chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pelvic pain, Photophobia, Skin burning sensation, Urticaria
Clinical narrative: Headache, Myalgia, SkinRash, Light sensitivity,  Narrative: Received 1st dose 1/5/21 - 1 week later noted arm pain, and swelling/redness at injection site - with a welt 4 inches in diameter. Received 2nd dose 2/2/21. Awoke the next morning with arm pain, otherwise feeling fine. Noted onset of headache with light sensitivity as day progressed, as well as neck and low back/pelvic pain. Symptoms improved later in the day 2/4/21. On 2/6/21 ate at a restaurant and had a margarita - shortly after felt face burning, a little short of breath and noted hives on face and neck. Also developed hives on her torso. No history of food/alcohol allergy. Treated with diphenhydramine with resolution within several hours. Missed work x 1.5 days. No known prior COVID infection.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Impaired work ability
Clinical narrative: Headache, Sedation, Myalgia, Chills, Poor sleep,  Narrative: Following 1st dose on 12/31/20 noted lethargy starting 5 hours after injection which lasted 10/15 hours. Received 2nd dose on 1/26/21. Received 2nd dose on 1/26/21. Within several hours noted onset of chills. Also noted fatigue and headache with interrupted sleep that night. On 1/27/21 noted persistent fatigue, myalgias, and felt hot. Symptoms resolved afternoon of 1/28/21. Missed work x 1 day. No known prior COVID infection.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Poor quality sleep, Sleep disorder
Clinical narrative: Headache, Sedation, Myalgia, Chills, Poor sleep,  Narrative: Following 1st dose on 12/31/20 noted lethargy starting 5 hours after injection which lasted 10/15 hours. Received 2nd dose on 1/26/21. Received 2nd dose on 1/26/21. Within several hours noted onset of chills. Also noted fatigue and headache with interrupted sleep that night. On 1/27/21 noted persistent fatigue, myalgias, and felt hot. Symptoms resolved afternoon of 1/28/21. Missed work x 1 day. No known prior COVID infection.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Headache & Diarrhea Narrative:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Nasal congestion
Clinical narrative: Headache, nasal congestion Narrative: Received 2nd dose on 1/29/21 - 16 hours later a severe headache and nasal congestion which persisted until 2/4/21. Missed work x 1 day due to severity of headache. No known prior COVID infection.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, FATIGUE CHILLS Narrative:  Other Relevant History:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Day 2 = HA, sore arm at injection site; Day 3 = sore arm at injection site. Narrative:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVERS 101 THEN 102 Narrative: Patient's wife called to report her husband has a fever. he received the Moderna vaccine yesterday he is only 2 months post covid infection. He had a fever of 101 this morning and she gave him 500mg of Tylenol at 2pm temp up to 102.6 so she gave him 2 more tylenol to equal 500mg. CONTINUED APA 650MG X'S 2 MORE DAYS THEN RESOLVED.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Musculoskeletal disorder, Vertigo
Clinical narrative: VERTIGO;UNABLE TO USE ARMS/LEGS;UNABLE TO SPEAK Narrative:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Computerised tomogram head normal, Confusional state, Full blood count normal, Hyperhidrosis
Clinical narrative: Confusion, diaphoresis, tunnel vision, hypoxemia Narrative:  Admitted to hospital from emergency room after presenting with altered mental status. Found to be hypoxic, given D50 and CT of head. CT negative, felt better with oxygen and was admitted to floor on telemetry. No cardiac irregularity on monitor during hospitalization. MRI of brain had no evidence of acute CVA subdural or acute abnormality to explain altered mental status that improved without anything more than hydration. CBC and chemistry panels were normal grossly, sugars were not a problem, blood pressure well controlled. Discharged to prior living circumstances. Was not given 2nd COVID injection.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Laboratory test normal, Mental status changes, Tunnel vision
Clinical narrative: Confusion, diaphoresis, tunnel vision, hypoxemia Narrative:  Admitted to hospital from emergency room after presenting with altered mental status. Found to be hypoxic, given D50 and CT of head. CT negative, felt better with oxygen and was admitted to floor on telemetry. No cardiac irregularity on monitor during hospitalization. MRI of brain had no evidence of acute CVA subdural or acute abnormality to explain altered mental status that improved without anything more than hydration. CBC and chemistry panels were normal grossly, sugars were not a problem, blood pressure well controlled. Discharged to prior living circumstances. Was not given 2nd COVID injection.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: injection site pain and induration Narrative: She received her first dose of Moderna COVID-19 vaccine on Wednesday, 3 March 2021. Had mild soreness at the injection site in the left deltoid at first. Then on Monday, 8 March 2021, she noted pain in the right armpit and swelling and redness in the lower part of the deltoid muscle.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE Narrative:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles Narrative: 53yo man received first dose of COVID-19 vaccine (pfizer) on 3/19. On or about 4/1 patient started developing a painful rash on the forehead. He went to a ER on 4/4 and was diagnosed with shingles. Treated as outpatient with oral acyclovir. Patient without evidence of shingle vaccine.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Ear pain
Clinical narrative: hearing loss in the right, pain and pressure in the right ear Narrative:  patient has had multiple medications and Tympanostomy to treat the condition
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: cramps and spasm Narrative:  hours after vaccine developed fever, headache, myalgia. 2 days following vaccine started getting cramping, L arm worse (vaccinated left arm). still has cramps day 3,.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Narrative: Dose 1 was 2/4. 1 week later developed urticarial rash under axiallae. Persisted. Got dose 3 moderna 3/4 and rash got more intense, now also on abdomen. No systemic symptoms.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Psoriasis, Rash
Clinical narrative: PSORIASIS FLARE ON TRUNK AND BACK Narrative:  PATIENT EXPERIENCED A MILD RASH AFTER THE FIRST DOSE OF MODERNA THAT HE TREATED WITH BENEDRYL AND HYDROCORTISONE CREAM WITH GOOD EFFECT. AFTER THE 2ND DOSE OF MODERNA PATIENT EXPERIENCED A SEVERE RASH AND DEVELOPED PSORIATIC PLAQUES ALL OVER HIS BACK, ON TRUNK AND ARMS THAT WAS INITIALLY TREATED AT HOME WITH THE SAME MEDICATIONS BUT WORSENED SO ON 04/08/2021 HE WAS EVALUATED AT THE AGENCY CLINIC BY PA WHO THEN PRESCRIBED A PREDNISONE TAPER AND CLOBETASOL PROPIONATE 0.05% CREAM.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills Narrative:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Narrative: Patient is a 61 yo male with PMG significant for HTN, HLD, sleep apnea, sleep disorder, and sleep disorder, and knee pain. Patient received 1st Pfizer COVID-19 vaccine dose on 3/2/21, and received 2nd dose 2 weeks later on 3/16/21. The team realized the 2nd dose was given too soon when they filled out his CDC card after the 2nd dose was given. Per the 3/17/21 MD note, "He was observed for 30 minutes and was asymptomatic. He was advised that there may be slight decreased efficacy of getting the second vaccine early and is unlikely to experience any adverse events from the scheduling error. He was advised to particularly pay attention in the news for booster doses related to new variants and will do so." On 3/29/21, reviewed on the vent w/ COVID-19 Vaccination Planning Team. Multiple failure points were identified: 1) The patient's COVID-19 vaccination appointments were scheduled 2 weeks apart (3/2/21 & 3/16/21) instead of 3 weeks apart (3/2/21 & 3/23/21); 2.) Upon 1st appointment check-in, staff didn't notice the 2nd dose was scheduled in 2 weeks; 3.) The patient's 3/2/21 1st Pfizer COVID-19 vaccine dose was not documented within system; 4.) Upon 2nd appointment check-in, check-in staff didn't notice the appointments were scheduled 2 weeks apart; and 5.) Nurse administering the 2nd vaccine did not notice there was no 1st dose note. The event was reviewed with staff involved and the following system-wide improvements were implemented: - Pfizer and Moderna COVID-19 vaccine calendar created to aid staff in identifying the 2nd appointment day; and - At the end of every clinic day, the clerk team provide a list of patients that checked in but haven't checked out, open encounters, and Action Required encounters. Staff must resolve the patient list that day. For Patient, COVID-19 vaccination notes were entered and his 2-dose series is listed in his immunization package. The vaccine clinic MD reviewed the event w/the patient at the time of identification and the 2nd dose did not need to be repeated per the CDC's Clinical Consideration for Use of COVID-19Vaccines Currently Authorized (Appendix A).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Muscle spasms
Clinical narrative: LEG CRAMPS AND DIZZINESS DAYS 1-2; DIARRHEA DAYS 1-7 Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: STIFFNESS; BODY ACHES RESOLVED IN 36 HOURS; Narrative:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure via skin contact
Clinical narrative: Unknown proportion of the dose was on the patient's skin and not administered intramuscularly Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Headache, Myalgia, NauseaVomiting, Chills, soreness and swelling at the injection site in the left arm Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Headache, Myalgia, NauseaVomiting, Chills, soreness and swelling at the injection site in the left arm Narrative:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sensation of foreign body, Urticaria
Clinical narrative: UrticarialPruritus, lump in throat Narrative:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Day 1-3 = sore arm; Day 2-4 = tired Narrative:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: site soreness/bursa was hit Narrative:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema multiforme, Injection site streaking, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, Erythema Multiform, LA streaking from site of injection down arm - resolved  Narrative: Symptoms resolved. Advised to seek medical attention with worsening and additional severe symptoms
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Paraesthesia
Clinical narrative: chest tightness, tingling in l arm and face Narrative: after 20 minutes developed chest tightness, tingling into left arm and face and face. Medical code called and taken to ER. Given meds and released after improvement.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Myalgia arm pain Narrative:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: fatigue, weakness Narrative:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Myalgia & Arthralgia Narrative:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Myalgia, chills Narrative:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Headache, Myalgia, Arthralgia, Chills, Fatigue and injection site soreness.  Narrative: Day 1- mild injection site pain/soreness day 2-Chills, headache,fatigue and myalgia.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Headache, Myalgia, Arthralgia, Chills, Fatigue and injection site soreness.  Narrative: Day 1- mild injection site pain/soreness day 2-Chills, headache,fatigue and myalgia.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia
Clinical narrative: Myalgia, Arthralgia, Chills Narrative:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Headache, Myalgia, NauseaVomiting Chills Narrative:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Brain fog, Fatigue, Injection site pain, Myalgia
Clinical narrative: Myalgia, Fever, extreme fatigue and "fogginess" Narrative: Emp started with soreness at sight and shoulder at 9pm day of vaccine 03/26/21. During the night he had a fever of 99. Took Ibuprofen 800mg and woke up with fever of 101.2.  on3/27. 03/28 had extreme fatigue, no longer had fever and felt a "fogginess" Rested and improved by 03/27 although still felt fatigued.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Myalgia, Fever, extreme fatigue and "fogginess" Narrative: Emp started with soreness at sight and shoulder at 9pm day of vaccine 03/26/21. During the night he had a fever of 99. Took Ibuprofen 800mg and woke up with fever of 101.2.  on3/27. 03/28 had extreme fatigue, no longer had fever and felt a "fogginess" Rested and improved by 03/27 although still felt fatigued.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Headache, Myalgia, Arthralgia, NauseaVomiting, Fatigue Narrative:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Myalgia, Arthralgia, NauseaVomiting, Fatigue Narrative:
Age: 25.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: her son's roommate also received a 6x overdose; Only had arm soreness and was working out the next day and felt fine; This is a spontaneous report from a contactable consumer. A 25-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that her son's roommate also received a 6x overdose, Arm soreness started that night and was really sore the next morning. No treatment taken. Feels much better now. The outcome of the events was recovered for arm has soreness and other event was unknown.  No follow up attempts are needed. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122342 Same reporter/drug, different patient/event.
Age: 25.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Overdose, Pain in extremity
Clinical narrative: her son's roommate also received a 6x overdose; Only had arm soreness and was working out the next day and felt fine; This is a spontaneous report from a contactable consumer. A 25-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that her son's roommate also received a 6x overdose, Arm soreness started that night and was really sore the next morning. No treatment taken. Feels much better now. The outcome of the events was recovered for arm has soreness and other event was unknown.  No follow up attempts are needed. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122342 Same reporter/drug, different patient/event.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Chills, Fatigue, Pain
Clinical narrative: Lost sense of taste and smell; Lost sense of taste and smell; fatigue; chills; body aches; This is a spontaneous report from a contactable consumer. A 66-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN5318 and expiration date was not reported), via an unspecified route of administration at the right arm on 03Feb2021 13:15 at single dose for COVID-19 immunization. Medical history included rheumatoid arthritis and known allergies: codeine. The patient's concomitant medications included Synthroid, Plaquenil, Vit D, Calcium, and Magnesium. Patient reported Lost sense of taste and smell on day 5 after vaccine on 08Feb2021. Patient had fatigue, body aches, chills days on 03Feb2021 20:00. No treatment received. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was not recovered
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Fatigue, Lip swelling
Clinical narrative: shortness of breath; tight chest/lungs; tingling in face; tight lips; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in right arm on 06Feb2021 at 05:30 PM at single dose for COVID-19 immunisation. Medical history included allergies to macadamia and brazil nuts, and was on medication for a few health issues. Concomitant medications included unspecified medication (medications in two weeks). No other vaccine received in four weeks. Patient has not tested COVID prior vaccination. The patient experienced shortness of breath, tight chest/lungs, tingling in face, tight lips, dizziness, fatigue on 06Feb2021 at 06:15 P.M. Events resulted in visit to doctor or other healthcare professional office/clinic. No treatment was given for events. Patient has not tested COVID post vaccination. The outcome of events was recovered with sequel.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: shortness of breath; tight chest/lungs; tingling in face; tight lips; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in right arm on 06Feb2021 at 05:30 PM at single dose for COVID-19 immunisation. Medical history included allergies to macadamia and brazil nuts, and was on medication for a few health issues. Concomitant medications included unspecified medication (medications in two weeks). No other vaccine received in four weeks. Patient has not tested COVID prior vaccination. The patient experienced shortness of breath, tight chest/lungs, tingling in face, tight lips, dizziness, fatigue on 06Feb2021 at 06:15 P.M. Events resulted in visit to doctor or other healthcare professional office/clinic. No treatment was given for events. Patient has not tested COVID post vaccination. The outcome of events was recovered with sequel.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Fatigue, Lip disorder
Clinical narrative: shortness of breath; tight chest/lungs; tingling in face; tight lips; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in right arm on 06Feb2021 at 05:30 PM at single dose for COVID-19 immunisation. Medical history included allergies to macadamia and brazil nuts, and was on medication for a few health issues. Concomitant medications included unspecified medication (medications in two weeks). No other vaccine received in four weeks. Patient has not tested COVID prior vaccination. The patient experienced shortness of breath, tight chest/lungs, tingling in face, tight lips, dizziness, fatigue on 06Feb2021 at 06:15 P.M. Events resulted in visit to doctor or other healthcare professional office/clinic. No treatment was given for events. Patient has not tested COVID post vaccination. The outcome of events was recovered with sequel.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: 4 days following the vaccination I experienced chills; my body temperature went 4 degrees F above normal; steady fever; flu; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot number: EM 9809) via an unspecified route of administration, administered in Arm Left on 08Feb2021 15:00 as single dose for covid-19 immunization. Medical history included mitral valve prolapse, other medical history= MVP, herpes, chronic sinusitis, enlarged prostate , herpes virus infection all from an unknown date and unknown if ongoing. Concomitant medications included Tamsulosin, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), vitamin C [ascorbic acid]. It was reported that, 4 days following the vaccination patient experienced chills, his body temperature went 4 degrees f above normal , steady fever, flu all on 12Feb2021 12:00. Also reported that, he was at day 8 following the vaccine, and he still have the fever. He was vaccinated for the flu, and these are not flu-like symptoms. It's not a cold, because he was not sneezing or coughing. It was a steady fever. The patient underwent lab tests included body temperature: 4 degrees f above normal on 05Feb2021, body temperature: steady fever on 05Feb2021, sars-cov-2 test: negative on 14Feb2021 covid test type post vaccination: Nasal Swab covid test name post vaccination: PCR, and Rapid Test covid test result: Negative. Outcome of the events was not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Influenza, Pyrexia
Clinical narrative: 4 days following the vaccination I experienced chills; my body temperature went 4 degrees F above normal; steady fever; flu; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot number: EM 9809) via an unspecified route of administration, administered in Arm Left on 08Feb2021 15:00 as single dose for covid-19 immunization. Medical history included mitral valve prolapse, other medical history= MVP, herpes, chronic sinusitis, enlarged prostate , herpes virus infection all from an unknown date and unknown if ongoing. Concomitant medications included Tamsulosin, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), vitamin C [ascorbic acid]. It was reported that, 4 days following the vaccination patient experienced chills, his body temperature went 4 degrees f above normal , steady fever, flu all on 12Feb2021 12:00. Also reported that, he was at day 8 following the vaccine, and he still have the fever. He was vaccinated for the flu, and these are not flu-like symptoms. It's not a cold, because he was not sneezing or coughing. It was a steady fever. The patient underwent lab tests included body temperature: 4 degrees f above normal on 05Feb2021, body temperature: steady fever on 05Feb2021, sars-cov-2 test: negative on 14Feb2021 covid test type post vaccination: Nasal Swab covid test name post vaccination: PCR, and Rapid Test covid test result: Negative. Outcome of the events was not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: 4 days following the vaccination I experienced chills; my body temperature went 4 degrees F above normal; steady fever; flu; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot number: EM 9809) via an unspecified route of administration, administered in Arm Left on 08Feb2021 15:00 as single dose for covid-19 immunization. Medical history included mitral valve prolapse, other medical history= MVP, herpes, chronic sinusitis, enlarged prostate , herpes virus infection all from an unknown date and unknown if ongoing. Concomitant medications included Tamsulosin, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), vitamin C [ascorbic acid]. It was reported that, 4 days following the vaccination patient experienced chills, his body temperature went 4 degrees f above normal , steady fever, flu all on 12Feb2021 12:00. Also reported that, he was at day 8 following the vaccine, and he still have the fever. He was vaccinated for the flu, and these are not flu-like symptoms. It's not a cold, because he was not sneezing or coughing. It was a steady fever. The patient underwent lab tests included body temperature: 4 degrees f above normal on 05Feb2021, body temperature: steady fever on 05Feb2021, sars-cov-2 test: negative on 14Feb2021 covid test type post vaccination: Nasal Swab covid test name post vaccination: PCR, and Rapid Test covid test result: Negative. Outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site swelling
Clinical narrative: 1 week after first dose I got a red bumpy rash on back of elbows and inner thighs. Did teledoc visit and got prescribed steroid cream.  Dr said probably vaccine reaction. Was supposed to start menstrual cycle on 03/02/2021 and have yet to have any cycle at all. Brought up to Dr. and he didn?t have time to address it at that visit. It is abnormal for me to miss a cycle, I am surgically sterilized with no Fallopian tubes. Pregnancy not a possibility.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Menstrual disorder, Rash, Rash erythematous
Clinical narrative: 1 week after first dose I got a red bumpy rash on back of elbows and inner thighs. Did teledoc visit and got prescribed steroid cream.  Dr said probably vaccine reaction. Was supposed to start menstrual cycle on 03/02/2021 and have yet to have any cycle at all. Brought up to Dr. and he didn?t have time to address it at that visit. It is abnormal for me to miss a cycle, I am surgically sterilized with no Fallopian tubes. Pregnancy not a possibility.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Mechanical ventilation
Clinical narrative: had sudden cardiac arrest; inflammatory reaction; CRP blood values were extremely high; This is a spontaneous report from a contactable consumer (wife of patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 71-year-old, via an unspecified route of administration, administered in the left arm on 19Feb2021 15:30 (Lot Number: EL9269) as single dose for COVID-19 immunization. Medical history included sulfa allergy and penicillin allergy. Concomitant medications included fosinopril sodium (MONOPRIL) and tamsulosin hydrochloride (FLOMAX RELIEF); both taken for an unspecified indication, start and stop date were not reported. It was reported that roughly 12 hours later at 4:30am on 20Feb2021, the patient had sudden cardiac arrest. The wife was concerned that on 20Feb2021, the patient had an inflammatory reaction. His CRP blood values were extremely high on 20Feb2021. The events resulted in emergency room visit and physician office visit. The patient was also hospitalized due to the events. The patient died a few days later on an unspecified date due to the events. It was unknown if an autopsy was performed. The events were also reported as life-threatening and disability. It was unknown if the patient received treatment for the events. The outcome of the events was fatal.; Reported Cause(s) of Death: he had sudden cardiac arrest; inflammatory reaction; CRP blood values were extremely high
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Cardiac arrest, Inflammation
Clinical narrative: had sudden cardiac arrest; inflammatory reaction; CRP blood values were extremely high; This is a spontaneous report from a contactable consumer (wife of patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 71-year-old, via an unspecified route of administration, administered in the left arm on 19Feb2021 15:30 (Lot Number: EL9269) as single dose for COVID-19 immunization. Medical history included sulfa allergy and penicillin allergy. Concomitant medications included fosinopril sodium (MONOPRIL) and tamsulosin hydrochloride (FLOMAX RELIEF); both taken for an unspecified indication, start and stop date were not reported. It was reported that roughly 12 hours later at 4:30am on 20Feb2021, the patient had sudden cardiac arrest. The wife was concerned that on 20Feb2021, the patient had an inflammatory reaction. His CRP blood values were extremely high on 20Feb2021. The events resulted in emergency room visit and physician office visit. The patient was also hospitalized due to the events. The patient died a few days later on an unspecified date due to the events. It was unknown if an autopsy was performed. The events were also reported as life-threatening and disability. It was unknown if the patient received treatment for the events. The outcome of the events was fatal.; Reported Cause(s) of Death: he had sudden cardiac arrest; inflammatory reaction; CRP blood values were extremely high
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Headache; body ache; fever; soreness at site of injection; This is a spontaneous report from a contactable consumer. A 65-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection) via an unspecified route of administration in Arm Left on 20Feb2021 at 11:30 (Lot Number: EN6203) as single dose for covid-19 immunisation.  Medical history and concomitant medications were not reported.  On 20Feb2021 at 17:00, the patient experienced headache, body ache, fever, soreness at site of injection. Patient did not test for covid post vaccination and did not received Other medications in two weeks, other vaccine in four weeks. The patient was recovering from the events.  No follow-up attempts are needed. Further information not expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site swelling, Pain, Pyrexia
Clinical narrative: Headache; body ache; fever; soreness at site of injection; This is a spontaneous report from a contactable consumer. A 65-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection) via an unspecified route of administration in Arm Left on 20Feb2021 at 11:30 (Lot Number: EN6203) as single dose for covid-19 immunisation.  Medical history and concomitant medications were not reported.  On 20Feb2021 at 17:00, the patient experienced headache, body ache, fever, soreness at site of injection. Patient did not test for covid post vaccination and did not received Other medications in two weeks, other vaccine in four weeks. The patient was recovering from the events.  No follow-up attempts are needed. Further information not expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Dizziness, Electrocardiogram, Headache
Clinical narrative: heart palpitations; chest pain; shortness of breath; Shaky/light Headed; Chest pain moved from left side, to arm; This is a spontaneous report received from a contactable consumer via e-mail forwarded by Medical Information Team. A 25-years-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6203 and Expiration Date was not reported) via an unspecified route of administration in left arm on 24Feb2021 09:00 as single dose for COVID-19 immunization. Medical history included Asthma, allergies, CREST and known allergies.  Morphine reaction at age 2. Concomitant medication(s) included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); montelukast sodium (SINGULAIR); nortripolyn; multivi and neddy pot all taken for an unspecified indication. Patient did not have covid prior vaccination. It was reported that 40 minutes after receiving it, patient started to get heart palpitations, chest pain, and shortness of breath. Shaky/light headed when standing. Chest pain moved from left side, to arm, to middle of chest. As result patient goes to Emergency room/department or urgent care. Patient received the treatment of Ativan to help with the heart rate. The outcome of the events was recovering.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Pain in extremity, Palpitations, Urine analysis
Clinical narrative: heart palpitations; chest pain; shortness of breath; Shaky/light Headed; Chest pain moved from left side, to arm; This is a spontaneous report received from a contactable consumer via e-mail forwarded by Medical Information Team. A 25-years-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6203 and Expiration Date was not reported) via an unspecified route of administration in left arm on 24Feb2021 09:00 as single dose for COVID-19 immunization. Medical history included Asthma, allergies, CREST and known allergies.  Morphine reaction at age 2. Concomitant medication(s) included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); montelukast sodium (SINGULAIR); nortripolyn; multivi and neddy pot all taken for an unspecified indication. Patient did not have covid prior vaccination. It was reported that 40 minutes after receiving it, patient started to get heart palpitations, chest pain, and shortness of breath. Shaky/light headed when standing. Chest pain moved from left side, to arm, to middle of chest. As result patient goes to Emergency room/department or urgent care. Patient received the treatment of Ativan to help with the heart rate. The outcome of the events was recovering.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Pain in extremity, Palpitations
Clinical narrative: heart palpitations; chest pain; shortness of breath; Shaky/light Headed; Chest pain moved from left side, to arm; This is a spontaneous report received from a contactable consumer via e-mail forwarded by Medical Information Team. A 25-years-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6203 and Expiration Date was not reported) via an unspecified route of administration in left arm on 24Feb2021 09:00 as single dose for COVID-19 immunization. Medical history included Asthma, allergies, CREST and known allergies.  Morphine reaction at age 2. Concomitant medication(s) included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); montelukast sodium (SINGULAIR); nortripolyn; multivi and neddy pot all taken for an unspecified indication. Patient did not have covid prior vaccination. It was reported that 40 minutes after receiving it, patient started to get heart palpitations, chest pain, and shortness of breath. Shaky/light headed when standing. Chest pain moved from left side, to arm, to middle of chest. As result patient goes to Emergency room/department or urgent care. Patient received the treatment of Ativan to help with the heart rate. The outcome of the events was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Gait disturbance, Joint swelling, Myalgia, Peripheral swelling
Clinical narrative: blood clot in the lung; my left leg from the knee down started to swell; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; blood clot in the leg; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN3248, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 16Feb2021, 15:30 PM at a single dose for covid-19 immunisation (age at vaccination was 69 years). Medical history included blood pressure and thyroid. Concomitant medication patient received within 2 weeks of vaccination included levothyroxine, valsartan, furosemide, acetaminophen. No other vaccine was received within 4 weeks prior to the COVID vaccine. On 16Feb2021, 3 hours after the patient received the vaccination at 18:30 the patient's left leg from the knee down started to swell, got really hard and became very painful. She could hardly walk and afterwards the pain was so intense that she went to the doctor. Doctor took X-rays of her left leg on 16Feb2021, then he diagnosed her with blood clots. He gave the patient 2 heparin shots and immediately sent her to the hospital for a deep vein ultrasound on 16Feb2021. The results showed blood clot in the leg. The patient was prescribed medication and sent home. Her leg continued to be rock hard and painful. On 02Mar2021, the patient was sent for a blood panel work up. There was no improvement. On 08Mar2021, the doctor sent her for a lung CT scan. On the same evening, the patient was called to the doctor's office and was sent to ER immediately as the results showed blood clot in the lung. The patient's dose of Eliquis was doubled. This has now been going for 5 weeks, the patient had not been without pain during this time. Her left leg hardness had gone down a little but was still twice the size of her right leg, knee was huge. The swelling never goes down, not even at night. No covid prior vaccination and no covid tested post vaccination was reported. This case was reported as serious. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: blood clot in the lung; my left leg from the knee down started to swell; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; blood clot in the leg; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN3248, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 16Feb2021, 15:30 PM at a single dose for covid-19 immunisation (age at vaccination was 69 years). Medical history included blood pressure and thyroid. Concomitant medication patient received within 2 weeks of vaccination included levothyroxine, valsartan, furosemide, acetaminophen. No other vaccine was received within 4 weeks prior to the COVID vaccine. On 16Feb2021, 3 hours after the patient received the vaccination at 18:30 the patient's left leg from the knee down started to swell, got really hard and became very painful. She could hardly walk and afterwards the pain was so intense that she went to the doctor. Doctor took X-rays of her left leg on 16Feb2021, then he diagnosed her with blood clots. He gave the patient 2 heparin shots and immediately sent her to the hospital for a deep vein ultrasound on 16Feb2021. The results showed blood clot in the leg. The patient was prescribed medication and sent home. Her leg continued to be rock hard and painful. On 02Mar2021, the patient was sent for a blood panel work up. There was no improvement. On 08Mar2021, the doctor sent her for a lung CT scan. On the same evening, the patient was called to the doctor's office and was sent to ER immediately as the results showed blood clot in the lung. The patient's dose of Eliquis was doubled. This has now been going for 5 weeks, the patient had not been without pain during this time. Her left leg hardness had gone down a little but was still twice the size of her right leg, knee was huge. The swelling never goes down, not even at night. No covid prior vaccination and no covid tested post vaccination was reported. This case was reported as serious. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Gait disturbance, Pain in extremity, Peripheral swelling, Pulmonary thrombosis
Clinical narrative: blood clot in the lung; my left leg from the knee down started to swell; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; blood clot in the leg; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN3248, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 16Feb2021, 15:30 PM at a single dose for covid-19 immunisation (age at vaccination was 69 years). Medical history included blood pressure and thyroid. Concomitant medication patient received within 2 weeks of vaccination included levothyroxine, valsartan, furosemide, acetaminophen. No other vaccine was received within 4 weeks prior to the COVID vaccine. On 16Feb2021, 3 hours after the patient received the vaccination at 18:30 the patient's left leg from the knee down started to swell, got really hard and became very painful. She could hardly walk and afterwards the pain was so intense that she went to the doctor. Doctor took X-rays of her left leg on 16Feb2021, then he diagnosed her with blood clots. He gave the patient 2 heparin shots and immediately sent her to the hospital for a deep vein ultrasound on 16Feb2021. The results showed blood clot in the leg. The patient was prescribed medication and sent home. Her leg continued to be rock hard and painful. On 02Mar2021, the patient was sent for a blood panel work up. There was no improvement. On 08Mar2021, the doctor sent her for a lung CT scan. On the same evening, the patient was called to the doctor's office and was sent to ER immediately as the results showed blood clot in the lung. The patient's dose of Eliquis was doubled. This has now been going for 5 weeks, the patient had not been without pain during this time. Her left leg hardness had gone down a little but was still twice the size of her right leg, knee was huge. The swelling never goes down, not even at night. No covid prior vaccination and no covid tested post vaccination was reported. This case was reported as serious. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Ultrasound scan, Ventilation/perfusion scan, X-ray
Clinical narrative: blood clot in the lung; my left leg from the knee down started to swell; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; blood clot in the leg; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN3248, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 16Feb2021, 15:30 PM at a single dose for covid-19 immunisation (age at vaccination was 69 years). Medical history included blood pressure and thyroid. Concomitant medication patient received within 2 weeks of vaccination included levothyroxine, valsartan, furosemide, acetaminophen. No other vaccine was received within 4 weeks prior to the COVID vaccine. On 16Feb2021, 3 hours after the patient received the vaccination at 18:30 the patient's left leg from the knee down started to swell, got really hard and became very painful. She could hardly walk and afterwards the pain was so intense that she went to the doctor. Doctor took X-rays of her left leg on 16Feb2021, then he diagnosed her with blood clots. He gave the patient 2 heparin shots and immediately sent her to the hospital for a deep vein ultrasound on 16Feb2021. The results showed blood clot in the leg. The patient was prescribed medication and sent home. Her leg continued to be rock hard and painful. On 02Mar2021, the patient was sent for a blood panel work up. There was no improvement. On 08Mar2021, the doctor sent her for a lung CT scan. On the same evening, the patient was called to the doctor's office and was sent to ER immediately as the results showed blood clot in the lung. The patient's dose of Eliquis was doubled. This has now been going for 5 weeks, the patient had not been without pain during this time. Her left leg hardness had gone down a little but was still twice the size of her right leg, knee was huge. The swelling never goes down, not even at night. No covid prior vaccination and no covid tested post vaccination was reported. This case was reported as serious. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: First dose of the covid vaccine 21Jan2021. Positive covid test on 23Jan2021; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 21Jan2021 the patient received first dose of the COVID vaccine and on 23Jan2021 the patient was tested positive for COVID. The patient had a treatment of antibiotic infusion. The second dose of vaccine was scheduled on 11Feb2021. The outcome of the event was unknown.  Information about Lot/batch Number has been requested.