chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Inappropriate schedule of product administration, Off label use
Clinical narrative: hacking cough that worsened with the 2nd dose; Dose number=1 Administration date=13Apr2021/ dose number=2 vaccine date=13Apr2021; Dose number=1 Administration date=13Apr2021/ dose number=2 vaccine date=13Apr2021; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration in left arm on 13Apr2021 (at the age of 53-years-old) as dose 2, single for COVID-19 immunization at hospital. The patient's medical history included chronic kidney disease, hypertension and COVID-19 from an unknown date and unknown if ongoing. Known Allergies: NA. Concomitant medications/other medications in two weeks included carvedilol (CARVEDILOL) and losartan (LOSARTAN); both were taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration in right arm on 13Apr2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization and experienced hacking cough. The patient received dose number=1 administration date=13apr2021/ dose number=2 vaccine date=13apr2021 (off label use) and inappropriate schedule of product administration. On 14Apr2021, the patient's hacking cough worsened with the second dose. No COVID tested post vaccination. No treatment for adverse events. The outcome of the event cough was not recovered.No follow-up attempts were required; information about lot/batch number cannot be obtained. No further information was expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional, the patient. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch no; not reported/Lot Number: ep6955) via an unspecified route of administration on 16Mar2021 (at the age of 59-year-old) as dose 1, single for COVID-19 immunization. The patient had no other medical history. The patient did not receive any concomitant medication within two weeks of vaccination. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced with flushed face that began with first shot and was experiencing this daily at the time of report. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event flushed face that began with first shot and was experiencing this daily was not resolved at the time of this report.No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: This is a spontaneous report from a non-contactable other HCP (patient). A non-pregnant 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via unspecified route, administered in left arm on 10Feb2021 (Lot number: EN6201) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19), penicillin (known allergies: penicillin) from an unknown date and unknown if ongoing. She received other medications in two weeks: Birth control- antidepressant. The patient did not receive other vaccination in four weeks. Patient had been diagnosed with COVID-19 prior to vaccination and not tested post vaccination. On 26Mar2021, the patient experienced Menstral cycle disruption- consistent period for 2 months straight. Heavier than normal flow. She had physician office visit for the events. No treatment received for the events. The clinical outcome of events was not recovered.No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Fatigue, Headache, Malaise
Clinical narrative: 2nd dose: Arm pain; Swelling at injection site; Headache; Lower back pain; fever of 99.9 degrees Fahrenheit; Nausea; Fatigue; Malaise; Runny nose; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176), dose 2 via an unspecified route of administration, administered in Left Arm on 12May2021 18:00 (at the age of 32-years-old) as dose 2, single for covid-19 immunization. Medical history included High blood pressure, Mild asthma, allergy to arthropod sting from an unknown date and unknown if ongoing known allergy: Bactrim, wasps. The patient previously took Bactrim and experienced drug hypersensitivity. Historical vaccine included the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number:ER8736) via an unspecified route of administration, administered in Left Arm on an 21Apr2021 at 15:00, single for covid-19 immunization and experienced pain in extremity. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and tested since the vaccination. On 13May2021 08:00, the patient experienced 2nd dose: arm pain, swelling at injection site, headache, lower back pain, fever of 99.9 degrees Fahrenheit, nausea, fatigue, malaise, runny nose. The patient underwent lab tests and procedures which included body temperature: 99.9 Fahrenheit on 13May2021 fever of 99.9 degrees Fahrenheit. Adverse events resulted in Pharmacy or Drug Store visit. Patient received no treatment for events. The outcome of the events were not recovered.No follow-up attempts are required. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Rhinorrhoea, Vaccination site swelling
Clinical narrative: 2nd dose: Arm pain; Swelling at injection site; Headache; Lower back pain; fever of 99.9 degrees Fahrenheit; Nausea; Fatigue; Malaise; Runny nose; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176), dose 2 via an unspecified route of administration, administered in Left Arm on 12May2021 18:00 (at the age of 32-years-old) as dose 2, single for covid-19 immunization. Medical history included High blood pressure, Mild asthma, allergy to arthropod sting from an unknown date and unknown if ongoing known allergy: Bactrim, wasps. The patient previously took Bactrim and experienced drug hypersensitivity. Historical vaccine included the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number:ER8736) via an unspecified route of administration, administered in Left Arm on an 21Apr2021 at 15:00, single for covid-19 immunization and experienced pain in extremity. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and tested since the vaccination. On 13May2021 08:00, the patient experienced 2nd dose: arm pain, swelling at injection site, headache, lower back pain, fever of 99.9 degrees Fahrenheit, nausea, fatigue, malaise, runny nose. The patient underwent lab tests and procedures which included body temperature: 99.9 Fahrenheit on 13May2021 fever of 99.9 degrees Fahrenheit. Adverse events resulted in Pharmacy or Drug Store visit. Patient received no treatment for events. The outcome of the events were not recovered.No follow-up attempts are required. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling, Varicose vein, Vascular pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Apr2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. The patient medical history was not reported. There were no concomitant medications. On 25Apr2021 the patient experienced swelling in left lymph node on same side as shot, exacerbating small varicose vein pain, swelling extended through bicep to elbow. Prior to vaccination, the patient not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Rash; Swelling in hands; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 06Apr2021 as a single dose for COVID-19 immunization. Medical history included undifferentiated connective tissue disease from an unknown date and unknown if ongoing UCTD. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no concomitant medications. On an unknown date in Apr2021, the patient experienced rash and swelling in the hands. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received treatment for the rash and swelling in the hands including Steroids (methylprednisolone) and antihistamine. The clinical outcome of the event rash and swelling in hands was Recovering. Therapeutic measures were taken as a result of rash (rash), swelling in hands (peripheral swelling).No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: developed 2 more on face about the same size. Plus 3 hives on right leg and 2 on left leg about same size.; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP, who reported for herself. A 61-years-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6204) via an unspecified route of administration, administered in left arm on 27Apr2021 (age at the time of vaccination was 61-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included Allergy: Macrofid and Allergy: sulfa drugs from an unspecified date. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Previously, the patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6203) via an unspecified route of administration, administered in left arm on 06Apr2021 (age at the time of vaccination was 61-years-old) as DOSE 1, SINGLE for COVID-19 immunization. After first dose, the patient developed 3 small raised hives 0.5 mm in size on face. Started subside right before 2nd dose. On an unspecified date in Apr2021, the patient experienced developed 2 more on face about the same size. Plus 3 hives on right leg and 2 on left leg about same size. After 2nd dose, the patient developed 2 more on face about the same size. Plus 3 hives on right leg and 2 on left leg about same size. No treatment was received for adverse event. The clinical outcome of event was Not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vomiting
Clinical narrative: FEVER; Vomiting; fatigue; This is a spontaneous report from a contactable nurse.  A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient was still taking Xeljanz but doses missed due COVID vaccine. The patient also reported a general side effect of Xeljanz of fatigue. On an unspecified date patient experienced stomach bug which included fever, vomiting and fatigue. Outcome of the events fever, vomiting was resolved and for fatigue was not resolved.No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Chills, Fatigue, Feeling hot
Clinical narrative: tiredness; muscle pain/painful muscles; chills; joint pain/joint pain particularly at wrist and elbow; arm pain; beginnings of rash on palm and arm(right side)/rash develops on arm; shooting pains in right arm; hot to touch; joints somewhat swollen; rash continues to develop into blisters on palm; painful to touch, can't really use it much due to pain; painful to touch, can't really use it much due to pain; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration, administered in Arm Right on 29Apr2021 at 13:00 as dose 1, single (at the age of 52-years-old) for covid-19 immunization at Hospital. The patient was non-pregnant at the time of vaccination. Medical history included poliomyelitis (possible nascent arthritis (undiagnosed), polio as a child) and seasonal allergy (not known at the time; only seasonal allergies). Concomitant medication included loratadine for an unspecified indication from an unspecified date and unknown if was ongoing. The patient did not have or diagnose covid prior to the vaccination. The patient had not been tested for covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 1 and 2 days after the vaccination on 02May2021, the patient experienced the tiredness, muscle pain, chills, joint pain, arm pain, beginnings of rash on palm and arm (right side), Days 3 to 5 patient had shooting pains in right arm, hot to touch, joint pain particularly at wrist and elbow, joints somewhat swollen, rash continued to develop into blisters on palm and rash developed on arm (little spots groups in diffused circular pattern). On day 6-10, the extreme painful blisters on palm (4 major ones), painful to touch, could not really use it much due to pain, rash on arm developed into two major blister spots (one at elbow, the other upper arm. Still painful muscles and shooting pains down arm. Smaller individual blisters form on fingers. On days 11 to 13, blisters started to subside although still had joint pain at wrist and elbow. On days 13 to 16, blisters definitely subsiding on arm, dried up, took longer on palm. The patient still had joint pain throughout all, the patient had been taking double dose of ibuprofen for the pain, and generic claritin for the inflammation (within 2 weeks of vaccination). The case reported as non-serious. Device Date was reported as, 16May2021. The outcome of the events was resolving.The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Loss of personal independence in daily activities, Myalgia, Pain, Pain in extremity
Clinical narrative: tiredness; muscle pain/painful muscles; chills; joint pain/joint pain particularly at wrist and elbow; arm pain; beginnings of rash on palm and arm(right side)/rash develops on arm; shooting pains in right arm; hot to touch; joints somewhat swollen; rash continues to develop into blisters on palm; painful to touch, can't really use it much due to pain; painful to touch, can't really use it much due to pain; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration, administered in Arm Right on 29Apr2021 at 13:00 as dose 1, single (at the age of 52-years-old) for covid-19 immunization at Hospital. The patient was non-pregnant at the time of vaccination. Medical history included poliomyelitis (possible nascent arthritis (undiagnosed), polio as a child) and seasonal allergy (not known at the time; only seasonal allergies). Concomitant medication included loratadine for an unspecified indication from an unspecified date and unknown if was ongoing. The patient did not have or diagnose covid prior to the vaccination. The patient had not been tested for covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 1 and 2 days after the vaccination on 02May2021, the patient experienced the tiredness, muscle pain, chills, joint pain, arm pain, beginnings of rash on palm and arm (right side), Days 3 to 5 patient had shooting pains in right arm, hot to touch, joint pain particularly at wrist and elbow, joints somewhat swollen, rash continued to develop into blisters on palm and rash developed on arm (little spots groups in diffused circular pattern). On day 6-10, the extreme painful blisters on palm (4 major ones), painful to touch, could not really use it much due to pain, rash on arm developed into two major blister spots (one at elbow, the other upper arm. Still painful muscles and shooting pains down arm. Smaller individual blisters form on fingers. On days 11 to 13, blisters started to subside although still had joint pain at wrist and elbow. On days 13 to 16, blisters definitely subsiding on arm, dried up, took longer on palm. The patient still had joint pain throughout all, the patient had been taking double dose of ibuprofen for the pain, and generic claritin for the inflammation (within 2 weeks of vaccination). The case reported as non-serious. Device Date was reported as, 16May2021. The outcome of the events was resolving.The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: tiredness; muscle pain/painful muscles; chills; joint pain/joint pain particularly at wrist and elbow; arm pain; beginnings of rash on palm and arm(right side)/rash develops on arm; shooting pains in right arm; hot to touch; joints somewhat swollen; rash continues to develop into blisters on palm; painful to touch, can't really use it much due to pain; painful to touch, can't really use it much due to pain; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration, administered in Arm Right on 29Apr2021 at 13:00 as dose 1, single (at the age of 52-years-old) for covid-19 immunization at Hospital. The patient was non-pregnant at the time of vaccination. Medical history included poliomyelitis (possible nascent arthritis (undiagnosed), polio as a child) and seasonal allergy (not known at the time; only seasonal allergies). Concomitant medication included loratadine for an unspecified indication from an unspecified date and unknown if was ongoing. The patient did not have or diagnose covid prior to the vaccination. The patient had not been tested for covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 1 and 2 days after the vaccination on 02May2021, the patient experienced the tiredness, muscle pain, chills, joint pain, arm pain, beginnings of rash on palm and arm (right side), Days 3 to 5 patient had shooting pains in right arm, hot to touch, joint pain particularly at wrist and elbow, joints somewhat swollen, rash continued to develop into blisters on palm and rash developed on arm (little spots groups in diffused circular pattern). On day 6-10, the extreme painful blisters on palm (4 major ones), painful to touch, could not really use it much due to pain, rash on arm developed into two major blister spots (one at elbow, the other upper arm. Still painful muscles and shooting pains down arm. Smaller individual blisters form on fingers. On days 11 to 13, blisters started to subside although still had joint pain at wrist and elbow. On days 13 to 16, blisters definitely subsiding on arm, dried up, took longer on palm. The patient still had joint pain throughout all, the patient had been taking double dose of ibuprofen for the pain, and generic claritin for the inflammation (within 2 weeks of vaccination). The case reported as non-serious. Device Date was reported as, 16May2021. The outcome of the events was resolving.The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Hypersensitivity, Pruritus, Rash macular
Clinical narrative: allergic reaction; itchiness and redness around the neck and spreads down the whole body; itchiness and redness around the neck and spreads down the whole body; my face and one of my eyelids was swollen too; my face and one of my eyelids was swollen too; blotchy skin with raised blister like bumps, very itchy; blotchy skin with raised blister like bumps, very itchy; This is a spontaneous report from a contactable consumer. This 43-year-old non-pregnant female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0162 HNMC) via an unspecified route of administration on 15Apr2021 at 09:30 AM on left arm (at 43-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included skin allergy to certain non-precious metal, no food or medication allergies. The patient's concomitant medications were not reported. No other vaccine was received in four weeks and no other medications in two weeks. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN5318 HNMC) via an unspecified route of administration on 25Mar2021 at 09:30 PM on left arm as dose 1, single for COVID-19 immunization for itchy rash. On 08May2021 at 08: 30 PM, 3 weeks after the 2nd dose, patient started getting allergic reaction that starts around 8:30 pm with itchiness and redness around the neck and spreads down the whole body as the night progresses. It was event on her face and one of her eyelids was swollen too. It was happening every night for the last week - blotchy skin with raised blister like bumps, very itchy. It was mostly gone by the morning - sometimes still some bumps and itchiness on the lower legs, feet and hands, but it disappears entirely by mid-morning. No treatment was received for the events. The outcome of events was unknown.No follow-up attempts were possible. No further information was expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: allergic reaction; itchiness and redness around the neck and spreads down the whole body; itchiness and redness around the neck and spreads down the whole body; my face and one of my eyelids was swollen too; my face and one of my eyelids was swollen too; blotchy skin with raised blister like bumps, very itchy; blotchy skin with raised blister like bumps, very itchy; This is a spontaneous report from a contactable consumer. This 43-year-old non-pregnant female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0162 HNMC) via an unspecified route of administration on 15Apr2021 at 09:30 AM on left arm (at 43-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included skin allergy to certain non-precious metal, no food or medication allergies. The patient's concomitant medications were not reported. No other vaccine was received in four weeks and no other medications in two weeks. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN5318 HNMC) via an unspecified route of administration on 25Mar2021 at 09:30 PM on left arm as dose 1, single for COVID-19 immunization for itchy rash. On 08May2021 at 08: 30 PM, 3 weeks after the 2nd dose, patient started getting allergic reaction that starts around 8:30 pm with itchiness and redness around the neck and spreads down the whole body as the night progresses. It was event on her face and one of her eyelids was swollen too. It was happening every night for the last week - blotchy skin with raised blister like bumps, very itchy. It was mostly gone by the morning - sometimes still some bumps and itchiness on the lower legs, feet and hands, but it disappears entirely by mid-morning. No treatment was received for the events. The outcome of events was unknown.No follow-up attempts were possible. No further information was expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: "Sharp chest pain beginning 4 days after vaccine, happened after 1st dose as dull aching in chest"; This is a spontaneous report from a non-contactable consumer, the patient. This is first of the two reports. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 27Mar2021 (at the age of 18-years-old) as dose 1, single for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 12May2021 at 19:15 (at the age of 19-years-old) as dose 2, single for COVID-19 immunisation. The patient received BCP (Birth Control Pill) within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced sharp chest pain beginning 4 days after vaccine, it happened after first dose as dull aching in chest, but resolved in 2 hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event sharp chest pain beginning 4 days after vaccine, happened after first dose as dull aching in chest was recovered on 31Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Dyspnoea
Clinical narrative: sore throat; Swollen lymph nodes; injection site hurt so much I couldn't lift arm; Extreme chills; 104.5F fever; headache; Sore joints; malaise; Cough; out of breath after walking around; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-years-old male patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) as dose 2, single via an unspecified route of administration, administered in Arm Left on 10May2021 09:00 (at the age of 37-years-old) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine received was bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) as dose 1, single via an unspecified route of administration, administered in Arm Left on 14Apr2021 09:00 for covid-19 immunisation and no reaction reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10May2021 16:00, the patient experienced sore throat, swollen lymph nodes, injection site hurt so much i couldn't lift arm, extreme chills, 104.5f fever, headache, sore joints, malaise, cough, out of breath after walking around. All events reported as non serious. The patient did not receive treatment for events. The clinical course reported as follows, my symptoms continued for 5 days. I had a sore throat and swollen lymph nodes for days 3-5. On day 1, injection site hurt so much I couldn't lift arm. Extreme chills on days 1, 3, 4 and 5. A 104.5F fever on day 4. A headache for most days. Sore joints and general malaise the entire time. Cough starting day 5, out of breath. The patient underwent lab tests and procedures which included body temperature: 104.5 fahrenheit on an unspecified date. The outcomes of events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; Swollen lymph nodes; injection site hurt so much I couldn't lift arm; Extreme chills; 104.5F fever; headache; Sore joints; malaise; Cough; out of breath after walking around; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-years-old male patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) as dose 2, single via an unspecified route of administration, administered in Arm Left on 10May2021 09:00 (at the age of 37-years-old) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine received was bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) as dose 1, single via an unspecified route of administration, administered in Arm Left on 14Apr2021 09:00 for covid-19 immunisation and no reaction reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10May2021 16:00, the patient experienced sore throat, swollen lymph nodes, injection site hurt so much i couldn't lift arm, extreme chills, 104.5f fever, headache, sore joints, malaise, cough, out of breath after walking around. All events reported as non serious. The patient did not receive treatment for events. The clinical course reported as follows, my symptoms continued for 5 days. I had a sore throat and swollen lymph nodes for days 3-5. On day 1, injection site hurt so much I couldn't lift arm. Extreme chills on days 1, 3, 4 and 5. A 104.5F fever on day 4. A headache for most days. Sore joints and general malaise the entire time. Cough starting day 5, out of breath. The patient underwent lab tests and procedures which included body temperature: 104.5 fahrenheit on an unspecified date. The outcomes of events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore throat; Swollen lymph nodes; injection site hurt so much I couldn't lift arm; Extreme chills; 104.5F fever; headache; Sore joints; malaise; Cough; out of breath after walking around; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-years-old male patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) as dose 2, single via an unspecified route of administration, administered in Arm Left on 10May2021 09:00 (at the age of 37-years-old) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine received was bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was Unknown, Expiration Date: Unknown) as dose 1, single via an unspecified route of administration, administered in Arm Left on 14Apr2021 09:00 for covid-19 immunisation and no reaction reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10May2021 16:00, the patient experienced sore throat, swollen lymph nodes, injection site hurt so much i couldn't lift arm, extreme chills, 104.5f fever, headache, sore joints, malaise, cough, out of breath after walking around. All events reported as non serious. The patient did not receive treatment for events. The clinical course reported as follows, my symptoms continued for 5 days. I had a sore throat and swollen lymph nodes for days 3-5. On day 1, injection site hurt so much I couldn't lift arm. Extreme chills on days 1, 3, 4 and 5. A 104.5F fever on day 4. A headache for most days. Sore joints and general malaise the entire time. Cough starting day 5, out of breath. The patient underwent lab tests and procedures which included body temperature: 104.5 fahrenheit on an unspecified date. The outcomes of events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Fatigue, Headache
Clinical narrative: 99F fever; fatigue; strong headache; chills; soreness in left arm, across top of chest, and right arm throughout the night; soreness in left arm, across top of chest, and right arm throughout the night; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer (patient) reported for herself. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0151), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 11:30 (age at the time of vaccination was 50-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications. No allergies were reported. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration administered in arm on 25Mar2021 as dose 1, single for COVID-19 immunization and experienced slightly sore arm after first dose. It was reported that after second dose, around 6pm (roughly 7 hours after injection) the patient experienced strong headache, then chills, soreness in left arm, across top of chest, and right arm throughout the night, fatigue on 15Apr2021 18:00 and 99F fever next morning on 16Apr2021. The patient underwent lab tests and procedures which included body temperature: 99 Fahrenheit on 16Apr2021. No treatment was received for all the reported events. Outcome of all the events was reported as recovered on an unspecified date at this time of the report. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 99F fever; fatigue; strong headache; chills; soreness in left arm, across top of chest, and right arm throughout the night; soreness in left arm, across top of chest, and right arm throughout the night; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer (patient) reported for herself. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0151), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 11:30 (age at the time of vaccination was 50-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications. No allergies were reported. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration administered in arm on 25Mar2021 as dose 1, single for COVID-19 immunization and experienced slightly sore arm after first dose. It was reported that after second dose, around 6pm (roughly 7 hours after injection) the patient experienced strong headache, then chills, soreness in left arm, across top of chest, and right arm throughout the night, fatigue on 15Apr2021 18:00 and 99F fever next morning on 16Apr2021. The patient underwent lab tests and procedures which included body temperature: 99 Fahrenheit on 16Apr2021. No treatment was received for all the reported events. Outcome of all the events was reported as recovered on an unspecified date at this time of the report. No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fatigue for 3 days; feverish after 2 weeks; This is a spontaneous report from a contactable consumer. A 34-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration, administered in Arm Left on 05May2021 17:00 (At the age of 34 years) as DOSE 2, SINGLE for covid-19 immunization. The patient was not pregnant during vaccination. The patient took no other vaccine in four weeks. The patient had took other medication in two weeks. The patient medical history was not reported. The patient previously took bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration, administered in Arm Right on 14Apr2021 04:45 (At the age of 34 years) as DOSE 1, SINGLE for covid-19 immunization. The patient experienced fatigue for 3 days on 05May2021 18:00 and feverish after 2 weeks on May2021. At the time of reporting the outcome of the events was unknown. No follow-up attempts are possible. No further information is expected
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Fatigue, Nasal congestion
Clinical narrative: pink eye type response without the discharge, typical with pink eye; Fatigue; Slight nasal congestion; This is a spontaneous report from a non-contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ew0161) via an unspecified route of administration on an unspecified date in Apr2021 at 12:00 PM (at the age of 62-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history was not reported. Concomitant medication included hydrochlorothiazide from an unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in May2021, 18 days after vaccination, the patient experienced pink eye type response without the discharge, typical with pink eye with fatigue and slight nasal congestion. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event pink eye type response without the discharge which included treatment with unspecified eye drops. The clinical outcome of the events pink eye type response without the discharge, typical with pink eye with fatigue and slight nasal congestion was recovering at the time of this report. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : -PFIZER INC-2021580139 same report/drug/AE, different patient.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Fall, Loss of consciousness, Seizure, Skin laceration
Clinical narrative: blacked out; fell; seizing on the ground; she was really out of it and non-responsive; when she fell she got a large laceration on her chin; This is a spontaneous report from contactable consumers. A 17-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EWO182/ UCFS), intramuscular on 01Jun2021 at 11:00 (at the age of 17-years-old) at dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. She was not diagnosed with COVID prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EWO182/ UCFS), intramuscular on 11May2021 at 11:45 (at the age of 17-years-old) at dose 1, single for COVID-19 immunisation. There were no other vaccines in four weeks. Vaccination facility type was reported as school or student health clinic. On 02Jun2021 at 14:00, the patient blacked out and fell. The reporter heard her fall and when he/she got to the patient, she was seizing on the ground which lasted about 2 minutes. The reporter was able to get her into a chair, but she was really out of it and non-responsive. The reporter had already called for an ambulance at that point. When the paramedics arrived, she was coming out of it but still was not able to stand up or really respond properly. When she fell, she got a large laceration on her chin, so they quickly bandaged that up and rushed her to the emergency room. The events required emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with intravenous sodium chloride, TYLENOL, and stitches for laceration. She was also seen by a pediatric neurologist. The patient was not tested for COVID post vaccination. The outcome of the event "blacked out" and "she was really out of it and non-responsive" was recovering; recovered on 02Jun2021 at 14:02 for "seizing on the ground"; and unknown for all other events.
Sex: M
Vaccine: FLUX
Symptoms: Dependence on respirator, Tracheostomy
Clinical narrative: The flu shot put the patient on a breathing machine with a trach; The flu shot put the patient on a breathing machine with a trach; Initial information received on 08-Nov-2021 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via social media.  This case involves a male patient (unknown age) who was put on a breathing machine with a trach (dependence on respirator) (tracheostomy), after receiving INFLUENZA VACCINE .  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was put on a breathing machine with a trach (dependence on respirator, serious, medically significant) (tracheostomy, non serious),  (unknown latency) following the administration of INFLUENZA VACCINE.  The patient's wife said, so no thanks to the flu shot and it was funny that they were seeing advertisement for the flu shot, for the past year and a half, there was very little mention of it. And that the people were finally realizing that corona virus disease (Covid) was the flu. She stated that she will keep taking her vitamins C and D and zinc and will be fine.  It was unknown if the patient experienced any additional symptoms/events  There were no laboratory data/results available.   The patient did not received additional corrective treatment.   At time of reporting, the outcome of the events were unknown.  Information on the batch number to be requested for this case.; Sender's Comments: This case involves a male patient who was dependence on respirator and had tracheostomy, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: very very sick; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown age and gender) who was very very sick (illness), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was very very sick (illness, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Good for y'all I can't bc it makes me very very sick."  It was unknown if the patient experienced any additional symptoms/events.   There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.