chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulse absent, Sudden death, Unresponsive to stimuli
Clinical narrative: died on 14Apr2021 01:30 pm of a sudden death; first dose of BNT16B2 on 15Mar2021 09:00 am/ second dose via an unspecified route of administration on 02Apr2021; first dose of BNT16B2 on 15Mar2021 09:00 am/ second dose via an unspecified route of administration on 02Apr2021; This is a spontaneous report from a contactable healthcare professional (patient's spouse, nurse practitioner). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 02Apr2021 (lot number: EW0150) as single dose (at the age of 47-years-old) for COVID-19 immunisation, vaccinated at a hospital. Medical history included hypothyroidism, anxiety, and chronic migraine (ongoing). The patient had no known food and drug allergies. Concomitant medications included levothyroxine sodium (SYNTHROID); sumatriptan for migraines; and clonazepam for anxiety. The patient received the first dose of BNT16B2 on 15Mar2021 09:00 am (lot number: EN6708) (at the age of 47-years-old) for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient died on 14Apr2021 01:30 pm of a sudden death. She was found at home unresponsive and pulseless. Efforts at resuscitation were unsuccessful. Her medical history of hypothyroidism, anxiety and chronic migraines do not appear to be contributory. The patient did not receive treatment (as reported). The reporter considered the event to be a serious adverse effect (SAE). A full autopsy has been performed; the results were pending.; Reported Cause(s) of Death: died on 14Apr2021 01:30 pm of a sudden death
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, SARS-CoV-2 test, Seizure, Vomiting
Clinical narrative: Severe nausea; vomiting; loss of consciousness; seizures; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727 and expiration date not provided) via an unspecified route of administration, administered in left arm on 25Mar2021 as a single dose for COVID-19 immunisation. Medical history included Cancer hx, Supraventricular tachycardia (SVT), Sjogrens, Epilepsy, Chronic kidney disease (CKD), Hyperthyroidism, Short gut, Osteoarthritis, malnutrition, Bartter's Syndrome Type 3, Hashimoto's Disease, Allergies to Penicillin, Adhesive, Vicryl sutures and cobalt. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydroxychloroquine; doxycycline; and levothyroxine sodium (SYNTHROID) and more (unspecified). The patient previously took iron dextran, povidone-iodine (BETADINE), metronidazole (FLAGYL), lamotrigine (LAMICTAL) and doxepin and experienced Allergies. The patient also took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) in the left arm on 04Mar2021, 01:15 PM for COVID-19 Immunization. The patient did not receive any other vaccine in 4 weeks. On 26Mar2021 19:00, the patient experienced Severe nausea, vomiting, loss of consciousness, seizures. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Life threatening illness (immediate risk of death from the event). Treatment was given in response to the events which included IV antiemetics, IV hydration, IV Benadryl, Antiepileptics. The patient underwent COVID test post vaccination via nasal swab (rapid antigen test) on 01Apr2021 which was negative and via nasal swab (PCR) on 16Apr2021 which was negative. The outcome of the events was not recovered.; Sender's Comments: Based on the close temporal relationship, the association between the events nausea, vomiting, loss of consciousness, and seizures with BNT162b2 can not be fully 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: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: paralysis; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient had partial paralysis since getting the Pfizer vaccine last week (unspecified date). Her claim is that the paralysis was due to her getting the shot last Friday (unspecified date). The doctors that are tending to her say they are indeed looking into the cause and that a possible one could be the vaccine. The patient was hospitalized due the event. The event was assessed as life-threatening. Outcome of the event was unknown.   Information about the Lot/batch number has been requested.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 38-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 38-years-old), administered in Arm Left on 23Mar2021 08:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included eosinophilic oesophagitis (Eoe), multiple allergies, Latex, bees, pollen, animals, eggs, corn, and wheat. No history of COVID prior vaccination. Concomitant medications included chlorthalidone, lisinopril, pantoprazole, bupropion hydrochloride (WELLBUTRIN), all taken for unspecified indications, start and stop dates were not reported. The patient experienced appendicitis on 23Mar2021 08:15. The patient was hospitalized for appendicitis for 1 day. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 24Mar2021 (Nasal Swab, Negative). Therapeutic measures were taken as a result of appendicitis which included Emergency Appendectomy. The outcome of the event was recovering. Event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Facility type vaccine was Hospital. No other vaccines in four weeks.  Information about the Lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic stroke, SARS-CoV-2 test
Clinical narrative: hemorrhagic stroke; This is a spontaneous report from a Non-contactable consumer Via Pfizer sales representative. A 60-years-old and female patient received the second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER7449 and expiry date: 30Jun2021), via an unspecified route on 22Apr2021 at single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER1741 and expiry date unknown,) via unspecified route on 28Feb2021 as single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. There was no known allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 post vaccination. On 08Apr2021, the patient had a hemorrhagic stroke on an island off the coast. She had taken to provincials and life flighted to a hospital for emergency brain surgery. The adverse resulted the patient emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was 14 days of hospitalization. On the same date, COVID test was negative. The patient did not receive any treatment for the event. Outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Factor V Leiden mutation, Laboratory test, Pain in extremity, Peripheral swelling
Clinical narrative: unprovoked right leg DVT; bilateral PEs; Factor V Leiden positive (hetereozygous); right leg swelling and pain progressively worsening; right leg swelling; This is a spontaneous report from a contactable consumer (patient). A 29 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 10:00 (Lot Number: EL1283) as SINGLE DOSE for COVID-19 immunisation. The patient previously had first dose of BNT162B2 on 29Dec2020 at the age of 29 years old for COVID-19 immunisation. Medical history included pleural effusion w/ thoracentesis x2 (5 years ago), known allergies: penicillin and sulfa drugs from an unknown date and unknown if ongoing. Concomitant medication included armodafinil taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the workplace. 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 28Jan2021. On 28Jan2021, the patient presented to the ED with right leg swelling and pain progressively worsening over the past week. Subsequently diagnosed with unprovoked right leg DVT and bilateral PEs, admitted overnight and given anticoagulation therapy. Labs ordered and reviewed with hematology consult 1 week later and found to be Factor V Leiden positive (hetereozygous). Treatment plan therapeutic dose of Eliquis twice a day for 1 year, prophylactic dose indefinitely after that. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The events were reported as life threatening illness as patient was in immediate risk of death from the events. The patient was hospitalized for 1 day. The events was recovering. The events was treated with anticoagulation therapy, pain medicine and stockings.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: unprovoked right leg DVT; bilateral PEs; Factor V Leiden positive (hetereozygous); right leg swelling and pain progressively worsening; right leg swelling; This is a spontaneous report from a contactable consumer (patient). A 29 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 10:00 (Lot Number: EL1283) as SINGLE DOSE for COVID-19 immunisation. The patient previously had first dose of BNT162B2 on 29Dec2020 at the age of 29 years old for COVID-19 immunisation. Medical history included pleural effusion w/ thoracentesis x2 (5 years ago), known allergies: penicillin and sulfa drugs from an unknown date and unknown if ongoing. Concomitant medication included armodafinil taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the workplace. 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 28Jan2021. On 28Jan2021, the patient presented to the ED with right leg swelling and pain progressively worsening over the past week. Subsequently diagnosed with unprovoked right leg DVT and bilateral PEs, admitted overnight and given anticoagulation therapy. Labs ordered and reviewed with hematology consult 1 week later and found to be Factor V Leiden positive (hetereozygous). Treatment plan therapeutic dose of Eliquis twice a day for 1 year, prophylactic dose indefinitely after that. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The events were reported as life threatening illness as patient was in immediate risk of death from the events. The patient was hospitalized for 1 day. The events was recovering. The events was treated with anticoagulation therapy, pain medicine and stockings.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Haemorrhage, Palpitations
Clinical narrative: Blood clots; Major blood loss; Blurred vision; Heart palpitations; Shortness of breath; Extreme fatigue; Dizziness; This is a spontaneous report from a contactable other hcp (patient).    This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 29Mar2021 12:00 (Lot number was not reported) as single dose (at 37 years old) for COVID-19 immunisation.  Medical history none. There were no concomitant medications. On 31Mar2021 01:00, the patient experienced blood clots, major blood loss, blurred vision, heart palpitations, shortness of breath, extreme fatigue, dizziness. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events included blood transfusion, ongoing tests, ultrasounds. The events required a visit to the emergency room and a visit to the physician's office. Seriousness criteria of the events was reported as serious due to disability and life threatening. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No allergies. The patient was not pregnant at the time of vaccination.  The information on the Lot / Batch number has been requested.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported events cannot be completely excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Vision blurred
Clinical narrative: Blood clots; Major blood loss; Blurred vision; Heart palpitations; Shortness of breath; Extreme fatigue; Dizziness; This is a spontaneous report from a contactable other hcp (patient).    This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 29Mar2021 12:00 (Lot number was not reported) as single dose (at 37 years old) for COVID-19 immunisation.  Medical history none. There were no concomitant medications. On 31Mar2021 01:00, the patient experienced blood clots, major blood loss, blurred vision, heart palpitations, shortness of breath, extreme fatigue, dizziness. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events included blood transfusion, ongoing tests, ultrasounds. The events required a visit to the emergency room and a visit to the physician's office. Seriousness criteria of the events was reported as serious due to disability and life threatening. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No allergies. The patient was not pregnant at the time of vaccination.  The information on the Lot / Batch number has been requested.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported events cannot be completely excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. 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
Symptoms: Biopsy, Death, Dizziness, Fatigue, Seizure
Clinical narrative: seizures; dizziness; fatigue; passed away; This is a spontaneous report from a contactable Consumer. This Consumer reported for a 33-year-old male patient (friend) who deceased who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown), via an unspecified route of administration on an unknown date in Mar2021 at a single dose for COVID-19 immunization. The reporter wanted to know if there were any reports or information on patients having severe seizures or blood clotting, he was trying to find out for some information on similar adverse events that occurred with the Johnson & Johnson COVID vaccine, but from receiving the Pfizer-BioNTech COVID-19 vaccine the person that had the severe reaction went to the doctor and the doctor said it was highly unlikely from the vaccine. The reporter tried to look online for potential side effects, to help the family provide some type of (information about this). The reported stated the patient was very healthy, young 33 years old, never had a history of seizures, he had no past medical issues. He received second dose middle of march, he passed on 13Apr2021. On the third week after receiving second dose, he started experiencing dizziness and fatigue that later progress into seizures, he was admitted into the hospital, and was no longer under control. Doctors said was highly unlikely it was from the vaccine however every test came back negative; X-Rays, biopsies, everything negative. The patient deceased and outcome of the events was unknwon.  Information on the Lot/Batch number has been requested. ; Reported Cause(s) of Death: passed away
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: seizures; dizziness; fatigue; passed away; This is a spontaneous report from a contactable Consumer. This Consumer reported for a 33-year-old male patient (friend) who deceased who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown), via an unspecified route of administration on an unknown date in Mar2021 at a single dose for COVID-19 immunization. The reporter wanted to know if there were any reports or information on patients having severe seizures or blood clotting, he was trying to find out for some information on similar adverse events that occurred with the Johnson & Johnson COVID vaccine, but from receiving the Pfizer-BioNTech COVID-19 vaccine the person that had the severe reaction went to the doctor and the doctor said it was highly unlikely from the vaccine. The reporter tried to look online for potential side effects, to help the family provide some type of (information about this). The reported stated the patient was very healthy, young 33 years old, never had a history of seizures, he had no past medical issues. He received second dose middle of march, he passed on 13Apr2021. On the third week after receiving second dose, he started experiencing dizziness and fatigue that later progress into seizures, he was admitted into the hospital, and was no longer under control. Doctors said was highly unlikely it was from the vaccine however every test came back negative; X-Rays, biopsies, everything negative. The patient deceased and outcome of the events was unknwon.  Information on the Lot/Batch number has been requested. ; Reported Cause(s) of Death: passed away
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Blood bilirubin, Blood bilirubin abnormal, Disorientation
Clinical narrative: Bilirubin level of 12 (jaundice); Bilirubin level of 12 (jaundice); Peeling & itching hands, feet; Peeling & itching hands, feet; faceSweats; lung pain with deep breaths; abdominal pain; lower back pain; disoriented; This is a spontaneous report from a Contactable Consumer. A 51-Year-old male patient received BNT162B2 (Pfizer Covid-19, Formulation: Solution for injection, Batch/Lot no: EW0153) first dose via unspecified route of administration, administered in left arm on 11Apr2021, as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Patient not had COVID prior vaccination. Patient not tested for COVID post vaccination. On unspecified date Bilirubin level of 12 (jaundice) Peeling & itching hands, feet, & face Sweats, lung pain with deep breaths, abdominal pain, lower back pain, disoriented. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event) hospitalized up to six days. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Jaundice, Pruritus, Pulmonary pain, Skin exfoliation
Clinical narrative: Bilirubin level of 12 (jaundice); Bilirubin level of 12 (jaundice); Peeling & itching hands, feet; Peeling & itching hands, feet; faceSweats; lung pain with deep breaths; abdominal pain; lower back pain; disoriented; This is a spontaneous report from a Contactable Consumer. A 51-Year-old male patient received BNT162B2 (Pfizer Covid-19, Formulation: Solution for injection, Batch/Lot no: EW0153) first dose via unspecified route of administration, administered in left arm on 11Apr2021, as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Patient not had COVID prior vaccination. Patient not tested for COVID post vaccination. On unspecified date Bilirubin level of 12 (jaundice) Peeling & itching hands, feet, & face Sweats, lung pain with deep breaths, abdominal pain, lower back pain, disoriented. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event) hospitalized up to six days. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Headache, Transient ischaemic attack
Clinical narrative: Having headaches every day since this has happened; Had TIA (memory loss); Have no memory of 24 hours, could not answer any questions had lost memory; This is a spontaneous report from a contactable consumer (patent).  A 70-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 04Mar2021 09:45; at the age of 70-years-old, (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.   The patient received the first dose of bnt162b2 on 02Feb2021.  Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported.  No Covid tested post vaccination performed.  The patient experienced Transient ischaemic attack (TIA) on 13Mar2021 and was admitted to hospital, she could not answer to any questions and had lost memory. The patient had no memory of 24 hours, could not answer any questions had lost memory. She also complained headaches every day since this has happened (as reported).  The reported events were  headache (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae,  Transient ischaemic attack (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae, Amnesia (have no memory of 24 hours), (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae.    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: dies hours after getting Covid-19 vaccine; This is a spontaneous report from a non-contactable consumer (Pfizer-sponsored program). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced dies hours after getting covid-19 vaccine on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal.  No follow-up attempts are Possible; information about batch/ lot number cannot be obtained.; Reported Cause(s) of Death: dies hours after getting Covid-19 vaccine
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: after second (day 3) dose ran a fever for about 24 hours then again after third (day 7) dose ran a high fever; 104 Fahrenheit fever for 24 hours; Initial information was received on 16-Apr-2021 regarding an unsolicited valid  non-serious case from a physician.  This case involves a four-year-old female patient who experienced after second (day 3) dose ran a fever for about 24 hours then again after third (day 7) dose ran a high fever; 104 Fahrenheit fever for 24 hours  (pyrexia), after receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history included Animal scratch. The patient's past medical treatment(s), vaccination(s) and family history were not provided. List concomitant -no other vaccines.  On 07-Apr-2021, the patient received a first dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via intramuscular route in the left leg. She also received second and third dose of the same vaccine on 09-Apr-2021 and 13-Apr-2021 respectively, (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in APR-2021, the patient developed non-serious after second (day 3) dose ran a fever for about 24 hours then again after third (day 7) dose ran a high fever; 104 Fahrenheit fever for 24 hours (pyrexia) (unknown latency) following the administration of RABIES (HDC) VACCINE.  It was reported that, the child received the first dose without problem. Her fourth (day 14) dose is due on Wednesday, 07-Apr-2021, and her parents are concerned regarding the elevated fever.  Relevant laboratory test results included: Body temperature - On an unknown date: 104 Fahrenheit.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown for the event.  There will be no information available on the lot number for the two doses in this case.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Back pain, Chills, Flatulence, Malaise
Clinical narrative: Moderna COVID-19 Vaccine EUA  04/28/2021 0925: Vaccination given 1000: Tylenol (1000mg) 2030: Noticed arm was sore at vacc spot 2105: Tylenol (1000mg) 2350: Started getting chills 04/29/2021 0030: Extreme chills, no apparent fever (temp: 98.7F) 0120: Lower back pain - felt similar to when I had a kidney stone. (About a 5 to 6) Passed some gas, but no relief 0134: Lower abdominal pain, like bad gas (About a 3 to 4) 0142: Lower back and abdominal pain subsiding 0150: Lower back and abdominal pain resolved 0157: Whole body aches;  malaise  If I remove the heavy coat keeping me warm, I get chilled quickly.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Moderna COVID-19 Vaccine EUA  04/28/2021 0925: Vaccination given 1000: Tylenol (1000mg) 2030: Noticed arm was sore at vacc spot 2105: Tylenol (1000mg) 2350: Started getting chills 04/29/2021 0030: Extreme chills, no apparent fever (temp: 98.7F) 0120: Lower back pain - felt similar to when I had a kidney stone. (About a 5 to 6) Passed some gas, but no relief 0134: Lower abdominal pain, like bad gas (About a 3 to 4) 0142: Lower back and abdominal pain subsiding 0150: Lower back and abdominal pain resolved 0157: Whole body aches;  malaise  If I remove the heavy coat keeping me warm, I get chilled quickly.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Pruritus
Clinical narrative: Pt reported itchiness at 1345. BP was 162/100 mmHg, HR 73 bpm, and spo2% 96%. Patient given water. Patient given oral dihpenhydramine oral solution 25 mg/10 ml (2 doses). Patient reassessed at 1408: BP  190/108 mmHg, HR 70 bpm, and spo2 98%. Patient reassessed at  1423.: BP 148/94, HR 69, spo2 98%. Patient educated on seeing primary care provider for high blood pressure and reaction to shrimp. Patient educated on carrying bendaryl with him. At approx. 1424, pt left facility with steady gait and unlabored respirations.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdomen scan normal, Abdominal pain, Blood test normal, Nausea, Urine analysis normal
Clinical narrative: Abdominal pain and nausea  lingering side effect of vaccine.  4/15: Prescribed Zofran For nausea (caused headaches, discontinued taking)  4/28:  Prescribed promethazine for nausea & Tylenol w/codeine for pain   The abdominal pain and nausea have been going on since Getting vaccine, no doctor has an answer as to when it might stop.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: At 1110, pt reported dizziness that started at 1055 and lasted for approximately 10-15 minutes.  BP was 132/78 mmHg and HR 70 bpm.  Patient given water and assisted into anti-gravity chair. Patient advised to wait for further observation.  Pt reassessed at 1140. Pt refused vitals. Pt reported no dizziness. Pt left facility to self with unlabored respirations and steady gait at 1141.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: General side effects: Fatigue, headache, muscle pain, joint pain, chills and nausea.  Treatment: Ibuprofen 800 mg and rest. Course: Approx 18 hours
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: General side effects: Fatigue, headache, muscle pain, joint pain, chills and nausea.  Treatment: Ibuprofen 800 mg and rest. Course: Approx 18 hours
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: A large red swollen and itchy bump appeared on my arm about a week after I received the shot. It is further down my arm than the injection site but aligns with pictures and reports of "Covid arm" I've researched and heard about from friends.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt reported dizziness to vaccinator at vaccination chair. Pt given water and orange juice. Patient advised to wait for further observation. Pt reassessed at approx. 1550. Pt had unlabored respirations and denied itchiness/rashes.  At approx. 1551, pt left facility to mother with unlabored respirations and steady gait.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Troponin increased
Clinical narrative: NSTEMI
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, very achy. Entire arm is in pain
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Syncope, Vomiting
Clinical narrative: Patient fainted and was unconscious for about 10-20 seconds. Patient also felt nauseous and vomited. Paramedics were called and patient was examined. No further treatment needed.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia
Clinical narrative: Headache, myalgia, cough
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Loss of consciousness, Syncope
Clinical narrative: Patient fainted and unconscious less than 10 seconds.  Patient flushed and admitted she had not eaten since the am. No further treatment required.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Within an hour, I had broken out in hive-like, chicken pox one by one. It started on my right on where I received vaccine and has now spread down both arms, my legs, feet, hands, back of neck, and chin. They are extremely uncomfortable and itchy. It?s been 12 hours since my shot, and rash has only gotten worse. Benadryl and Hydrocortisone Cream isn?t helping much.
Age: 99.0
Sex: U
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: mild diaria from Sunday 25 of April, than evening 27 of April  diaria got very intens. The same evening I went to sleep and wake up at 2 am 28 of April with vomiting.  at 6.00 am I walk up with massive body ache, headache and fever was reaching 39. at 10 am I manage to take paracetamol but didn't feel any relief, fever was still 39. Later the same day I took paracetamol 2 more times. on the end of the day I took aspirin.  Fever decreased at 6 am 29 of April but body ache and headache are still present
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: mild diaria from Sunday 25 of April, than evening 27 of April  diaria got very intens. The same evening I went to sleep and wake up at 2 am 28 of April with vomiting.  at 6.00 am I walk up with massive body ache, headache and fever was reaching 39. at 10 am I manage to take paracetamol but didn't feel any relief, fever was still 39. Later the same day I took paracetamol 2 more times. on the end of the day I took aspirin.  Fever decreased at 6 am 29 of April but body ache and headache are still present
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Full blood count, Lipids, Magnetic resonance imaging, Metabolic function test
Clinical narrative: Patient had TIA affecting left side of body with symptoms persistent out to 2 hours after onset.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: Patient had TIA affecting left side of body with symptoms persistent out to 2 hours after onset.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Pyrexia, Tremor
Clinical narrative: Slight fever, severe chills and shaking to the bone where whole body tightens. Took 2 alka-seltzer plus cold and flu evervescent  tablets. Waiting to see if works.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Computerised tomogram abnormal, Flank pain, Pulmonary embolism
Clinical narrative: I developed severe lower back/flank pain about 4 days after receiving my 2nd Moderna vaccination.  The pain was most pronounced while lying supine and , while in that position, manifested a creeping , fluid nature, i.e. migrating from my lower back to my shoulder.  I was unable to lie down comfortably.  In thinking about the nature of this pain, I determined that it was possibly/probably from a PE as it seemed as if  pain was migrating from my lower back to my shoulder.  I'm "not a doctor but play one on TV" (LOL ) so surmised that it was something serious that  decided that this was something needing attention.  I presented to a hospital ER for care and was ultimately told I had 2 small PE blood clots - 1 in the base of each lung.  My diagnosis was confirmed by a CT scan and I was subsequently admitted for observation.  I was discharged the following day with blood thinners and blood pressure medication.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: See previous. I am in agony.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Urinary incontinence
Clinical narrative: Dizziness, Fainting and loss of bladder control (possible seizure?)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Hard lump, itchy skin at injection site
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Moderna arm 8 days after shot.  Itchy large red patch about 4? tall and 2? wide Over 3 days, grew larger then faded
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Head injury, Nausea
Clinical narrative: 33 year old female with no significant past medical history presents to the ED with syncope s/p receiving first COVID-19 vaccination this evening at 1758. The patient states that she completed her 15 minutes of observation when she suddenly felt dizziness after standing and had a syncopal episode, waking up on the ground. Per the nurse at the scene, the patient hit the back of her head. The patient does not remember hitting the back of her head as she lost consciousness prior to falling. Since then, the patient has been experiencing symptoms of generalized weakness and intermittent nausea, but denies symptoms of headache, visual changes, vomiting, neck pain, back pain, shortness of breath, chest pain, or abdominal pain. The patient has had normal PO intake today. She reports that she has had three separate syncopal episodes s/p getting her blood drawn in the past, but denies syncopal episode s/p receiving vaccinations in the past. The patient is an otherwise healthy individual with no known drug allergies, taking no daily medications, and denies the use of alcohol, tobacco, or drugs. Her last normal menstrual period was completed recently and she denies any chance of pregnancy, recent pregnancies, or currently nursing.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: 33 year old female with no significant past medical history presents to the ED with syncope s/p receiving first COVID-19 vaccination this evening at 1758. The patient states that she completed her 15 minutes of observation when she suddenly felt dizziness after standing and had a syncopal episode, waking up on the ground. Per the nurse at the scene, the patient hit the back of her head. The patient does not remember hitting the back of her head as she lost consciousness prior to falling. Since then, the patient has been experiencing symptoms of generalized weakness and intermittent nausea, but denies symptoms of headache, visual changes, vomiting, neck pain, back pain, shortness of breath, chest pain, or abdominal pain. The patient has had normal PO intake today. She reports that she has had three separate syncopal episodes s/p getting her blood drawn in the past, but denies syncopal episode s/p receiving vaccinations in the past. The patient is an otherwise healthy individual with no known drug allergies, taking no daily medications, and denies the use of alcohol, tobacco, or drugs. Her last normal menstrual period was completed recently and she denies any chance of pregnancy, recent pregnancies, or currently nursing.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Oropharyngeal pain, Product administered to patient of inappropriate age, Swollen tongue
Clinical narrative: History of Present Illness: This is a 17-year-old male with history of asthma brought in by his mother who presents to the ED after an allergic reaction. The patient was receiving his first dose of the Pfizer vaccine at the vaccine clinic here approximately at 1:15 PM. He then started to develop left-sided neck tightness, throat pain, and tongue swelling 30 minutes afterwards and brought here. Currently, the patient's symptoms are constant, moderate in severity, and has no alleviating or aggravating factors. The patient has significant allergies to cats, grass, and dust but no known drug allergies. The patient also received a meningitis vaccine 1 month ago. The patient's parents are both fully vaccinated.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Epistaxis
Clinical narrative: nose bleeds, black and blue marks weeks later,
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood urine present, Dyspnoea, Fatigue, Headache
Clinical narrative: Full body aches and pain in both the joints and muscles. Headache, fatigue,  easily out of breath. These started the day after and went away the next day. Day after injection saw blood in urine. Has not gone away.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Full body aches and pain in both the joints and muscles. Headache, fatigue,  easily out of breath. These started the day after and went away the next day. Day after injection saw blood in urine. Has not gone away.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: fever, headache, nausea, chills
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Nausea
Clinical narrative: Shortness of breath, cough, nausea
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Nausea, Wheezing
Clinical narrative: Shortness of breath, cough, nausea
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Nausea
Clinical narrative: Patient presented to virtual urgent care with SOB, wheezing, chest tightness, nausea after receiving 2nd dose of Moderna on 4/28/2021. She was referred to the ER for face to face evaluation.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Nausea, Wheezing
Clinical narrative: Patient presented to virtual urgent care with SOB, wheezing, chest tightness, nausea after receiving 2nd dose of Moderna on 4/28/2021. She was referred to the ER for face to face evaluation.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: A rash occurred on my neck around 9pm on 4/25. Two days later the rash has progressed from my neck up to my face. Extremely itchy.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID19 INFECTION; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 07:00 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the subject experienced confirmed covid19 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive (units unspecified), and COVID-19 rapid POC test (NR: not provided) Positive (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid19 infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Disturbance in attention, Dizziness, Paraesthesia
Clinical narrative: TINGLING; LOSS OF CONCENTRATION; DIZZINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled high blood pressure, and compazine allergy. 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 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tingling, loss of concentration, and dizziness. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, and CT scan (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling, loss of concentration and dizziness was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cough, Dysphonia, Rash
Clinical narrative: During observation period at the clinic, patient developed rash and a hoarse voice. Rash spread out through her arms and back. No tongue or lips edema.  No slurred speech. Pt speaking in full sentences, provided her mother's full name and phone number. BP stable in 128/72, HR 80. She was given 2 tablets of Benadryl 25mg PO. Pt walked towards ambulance on site. Placed in supine position, vitals remained stable, BP now in 120/76. Pt developed dry cough and was feeling anxious. Nasal cannula  and Solumedrol were started by paramedics. Was also placed on Atrovent respiratory therapy. Pt was then taken to the ER. Pt was contacted 3 days after event, she refers to be feeling better. Reports
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Bursitis, Injected limb mobility decreased, Product administration error
Clinical narrative: Bursitis from vaccine. Poorly administered in wrong location with a needle that was possibly too long. Clinician did not  roll up my sleeve and examine my arm before choosing needle size. Cannot lift or use left arm after 1 week.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Cough, Pyrexia
Clinical narrative: 4/10 - 4/11 -- chills throughout the evening 4/11 -- fever* of 102 4/12 -- fever* of 103 -- took 1 acetaminophen at 2 pm & 12 pm 4/13 -- fever* back to 103 by 6 pm, so started taking 1 acetaminphen every 6 hours until 11 pm 4/14 -- fever* of 100 at 5 pm, took last acetaminophen at 6 pm 4/15 -- no fever at 7 a.m. or 2 p.m.; very weak  * Fever accompanied by chills & cold sweats. Slight cough also developed & lasted a couple weeks (possibly allergies tho' I'm on allergy meds).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Incorrect route of product administration, Movement disorder, Pain in extremity, Sleep disorder
Clinical narrative: When I received the shot I felt it in my teeth.  Didn't think anything of it until that evening when my shoulder started hurting much more than any other shot I'd had before.  Sleepless night with so much pain.  Pain the next day and next evening so bad that it was impossible to sleep.  Finally took a Tylenol and that helped a bit.  Better for a few days and then a week after the shot my shoulder is hurting again, with weakness and reduced range of motion.  I'm thinking that the needed went in too deep and caused an injury.  I have had this issue before where I've had a year of pain and therapy to my shoulder and am wondering if it was caused by an incorrect injection during a flu shot.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: I suffer from tinnitus and immediately after the shot my ears started roaring! Stayed that was for almost two weeks. I visited my doctor over it and she said make sure and report it to CDC so here you go!
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Breast discomfort
Clinical narrative: Breast discomfort terrible sorry i got 2 pfizers