chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, SARS-CoV-2 antibody test, Status migrainosus
Clinical narrative: Status Migrainsosus; headaches; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 13Apr2021 10:45 (Lot Number: ER 8735) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (lot number: EP6955) 1ST DOSE, on 03Mar2021 04:30pm for COVID-19 immunisation. On 13Apr2021, the patient experienced status migrainsosus and was being seen at the hospital. The patient had severe headaches on 13Apr2021 that's been ongoing since the day the second shot was given. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (nasal swab): negative on 27apr2021. The outcome of the events was not recovered. Treatment of IV infusions migraine emergency medicine was given for the events. The events resulted in emergency room/department or urgent care. The patient was in the hospital for 2 days.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, ringing in the ears; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EN6206), via an unspecified route of administration, administered in arm left on 10Mar2021 12:00 at single dose for COVID-19 immunization at the age of 51-year-old. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced tinnitus, ringing in the ears on 28Mar2021 with outcome of not recovered. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for the event.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Impaired work ability, Injection site pain
Clinical narrative: This is follow-up spontaneous report from a contactable Nurse (patient). A 40-years-old non-pregnant female patient received bnt162b2 (Pfizer biontech, Solution for injection, Lot Number: EW0150), dose 1 via an unspecified route of administration, administered in arm right on 09Apr2021 08:45 (at the time of 40-years-old) as first dose, single for Covid-19 immunisation. Medical history included asthma, POTS (postural orthostatic tachycardia syndrome), depression, anxiety, GERD (gastrooesophageal reflux disease), osteoarthritis, known allergies Latex,zyrtec and walnuts (known allergies Latex, augmentin, mushroom, walnuts. Intolerant of versed, Zyrtec). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.Since the vaccination, the patient had been tested positive for COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); loratadine (CLARITINE) and one a day womens 50 plus vitamin's, all for an unspecified indication, from unknown dates and unknown if ongoing. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and had allergy.  It was reported that within 3 hours moderate dry hacking cough, severe muscle fatigue. On 11Apr2021, rapid test negative for Covid. On 12Apr2021, severe coughing pcp telehealth visit nebulizers ordered. On 14Apr2021, rapid test was positive and on 17Apr2021, PCR performed result positive. The patient underwent lab tests and procedures which included Abbott-Rapid test/Pcr through riteaid: negative-nasal swab on 11Apr2021, positive-nasal swab on 14Apr2021 and positive-nasal swab on 17Apr2021. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, SARS-CoV-2 test positive
Clinical narrative: This is follow-up spontaneous report from a contactable Nurse (patient). A 40-years-old non-pregnant female patient received bnt162b2 (Pfizer biontech, Solution for injection, Lot Number: EW0150), dose 1 via an unspecified route of administration, administered in arm right on 09Apr2021 08:45 (at the time of 40-years-old) as first dose, single for Covid-19 immunisation. Medical history included asthma, POTS (postural orthostatic tachycardia syndrome), depression, anxiety, GERD (gastrooesophageal reflux disease), osteoarthritis, known allergies Latex,zyrtec and walnuts (known allergies Latex, augmentin, mushroom, walnuts. Intolerant of versed, Zyrtec). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.Since the vaccination, the patient had been tested positive for COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); loratadine (CLARITINE) and one a day womens 50 plus vitamin's, all for an unspecified indication, from unknown dates and unknown if ongoing. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and had allergy.  It was reported that within 3 hours moderate dry hacking cough, severe muscle fatigue. On 11Apr2021, rapid test negative for Covid. On 12Apr2021, severe coughing pcp telehealth visit nebulizers ordered. On 14Apr2021, rapid test was positive and on 17Apr2021, PCR performed result positive. The patient underwent lab tests and procedures which included Abbott-Rapid test/Pcr through riteaid: negative-nasal swab on 11Apr2021, positive-nasal swab on 14Apr2021 and positive-nasal swab on 17Apr2021. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Muscle fatigue, SARS-CoV-2 test
Clinical narrative: This is follow-up spontaneous report from a contactable Nurse (patient). A 40-years-old non-pregnant female patient received bnt162b2 (Pfizer biontech, Solution for injection, Lot Number: EW0150), dose 1 via an unspecified route of administration, administered in arm right on 09Apr2021 08:45 (at the time of 40-years-old) as first dose, single for Covid-19 immunisation. Medical history included asthma, POTS (postural orthostatic tachycardia syndrome), depression, anxiety, GERD (gastrooesophageal reflux disease), osteoarthritis, known allergies Latex,zyrtec and walnuts (known allergies Latex, augmentin, mushroom, walnuts. Intolerant of versed, Zyrtec). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.Since the vaccination, the patient had been tested positive for COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); loratadine (CLARITINE) and one a day womens 50 plus vitamin's, all for an unspecified indication, from unknown dates and unknown if ongoing. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and had allergy.  It was reported that within 3 hours moderate dry hacking cough, severe muscle fatigue. On 11Apr2021, rapid test negative for Covid. On 12Apr2021, severe coughing pcp telehealth visit nebulizers ordered. On 14Apr2021, rapid test was positive and on 17Apr2021, PCR performed result positive. The patient underwent lab tests and procedures which included Abbott-Rapid test/Pcr through riteaid: negative-nasal swab on 11Apr2021, positive-nasal swab on 14Apr2021 and positive-nasal swab on 17Apr2021. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dermatitis contact, Feeling abnormal, Migraine, Nausea
Clinical narrative: MIGRAINE HEADACHE; PRONOUNCED FATIGUE; NAUSEA (NO VOMIT); This spontaneous report received from a patient concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On MAR-2021, the subject experienced migraine headache. On MAR-2021, the subject experienced pronounced fatigue. On MAR-2021, the subject experienced nausea (no vomit). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The outcome of the pronounced fatigue, nausea (no vomit) and migraine headache was not reported. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Migraine, Nausea
Clinical narrative: MIGRAINE HEADACHE; PRONOUNCED FATIGUE; NAUSEA (NO VOMIT); This spontaneous report received from a patient concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On MAR-2021, the subject experienced migraine headache. On MAR-2021, the subject experienced pronounced fatigue. On MAR-2021, the subject experienced nausea (no vomit). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The outcome of the pronounced fatigue, nausea (no vomit) and migraine headache was not reported. This report was non-serious.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure decreased, Chest X-ray, Dysstasia, Electrocardiogram, Hypotension
Clinical narrative: Mother states that 18 hours post-vaccination her daughter fainted. She was taken to receive medical help and it was determined that her blood pressure was low and she was given IV fluids. Patient's blood pressure remained low for 11 hours.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Syncope
Clinical narrative: Mother states that 18 hours post-vaccination her daughter fainted. She was taken to receive medical help and it was determined that her blood pressure was low and she was given IV fluids. Patient's blood pressure remained low for 11 hours.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood calcium decreased, Blood pressure decreased, Blood pressure measurement, Chest X-ray, Dysstasia
Clinical narrative: Mother states that 18 hours post-vaccination her daughter fainted. She was taken to receive medical help and it was determined that her blood pressure was low and she was given IV fluids. Patient's blood pressure remained low for 11 hours.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Exercise electrocardiogram abnormal, Loss of consciousness, Urine analysis
Clinical narrative: Mother states that 18 hours post-vaccination her daughter fainted. She was taken to receive medical help and it was determined that her blood pressure was low and she was given IV fluids. Patient's blood pressure remained low for 11 hours.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypotension, Syncope
Clinical narrative: Mother states that 18 hours post-vaccination her daughter fainted. She was taken to receive medical help and it was determined that her blood pressure was low and she was given IV fluids. Patient's blood pressure remained low for 11 hours.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bedridden, Hypotension, Loss of consciousness
Clinical narrative: Mother states that 18 hours post-vaccination her daughter fainted. She was taken to receive medical help and it was determined that her blood pressure was low and she was given IV fluids. Patient's blood pressure remained low for 11 hours.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Minor received Moderna vaccine. Vaccine not approved for use in minors per EUA.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache
Clinical narrative: SHORTNESS OF BREATH; HEAVINESS IN CHEST; HEADACHES; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 135 pounds, and height was 162.56 centimeters. The patient's concurrent conditions included non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage and no medical history. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042AZ1A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced shortness of breath. On 02-APR-2021, the subject experienced heaviness in chest. On 02-APR-2021, the subject experienced headaches. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown, and Ultrasound chest (NR: not provided) unknown. On 16-APR-2021, Laboratory data included: Stress test (NR: not provided) negative/false positive. On 05-MAY-2021, Laboratory data included: CT scan (NR: not provided) results awaiting, and Scan with contrast (NR: not provided) not definitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heaviness in chest, shortness of breath, and headaches. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac stress test, Chest discomfort, Computerised tomogram, Dyspnoea
Clinical narrative: SHORTNESS OF BREATH; HEAVINESS IN CHEST; HEADACHES; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 135 pounds, and height was 162.56 centimeters. The patient's concurrent conditions included non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage and no medical history. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042AZ1A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced shortness of breath. On 02-APR-2021, the subject experienced heaviness in chest. On 02-APR-2021, the subject experienced headaches. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown, and Ultrasound chest (NR: not provided) unknown. On 16-APR-2021, Laboratory data included: Stress test (NR: not provided) negative/false positive. On 05-MAY-2021, Laboratory data included: CT scan (NR: not provided) results awaiting, and Scan with contrast (NR: not provided) not definitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heaviness in chest, shortness of breath, and headaches. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Scan with contrast, Ultrasound chest
Clinical narrative: SHORTNESS OF BREATH; HEAVINESS IN CHEST; HEADACHES; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 135 pounds, and height was 162.56 centimeters. The patient's concurrent conditions included non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage and no medical history. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042AZ1A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced shortness of breath. On 02-APR-2021, the subject experienced heaviness in chest. On 02-APR-2021, the subject experienced headaches. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown, and Ultrasound chest (NR: not provided) unknown. On 16-APR-2021, Laboratory data included: Stress test (NR: not provided) negative/false positive. On 05-MAY-2021, Laboratory data included: CT scan (NR: not provided) results awaiting, and Scan with contrast (NR: not provided) not definitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heaviness in chest, shortness of breath, and headaches. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with COVID; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Apr2021 (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient went to get the shot on 26Apr2021 and on 28Apr2021 she was diagnosed with COVID. On 28Apr2021, the patient tested positive. They wanted to know if they need to get the second shot or delay it. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Apr2021 (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient went to get the shot on 26Apr2021 and on 28Apr2021 she was diagnosed with COVID. On 28Apr2021, the patient tested positive. They wanted to know if they need to get the second shot or delay it. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: acute myocarditis; Pericarditis; This is a spontaneous report from a contactable a physician. A 21-year-old male patient started to receive 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 29Apr2021 at age of 21-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received 1st dose of BNT162B2 on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Acute myocarditis/pericarditis started on 01May2021, 2 days post vaccination, diagnosed on 03May2021, 4 days post vaccination (second dose vaccine). The events resulted in emergency room/department or urgent care visit. Events were serious as hospitalization. Patient received anti inflammatory medications for the events. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: acute myocarditis; Pericarditis; This is a spontaneous report from a contactable a physician. A 21-year-old male patient started to receive 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 29Apr2021 at age of 21-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received 1st dose of BNT162B2 on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Acute myocarditis/pericarditis started on 01May2021, 2 days post vaccination, diagnosed on 03May2021, 4 days post vaccination (second dose vaccine). The events resulted in emergency room/department or urgent care visit. Events were serious as hospitalization. Patient received anti inflammatory medications for the events. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: CAN HARDLY SEE (EVERYTHING FOGGY); SOMETHING MOVING AROUND IN HEAD; SPLITTING HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced can hardly see (everything foggy). On 13-MAY-2021, the subject experienced something moving around in head. On 13-MAY-2021, the subject experienced splitting headache. The action taken with covid-19 vaccine  was not applicable. The outcome of the splitting headache, can hardly see (everything foggy) and something moving around in head was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Vision blurred
Clinical narrative: CAN HARDLY SEE (EVERYTHING FOGGY); SOMETHING MOVING AROUND IN HEAD; SPLITTING HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced can hardly see (everything foggy). On 13-MAY-2021, the subject experienced something moving around in head. On 13-MAY-2021, the subject experienced splitting headache. The action taken with covid-19 vaccine  was not applicable. The outcome of the splitting headache, can hardly see (everything foggy) and something moving around in head was not reported. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea, Pyrexia, Wrong product administered
Clinical narrative: Mixed series: Incorrect mRNA COVID-19 vaccine administered during 2nd dose.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product use issue
Clinical narrative: Mixed series: Incorrect mRNA COVID-19 vaccine administered during 2nd dose.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysstasia, Hyperhidrosis, Loss of consciousness
Clinical narrative: Passed out about 2 minutes after the shot, about 10 steps from where he got the shot.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out about 2 minutes after the shot, about 10 steps from where he got the shot.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Pain in extremity, Peripheral swelling, Thrombectomy
Clinical narrative: 4/24-4/28/2021 pain in left leg hurts to walk or put weight on it 4/29/2021 swelling begins in left lower leg and foot 4/30/2021- 5/4/2021 swelling continues to worsen left leg, can't walk, can't move or feel toes, purple discoloration of foot 5/5/2021 go to Emergency Room                        Admitted into hospital due to extensive blood clot in left leg 5/6/2021 Surgery for removal of blood clot with Dr. 3 hour procedure 70 percent removed 5/7/2021 Released with blood thinner med 5/7/2021 revisit emergency room due to pain swelling and numbness moving into left upper leg and thigh 5/8-512/2021 swelling continues to progress 5/13/2021 follow up at vascular                           Dr.  Readmitted into hospital 5/13 surgery for removal of clot    Not all removed 5/16/2021 released from hospital on blood thinner
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan abnormal
Clinical narrative: 4/24-4/28/2021 pain in left leg hurts to walk or put weight on it 4/29/2021 swelling begins in left lower leg and foot 4/30/2021- 5/4/2021 swelling continues to worsen left leg, can't walk, can't move or feel toes, purple discoloration of foot 5/5/2021 go to Emergency Room                        Admitted into hospital due to extensive blood clot in left leg 5/6/2021 Surgery for removal of blood clot with Dr. 3 hour procedure 70 percent removed 5/7/2021 Released with blood thinner med 5/7/2021 revisit emergency room due to pain swelling and numbness moving into left upper leg and thigh 5/8-512/2021 swelling continues to progress 5/13/2021 follow up at vascular                           Dr.  Readmitted into hospital 5/13 surgery for removal of clot    Not all removed 5/16/2021 released from hospital on blood thinner
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, Computerised tomogram abnormal, Gait disturbance, Gait inability
Clinical narrative: 4/24-4/28/2021 pain in left leg hurts to walk or put weight on it 4/29/2021 swelling begins in left lower leg and foot 4/30/2021- 5/4/2021 swelling continues to worsen left leg, can't walk, can't move or feel toes, purple discoloration of foot 5/5/2021 go to Emergency Room                        Admitted into hospital due to extensive blood clot in left leg 5/6/2021 Surgery for removal of blood clot with Dr. 3 hour procedure 70 percent removed 5/7/2021 Released with blood thinner med 5/7/2021 revisit emergency room due to pain swelling and numbness moving into left upper leg and thigh 5/8-512/2021 swelling continues to progress 5/13/2021 follow up at vascular                           Dr.  Readmitted into hospital 5/13 surgery for removal of clot    Not all removed 5/16/2021 released from hospital on blood thinner
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling, Skin discolouration, Surgical procedure repeated
Clinical narrative: 4/24-4/28/2021 pain in left leg hurts to walk or put weight on it 4/29/2021 swelling begins in left lower leg and foot 4/30/2021- 5/4/2021 swelling continues to worsen left leg, can't walk, can't move or feel toes, purple discoloration of foot 5/5/2021 go to Emergency Room                        Admitted into hospital due to extensive blood clot in left leg 5/6/2021 Surgery for removal of blood clot with Dr. 3 hour procedure 70 percent removed 5/7/2021 Released with blood thinner med 5/7/2021 revisit emergency room due to pain swelling and numbness moving into left upper leg and thigh 5/8-512/2021 swelling continues to progress 5/13/2021 follow up at vascular                           Dr.  Readmitted into hospital 5/13 surgery for removal of clot    Not all removed 5/16/2021 released from hospital on blood thinner
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombectomy, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: 4/24-4/28/2021 pain in left leg hurts to walk or put weight on it 4/29/2021 swelling begins in left lower leg and foot 4/30/2021- 5/4/2021 swelling continues to worsen left leg, can't walk, can't move or feel toes, purple discoloration of foot 5/5/2021 go to Emergency Room                        Admitted into hospital due to extensive blood clot in left leg 5/6/2021 Surgery for removal of blood clot with Dr. 3 hour procedure 70 percent removed 5/7/2021 Released with blood thinner med 5/7/2021 revisit emergency room due to pain swelling and numbness moving into left upper leg and thigh 5/8-512/2021 swelling continues to progress 5/13/2021 follow up at vascular                           Dr.  Readmitted into hospital 5/13 surgery for removal of clot    Not all removed 5/16/2021 released from hospital on blood thinner
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Needle issue, Underdose
Clinical narrative: Per vaccinator,  when attempted to administer vaccination the needle separated from the syringe and all of the vaccine dose sprayed out of syringe. None of the dose was received by the patient, so the dose was readministered.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syringe issue
Clinical narrative: Per vaccinator,  when attempted to administer vaccination the needle separated from the syringe and all of the vaccine dose sprayed out of syringe. None of the dose was received by the patient, so the dose was readministered.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye movement disorder, Fatigue, Loss of consciousness, Musculoskeletal stiffness, Nausea
Clinical narrative: He became nauseated, skin turned pale, and he became lethargic.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pallor, Seizure, Tremor, Visual impairment
Clinical narrative: He became nauseated, skin turned pale, and he became lethargic.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Nausea, Pallor
Clinical narrative: He became nauseated, skin turned pale, and he became lethargic.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Frequent bowel movements, Headache, Somnolence
Clinical narrative: BODY ACHES; THROAT ACHE; CEPHALGIA; PAIN ON APPLICATION SPOT; DROWSINESS; LIGHTHEADED; MIXED UP WORDS; INCREASED BOWEL MOVEMENT; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ibuprofen. On an unspecified date, the subject experienced body aches, drowsiness, lightheaded, mixed up words, increased bowel movement, throat ache, pain on application spot, and cephalgia. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, drowsiness, lightheaded, mixed up words, increased bowel movement, pain on application spot, and cephalgia, and the outcome of throat ache was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Application site pain, Confusional state, Dizziness, Frequent bowel movements, Headache
Clinical narrative: BODY ACHES; THROAT ACHE; CEPHALGIA; PAIN ON APPLICATION SPOT; DROWSINESS; LIGHTHEADED; MIXED UP WORDS; INCREASED BOWEL MOVEMENT; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ibuprofen. On an unspecified date, the subject experienced body aches, drowsiness, lightheaded, mixed up words, increased bowel movement, throat ache, pain on application spot, and cephalgia. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, drowsiness, lightheaded, mixed up words, increased bowel movement, pain on application spot, and cephalgia, and the outcome of throat ache was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Somnolence
Clinical narrative: BODY ACHES; THROAT ACHE; CEPHALGIA; PAIN ON APPLICATION SPOT; DROWSINESS; LIGHTHEADED; MIXED UP WORDS; INCREASED BOWEL MOVEMENT; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ibuprofen. On an unspecified date, the subject experienced body aches, drowsiness, lightheaded, mixed up words, increased bowel movement, throat ache, pain on application spot, and cephalgia. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, drowsiness, lightheaded, mixed up words, increased bowel movement, pain on application spot, and cephalgia, and the outcome of throat ache was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: The bottom of the jaw is swollen and a hump has formed.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness near injection site. Started the evening on the 7th day after 1st vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Discomfort, Dry mouth, Dysgeusia, Electric shock sensation
Clinical narrative: 5/7/21 1:15 pm -  Couple of minutes after my top lip felt swollen and felt tingling with a slight headache.  Had a bit of dry mouth.   5/8/21   7:30 am. -  Heart started racing with elevated blood pressure.  Had a headache and fatigue all day. 5/9/21- headache and fatigue.  Felt an electrifying sensation upon waking throughout my body. 5/10/21 -  left side pressure headache,  fatigue.  Felt an electrifying sensation upon waking throughout my body.  Felt tingling in my face.  5/11/21 -  left pressure headache throughout the day  then at 9:30 pm my left arm went numb and felt left sided pressure headache with tingling in my face. 5/12/21 -  mild headache.  Had metal taste in my mouth. 5/13/21. Mild headache 5/14/21 - heart racing with elevated blood pressure 5/15/21 -  pressure headache
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Lip swelling, Palpitations
Clinical narrative: 5/7/21 1:15 pm -  Couple of minutes after my top lip felt swollen and felt tingling with a slight headache.  Had a bit of dry mouth.   5/8/21   7:30 am. -  Heart started racing with elevated blood pressure.  Had a headache and fatigue all day. 5/9/21- headache and fatigue.  Felt an electrifying sensation upon waking throughout my body. 5/10/21 -  left side pressure headache,  fatigue.  Felt an electrifying sensation upon waking throughout my body.  Felt tingling in my face.  5/11/21 -  left pressure headache throughout the day  then at 9:30 pm my left arm went numb and felt left sided pressure headache with tingling in my face. 5/12/21 -  mild headache.  Had metal taste in my mouth. 5/13/21. Mild headache 5/14/21 - heart racing with elevated blood pressure 5/15/21 -  pressure headache
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: 5/7/21 1:15 pm -  Couple of minutes after my top lip felt swollen and felt tingling with a slight headache.  Had a bit of dry mouth.   5/8/21   7:30 am. -  Heart started racing with elevated blood pressure.  Had a headache and fatigue all day. 5/9/21- headache and fatigue.  Felt an electrifying sensation upon waking throughout my body. 5/10/21 -  left side pressure headache,  fatigue.  Felt an electrifying sensation upon waking throughout my body.  Felt tingling in my face.  5/11/21 -  left pressure headache throughout the day  then at 9:30 pm my left arm went numb and felt left sided pressure headache with tingling in my face. 5/12/21 -  mild headache.  Had metal taste in my mouth. 5/13/21. Mild headache 5/14/21 - heart racing with elevated blood pressure 5/15/21 -  pressure headache
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Diarrhoea, Headache, Nausea
Clinical narrative: Nausea 72hrs Diarrhea 72hrs Chills 72hrs Cold sweats 72hrs Unable to keep any liquids or foods down 72hrs Sore arm 48hrs No energy. 72hrs Ringing sound in head with headache (like TV ringing sound) 72hrs
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Nausea 72hrs Diarrhea 72hrs Chills 72hrs Cold sweats 72hrs Unable to keep any liquids or foods down 72hrs Sore arm 48hrs No energy. 72hrs Ringing sound in head with headache (like TV ringing sound) 72hrs
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 5/14/21 Patient received 2nd dose of COVID Moderna vaccine at 21 days after the 1st dose given on 4/23/21.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: She received immunizations on 5/14/2021.  Parent reported noticing redness and swelling that started the same evening that has been increasing in size. Denies pain, denies limping, denies fever, denies any drainage.  Seen in clinic on 5/17/2021 for evaluation.  10 x 12 cm area of erythema and warmth with minimal swelling to the area.  Consulted with Infectious Disease attending on call who advised that you can see significant redness after getting immunizations.  Watchful waiting advised with close follow-up and recommendations for elevating the area.  Plan to see her back on 5/19/2021 for a recheck. Advised parent if increased swelling, redness, or fever , or she has difficulty walking develops before then to seek care in the Emergency Department or Urgent care.  Mom verbalized understanding.  If no improvement at follow-up plan for further workup as recommended by infectious Disease.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old male patient received 1st dose of COVID Moderna vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Asthenia, Confusional state
Clinical narrative: very fast heartbeat very high blood pressure at onset low blood pressure next day and after difficulty breathing arm pain and can't raise 45 degree trouble sleeping dizzy very very weakness can't open eyes nose bleeding a lot difficulty sitting difficulty chewing food brain fog and confusion muscle joint pain yellow face and palm congestion and running sneezing nose lost smell and taste it's been more than 5 weeks still can't recover most of the symptoms seems like damaged a lot can't do as heavy physical activities and house work lot more food to keep up the energy
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Epistaxis, Feeling abnormal, Heart rate increased
Clinical narrative: very fast heartbeat very high blood pressure at onset low blood pressure next day and after difficulty breathing arm pain and can't raise 45 degree trouble sleeping dizzy very very weakness can't open eyes nose bleeding a lot difficulty sitting difficulty chewing food brain fog and confusion muscle joint pain yellow face and palm congestion and running sneezing nose lost smell and taste it's been more than 5 weeks still can't recover most of the symptoms seems like damaged a lot can't do as heavy physical activities and house work lot more food to keep up the energy
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypotension, Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities
Clinical narrative: very fast heartbeat very high blood pressure at onset low blood pressure next day and after difficulty breathing arm pain and can't raise 45 degree trouble sleeping dizzy very very weakness can't open eyes nose bleeding a lot difficulty sitting difficulty chewing food brain fog and confusion muscle joint pain yellow face and palm congestion and running sneezing nose lost smell and taste it's been more than 5 weeks still can't recover most of the symptoms seems like damaged a lot can't do as heavy physical activities and house work lot more food to keep up the energy
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mastication disorder, Mobility decreased, Myalgia, Pain in extremity, Respiratory tract congestion
Clinical narrative: very fast heartbeat very high blood pressure at onset low blood pressure next day and after difficulty breathing arm pain and can't raise 45 degree trouble sleeping dizzy very very weakness can't open eyes nose bleeding a lot difficulty sitting difficulty chewing food brain fog and confusion muscle joint pain yellow face and palm congestion and running sneezing nose lost smell and taste it's been more than 5 weeks still can't recover most of the symptoms seems like damaged a lot can't do as heavy physical activities and house work lot more food to keep up the energy
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Skin discolouration, Sneezing, Somnolence
Clinical narrative: very fast heartbeat very high blood pressure at onset low blood pressure next day and after difficulty breathing arm pain and can't raise 45 degree trouble sleeping dizzy very very weakness can't open eyes nose bleeding a lot difficulty sitting difficulty chewing food brain fog and confusion muscle joint pain yellow face and palm congestion and running sneezing nose lost smell and taste it's been more than 5 weeks still can't recover most of the symptoms seems like damaged a lot can't do as heavy physical activities and house work lot more food to keep up the energy
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Syncope
Clinical narrative: Patient bopped her head back and then forward (fainted for about one second) after receiving vaccine. Reports of low blood pressure and  dizziness
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Condition aggravated, Headache, Nausea, Neuropathy peripheral
Clinical narrative: Two shots caused severe arm pain body pain fever and nausea headache. First shot those and 4 days later heel Achilles pain neuropathy feet. Se one those and neuropathy myopathy spread to entire body from feet. Referral to neurology and rheumatology. Also waiting  for appt to clinic.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vitamin B12 decreased
Clinical narrative: Two shots caused severe arm pain body pain fever and nausea headache. First shot those and 4 days later heel Achilles pain neuropathy feet. Se one those and neuropathy myopathy spread to entire body from feet. Referral to neurology and rheumatology. Also waiting  for appt to clinic.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Woke up in middle of the night with chills and intense sweating that lasted for approximately one hour.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash determined as shingles activation. Treated with oral and topical steriods and shingles medication.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Syncope
Clinical narrative: After receiving the Pfizer covid-19 vaccine. During the 15 minutes waiting, patient's father took pt to the front of the store to buy ice cream. While he was paying the ice cream, pt fainted and hit head on the register counter.  Ambulance was called. Store personnel and pharmacist check up on pt. She said she was feeling fine. No sign of short of breath or allergic reaction. Emergency personnel arrived and performed check up on pt. Pt stated she was fine and refused the ambulance or the trip to hospital for check up. Pt's dad sign waiver and release with emergency personnel and left store with pt.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Significant changes to menstrual cycle (two separate and distinct mentsruations in a 3 week time period following 6 months with no menstruation)
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Developed pruritis and rash on forearms.  No throat symptoms, chest tightness, shortness of breath, nausea or vomiting.  Rash improved and itching decreased without treatment.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood count, Blood thyroid stimulating hormone, Dizziness, Eyelid ptosis
Clinical narrative: Droopy left eye Dizziness Light headedness Panic attacks Extreme anxiety Headaches Shakiness Fatigue
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Panic attack, Tremor, Vitamin D
Clinical narrative: Droopy left eye Dizziness Light headedness Panic attacks Extreme anxiety Headaches Shakiness Fatigue
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine normal, Full blood count normal, Lipase normal, Liver function test normal, Rash
Clinical narrative: Constitutional symptoms on evening of vaccine. Then with development of rash on chest and forearms the following day.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis normal
Clinical narrative: Constitutional symptoms on evening of vaccine. Then with development of rash on chest and forearms the following day.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Biliary colic, Blood glucose increased, Blood test normal, Hepatic pain, Pain
Clinical narrative: Pain woke me up on the 4th day after vaccine. Pain was on my liver area. The following day my gallbladder was also acting up. On march 14, sharp pain was coming from appendix area, this pain continued for 2 weeks. Til today I still feel that sharp pain, with also liver pain.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Thyroid function test abnormal
Clinical narrative: Pain woke me up on the 4th day after vaccine. Pain was on my liver area. The following day my gallbladder was also acting up. On march 14, sharp pain was coming from appendix area, this pain continued for 2 weeks. Til today I still feel that sharp pain, with also liver pain.