chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: face/hand sensation/Tingling; Elevated tinnitus; Night sweats; Sweats; light-headed; Vertigo; Dizzy; Nausea; vomiting; diarrhea; hands sizzling; chills; Tinnitus/Tinnitus in other ear; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP letter sent in cross referenced case.   A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EP7533, Expiration Date: not reported) via intramuscular, administered in left arm on 05Apr2021 at 13:00 as dose 2, single for COVID-19 immunization. Prior vaccination within 4 weeks was none. Medical history included vitamin d deficiency, dry eye, and Injury. Concomitant medication included vitamin d [vitamin d nos] taken for vitamin d deficiency and ciclosporin (RESTASIS) taken for dry eye. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) on 08Mar2021 at 13:00, and experienced vertigo, dizzy, hearing loss, tinnitus, nauseous, diarrhea, chills, sweating, Hands felt like vibrating, and vomiting. The patient experienced vertigo, dizzy, nausea, vomiting, diarrhea, hands sizzling, chills and tinnitus/tinnitus in another ear on 05Apr2021 at 14:00. On 10Apr2021, the patient experienced light-headed. On 15Apr2021, the patient experienced sweats and on 19Apr2021, night sweats. Elevated tinnitus on 20Apr2021, face/hand sensation/tingling on 24Apr2021. The patient underwent lab tests and procedures which included blood test: all else normal, eosinophil count: low Eosinophil absolute- low, full blood count: normal, lymphocyte count: low and neutrophil count: high on 05Apr2021. The events recovered but reoccurred again. The patient did not received treatment for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Blood pressure decreased, Dizziness, Eye movement disorder, Immediate post-injection reaction
Clinical narrative: LOST CONSCIOUSNESS; LOW BLOOD PRESSURE; SEVERE PAIN; HAND IN CLAW POSITION; DIFFICULTY SITTING UP; KEPT ROLLING EYES BACK; SHARP PAIN GOING DOWN ARM; NAUSEA; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage and no medication taken prior. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) frequency 1 total,  dose was not reported, administered on left arm on  09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, after receiving the vaccine, the patient experienced a sharp pain running down left arm. Patient stated that her hand was clenched in a claw position and blood pressure began to drop. On 09-Apr-2021, the patient went to emergency room for lost consciousness and was sent to the hospital around 11:15 AM. Patient experienced some nausea and was given something with benadryl inside but the patient wasn't sure exactly about it. Electrocardiogram (EKG) was performed, but the results were normal. Patient was able to regain consciousness and stand up around 1:30 PM. Patient was given a prescription that was to help with her nausea and was told to take it with benadryl in case she needed to but never got it filled. The patient was not admitted overnight to the hospital. Patient stated that none of the symptoms she experienced persisted after the first day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost consciousness, low blood pressure, severe pain, hand in claw position, difficulty sitting up, kept rolling eyes back, sharp pain going down arm, and nausea on 09-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210700983-covid-19 vaccine ad26.cov2.s-lost consciousness; low blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Nausea, Pruritus
Clinical narrative: LOST CONSCIOUSNESS; LOW BLOOD PRESSURE; SEVERE PAIN; HAND IN CLAW POSITION; DIFFICULTY SITTING UP; KEPT ROLLING EYES BACK; SHARP PAIN GOING DOWN ARM; NAUSEA; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage and no medication taken prior. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) frequency 1 total,  dose was not reported, administered on left arm on  09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, after receiving the vaccine, the patient experienced a sharp pain running down left arm. Patient stated that her hand was clenched in a claw position and blood pressure began to drop. On 09-Apr-2021, the patient went to emergency room for lost consciousness and was sent to the hospital around 11:15 AM. Patient experienced some nausea and was given something with benadryl inside but the patient wasn't sure exactly about it. Electrocardiogram (EKG) was performed, but the results were normal. Patient was able to regain consciousness and stand up around 1:30 PM. Patient was given a prescription that was to help with her nausea and was told to take it with benadryl in case she needed to but never got it filled. The patient was not admitted overnight to the hospital. Patient stated that none of the symptoms she experienced persisted after the first day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost consciousness, low blood pressure, severe pain, hand in claw position, difficulty sitting up, kept rolling eyes back, sharp pain going down arm, and nausea on 09-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210700983-covid-19 vaccine ad26.cov2.s-lost consciousness; low blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Eye movement disorder, Hand deformity, Hypotension, Loss of consciousness
Clinical narrative: LOST CONSCIOUSNESS; LOW BLOOD PRESSURE; SEVERE PAIN; HAND IN CLAW POSITION; DIFFICULTY SITTING UP; KEPT ROLLING EYES BACK; SHARP PAIN GOING DOWN ARM; NAUSEA; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage and no medication taken prior. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) frequency 1 total,  dose was not reported, administered on left arm on  09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, after receiving the vaccine, the patient experienced a sharp pain running down left arm. Patient stated that her hand was clenched in a claw position and blood pressure began to drop. On 09-Apr-2021, the patient went to emergency room for lost consciousness and was sent to the hospital around 11:15 AM. Patient experienced some nausea and was given something with benadryl inside but the patient wasn't sure exactly about it. Electrocardiogram (EKG) was performed, but the results were normal. Patient was able to regain consciousness and stand up around 1:30 PM. Patient was given a prescription that was to help with her nausea and was told to take it with benadryl in case she needed to but never got it filled. The patient was not admitted overnight to the hospital. Patient stated that none of the symptoms she experienced persisted after the first day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost consciousness, low blood pressure, severe pain, hand in claw position, difficulty sitting up, kept rolling eyes back, sharp pain going down arm, and nausea on 09-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210700983-covid-19 vaccine ad26.cov2.s-lost consciousness; low blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Movement disorder, Nausea, Pain, Pain in extremity
Clinical narrative: LOST CONSCIOUSNESS; LOW BLOOD PRESSURE; SEVERE PAIN; HAND IN CLAW POSITION; DIFFICULTY SITTING UP; KEPT ROLLING EYES BACK; SHARP PAIN GOING DOWN ARM; NAUSEA; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage and no medication taken prior. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) frequency 1 total,  dose was not reported, administered on left arm on  09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, after receiving the vaccine, the patient experienced a sharp pain running down left arm. Patient stated that her hand was clenched in a claw position and blood pressure began to drop. On 09-Apr-2021, the patient went to emergency room for lost consciousness and was sent to the hospital around 11:15 AM. Patient experienced some nausea and was given something with benadryl inside but the patient wasn't sure exactly about it. Electrocardiogram (EKG) was performed, but the results were normal. Patient was able to regain consciousness and stand up around 1:30 PM. Patient was given a prescription that was to help with her nausea and was told to take it with benadryl in case she needed to but never got it filled. The patient was not admitted overnight to the hospital. Patient stated that none of the symptoms she experienced persisted after the first day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost consciousness, low blood pressure, severe pain, hand in claw position, difficulty sitting up, kept rolling eyes back, sharp pain going down arm, and nausea on 09-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210700983-covid-19 vaccine ad26.cov2.s-lost consciousness; low blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test abnormal, Computerised tomogram thorax abnormal, Cough, Deep vein thrombosis
Clinical narrative: DVT and PE
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: DVT and PE
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary thrombosis, Ultrasound Doppler abnormal
Clinical narrative: DVT and PE
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Blood test, Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DVT and PE
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Fatigue, Fibrin D dimer increased, Headache
Clinical narrative: DVT and PE
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Impaired driving ability, Pain in extremity, Pulmonary embolism, Ultrasound Doppler
Clinical narrative: DVT and PE
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: light headed; feeling off; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included levothyroxine 35 mcg (MANUFACTURER UNKNOWN) from unknown date for unknown indication. The patient was allergic to eggs, sulpha and Pyridium. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 24Mar2021 at 14:00 (five minutes after vaccination), the patient experienced very light headed and off. She felt like tiny bubbles under her skin and patient ears had got hot, turned red. The patients blood pressure was 160/100, oxygen level was 99% and pulse rate was 105 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for events. The clinical outcome of events light headed and feeling off was resolved on 24Mar2021 (4 hours after vaccination).   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Dizziness, Feeling abnormal, Heart rate, Oxygen saturation
Clinical narrative: light headed; feeling off; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included levothyroxine 35 mcg (MANUFACTURER UNKNOWN) from unknown date for unknown indication. The patient was allergic to eggs, sulpha and Pyridium. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 24Mar2021 at 14:00 (five minutes after vaccination), the patient experienced very light headed and off. She felt like tiny bubbles under her skin and patient ears had got hot, turned red. The patients blood pressure was 160/100, oxygen level was 99% and pulse rate was 105 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for events. The clinical outcome of events light headed and feeling off was resolved on 24Mar2021 (4 hours after vaccination).   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Dizziness, Muscle spasms
Clinical narrative: BLOOD CLOTS; LEG CRAMPS IN BOTH LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, weeks later, the patient found out about of the blood clots findings related to the vaccine. The patient was experiencing some leg cramps in both legs and went to the emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and leg cramps in both legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210701243-Covid-19 vaccine ad26.cov2.s-Blood clots. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Thrombosis
Clinical narrative: BLOOD CLOTS; LEG CRAMPS IN BOTH LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, weeks later, the patient found out about of the blood clots findings related to the vaccine. The patient was experiencing some leg cramps in both legs and went to the emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and leg cramps in both legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210701243-Covid-19 vaccine ad26.cov2.s-Blood clots. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest pain, Costochondritis, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Visit summaries/notes attached on below visits  3/25/2021 ER with chest pain, worse with deep breath; diagnosis costochondritis 4/14/2021 ER with chest pain, painful breathing, wheezing, weakness, fever (101.3 rectal). 4 pound weight gain overnight.   Differential diagnoses costochondritis, pleurisy, pneumonia, COVID-19; admitted to hospital.Discharged 4/16.   4/25/2021 admitted to hospital; chest pain, shortness of breath, weakness, bloat, inflammation markers high, mild pericardial effusion, near syncope.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal distension, Asthenia, COVID-19, Chest pain, Costochondritis
Clinical narrative: Visit summaries/notes attached on below visits  3/25/2021 ER with chest pain, worse with deep breath; diagnosis costochondritis 4/14/2021 ER with chest pain, painful breathing, wheezing, weakness, fever (101.3 rectal). 4 pound weight gain overnight.   Differential diagnoses costochondritis, pleurisy, pneumonia, COVID-19; admitted to hospital.Discharged 4/16.   4/25/2021 admitted to hospital; chest pain, shortness of breath, weakness, bloat, inflammation markers high, mild pericardial effusion, near syncope.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Inflammatory marker increased, Painful respiration, Pericardial effusion, Pleurisy
Clinical narrative: Visit summaries/notes attached on below visits  3/25/2021 ER with chest pain, worse with deep breath; diagnosis costochondritis 4/14/2021 ER with chest pain, painful breathing, wheezing, weakness, fever (101.3 rectal). 4 pound weight gain overnight.   Differential diagnoses costochondritis, pleurisy, pneumonia, COVID-19; admitted to hospital.Discharged 4/16.   4/25/2021 admitted to hospital; chest pain, shortness of breath, weakness, bloat, inflammation markers high, mild pericardial effusion, near syncope.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pneumonia, Presyncope, Pyrexia, Weight increased, Wheezing
Clinical narrative: Visit summaries/notes attached on below visits  3/25/2021 ER with chest pain, worse with deep breath; diagnosis costochondritis 4/14/2021 ER with chest pain, painful breathing, wheezing, weakness, fever (101.3 rectal). 4 pound weight gain overnight.   Differential diagnoses costochondritis, pleurisy, pneumonia, COVID-19; admitted to hospital.Discharged 4/16.   4/25/2021 admitted to hospital; chest pain, shortness of breath, weakness, bloat, inflammation markers high, mild pericardial effusion, near syncope.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Face injury, Fall
Clinical narrative: After I was given the injection for the vaccine the pharmacist said I could leave lor walk around the store for 15min. I decided to walk and in less than a minute I fainted on my face and fractured 3 teeth and shattered 5 additional teeth. Since I la ded on my face, my chin suffered the fall and was opened. Due to this, they had to stitch my chin and I am undergoing medical repairs for my teeth and extractions for the fractures.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Face injury, Skin laceration, Suture insertion, Syncope, Tooth extraction
Clinical narrative: After I was given the injection for the vaccine the pharmacist said I could leave lor walk around the store for 15min. I decided to walk and in less than a minute I fainted on my face and fractured 3 teeth and shattered 5 additional teeth. Since I la ded on my face, my chin suffered the fall and was opened. Due to this, they had to stitch my chin and I am undergoing medical repairs for my teeth and extractions for the fractures.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tooth fracture, Tooth repair, X-ray dental
Clinical narrative: After I was given the injection for the vaccine the pharmacist said I could leave lor walk around the store for 15min. I decided to walk and in less than a minute I fainted on my face and fractured 3 teeth and shattered 5 additional teeth. Since I la ded on my face, my chin suffered the fall and was opened. Due to this, they had to stitch my chin and I am undergoing medical repairs for my teeth and extractions for the fractures.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient said his arm has been sore since he received the second dose and the pain has now moved down his arm and his thumb has become numb.. travels a lot so couldn't let us know til now.. Did not consult a md yet
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient said his arm has been sore since he received the second dose and the pain has now moved down his arm and his thumb has become numb.. travels a lot so couldn't let us know til now.. Did not consult a md yet
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Neck pain
Clinical narrative: Patient said his arm has been sore since he received the second dose and the pain has now moved down his arm and his thumb has become numb.. travels a lot so couldn't let us know til now.. Did not consult a md yet
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Swollen tongue, Throat tightness
Clinical narrative: Allergic Reaction; Tongue swelled; Throat closing up; This is a spontaneous report from a contactable consumer or other non hcp, who is Pfizer colleague (patient). An adult non-pregnant female patient of an unspecified age 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, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and unknown if has been tested positive since the vaccination. On 23Mar2021, after getting first dose of Pfizer Covid 19 vaccine, the patient had allergic reaction; and her tongue swelled and throat closing up. On 24Mar2021, she went to emergency room. Unspecified therapeutic measures were taken as a result of allergic reaction. She further added, her second dose of the vaccine was due today hence asking if she should get it. The patient referred to her vaccination provider and health care professional (HCP). The outcome of the events was unknown. The reporter assessed case as non-serious.   Follow up needed, further information was requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Swollen tongue, Throat tightness
Clinical narrative: Allergic Reaction; Tongue swelled; Throat closing up; This is a spontaneous report from a contactable consumer or other non hcp, who is Pfizer colleague (patient). An adult non-pregnant female patient of an unspecified age 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, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and unknown if has been tested positive since the vaccination. On 23Mar2021, after getting first dose of Pfizer Covid 19 vaccine, the patient had allergic reaction; and her tongue swelled and throat closing up. On 24Mar2021, she went to emergency room. Unspecified therapeutic measures were taken as a result of allergic reaction. She further added, her second dose of the vaccine was due today hence asking if she should get it. The patient referred to her vaccination provider and health care professional (HCP). The outcome of the events was unknown. The reporter assessed case as non-serious.   Follow up needed, further information was requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in right ear; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received bnt162b2, via an unspecified route of administration, administered in left arm on 05Jun2021 13:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient had none other medical history and no known allergies. The patient was not diagnosed with covid prior vaccination. There was no covid tested post vaccination. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, in two weeks. There was no other vaccine in four weeks. The patient experienced tinnitus in right ear on an unspecified date. Therapeutic measures were not taken as a result of event. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: ONE TIME HEADACHE FROM MEDIUM TO STRONG FOR 2 MINUTES; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 13:10 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced one time headache from medium to strong for 2 minutes. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from one time headache from medium to strong for 2 minutes on 22-JUN-2021. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She was tested positive for the Covid-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 24Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for the COVID-19 on 04Apr2021. She wanted to know what she needs to do now (as reported). The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test positive
Clinical narrative: She was tested positive for the Covid-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 24Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for the COVID-19 on 04Apr2021. She wanted to know what she needs to do now (as reported). The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: NEGATIVE ANTIBODY TEST; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced negative antibody test. Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative antibody test was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Antibody test
Clinical narrative: NEGATIVE ANTIBODY TEST; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced negative antibody test. Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative antibody test was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on 23Mar2021 at 13:30 (at the age of 38-years-old) in the left arm as a single dose for COVID-19 immunisation. The patients medical history included allergic to penicillin. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, on an unknown date, the patient was tested for COVID-19 and the result was positive. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021, at 06:30, the patient experienced fatigue. The event did not result in a doctor or other healthcare professional office/clinic visit and the emergency room/ department or urgent care. No treatment was received as a result of the event fatigue. The clinical outcome of the event fatigue was recovering at the time of the report.   No follow-up are attempts needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on 23Mar2021 at 13:30 (at the age of 38-years-old) in the left arm as a single dose for COVID-19 immunisation. The patients medical history included allergic to penicillin. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, on an unknown date, the patient was tested for COVID-19 and the result was positive. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021, at 06:30, the patient experienced fatigue. The event did not result in a doctor or other healthcare professional office/clinic visit and the emergency room/ department or urgent care. No treatment was received as a result of the event fatigue. The clinical outcome of the event fatigue was recovering at the time of the report.   No follow-up are attempts needed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Patient transferred from an outside hospital due to myocarditis after 2nd COVID vaccine
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Injection site pain, Pain
Clinical narrative: Pinching pain on injection side, including left breast that radiates to left shoulder blade for more than 2 weeks.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arteriogram coronary normal, C-reactive protein normal, Chest X-ray normal, Chest pain, Electrocardiogram normal
Clinical narrative: within 24 hours of shot  felt very tired and within 48 hours DOE followed by pain across lower chest with significant impaired ADLs for 17d prompting UC visit - CXR negative, COVID negative given fluticasone MDI & breathing/DOE improved but did not resolve; got 2nd vaccine 5/7; stopped MDI 5/16 due to stomach side effects but by 5/20 significant left sided chest pain eventually prompting ED presentation and admission 5/30
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Liver function test normal, Loss of personal independence in daily activities, Red blood cell sedimentation rate normal, SARS-CoV-2 test negative
Clinical narrative: within 24 hours of shot  felt very tired and within 48 hours DOE followed by pain across lower chest with significant impaired ADLs for 17d prompting UC visit - CXR negative, COVID negative given fluticasone MDI & breathing/DOE improved but did not resolve; got 2nd vaccine 5/7; stopped MDI 5/16 due to stomach side effects but by 5/20 significant left sided chest pain eventually prompting ED presentation and admission 5/30
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin normal
Clinical narrative: within 24 hours of shot  felt very tired and within 48 hours DOE followed by pain across lower chest with significant impaired ADLs for 17d prompting UC visit - CXR negative, COVID negative given fluticasone MDI & breathing/DOE improved but did not resolve; got 2nd vaccine 5/7; stopped MDI 5/16 due to stomach side effects but by 5/20 significant left sided chest pain eventually prompting ED presentation and admission 5/30
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient was given Janssen covid 19 vaccine. Patient fainted during her 15 minutes post vaccine observation period. Patient regained consciousness and refused emergency medical help. Patient did not get inquired and felt better after after resting  in the pharmacy area for over 30 minutes. She was feeling better and left the pharmacy with her father.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture, C-reactive protein increased, Condition aggravated, Epstein-Barr virus infection, Epstein-Barr virus test positive
Clinical narrative: Low-grade fever every day for 2 weeks between 99 and 101 degrees that did not respond to Motrin, Advil or Tylenol, flu-like body aches, extreme fatigue, migraines that interfered with daily activities.  Called my doctor who ordered lab work. Lab worked showed active Epstein Barr infection, positive Covid antibodies, elevated SED rate and high c-reactive protein.  As of July 2, 2021. Still suffering from fatigue, body aches and less frequent fevers. I have sought out alternative medicine with chiropractor care and acupuncture for relief from chronic pain and headaches.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Full blood count, Headache, Laboratory test normal, Loss of personal independence in daily activities
Clinical narrative: Low-grade fever every day for 2 weeks between 99 and 101 degrees that did not respond to Motrin, Advil or Tylenol, flu-like body aches, extreme fatigue, migraines that interfered with daily activities.  Called my doctor who ordered lab work. Lab worked showed active Epstein Barr infection, positive Covid antibodies, elevated SED rate and high c-reactive protein.  As of July 2, 2021. Still suffering from fatigue, body aches and less frequent fevers. I have sought out alternative medicine with chiropractor care and acupuncture for relief from chronic pain and headaches.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Pain, Pyrexia, Red blood cell sedimentation rate increased, SARS-CoV-2 antibody test positive
Clinical narrative: Low-grade fever every day for 2 weeks between 99 and 101 degrees that did not respond to Motrin, Advil or Tylenol, flu-like body aches, extreme fatigue, migraines that interfered with daily activities.  Called my doctor who ordered lab work. Lab worked showed active Epstein Barr infection, positive Covid antibodies, elevated SED rate and high c-reactive protein.  As of July 2, 2021. Still suffering from fatigue, body aches and less frequent fevers. I have sought out alternative medicine with chiropractor care and acupuncture for relief from chronic pain and headaches.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Epstein-Barr virus infection, Epstein-Barr virus test, Fatigue, Headache
Clinical narrative: Low-grade fever every day for 2 weeks between 99 and 101 degrees that did not respond to Motrin, Advil or Tylenol, flu-like body aches, extreme fatigue, migraines that interfered with daily activities.  Called my doctor who ordered lab work. Lab worked showed active Epstein Barr infection, positive Covid antibodies, elevated SED rate and high c-reactive protein.  As of July 2, 2021. Still suffering from fatigue, body aches and less frequent fevers. I have sought out alternative medicine with chiropractor care and acupuncture for relief from chronic pain and headaches.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Pain, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Low-grade fever every day for 2 weeks between 99 and 101 degrees that did not respond to Motrin, Advil or Tylenol, flu-like body aches, extreme fatigue, migraines that interfered with daily activities.  Called my doctor who ordered lab work. Lab worked showed active Epstein Barr infection, positive Covid antibodies, elevated SED rate and high c-reactive protein.  As of July 2, 2021. Still suffering from fatigue, body aches and less frequent fevers. I have sought out alternative medicine with chiropractor care and acupuncture for relief from chronic pain and headaches.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Exposure to vaccinated person, Heavy menstrual bleeding, Intermenstrual bleeding, Pericarditis
Clinical narrative: He has severe headaches  I had pericarditis and spotting and menstrual pain/clots and heavy bleeding.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Syncope, Vomiting
Clinical narrative: Patient has a history of fainting after receiving vaccines.  About 15 seconds after receiving the vaccine, the patient stated that he felt dizzy and then the patient fainted, caught by his wife.  He came to after about 10 seconds.  He then started throwing up and felt dizzy and did not feel good.  Paramedics were called and came to the pharmacy to evaluate vitals etc.  Pt remained conscious.  He declined transport to hospital and paramedics left.  The patient then drank orange juice and water.  He started to feel dizzy again and started throwing up.  Paramedics were called again and they were able to help him into the bathroom and evaluate the patient.  Paramedics walked him to the car and the patient and his wife were going  to drive to the hospital for further evaluation.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies negative, Arthralgia, Blood test, Inflammation, Loss of personal independence in daily activities
Clinical narrative: Two days after receiving the 2nd shot, began to experience inflammation and pain in joints from head to toe. These both have been debilitating, hard to move around, hard to get out of bed, hard climb stairs, hard to use hands due to swelling, hard turn head and cannot kneel down. Life has become very hard and painful. Gabapentin was prescribed and did nothing. My doctor prescribed celecoxib for the pain and inflammation. I've only been using it for 3 days and am having moderate relief, but too soon to tell.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: Two days after receiving the 2nd shot, began to experience inflammation and pain in joints from head to toe. These both have been debilitating, hard to move around, hard to get out of bed, hard climb stairs, hard to use hands due to swelling, hard turn head and cannot kneel down. Life has become very hard and painful. Gabapentin was prescribed and did nothing. My doctor prescribed celecoxib for the pain and inflammation. I've only been using it for 3 days and am having moderate relief, but too soon to tell.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Syncope
Clinical narrative: PATIENT STATED WHILE WAITING IN PHRMACY WAITING SEATED IN  ROOM  HE WAS FEELING  SWEATY /CLAMMY , LIGHT HEADED  ABOUT 10 MINUTES  AFTER  2ND DOSE OF PFIZER COVID 19 VACCINATION GIVIN  AT APPROX 3PM .PATIENT THEN SAID HE STOOD UP TO GET ATTENTION FROM PHARMACY PERSONNELL AND FEINTED . BOTH PHARMACIST AND CLERK SAW PATIENT  PASSING OUT AND LOWERED PATIENT TO THE FLOOR. A  FEW MINUTES LATER PATIENT REGAINED CONCIOUSNESS. PARAMEDICS WERE CALLED AND WAS TAKEN TO HOSPITAL FOR CHECK UP
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Loss of personal independence in daily activities, Magnetic resonance imaging head normal
Clinical narrative: Pt experienced mild symptoms in the first 24-48 hours after the vaccination, including sore arm, low grade fever, chills and fatigue. These symptoms faded within 48 hours. Approximately one day later, Laila experienced an acute onset headache (tension) which has been constant for the past two months. She describes this tension headache as a band of pressure all the way around her head that never goes away.  The constant headache does not interfere with her sleep but impacts her quality of life. She also has intermittent headache pain a few times a week that is more intense but which responds to Excedrin Migraine. She has been taking Topiramate for the past 3-4 weeks to try to address the tension headache but so far it has not relieved the constant headache.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tension headache
Clinical narrative: Pt experienced mild symptoms in the first 24-48 hours after the vaccination, including sore arm, low grade fever, chills and fatigue. These symptoms faded within 48 hours. Approximately one day later, Laila experienced an acute onset headache (tension) which has been constant for the past two months. She describes this tension headache as a band of pressure all the way around her head that never goes away.  The constant headache does not interfere with her sleep but impacts her quality of life. She also has intermittent headache pain a few times a week that is more intense but which responds to Excedrin Migraine. She has been taking Topiramate for the past 3-4 weeks to try to address the tension headache but so far it has not relieved the constant headache.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest X-ray normal, Chest pain, Electrocardiogram normal, Hypertension
Clinical narrative: 8 days after my first dose I woke up with vertigo and chest pain.  I called 911, the EMTs arrived within in minutes.  they checked my vitals, gave me an EKG.  EKG was ok .. blood pressure was very very high.  They took me to the ER.  There they took a chest x-ray (looked ok),  tested me for Covid (negative), tested enzyme for heart attack (negative). They kept me under observation for an hour plus.  Things stabilized so I was discharged.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial necrosis marker normal, SARS-CoV-2 test negative, Vertigo
Clinical narrative: 8 days after my first dose I woke up with vertigo and chest pain.  I called 911, the EMTs arrived within in minutes.  they checked my vitals, gave me an EKG.  EKG was ok .. blood pressure was very very high.  They took me to the ER.  There they took a chest x-ray (looked ok),  tested me for Covid (negative), tested enzyme for heart attack (negative). They kept me under observation for an hour plus.  Things stabilized so I was discharged.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Full blood count normal, Glycosylated haemoglobin, Herpes zoster, Metabolic function test
Clinical narrative: Shingles to right leg,  4 days after 2nd vaccine, near ankle.  9 days later rash started to spread resembling amoxicillin rash in children ( no recent medication taken except Tylenol, benadryl)
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Shingles to right leg,  4 days after 2nd vaccine, near ankle.  9 days later rash started to spread resembling amoxicillin rash in children ( no recent medication taken except Tylenol, benadryl)
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PT vaccinated outside of age range. No adverse reactions noted.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: About one week after I received the Covid vaccine, I got a rash on my left arm. It was about 3 inches across. It did not itch, was not warm, no raised portions. It was red, mostly solid in color.