chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; The initial case was missing the following minimum criteria: no adverse  events. Upon receipt of follow-up information on 07May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient).   A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 11Feb2021 12:15 (Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive prior vaccination. The patient experienced headache on 11Feb2021 12:50; patient never experienced a routing headache like the one had after the vaccine. No treatment was given for the event. The patient recovered form the event on 11Feb2021 (stopped several hours after vaccine).  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: experienced nausea; sore arm at the injection site; sore arm at the injection site; at night felt really tired; This is a spontaneous report from a non-contactable consumer (patient himself). A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 15Feb2021 (at the age of 55-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 on 26Jan2021 at the age of 55-year-old without any side effect. Concomitant medications were not reported. On 15feb2021 after second dose of vaccine the patient experienced sore arm at the injection site and at night felt really tired. On the morning of 16Feb2021 he experienced nausea lasting for a day. On 17Feb2021 the patient felt fine and the events resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: pain in the injection site for few days; pain starts to increase in my arm and radiate down to my armpit; swollen lymph nodes; felling of unwell; sever muscle pain; redness/redness on the right side of the breast; pain starts to increase in my arm and radiate down to my armpit; This is a spontaneous report from a contactable consumer. A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 9269), via an unspecified route of administration, on 07Feb2021 at 14:00 (at the age of 47-year-old), as 1st dose, single for COVID-19 immunisation. The patient's medical history included thyroid issue. Patient had no known allergies. Concomitant medication in two weeks included levothyroxine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Feb2021, at 14:30, 30 minutes after vaccination, the patient experienced pain in the injection site, which lasted for few days. Pain started to increase in her arm and radiated down to her armpit, with swollen lymph nodes and redness. Patient experienced a felling of unwell, with sever muscle pain and the injection area was very painful. Patient had redness on the right side of the breast. Patient enquired about the outcome or treatment for this vaccine side effect. The clinical outcome of all the events was not recovered.  No follow-up attempts are possible, information on batch numbers cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: pain in the injection site for few days; pain starts to increase in my arm and radiate down to my armpit; swollen lymph nodes; felling of unwell; sever muscle pain; redness/redness on the right side of the breast; pain starts to increase in my arm and radiate down to my armpit; This is a spontaneous report from a contactable consumer. A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 9269), via an unspecified route of administration, on 07Feb2021 at 14:00 (at the age of 47-year-old), as 1st dose, single for COVID-19 immunisation. The patient's medical history included thyroid issue. Patient had no known allergies. Concomitant medication in two weeks included levothyroxine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Feb2021, at 14:30, 30 minutes after vaccination, the patient experienced pain in the injection site, which lasted for few days. Pain started to increase in her arm and radiated down to her armpit, with swollen lymph nodes and redness. Patient experienced a felling of unwell, with sever muscle pain and the injection area was very painful. Patient had redness on the right side of the breast. Patient enquired about the outcome or treatment for this vaccine side effect. The clinical outcome of all the events was not recovered.  No follow-up attempts are possible, information on batch numbers cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever (100.2F); Body aches; Headache; Chills; This is a spontaneous report from a contactable consumer (patient herself).  This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EN5318), via an unknown route in the left arm, on 16Feb2021 13:15 (at the age of 38-year-old) at single dose for COVID-19 immunisation, administered at Workplace facility. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number Lot number EN5318), via an unknown route in the left arm, on 26Jan2021 10:00 AM (at the age of 38-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included hyperthyroidism. Past drug history included penicillin allergy. Relevant concomitant medications included methimazole. On 16Feb2021 at 20:00, the patient had low grade fever (100.2F), body aches, headache and chills. The events were assessed as non-serious. Pre and Post-vaccination COVID-19 test were not done. No treatments were given for the events. The patient had recovered from the events on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This is a spontaneous report from a contactable consumer for her husband. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EH9899, Expiration date: Unknown), via unspecified route of administration, administered in left arm on 05Jan2021 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Patient had no medical history. Concomitant medications were not reported. On 05Jan2021, after the vaccination, the patient experienced soreness at the injection site for 1 day. Outcome of the event was recovered on 06Jan2021.  Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm (but not very sore) on day 1 of first vaccine and barely felt it on day 2.No side effects for dose 2.; This is a spontaneous report from a non-contactable consumer.   A 32-year-old female patient (age at vaccination 31 years) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on 25Jan2021 at 20:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization.  Relevant medical history and concomitant medications were not reported. On 25Jan2021 at 20:45 the patient experienced sore arm (but not very sore) and barely felt it on day 2 (as reported). It was also informed that patient received second dose of BNT162B2  (lot #: EL9266) on 15Feb2021 at 08:00 on left arm and no side effect occurred. At the time of the reporting event outcome was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hot flush, Myalgia
Clinical narrative: hot flashes; headache; joint pain; Muscle pain; Fatigue; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration in left arm on 17Feb2021 at 15:45 (at 33 years)at single dose for covid-19 immunisation. Medical history included depression and patient was allergic to Dioscorea japonica. No covid prior vaccination. Patient was not covid tested post vaccination. Previously on 28Jan2021 at 13:00 (at 33 years) patient took the first dose of the vaccine (lot EL3247) administered in Left arm for covid-19 immunisation.The patient's concomitant medications were not reported. On 17Feb2021 at 16:15 patient experienced hot flashes, headache, joint pain, muscle pain, fatigue and pain at injection site. No treatment was given and the outcome of all the event was not recovered.Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: hot flashes; headache; joint pain; Muscle pain; Fatigue; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration in left arm on 17Feb2021 at 15:45 (at 33 years)at single dose for covid-19 immunisation. Medical history included depression and patient was allergic to Dioscorea japonica. No covid prior vaccination. Patient was not covid tested post vaccination. Previously on 28Jan2021 at 13:00 (at 33 years) patient took the first dose of the vaccine (lot EL3247) administered in Left arm for covid-19 immunisation.The patient's concomitant medications were not reported. On 17Feb2021 at 16:15 patient experienced hot flashes, headache, joint pain, muscle pain, fatigue and pain at injection site. No treatment was given and the outcome of all the event was not recovered.Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Limb discomfort, Peripheral swelling
Clinical narrative: Swollen, warm arm; Unable to lift above head; Chills; tired; This is a spontaneous report from a contactable consumer (patient). A 68-Year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 at single dose in left arm for COVID-19 immunization at the age of 68-Year-old. Lot number was EL9269. Medical history included asthma, hypertension, diabetes. Concomitant medications included albuterol, mometasone furoate (ASMANEX), nebivolol hydrochloride (Bystolic), Montelukast sodium (SINGULAIR). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at single dose in left arm for COVID-19 immunization at the age of 68-Year-old. On 17Feb2021, the patient experienced swollen, warm arm. Unable to lift above head. Chills, tired. The patient was not treated for the events. The patient recovered from the events. Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever of 101F; headache; tiredness; arm pain; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), on 17Feb2021 at 11:30 AM (at the age of 26-years-old) at 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. No other vaccine was received in four weeks. The patient experienced fever of 101F, headache, tiredness, arm pain on 18Feb2021 at 12:00 AM. No treatment was received for the events. The patient was recovering from the events.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lacrimation increased, Rhinorrhoea
Clinical narrative: constant runny nose; Mild fatigue; constant watering eye; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female non-pregnant patient received at workplace clinic BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via unspecified route of administration in right arm on 18Feb2021 10:00 AM (at the age of 59-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history included that patient was healthy at present she had cancer (ovarian) with chemotherapy on 2013 (also reported as 7 years before the present report) and she had cancer (breast) with radiation 6 years before the present report on 2015. No COVID prior vaccination was reported. The patient's concomitant medications administered in two weeks included anastrozole (ARIMIDEX), calcium carbonate (CALTRATE) and centrum multivitamin, all from unspecified date. No other vaccine administered in four weeks. As per known allergies it was reported that the patient previously received penicillin, sulfa drugs and she experienced rash with both, vancomycin and she experienced intolerance, codeine and she experienced vomiting. On 18Feb2021 04:45 PM (as reported) the patient experienced constant runny nose and constant watering eye, both over the course of about 6 hours in the evening after the vaccination (as reported) and mild fatigue. No treatment was received due to events. Patient was not tested for COVID post-vaccination. The outcome of the events was resolved.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Headache, Pruritus
Clinical narrative: Dull headache; chills; feet/toes burning and itching; feet/toes burning and itching; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 17Feb2021 at 12:45 PM (at the age of 68-years-old) at 1st dose, single, administered in left arm, for COVID-19 immunisation. Medical history included seasonal allergy. The patient had no other known allergies. No COVID prior vaccination and no COVID tested post vaccination. Other medications in two weeks included seasonal allergy shot, gabapentin and benazepril. No other vaccine was received in four weeks. The patient experienced dull headache, chills, feet/toes burning and itching on 17Feb2021 at 21:00. No treatment was received for the events.  The patient had recovered from the events in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Just a sore arm; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9266; expiration date: May2021), on 18Feb2021 at 09:30 AM (at the age of 21-years-old) at 1st dose, single, administered in left arm, for COVID-19 immunisation. Medical history included Crohns disease, depression, anxiety, seasonal allergies. The patient was not pregnant. The patient had no known allergies, no COVID prior vaccination and no COVID tested post vaccination. Other medications in two weeks included adalimumab (HUMIRA), gabapentin, escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D). No other vaccine was received in four weeks. The patient experienced just a sore arm on 18Feb2021 at 10:30 AM. No treatment was received for the event. The patient was recovering from the event.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: up all night with diarrhea; dry heaving; headache,splitting headache; chills; sick; felt tired,fatigue; brain fog; nausea; This is a spontaneous report from a contactable consumer (patient).    A 24-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9809), via an unspecified route of administration, in Arm Right on 10Feb2021 at 12:00 (at 24 years) at single dose for covid-19 immunisation. Medical history included seasonal allergy. Patient previously took Levaquin and had allergy. The patient previously took the first dose of the vaccine on 15Jan2021 at 10:00 am (at 24 years; lot EL9261) administered in right arm for covid-19 immunisation with no adverse event.Concomitant medications included probiotics, cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D) and birth control pills (unspecified).  Patient received second dose of the vaccine on 10Feb2021 and she felt tired and sick on 11Feb2021 and on 12Feb2021. On 13Feb2021 night patient was up all night with diarrhea, dry heaving, chills and headache. On 14Feb2021 she was in bed all day. Every day since then (Feb2021) she had a horrible splitting headache, nausea, brain fog, fatigue and chills. She had not had a fever. Her doctor tested her for covid via Nasal swab on 17Feb2021 and she was negative. On 17Feb2021 she also ran comprehensive metabolic panel and other labs and they were normal. Her symptoms point towards an extreme and long reaction to the covid vaccine. Events required doctor or other healthcare professional office/clinic visit. Treatment included Prescription nausea medication. The final outcome of all the events was recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Investigation, Metabolic function test, Nausea, Retching
Clinical narrative: up all night with diarrhea; dry heaving; headache,splitting headache; chills; sick; felt tired,fatigue; brain fog; nausea; This is a spontaneous report from a contactable consumer (patient).    A 24-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9809), via an unspecified route of administration, in Arm Right on 10Feb2021 at 12:00 (at 24 years) at single dose for covid-19 immunisation. Medical history included seasonal allergy. Patient previously took Levaquin and had allergy. The patient previously took the first dose of the vaccine on 15Jan2021 at 10:00 am (at 24 years; lot EL9261) administered in right arm for covid-19 immunisation with no adverse event.Concomitant medications included probiotics, cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D) and birth control pills (unspecified).  Patient received second dose of the vaccine on 10Feb2021 and she felt tired and sick on 11Feb2021 and on 12Feb2021. On 13Feb2021 night patient was up all night with diarrhea, dry heaving, chills and headache. On 14Feb2021 she was in bed all day. Every day since then (Feb2021) she had a horrible splitting headache, nausea, brain fog, fatigue and chills. She had not had a fever. Her doctor tested her for covid via Nasal swab on 17Feb2021 and she was negative. On 17Feb2021 she also ran comprehensive metabolic panel and other labs and they were normal. Her symptoms point towards an extreme and long reaction to the covid vaccine. Events required doctor or other healthcare professional office/clinic visit. Treatment included Prescription nausea medication. The final outcome of all the events was recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: up all night with diarrhea; dry heaving; headache,splitting headache; chills; sick; felt tired,fatigue; brain fog; nausea; This is a spontaneous report from a contactable consumer (patient).    A 24-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9809), via an unspecified route of administration, in Arm Right on 10Feb2021 at 12:00 (at 24 years) at single dose for covid-19 immunisation. Medical history included seasonal allergy. Patient previously took Levaquin and had allergy. The patient previously took the first dose of the vaccine on 15Jan2021 at 10:00 am (at 24 years; lot EL9261) administered in right arm for covid-19 immunisation with no adverse event.Concomitant medications included probiotics, cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D) and birth control pills (unspecified).  Patient received second dose of the vaccine on 10Feb2021 and she felt tired and sick on 11Feb2021 and on 12Feb2021. On 13Feb2021 night patient was up all night with diarrhea, dry heaving, chills and headache. On 14Feb2021 she was in bed all day. Every day since then (Feb2021) she had a horrible splitting headache, nausea, brain fog, fatigue and chills. She had not had a fever. Her doctor tested her for covid via Nasal swab on 17Feb2021 and she was negative. On 17Feb2021 she also ran comprehensive metabolic panel and other labs and they were normal. Her symptoms point towards an extreme and long reaction to the covid vaccine. Events required doctor or other healthcare professional office/clinic visit. Treatment included Prescription nausea medication. The final outcome of all the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleed; This is a spontaneous report from a contactable consumer (patient's husband) Pfizer-sponsored program . A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient took the first dose and had a nose bleed this morning. She is on a blood thinner. The outcome of the event was unknown.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Lymph node pain
Clinical narrative: fever; chills; sweating; warmth at injection site; lymph nodes swollen and painful; lymph nodes swollen and painful; Body aches; headache; tired; nauseous; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Lot number was not reported) as single dose (at age of 26-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. First dose of bnt162b2 (BNT162B2) was administered on 27Jan2021 (at age of 25-year-old) for covid-19 immunisation. On 18Feb2021 08:00 patient experienced fever, chills, sweating, warmth at injection site, lymph nodes swollen and painful, headache, body aches, tired, nauseous. No treatment was administered for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain, Pyrexia, Vaccination site warmth
Clinical narrative: fever; chills; sweating; warmth at injection site; lymph nodes swollen and painful; lymph nodes swollen and painful; Body aches; headache; tired; nauseous; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Lot number was not reported) as single dose (at age of 26-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. First dose of bnt162b2 (BNT162B2) was administered on 27Jan2021 (at age of 25-year-old) for covid-19 immunisation. On 18Feb2021 08:00 patient experienced fever, chills, sweating, warmth at injection site, lymph nodes swollen and painful, headache, body aches, tired, nauseous. No treatment was administered for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021 at 10:30 at single dose in left arm for COVID-19 immunisation at the age of 75-year-old. Lot number was EL9262. Medical history included Heart problem and a block for migraines, Supplementation therapy, Thyroid problem, Nervousness. Concomitant medications included amlodipine for Heart problem and a block for migraines, levothyroxine sodium (LEVOTHYROXINE) for Thyroid problem, lorazepam for nervousness, colecalciferol (VITAMIN D); all drugs were ongoing. On 10Feb2021, the patient experienced nausea. The patient did not recover from the event. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021211507 same reporter/drug/event, different patient
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: redness, swelling half way down to his wrist, itching and warm to the touch on the injection arm; redness, swelling half way down to his wrist, itching and warm to the touch on the injection arm; redness, swelling half way down to his wrist, itching and warm to the touch on the injection arm; warm to the touch on the injection arm; This is a spontaneous report from a contactable consumer (patient's partner). An 81-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9267), on 11Feb2021 (at the age of 81-years-old) at 2nd dose, single, administered in arm, for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included he took medications daily but nothing the reporter thought would be relevant. The patient previously received the first dose of BNT162b2 (lot number: EL8982) on 21Jan2021 (at the age of 81-years-old) at 1st dose, single for COVID-19 immunisation at grocery store. The patient was experiencing redness, swelling half way down to his wrist, itching and warm to the touch on the injection arm for one week, on 13Feb2021, after the second dose of the vaccine. The reporter wanted to know if this was associated with the vaccine because of the duration of the symptoms. He was having some kind of reaction for about a week. They wanted to report it, where he got the shot on that arm it went down the arm just past the elbow, it was red swollen and itching. Reporter confirmed they were seeking information about this reaction, if it was associated with the product to go on this long. It was about 2 days after the dose that he noticed the redness swelling and itching. It was pretty puffy, reporter thought it had worsened since it began. No investigation assessment was performed. The patient had not recovered from the events.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site pain  Narrative:   Other Relevant History:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Developed throbbing headache, high fever, severe pain at injection site, and extreme body pain.  Symptoms began approximately 10 hours after vaccine and lasted about 24 hours.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Fever, diarrhea, muscle pain, headache, pain throughout the body
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: patient complained of headache, cold sweats, and elevated and heart rate
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Raised red bump and itchy
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 5/24/21 patient stated at injection site, arm feels raised, warm and sore
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Bone densitometry, Chills, Colonoscopy, Diarrhoea
Clinical narrative: A few hours after the vaccine, began having a headache.  The next day had severe body aches and chills, which continued for another 4 days.  I missed 4 days of work.  I began feeling better a week after the vaccine.  24 days after the vaccine, I was awaken with excruciating pain in my left abdomen, and had severe diarrhea.  The diarrhea lasted most of that day, the pain continued.  I went to an Emergency Room on 4/1/21, and a CT scan revealed what appeared to be a stomach ulcer, a kidney stone and a post-menopausal ovarian cyst, all of which were causing the pain.  I have been through many tests and seeing a variety of doctors, and currently am awaiting results and treatment plans for the stomach problem and the ovarian cyst.  The cyst has grown and is causing continued pain.  The stomach issue is being treated with Sucralfate 1 g 4 times per day and Pepcid 20 mg.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy, Gastric ulcer, Headache, Impaired work ability, Mammogram
Clinical narrative: A few hours after the vaccine, began having a headache.  The next day had severe body aches and chills, which continued for another 4 days.  I missed 4 days of work.  I began feeling better a week after the vaccine.  24 days after the vaccine, I was awaken with excruciating pain in my left abdomen, and had severe diarrhea.  The diarrhea lasted most of that day, the pain continued.  I went to an Emergency Room on 4/1/21, and a CT scan revealed what appeared to be a stomach ulcer, a kidney stone and a post-menopausal ovarian cyst, all of which were causing the pain.  I have been through many tests and seeing a variety of doctors, and currently am awaiting results and treatment plans for the stomach problem and the ovarian cyst.  The cyst has grown and is causing continued pain.  The stomach issue is being treated with Sucralfate 1 g 4 times per day and Pepcid 20 mg.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis, Ovarian cyst, Pain, Ultrasound scan vagina
Clinical narrative: A few hours after the vaccine, began having a headache.  The next day had severe body aches and chills, which continued for another 4 days.  I missed 4 days of work.  I began feeling better a week after the vaccine.  24 days after the vaccine, I was awaken with excruciating pain in my left abdomen, and had severe diarrhea.  The diarrhea lasted most of that day, the pain continued.  I went to an Emergency Room on 4/1/21, and a CT scan revealed what appeared to be a stomach ulcer, a kidney stone and a post-menopausal ovarian cyst, all of which were causing the pain.  I have been through many tests and seeing a variety of doctors, and currently am awaiting results and treatment plans for the stomach problem and the ovarian cyst.  The cyst has grown and is causing continued pain.  The stomach issue is being treated with Sucralfate 1 g 4 times per day and Pepcid 20 mg.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Lethargy
Clinical narrative: lightheaded, lethargic, diaphoretic, low blood pressure 86/46, P 65, O2 98%. 8:27am IV o left arm. 8:35 Hospital
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Systemic: Metallic Taste in Mouth-Mild
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Dyspnoea, Gait inability, Lethargy, Palpitations, Pyrexia
Clinical narrative: Unable to walk because legs hurt so bad, complaining of inability to breathe through nose, lethargic, 103 fever, racing heart beat
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Pruritus, Rash macular, Vision blurred
Clinical narrative: pt experienced itching in upper torso area starting 2-3 days after vaccination, splotches appeared at this time and have not resolved at this time Pt also experienced blurred vision in her right eye with eye twitch starting 5 days after vaccination
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Confusional state, Decreased appetite
Clinical narrative: Received second dose of Moderna COVID 19 vaccine at 10AM Thursday 05/20.  T+12-18hrs: Feeling flushed. Slightly confused. Body aches build over the night. Wake up with mild/moderate pain in back, knees, arm. Groggy. Went to work on something with a friend at 10:00 AM (T+24Hrs), but had to return home because....  T+24hr: ....headache growing. Went home and found fever at 102°.  Slight chills, bit mainly just heat without sweating. Fever hit 103.2 at peak. Went through 10lbs ice to keep the fever in check. Headache from T24hr-T36HR feels like a spike through the top of frontal lobe to my left eye.  T+32hr: Headache still intense. Only back pain now. Appetite slowly increasing.  T+48hr (Saturday morning). Back pain persists, but mild. Headache gone. Have a relatively normal day.  T+60hrs (Sat. Afternoon): Back pain increasing. Stop all unnecessary lifting/moving.  T+68hrs (early Sunday morning): Go to ER with the back pain. Absolutely excruciating spasms from top of sacrum - roughly LI/12T. Lower back stiff as wood. Given shot or Toradol, dose/prescription to flexiril. I specifically request this plan because usually takes care of the spasms; basically, get me able to move and the pain/spasms will go away.   NOTE: I have a history of back issues in this area, but I have not had an episode in years and certainly never had an episode that works like this with no relief. From about 2017-2019, I r  T+70-78hrs: Feel normal.  T + 78-88hrs: lower back pain comes back with an absolute vengeance.  T+90hrs (early Monday morning): Return to ER. Back pain worse than Sunday morning. Receive toradol shot and prescription Prednisone. Back pain gone by around 10:30 AM. Decide to take prednisone Tuesday morning as its getting a bit late in the day by the time pharmacy fills the prescription.   T+90hrs: Back pain returns in similar fashion as Sunday afternoon. Still. Barely mobile.   T+96 hours: Wake up with lower back pain similar to Sunday/Monday morning. Took prednisone and flexiril this morning.   Please help me.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Feeling hot, Flushing, Headache, Mobility decreased
Clinical narrative: Received second dose of Moderna COVID 19 vaccine at 10AM Thursday 05/20.  T+12-18hrs: Feeling flushed. Slightly confused. Body aches build over the night. Wake up with mild/moderate pain in back, knees, arm. Groggy. Went to work on something with a friend at 10:00 AM (T+24Hrs), but had to return home because....  T+24hr: ....headache growing. Went home and found fever at 102°.  Slight chills, bit mainly just heat without sweating. Fever hit 103.2 at peak. Went through 10lbs ice to keep the fever in check. Headache from T24hr-T36HR feels like a spike through the top of frontal lobe to my left eye.  T+32hr: Headache still intense. Only back pain now. Appetite slowly increasing.  T+48hr (Saturday morning). Back pain persists, but mild. Headache gone. Have a relatively normal day.  T+60hrs (Sat. Afternoon): Back pain increasing. Stop all unnecessary lifting/moving.  T+68hrs (early Sunday morning): Go to ER with the back pain. Absolutely excruciating spasms from top of sacrum - roughly LI/12T. Lower back stiff as wood. Given shot or Toradol, dose/prescription to flexiril. I specifically request this plan because usually takes care of the spasms; basically, get me able to move and the pain/spasms will go away.   NOTE: I have a history of back issues in this area, but I have not had an episode in years and certainly never had an episode that works like this with no relief. From about 2017-2019, I r  T+70-78hrs: Feel normal.  T + 78-88hrs: lower back pain comes back with an absolute vengeance.  T+90hrs (early Monday morning): Return to ER. Back pain worse than Sunday morning. Receive toradol shot and prescription Prednisone. Back pain gone by around 10:30 AM. Decide to take prednisone Tuesday morning as its getting a bit late in the day by the time pharmacy fills the prescription.   T+90hrs: Back pain returns in similar fashion as Sunday afternoon. Still. Barely mobile.   T+96 hours: Wake up with lower back pain similar to Sunday/Monday morning. Took prednisone and flexiril this morning.   Please help me.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Received second dose of Moderna COVID 19 vaccine at 10AM Thursday 05/20.  T+12-18hrs: Feeling flushed. Slightly confused. Body aches build over the night. Wake up with mild/moderate pain in back, knees, arm. Groggy. Went to work on something with a friend at 10:00 AM (T+24Hrs), but had to return home because....  T+24hr: ....headache growing. Went home and found fever at 102°.  Slight chills, bit mainly just heat without sweating. Fever hit 103.2 at peak. Went through 10lbs ice to keep the fever in check. Headache from T24hr-T36HR feels like a spike through the top of frontal lobe to my left eye.  T+32hr: Headache still intense. Only back pain now. Appetite slowly increasing.  T+48hr (Saturday morning). Back pain persists, but mild. Headache gone. Have a relatively normal day.  T+60hrs (Sat. Afternoon): Back pain increasing. Stop all unnecessary lifting/moving.  T+68hrs (early Sunday morning): Go to ER with the back pain. Absolutely excruciating spasms from top of sacrum - roughly LI/12T. Lower back stiff as wood. Given shot or Toradol, dose/prescription to flexiril. I specifically request this plan because usually takes care of the spasms; basically, get me able to move and the pain/spasms will go away.   NOTE: I have a history of back issues in this area, but I have not had an episode in years and certainly never had an episode that works like this with no relief. From about 2017-2019, I r  T+70-78hrs: Feel normal.  T + 78-88hrs: lower back pain comes back with an absolute vengeance.  T+90hrs (early Monday morning): Return to ER. Back pain worse than Sunday morning. Receive toradol shot and prescription Prednisone. Back pain gone by around 10:30 AM. Decide to take prednisone Tuesday morning as its getting a bit late in the day by the time pharmacy fills the prescription.   T+90hrs: Back pain returns in similar fashion as Sunday afternoon. Still. Barely mobile.   T+96 hours: Wake up with lower back pain similar to Sunday/Monday morning. Took prednisone and flexiril this morning.   Please help me.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Spinal X-ray normal
Clinical narrative: Received second dose of Moderna COVID 19 vaccine at 10AM Thursday 05/20.  T+12-18hrs: Feeling flushed. Slightly confused. Body aches build over the night. Wake up with mild/moderate pain in back, knees, arm. Groggy. Went to work on something with a friend at 10:00 AM (T+24Hrs), but had to return home because....  T+24hr: ....headache growing. Went home and found fever at 102°.  Slight chills, bit mainly just heat without sweating. Fever hit 103.2 at peak. Went through 10lbs ice to keep the fever in check. Headache from T24hr-T36HR feels like a spike through the top of frontal lobe to my left eye.  T+32hr: Headache still intense. Only back pain now. Appetite slowly increasing.  T+48hr (Saturday morning). Back pain persists, but mild. Headache gone. Have a relatively normal day.  T+60hrs (Sat. Afternoon): Back pain increasing. Stop all unnecessary lifting/moving.  T+68hrs (early Sunday morning): Go to ER with the back pain. Absolutely excruciating spasms from top of sacrum - roughly LI/12T. Lower back stiff as wood. Given shot or Toradol, dose/prescription to flexiril. I specifically request this plan because usually takes care of the spasms; basically, get me able to move and the pain/spasms will go away.   NOTE: I have a history of back issues in this area, but I have not had an episode in years and certainly never had an episode that works like this with no relief. From about 2017-2019, I r  T+70-78hrs: Feel normal.  T + 78-88hrs: lower back pain comes back with an absolute vengeance.  T+90hrs (early Monday morning): Return to ER. Back pain worse than Sunday morning. Receive toradol shot and prescription Prednisone. Back pain gone by around 10:30 AM. Decide to take prednisone Tuesday morning as its getting a bit late in the day by the time pharmacy fills the prescription.   T+90hrs: Back pain returns in similar fashion as Sunday afternoon. Still. Barely mobile.   T+96 hours: Wake up with lower back pain similar to Sunday/Monday morning. Took prednisone and flexiril this morning.   Please help me.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Arm still sore at injection site (bruise feeling) 3 months post vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Neuralgia, Pain, Pain in extremity
Clinical narrative: Left arm/nerve pain radiating down arm  for 2 weeks. 1st week she could not lift arm at all.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Insomnia
Clinical narrative: can not sleep, when adverts reaction happened up to today I have had 26.5 hrs of sleep
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Headache, Myalgia
Clinical narrative: High fever for three days 101- 103. My regular temperature is 96 not 98. Nauseas/ vomiting. Headache. Painful muscles and joints. Cough. Excessive tiredness.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: High fever for three days 101- 103. My regular temperature is 96 not 98. Nauseas/ vomiting. Headache. Painful muscles and joints. Cough. Excessive tiredness.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: 7 days after receiving the first vaccine shot a lump developed at the site of the injection. The lump is hard, hot to the touch, and itches. Online resources that describe this delayed reaction advise to treat with over the counter pain reliver, itch cream, and a cold compress. Lump has yet to subside; however it has only been 24 hours since the lump appeared.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: My left arm/ shoulder is extremely sore since the shot on 4-1.  7 weeks ago.  It does not seam to be improving as days go by.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Hypertension, Vertigo
Clinical narrative: After about 4 days with a temperature of 37.7 centigrade: high blood pressure -- > systolic 190 diastolic 115 (despite Ramipril 5mg morning and evening) Vertigo Acufene General discomfort duration of symptoms: 5 days
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Headache, Palpitations, Paraesthesia
Clinical narrative: Within seconds, heart racing, headache, shooting tingling down arm and leg, tingling all over, couldn't walk. Lasted at least until got home. Slept for 1-2 days.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Around 6 AM March 24 about 30 hours after my first injection of the Pfizer vaccine I experience stroke like symptoms. Numbness on the left side of my body. Including my face arm and leg. I went to hospital. Where I was first given a CAT scan. And a day later an MRI.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Bleared vision, ringing in the left ear
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Swelling face
Clinical narrative: 6 hours later, severe headache, neck stiffness, facial swelling, lasted 24 hours. This recurred with second dose, lasted several days.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine given to patient under the age of 18, although not approved for that age.  Spoke with parent after discovery, and no side effects to report.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Confusional state, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Abdominal Pain-Mild, Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia
Clinical narrative: Systemic: numbness in fingers on right hand, started before injection-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient reported numbness after vaccine, when asked when it started she said before she got the vaccine but got worse after.  She denied any other side effects and was not showing any signs of allergic reaction. She said she was nervous & not sure if her tension impacted sx. Recommended she follow up with her MD if symptoms got worse or did not resolve
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: 4 hours later, subjective SOB and chest tightness. Worsened by the next morning, slowly eased off. No other symptoms.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin exfoliation, Skin warm
Clinical narrative: after first shot i notice sunburn and blistering on the top shoulder of injection site arm. second dose i received in the opposite arm. a few hours after injection my entire face turned red and itchy. it has been a week and i am less red but my face is still itchy. my right cheek had gotten very hot and red and now the skin is peeling like it was burned.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: i administered pfizer vaccine to patient and after 5 minutes she experienced syncope and we had to call an ambulance for the patient.  The NP within the store helped the patient as well by checking blood sugar, blood pressure and o2.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Culture urine, Dysuria, Hypersensitivity, Micturition urgency
Clinical narrative: I had a burning sensation every time I urinated, I felt a lot of urgency to go to the bathroom, I had to go to the bathroom up to five or six times a night, I felt the sphincter of the penis felt very sensitive and painful, Since the symptoms did not go away I had to go to a clinic where they did a urine culture, and days later I was called to start taking antibiotics for 7 days, most of the symptoms have passed but I continue with a little urgency when I have to urinate. I was taking Cefdinir 300 Mg twice a day for 7 days