to rule that out and to clear her to go back to work. Wants to see if it's okay for her to that testing or if she can pretty much go back once the symptoms subside. Fever started yesterday evening around 6:30-7:00. The patient underwent lab tests and procedures which included fever resulted as 100-101.4 on 10Feb2021 hovering about 100-101.4 even this morning. It's been hovering over the 100's. The clinical outcome of the events received was not resolved and the event received the second and final dose of the Pfizer BioNTech vaccine on 09Feb/receive the first dose of the Pfizer BioNTech vaccine on 17Jan2021 was unknown.  Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: received the second and final dose of the Pfizer BioNTech vaccine on 09Feb/receive the first dose of the Pfizer BioNTech vaccine on 17Jan2021; fever; body aches; chills; severe nausea; even vomited a few times; overall weakness and fatigue; overall weakness and fatigue; This is a spontaneous report from a contactable Consumer. This 29-year-old female consumer reported for herself. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EK9231) via an unspecified route of administration in arm Left on 09Feb2021 18:30 as dose 2, single (age at vaccination: 29 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EL9261) via intramuscularly in arm Left on 17Jan2021 18:30 as dose 1, single (age at vaccination: 29 years) for COVID-19 immunisation. No other vaccines given the same day and no problems with vaccines in past. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. On 10Feb2021, the patient experienced fever, other symptoms associated with after the vaccine were body aches, chills, severe nausea, even vomited a few times, overall weakness and fatigue and this was reported as worsened. The patient received vaccine doses, reported post vaccination experience with DSU. On 11Feb2021, stated that she was out of work today for fever. It was queried that will the vaccine cause a false positive on covid-19 rapid test. Her workplace is wanting her to get a rapid Covid test to rule that out and to clear her to go back to work. Wants to see if it's okay for her to that testing or if she can pretty much go back once the symptoms subside. Fever started yesterday evening around 6:30-7:00. The patient underwent lab tests and procedures which included fever resulted as 100-101.4 on 10Feb2021 hovering about 100-101.4 even this morning. It's been hovering over the 100's. The clinical outcome of the events received was not resolved and the event received the second and final dose of the Pfizer BioNTech vaccine on 09Feb/receive the first dose of the Pfizer BioNTech vaccine on 17Jan2021 was unknown.  Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: drowsy; sore arm; abdominal pain; fever; chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 29-years-old female patient received bnt162b2 (BNT162B2, Pfizer Covid-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 13:00 (Batch/Lot Number: EH5318, Expiry date was not reported) (at the age of 29-years-old) as DOSE 1, SINGLE for covid-19 immunization at hospital. Medical history included asthma. There were no known allergies. Concomitant medications included senna alexandrina leaf (BLACK FOREST HERBAL TEA, Herbal Tea for fertility), start and stop dates were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine. The patient did not have covid prior to vaccination and has not been tested for covid since vaccination. On an unspecified date, the patient experienced drowsy, sore arm, abdominal pain, fever and chills. It was reported as the day the patient got the vaccine, she was drowsy and had a sore arm until Sunday. She was fine until Tuesday and started having abdominal pain and fever/chills. The clinical outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: rash at the site of the injection that has not increased or decreased in size, it's the size of my palm; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female 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 on 02Feb2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash at the site of the injection that has not increased or decreased in size, it's the size of her palm on an unspecified date. Patient was asking if her symptom following administration of the second dose of the covid vaccine was normal and asking what she should do about it. Seriousness was reported as non-serious. The outcome of the event was unknown.  Information about lot/batch has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (husband) or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 30Jan2021 as DOSE 1, SINGLE for covid-19 immunisation (Age: 70; Unit: Unknown). The patient medical history and concomitant medications were not reported. The patient experienced diarrhea on 04Feb2021. Therapeutic measures were taken as a result of diarrhea (still trying to treat the diarrhea). Caller states that the patient is supposed to receive the second dose on 20Feb. Caller asked if the patient can receive the second dose safely or if they should hold off on the second dose. Outcome of the event was unknown.  Information about lot/batch has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Malaise
Clinical narrative: nosebleed; headache; malaise; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 78 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 15:45 (Batch/Lot Number: EL3302) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing , rheumatoid arthritis from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , hyperlipidaemia from an unknown date and unknown if ongoing , urinary incontinence from an unknown date and unknown if ongoing , back pain from an unknown date and unknown if ongoing , myalgia from an unknown date and unknown if ongoing , hypersensitivity from an unknown date and unknown if ongoing.     The patient experienced nosebleed, headache and malaise on 11Feb2021 09:30 with outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophil count, Neutrophil count decreased, White blood cell count, White blood cell count decreased
Clinical narrative: WBC being low at 2.87; Neutrophils being low at 35.9; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 78-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL9292, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on 02Feb2021 10:15 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization at the hospital. Medical history included diffuse large b-cell lymphoma from May2020 to Nov2020 (Cancer free Nov 2020), infusion from Oct2020 to an unknown date. The patient did not received any vaccine prior to the immunization. Concomitant medication(s) included amlodipine (AM-LODIPINE) taken for an unspecified indication, from an unknown start date, metformin (METFORMIN) taken for an unspecified indication, from an unknown start date, atorvastatin (ATORVASTATIN) taken for an unspecified indication, from an unknown start date. The patient previously took morphine and experienced drug hypersensitivity, Ancef [cefradine] and experienced drug hypersensitivity. On 10Feb2021, being a cancer patient in 2020 the patient had many blood tests but the blood test on this day (10Feb2021 11:15) surprised the patient white blood cells count was 2.87 and Neutrophils were low at 35.9. The patient underwent WBC test and Neutrophils count test and results were 2.87 and 35.9 respectively. The patient did not receive any treatment for the events. The outcome of the events was reported as unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills; body aches; slight headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9269), via an unspecified route of administration on Feb2021 as dose number unknown, single for covid-19 immunisation. Medical history included contraception from an unknown date and unknown if ongoing. The patient did not have any known allergies. Concomitant medications included drospirenone, ethinylestradiol (SYEDA), orally for contraception; montelukast. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 10Feb2021 at 12:00, 19 hours after injection patient experienced chills, body aches, slight headache. The patient did not received treatment due to the events. The outcome of events was recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: has right hand pain; difficulty gripping her coffee cup; fatigued; This is a spontaneous report from a contactable consumer (Caregiver). A 86-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number, Expiration date were not reported) via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. Medical history included arthritis, this is localized to one hand from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date Feb2021, the caller stated, calling on behalf of mother, received vaccine on Tuesday. approximately 36 hours later she had right hand pain, and having difficulty gripping her coffee cup or cane. The hand that is in pain is on the same side as the vaccination site. She is also fatigued. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia
Clinical narrative: Had muscle pain in the back and legs; Difficult for him to walk straight; This is a spontaneous report from a contactable consumer, reported for male patient (Uncle) of an unspecified age received second 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 previously received first dose of BNT162b2 vaccine, 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 Had muscle pain in the back and legs, and Difficult for him to walk straight. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: she has an infection and is on antibiotics from a cat bite; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (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 she has an infection and is on antibiotics from a cat bite leading to infection on an unspecified date with outcome of unknown. She is left handed and the cat bit her left hand..Therapeutic measures were taken as a result of she has an infection and is on antibiotics from a cat bite.was treated with IV Rocephin,is actually Ceftriaxone. Amox/K Clav clarified the antibiotic as Amoxicillin Clavulant Tablets.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Arm soreness; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age (Age: 65; Unit: Unknown as reported) received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient experienced arm soreness on an unspecified date. The patient stated she had nothing, absolutely nothing and it worried her. She asked if she needed to have antibodies checked to see if there was something with the dose that wasn't right. She stated she needs to had lab work done anyway. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on an unspecified date. The outcome of the event was reported as unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Body temperature increased, Feeling abnormal, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 76-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 10Feb2021 (76-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 10Feb2021, the patient experienced little pain in middle of his back, Arm started hurting a little bit. On 11Feb2021, the patient Not feeling so good and Temperature of a hundred" [100 degrees F]. It was reported that, no reaction on Thursday (10Feb2021) but "later that day there was some pain in the back". Later in the day on 10Feb2021 he had a little pain in middle of his back; but was not really sure if from that or something else. He went to bed last night and while sleeping his arm started hurting a little bit. he heard that could happen and it was not too bad. When he woke up this morning he was not feeling so good, and has a temperature of 100-units of measurement such as degrees Fahrenheit/Celsius not clarified. He called because he did not know if he should take Tylenol or if there was something more appropriate he should take instead of Tylenol after the vaccine; he wanted to check that information with Pfizer before taking anything. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu like symptoms; Chills; Fatigue; Headache; Nausea; Achiness/soreness; Dry mouth; This is a spontaneous report from a contactable consumer (patient). A 57-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247, Expiry date: not reported), via an unspecified route of administration in left arm on 10Feb2021 14:00 (at age of 57-years-old) as dose 2, single for covid-19 immunisation. Medical history included lyme disease and allergy to Sulfa drugs. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL33247, Expiration Date: Not reported), via an unspecified route of administration in left arm on 20Jan2021 (at age of 57-years-old) as dose 1, single dose for covid-19 immunisation. On 10Feb2021 at 16:00, the patient experienced flu like symptoms, chills, fatigue, headache, nausea, achiness, soreness and dry mouth. No therapeutic measures were taken. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Flu like symptoms; Chills; Fatigue; Headache; Nausea; Achiness/soreness; Dry mouth; This is a spontaneous report from a contactable consumer (patient). A 57-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247, Expiry date: not reported), via an unspecified route of administration in left arm on 10Feb2021 14:00 (at age of 57-years-old) as dose 2, single for covid-19 immunisation. Medical history included lyme disease and allergy to Sulfa drugs. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL33247, Expiration Date: Not reported), via an unspecified route of administration in left arm on 20Jan2021 (at age of 57-years-old) as dose 1, single dose for covid-19 immunisation. On 10Feb2021 at 16:00, the patient experienced flu like symptoms, chills, fatigue, headache, nausea, achiness, soreness and dry mouth. No therapeutic measures were taken. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: extreme joint pain; Fatigue; This is a spontaneous report received from a contactable consumer or other non hcp. A 66-years-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported),via an unspecified route of administration ,at the age of 66 years old,on 10Feb2021 as Dose 1,single for an unspecified indication. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient previously took advil [ibuprofen] for arthritis and prednisone for arthritis.The patient experienced extreme joint pain and fatigue on an unspecified date.Therapeutic measures were taken as a result of extreme joint pain.The outcome of the event was unknown.  Follow up (11Feb2021): This is a follow-up spontaneous report received from a Pfizer-sponsored program. A contactable consumer reported for a patient (husband),The caller stated that the patient or her husband suffered from joint pain after taking 1st dose of Pfizer covid19 vaccine.The caller was asking if her husband can take anti-inflammatory medications for pain. Follow-up (11Feb2021): This is a follow-up spontaneous report received from a contactable consumer.This consumer reported for a patient (husband) that:dates for fatigue,joint pain.Reason for no lot number of Unspecified Vaccine was due to Caller unwilling to complete the report,and no lot number of Advil and prednisone was due to Suspect captured for MI query.Reporter was unwilling to share further information, hence, product details (LOT#, expiration date, NDC#, UPC#) and other details were unknown.Limited information was available over the call.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness to his arm; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness to his arm on an unspecified date. Caller wanted to know how long the vaccine will lose its efficacy under room temperature. The outcome of the event pain in extremity was unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dry throat, Pain, Pyrexia
Clinical narrative: Fever; Dry throat; Weakness; First 2 days he slept 12-14 hours; Pain; soreness in left shoulder and arm to wrist in the injection arm; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age (79 unit not reported) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as DOSE 1, SINGLE, for covid-19 immunisation and he had similar symptoms after the first shot but mild. Patient stated that, he had his second dose last Friday and had side effects they were gone now. Last Friday (05Feb2021) after second dose, first 2 days he slept 12-14 hours, pain, soreness in left shoulder and arm to wrist in the injection arm. After the 4th day (09Feb2021) had fever, dry throat, weakness did not feel himself. He said Today he is good. Patient wanted to know when does this vaccine start protecting after the second dose, 7 days 14 days. At the time of this report event outcome was recovered on an unknown date in Feb2021.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Fever; Dry throat; Weakness; First 2 days he slept 12-14 hours; Pain; soreness in left shoulder and arm to wrist in the injection arm; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age (79 unit not reported) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as DOSE 1, SINGLE, for covid-19 immunisation and he had similar symptoms after the first shot but mild. Patient stated that, he had his second dose last Friday and had side effects they were gone now. Last Friday (05Feb2021) after second dose, first 2 days he slept 12-14 hours, pain, soreness in left shoulder and arm to wrist in the injection arm. After the 4th day (09Feb2021) had fever, dry throat, weakness did not feel himself. He said Today he is good. Patient wanted to know when does this vaccine start protecting after the second dose, 7 days 14 days. At the time of this report event outcome was recovered on an unknown date in Feb2021.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: sore throat; swollen lymph nodes; chills; feeling unwell; tiredness; headache; joint pain; pain in injection site; This is a spontaneous report from a contactable consumer. A female patient (age: 30, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb201, this morning patient experienced sore throat, swollen lymph nodes, chills, feeling unwell, tiredness, headache, joint pain and pain in the injection site. Patient side effects have not gone away. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Vaccination site pain
Clinical narrative: sore throat; swollen lymph nodes; chills; feeling unwell; tiredness; headache; joint pain; pain in injection site; This is a spontaneous report from a contactable consumer. A female patient (age: 30, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb201, this morning patient experienced sore throat, swollen lymph nodes, chills, feeling unwell, tiredness, headache, joint pain and pain in the injection site. Patient side effects have not gone away. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: headache; feeling nauseous; whole body felt achy; chills; This is a spontaneous report from a contactable other hcp (patient). A non-pregnant 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9265, Expiration date were not reported), via an unspecified route of administration, administered in the left arm on 04Feb2021 (at the age of 26-years-old), as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL3249, Expiration date were not reported), via an unspecified route of administration, administered in the left arm on 14Jan2021 17:45 (at the age of 26-years-old), as dose 1, single for COVID-19 immunisation. Concomitant medication included unspecified birth control and venlafaxine, both taken for an unspecified indication, start and stop date were not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient experienced headache, the morning after the vaccine on 05Feb2021. About an hour later, on 05Feb2021, patient started feeling nauseous but that subsided relatively quickly. About three hours after that, on 05Feb2021, patient's whole body felt achy and she had the chills. She did not present with a fever at this time. No treatment was received as a result of the events. The outcome of feeling nauseous was recovered on 05Feb2021 while the rest of the events recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling cold, Pain
Clinical narrative: I had a fever 99.9 I also had body aches; felt very tired; At 4pm I start feeling really cold and I could not warm up; came the shivers and aches; came the shivers and aches; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL969? Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 21:00 (age at vaccination 66 years) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from Jul2020 to an unknown date (if covid prior vaccination: Yes). Concomitant medication(s) included colecalciferol (VITAMIN D); simvastatin (SIMVASTATIN); bifidobacterium infantis (ALIGN). Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient previously took bactrim and experienced allergy, celebrex and experienced allergy. On 09Feb2021 16:00 the patient experienced at 4pm she start feeling really cold and she could not warm up, came the shivers and aches, she had a fever 99.9 she also had body aches, felt very tired. The patient underwent lab tests and procedures which included body temperature was 99.9 on 09Feb2021 evening around 9pm I had a fever. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I had a fever 99.9 I also had body aches; felt very tired; At 4pm I start feeling really cold and I could not warm up; came the shivers and aches; came the shivers and aches; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL969? Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 21:00 (age at vaccination 66 years) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from Jul2020 to an unknown date (if covid prior vaccination: Yes). Concomitant medication(s) included colecalciferol (VITAMIN D); simvastatin (SIMVASTATIN); bifidobacterium infantis (ALIGN). Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient previously took bactrim and experienced allergy, celebrex and experienced allergy. On 09Feb2021 16:00 the patient experienced at 4pm she start feeling really cold and she could not warm up, came the shivers and aches, she had a fever 99.9 she also had body aches, felt very tired. The patient underwent lab tests and procedures which included body temperature was 99.9 on 09Feb2021 evening around 9pm I had a fever. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches; This is a spontaneous report received from a contactable consumer (Patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9809), Solution for injection, via an unspecified route of administration, administered in Arm Right on Patient's Medical History (including any illness at time of vaccination) was reported as none. Concomitant medications were not reported. Family Medical History Relevant to adverse event was reported as none. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 10Feb2021 at 06:00 AM, the patient experienced body aches. He stated that the body aches started the morning after the shot at about 6am. He did play golf yesterday and was achy, and today he has no side effects. Patient did not have other relevant diagnostic and confirmatory test results for event. Patient did not visit emergency room or physician's office due to adverse event. The event was recovered on 11Feb2021.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection), via an unspecified route of administration, on Feb 10, 2021, single dose, for COVID-19 immunisation. The patient's medical history included tested positive for COVID-19 on Nov 28, 2020, to an unknown date. The patient's concomitant medications not reported. On an unspecified date, patient experienced headache and fatigue. Patient inquired if she can take Tylenol for the headaches and asked how long do the headaches last. Her hospital protocol recommends taking Zinc 50 mg, Cosequin 500 mg twice daily and vitamin C 500 mg twice daily. She asked if there are any recommendations on these and inquired about hydroxychloroquine and ivermectin. The outcome of the events: unknown. Batch/lot number requested. Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: My blood sugar has gone up from average 130 to 190; This is a spontaneous report from a contactable consumer (reported for himself ). A 78-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot Number: 89-82) via unspecified route in arm left on 28Jan2021 at 10:30 AM as DOSE 2, SINGLE for COVID-19 Immunization (at the age of 78 Years). The patients medical history included Kidney Stage 3, Diabetes, Neuropathy on an unknown dates and CRT-D surgery on 25Jan2021. It was reported that the patient had known allergies to Zoocor, Rocephin. Concomitant medications included Alogliptin, Empagliflozin (JARDIANCE), Insulin Glargine (LANTUS) these are the medications the patient received within 2 weeks of vaccination. The patient previously took first dose bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot Number: EK9231) via unspecified route into Left arm on 07Jan2021 at 10:30 AM as DOSE 1, SINGLE for COVID-19 Immunization. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. On 30Jan2021 at 08:00 AM the patient experienced my blood sugar has gone up from average 130 to 190. The patient underwent lab tests and procedures which included Blood glucose result as 130 to 190 on 30Jan2021. The patient visited physician office. The patient did not receive any treatment for adverse event. The clinical outcome of the event was not recovered.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.