chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her left arm was sore after the first COVID-19 Vaccine shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Dec2020 (Lot number: EL0140) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2020, outcome "recovered", described as "her left arm was sore after the first COVID-19 Vaccine shot".  Additional information: The patient said she didn't have any side effects other than her (left) arm was sore (after the first COVID-19 Vaccine shot). She said she had her first COVID-19 Vaccine shot on 28Dec2020 (Pfizer Lot Number: EL0140) and her second COVID-19 Vaccine shot on 14Jan2021 (Pfizer Lot Number: EL1283) through her healthcare facility.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Covid arm/which she described as sore/heavy arm; Covid arm/which she described as sore/heavy arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Manufacturer unknown), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), LIMB DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "Covid arm/which she described as sore/heavy arm".  Additional information: description of event: mentioned during an online class that we are both in that she had "Covid arm" following her second Pfizer covid shot which she described as sore/heavy arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased
Clinical narrative: his blood sugar numbers dropped noticeably for 2 weeks after he received both doses of the COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "type 2 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE DECREASED (non-serious) with onset 2021, outcome "unknown", described as "his blood sugar numbers dropped noticeably for 2 weeks after he received both doses of the COVID vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: After the first Covid 19 vaccine, caller reports the tired feeling lasted a few days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Mar2021 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 84 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "high blood pressure" (ongoing), notes: Verbatim: high blood pressure. Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "After the first Covid 19 vaccine, caller reports the tired feeling lasted a few days".  Additional information: No investigation assessment was done. Caller realized there may be a connection between the Covid 19 vaccine and having higher than normal blood pressure. Caller felt tired the next day after the Covid 19 vaccine and it lasted 6 days or so. With the tiredness she also had high blood pressure. Caller had an Amron blood pressure machine at home. No emergency room visit was required. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were reported as none.  regarding Amlodipine on 08Apr2021 at 12:36:11 PM. Call went to voicemail, no message left. ININ: 2013720874. Second attempt made at 12:40:35 PM and was answered but no voice contact made. ININ: 2013721044. Description of complaint: NOT THE SUSPECT PRODUCT. Amlodipine provided as her blood pressure medication and caller stated it didn't help much, didn't bring the numbers down much, when asked for treatment for the increase in blood pressure after getting the COVID vaccine. Stated during the call this is her only medication. Outbound call made in QR in an attempt to obtain Lot for the PC regarding Amlodipine on 08Apr2021 at 12:36:11 PM. Call went to voicemail, no message left. ININ: 2013720874. Second attempt made at 12:40:35 PM and was answered but no voice contact made. ININ: 2013721044.  Product strength and count size dispensed: 2.5 once a day Additional lot numbers: not available
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I had fatigue after first covid vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820).  A 51 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "I had fatigue after first covid vaccine".  Additional Information: Patient was taking anastrozole 75 mg daily times 21 days out of which for 7 days it was on and off. Patient reported that she had fatigue after first covid vaccine as like that with bone density medication. she slept a lot and received second vaccine on 14Apr2021. At that time she was feeling good and she went for camping. Lab done on 07Apr2021 and both tumor markers were way down. she visited medical doctors office on 13Apr2021. will start next cycle today. MD aware.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: polymyalgia seemed reduced/ improvement of around 50 percent; This is a spontaneous report received from contactable other healthcare professional. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "polymyalgia rheumatica", start date: May2020 (unspecified if ongoing). Concomitant medication included: PREDNISONE. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), administration date: 01Mar2021, for COVID-19 immunisation, reaction: "no negative symptoms". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 24Mar2021, outcome "unknown", described as "polymyalgia seemed reduced/ improvement of around 50 percent".  Additional information: In late May2020, the patient was diagnosed with polymyalgia rheumatica. It came on almost suddenly. His legs became weak as he attempted to stand up after sitting an hour or so. His arms, especially his left, became uncomfortably sore when he tried to put on a coat. He could not raise it without pain when flexed but many times the pain lessened if he held it straight out. His neck became stiff all the time, being unable to turn my head to the left to check for cars while driving, so had to rotate his whole body in the car seat. Same but a bit less on the right. He also became more fatigued, retiring around 10:00 PM. He would awaken around 5:00 AM wanting to get up and move around. He would then be tired and would take an early nap or wait until later and nap for about 50 minutes. Things seemed a bit better until around 9:30 when the pains increased. He believed he was started on about 15 mg of prednisone/day and then began a reducing dosage of 1 mg/month on the 1st of every month. So each month reduced by 1 mg/day to the point he was at now, 3mg/day. In 01Apr (unspecified year), he then reduced to 2 mg/day, 01May (unspecified year) down to 1 mg/day until June 1st (unspecified year) when he stopped prednisone. So this pain has really been classic polymyalgia rheumatica. However, even with improvements, it was still "vary" annoying. Then he went and received his 1st Pfizer vaccine on 01Mar2021. Then following protocol he returned for his second Pfizer dose on 22Mar2021. After the second dose, he realized that his polymyalgia seemed reduced and by 2 days after the second vaccine he felt a definite reduction in the pain, and in the fatigue. There has been an improvement of around 50 percent. He was being alert for signs after receiving the vaccines, but never dreamed he would feel better. From reading, he did find out that a possibility of a virus being involved has been considered. The patient mentioned that he had no negative symptoms from the vaccine doses at all.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After the second dose, polymyalgia seemed reduced, a definite reduction in pain and fatigue/ improvement of around 50%; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Polymyalgia rheumatica (with pain and fatigue)", start date: May2020 (ongoing). Concomitant medication(s) included: PREDNISONE taken for polymyalgia rheumatica (ongoing). Vaccination history included: BNT162B2 (DOSE 1, SINGLE), administration date: 01Mar2021, for COVID-19 immunisation, reaction(s): "No adverse event". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 24Mar2021, outcome "unknown", described as "After the second dose, polymyalgia seemed reduced, a definite reduction in pain and fatigue/ improvement of around 50%".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: General malaise following 1st covid injection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ovarian CA" (unspecified if ongoing); "covid 19 infection" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "General malaise following 1st covid injection".  Additional Information: Event took place after use of product. Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: has received second Covid-19 vaccine and has developed cherry-sized knots; This is a spontaneous report received from a contactable reporter(s) (Physician) received.   A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious), outcome "unknown", described as "has received second Covid-19 vaccine and has developed cherry-sized knots".  Additional information: Patient has been injected with Juvéderm® VOLUX last year. Patient has received second Covid-19 vaccine and has developed. "cherry-sized knots" (symptom site unknown) less than 24 hours later. Symptom status unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: She did get covid vaccine 2-3 days ago and was having intermittent dizzy spells; This is a spontaneous report received from contactable reporter(s) other HCP and a contactable female consumer (patient).  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE; IBRANCE taken for breast cancer female, start date: 05Apr2021. The following information was reported: DIZZINESS (non-serious) with onset Apr2021, outcome "unknown", described as "She did get covid vaccine 2-3 days ago and was having intermittent dizzy spells".  Additional information: The dosage of drug Ibrance was decreased to current dosing from previous dose:125 mg 1 tablet daily 21 days, 7 days off. The patient reports her ibrance was lowered to 100 mg dose per md it is time to decrease. She did get covid vaccine 2-3 days ago and was having intermittent dizzy spells, md not aware.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: This is a spontaneous report received from contactable other HCP and consumer or other non-HCP, for a Pfizer sponsored program (143231). A 54-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had chills (experienced chills after first COVID-19 vaccine), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Crying, Migraine, Pain, Pain assessment
Clinical narrative: After getting the doses of the Covid her migrains were out of control; Caller got her second dose 2 days ago it sent her cronic pain into a flair up; She litterly was lying in bed in tears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program Support (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "imunnocompramised" (unspecified if ongoing); "Migrains" (unspecified if ongoing); "heart problems" (unspecified if ongoing), notes: heart problems about 2 months ago; "histarectomy" (unspecified if ongoing); "chronic pain" (unspecified if ongoing), notes: chronic pain for 16 years. Concomitant medication(s) included: HYDROCODONE taken for pain, start date: Apr2021, stop date: Apr2021. Past drug history included: Simponi for imunnocompramised; Botox for Migraine, reaction(s): "Chronic pain", notes: had this done 2 to 3 weeks prior to getting the vaccines; Hydrocodon for Hysterectomy. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "After getting the doses of the Covid her migrains were out of control"; PAIN (non-serious), outcome "unknown", described as "Caller got her second dose 2 days ago it sent her cronic pain into a flair up"; CRYING (non-serious), outcome "unknown", described as "She litterly was lying in bed in tears". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: she felt a little tired after the first dose of the pfizer covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "she felt a little tired after the first dose of the pfizer covid 19 vaccine".  Additional information: Patient was scheduled to get an eye examination and her optometrist will be putting some solution to both of her eyes next Tuesday. She wanted to know if she should wait longer because she didn't want to mess up the vaccine's efficacy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021412212 PFIZER (Same reporter/patient/product, different dose/event)
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio decreased
Clinical narrative: INR was 1.6; INR was 1.6; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: EN6199) as dose 1, single and administration date 29Mar2021 (Lot number: EN6199) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERNATIONAL NORMALISED RATIO DECREASED (non-serious), INTERNATIONAL NORMALISED RATIO DECREASED (non-serious) all with onset 08Apr2021, outcome "unknown" and all described as "INR was 1.6". Relevant laboratory tests and procedures are available in the appropriate section.  Note: The reporter wanted to know if the vaccine interferes with the INR.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back pain". Therapeutic measures were taken as a result of back pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: On an unknown date, the patient got her Covid (corona virus disease) vaccine and the site was red, itchy, sore and warm to the touch.; On an unknown date, the patient got her Covid (corona virus disease) vaccine and the site was red, itchy, sore and warm to the touch.; On an unknown date, the patient got her Covid (corona virus disease) vaccine and the site was red, itchy, sore and warm to the touch.; On an unknown date, the patient got her Covid (corona virus disease) vaccine and the site was red, itchy, sore and warm to the touch.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 84 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis, start date: Jan2021 (ongoing). The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "On an unknown date, the patient got her Covid (corona virus disease) vaccine and the site was red, itchy, sore and warm to the touch."  Additional information: It was reported that on an unknown date, the patient got her Covid (corona virus disease) vaccine and the site was red, itchy, sore and warm to the touch. The reporter declined consent for follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Additional Details: 24 year old female post first immunization of Pfizer.  Advised to wait 15 minutes in the chairs in front of the pharmacy.  Shortly after, approximately 10 minutes she returned to the vaccination "area" and looked sweaty and flushed.  Immediately got weak, started to fall to the ground but was caught and assisted to the floor where she was placed on her back and started to regain color and consciousness.  Patient was given fluids, B/P taken 110/60, HR 58.  911 arrived, patient home with husband.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Additional Details: 24 year old female post first immunization of Pfizer.  Advised to wait 15 minutes in the chairs in front of the pharmacy.  Shortly after, approximately 10 minutes she returned to the vaccination "area" and looked sweaty and flushed.  Immediately got weak, started to fall to the ground but was caught and assisted to the floor where she was placed on her back and started to regain color and consciousness.  Patient was given fluids, B/P taken 110/60, HR 58.  911 arrived, patient home with husband.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Lethargy, Seizure
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tachycardia, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bacteraemia, COVID-19, Chest X-ray abnormal, Gastrointestinal haemorrhage
Clinical narrative: Covid19 breakthrough. Vaccine received on 05/17/2021.  66 y/o PMHx HTN, T2DM, Stage 4 liver cancer presents to ED with c/o of severe RUQ pain and increasing abdominal girth.  Pt was recently discharged from hospital where was treated for Bacteremia and GIB.  Pt afebrile, Room air sats 95% and CXR- unchanged with patchy opacities.  Per ID no specific treatment for Covid at this time, monitoring.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lung opacity, SARS-CoV-2 test positive, Vaccine breakthrough infection, Waist circumference increased
Clinical narrative: Covid19 breakthrough. Vaccine received on 05/17/2021.  66 y/o PMHx HTN, T2DM, Stage 4 liver cancer presents to ED with c/o of severe RUQ pain and increasing abdominal girth.  Pt was recently discharged from hospital where was treated for Bacteremia and GIB.  Pt afebrile, Room air sats 95% and CXR- unchanged with patchy opacities.  Per ID no specific treatment for Covid at this time, monitoring.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Injection site erythema, Injection site swelling, Myocardial infarction
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient's partner called on 02/04/2022 to explain Mr. received vaccine on 01/28/22 and passed away shortly after on 01/30/22. She informed that patient developed a lot of swelling at injection site after getting vaccine, went to hospital the day after, and died of a heart attack on 01/30/22.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Flushing, Hyperhidrosis, Hypotension, Seizure
Clinical narrative: Systemic: Confusion-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Seizure-Severe, Additional Details: Pt had a seizure and fainted, EMS was called and brought pt to hospital
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Systemic: Confusion-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Seizure-Severe, Additional Details: Pt had a seizure and fainted, EMS was called and brought pt to hospital
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Injection site pain, Rash
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: Patient reports having a rash on both arms below the elbows described as red bumps, but not blisters. Patient reports having soreness and ongoing weakness in left shoulder area since Shingrix vaccine. Patient states the "weird sorness" in his left arm feels similar to the nerve issue he had with a previous bulging disc in back. Patient reports he did previously have a Shingles outbreak in his thirties.  Patient has not discussed issues with his provider yet.  Reported when contacted for 2nd shingrix
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Irregular menstrual cycle- much shorter cycle one month, followed by missing period the next month. Booster Covid vaccine on 12/1/21. Period started as normal on 12/8/21 (per my usual 27-day cycle.) But then got another period just 16 days later, on 12/24/21. Now it is 44 days later, on 2/5/22, and I have not had another period. Use condoms with husband, and have taken 2 negative pregnancy tests in the past 2 weeks so not pregnant. Only 38 years old now, unlikely menopausal. I have very regular periods, have never before had a cycle that was only 16 day, nor that was missed/44+ days, and certainly not back to back.
Age: 96.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Cough, Diarrhoea
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 04/30/2021.  97 y/o PMHx HTN, COPD, HLD, CHF presents to ED with 1 week history of diarrhea and cough.  Pt has been on hospice x2 years at home.  Afebrile, Room air sat 96%,  CXR indicative of Covid PNA.  Started on IV ABX.
Age: 96.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 04/30/2021.  97 y/o PMHx HTN, COPD, HLD, CHF presents to ED with 1 week history of diarrhea and cough.  Pt has been on hospice x2 years at home.  Afebrile, Room air sat 96%,  CXR indicative of Covid PNA.  Started on IV ABX.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, Brain natriuretic peptide increased, Cardiac stress test normal, Chest X-ray abnormal
Clinical narrative: Patient began having sudden weakness, leg swelling, abdominal pain, dyspnea.  Placed on 4L NC in ER.   Chest xray showed "ground glass" appearance.  CT chest showed no PE.  BNP level 8472.  Stress test show no ischemia, Ejection Fraction 66%, no chest pain but did have shortness of breath.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram thorax normal, Dyspnoea, Ejection fraction normal, Lung opacity, Peripheral swelling
Clinical narrative: Patient began having sudden weakness, leg swelling, abdominal pain, dyspnea.  Placed on 4L NC in ER.   Chest xray showed "ground glass" appearance.  CT chest showed no PE.  BNP level 8472.  Stress test show no ischemia, Ejection Fraction 66%, no chest pain but did have shortness of breath.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Mechanical urticaria, Pain, Rash, Rash pruritic
Clinical narrative: First dose 12/10/21. Second dose 1/5/22. On 12/23, Patient had a fever of 101.7, runny nose, cough, fatigue. Was COVID negative. She was sick for a little over 24hrs. About 5 days later she started having episodic rashes. Her skin would turn bright red in blotchy areas and be hot to the touch. It was on every part form her ears down her torso. It looked very much like an allergic reaction, but couldn't figure out a source - no new foods, soaps, lotions, detergents or other exposures. This has continued intermittently since then. About 30min after her second COVID shot (1/5/22), her entire belly was covered with rash and was very itchy. She then had fever, fatigue, body aches for 48 hrs. She has still having the very reactive skin anytime her skin is rubbed. If skin is rubbed or scratched, will get red and warm.  Not significantly itchy though. No treatment tried. At recent clinic evaluation, advised that recurrent dermatographic hives could be related to vaccine, viral illness, or other environmental or idiopathic trigger. Recommended antihistamine treatment + allergist evaluation.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: First dose 12/10/21. Second dose 1/5/22. On 12/23, Patient had a fever of 101.7, runny nose, cough, fatigue. Was COVID negative. She was sick for a little over 24hrs. About 5 days later she started having episodic rashes. Her skin would turn bright red in blotchy areas and be hot to the touch. It was on every part form her ears down her torso. It looked very much like an allergic reaction, but couldn't figure out a source - no new foods, soaps, lotions, detergents or other exposures. This has continued intermittently since then. About 30min after her second COVID shot (1/5/22), her entire belly was covered with rash and was very itchy. She then had fever, fatigue, body aches for 48 hrs. She has still having the very reactive skin anytime her skin is rubbed. If skin is rubbed or scratched, will get red and warm.  Not significantly itchy though. No treatment tried. At recent clinic evaluation, advised that recurrent dermatographic hives could be related to vaccine, viral illness, or other environmental or idiopathic trigger. Recommended antihistamine treatment + allergist evaluation.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I became really itchy in different areas of my body and when I scratched those areas, my body broke out in hives. I took some Zyrtec to help which does relieve the itchy for the day but it comes back after not taking it.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Inflammation, Musculoskeletal stiffness, Neuralgia
Clinical narrative: About 6 weeks after my second dose in February, I began to experience inflammation in various parts of my body.  It began with my knees.  I received cortisone shots.  I also needed a shot in my left hand for stiffness in my middle finger.  Then I began to experience pain in the nerve endings of my scalp also on the left side.  Yesterday, I had a Cath scan and am awaiting the results.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Chest X-ray abnormal, Interstitial lung disease, Obstructive pancreatitis
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/05/2021.  70 y/o PMHx OA presents to ED with c/o progressive abdominal pain and vomiting. Pt findings consistent with biliary pancreatitis.  Pt denies fevers, cough,  room air sats 93%, cxr with increased interstitial markings.  On IV ABx.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection, Vomiting
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/05/2021.  70 y/o PMHx OA presents to ED with c/o progressive abdominal pain and vomiting. Pt findings consistent with biliary pancreatitis.  Pt denies fevers, cough,  room air sats 93%, cxr with increased interstitial markings.  On IV ABx.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Maternal exposure timing unspecified, Pain
Clinical narrative: Body ache; Bad headache; Chills; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported) via an unspecified route of administration on 15Apr2021 (at the age of 30-years) as dose number unknown, single for COVID-19 immunisation. Medical history was not reported. Concomitant medication included quetiapine fumarate (SEROQUEL) for an unknown indication from an unknown duration. The patient did not have any allergies to medications, food, or other products. Prior to 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 15Apr2021, at 16:00, the patient had experienced bad headache, chills and body ache. The patient received the vaccine during pregnancy and hence there was maternal exposure during pregnancy. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. The outcome of the events, bad headache, chills and body ache was resolved with sequelae on 15Apr2021.   The lot number for [BNT162B2], was not provided and will be requested during follow up  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Remove Ethnic Group since not provided in source 2. Event description updated as Pregnant at the time of vaccination?: Yes 3. Update final sentence as The lot number for [BNT162B2], was not provided and will be requested during follow up
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Off label use, Product use issue
Clinical narrative: Report covid 19 who did not meet age requirement for vaccine; Report covid 19 who did not meet age requirement for vaccine; Cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Report covid 19 who did not meet age requirement for vaccine"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Swollen fingers; rash all over body; hurts to bend fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 13:00 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: XANAX; WELLBUTRIN; LEXAPRO. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "Swollen fingers"; RASH (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "rash all over body"; PAIN IN EXTREMITY (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "hurts to bend fingers". The events "swollen fingers", "rash all over body" and "hurts to bend fingers" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of peripheral swelling, rash, pain in extremity.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. The events swollen fingers, rash all over body and hurts to bend fingers occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  Amendment: This follow-up report is being submitted to amend previously reported information: narrative updated to reflect that patient had no relevant medical history  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   Follow-up (20Aug2021): This is a follow up spontaneous report received from a contactable consumer. This consumer reported in response to Non-HCP letter sent to consumer via telephonic follow-up activity
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at Covid-19 vaccination site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at Covid-19 vaccination site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, SARS-CoV-2 test
Clinical narrative: My whole body felt unusually warm and sore; My whole body felt unusually warm and sore; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 14:15 (Lot number: EP6955) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; VITAMIN D 3; ZINC; ZOLOFT; VITAMIN-C. Vaccination history included: Bnt162b2 (lot number=EL3247,, administration_time=02:00 PM,, vaccine_location=Left arm), administration date: 08Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: FEELING HOT (non-serious), PAIN (non-serious) all with onset 30Mar2021 08:00, outcome "recovered" and all described as "My whole body felt unusually warm and sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling hot, pain.  Additional information: The patient was not diagnosed with COVID-19 prior the vaccination. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain, Muscle spasms, Myalgia
Clinical narrative: diarrhea; severe cramping/leg cramping; severe muscle aches; injection site pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "severe cramping/leg cramping"; MYALGIA (non-serious), outcome "unknown", described as "severe muscle aches"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyposmia
Clinical narrative: a friend of hers reported "an ENT issue" after her second dose of the Pfizer Covid vaccine, as well.  The caller's friend said that her "smell was compromised"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Immunization.  The following information was reported: HYPOSMIA (non-serious), outcome "unknown", described as "a friend of hers reported "an ENT issue" after her second dose of the Pfizer Covid vaccine, as well.  The caller's friend said that her "smell was compromised".  Additional Information: Questioned: Auto-Callback to a consumer who reports that about 3-4 days after her second dose of the Pfizer-Biontech Covid19 vaccine, she developed a "patter" in her ears that occurred when chewing or swallowing, and only lasts about 4-5 seconds at a time. She just wanted to report because it started happening after her dose of vaccine.  She also states that a friend of hers reported "an ENT issue" after her second dose of the Pfizer Covid vaccine, as well. The caller's friend said that her "smell was compromised" but the caller doesn't think she's "lost it all together".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: "she's having major back pain since sunday, after she got the 2nd covid shot."; This is a spontaneous report received from contactable reporter(s) (Other HCP, Consumer or other non HCP and Physician) for a Pfizer sponsored program (141003).  A 71-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ XR taken for rheumatoid arthritis, start date: Sep2020. Vaccination history included: Bnt162b2, for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as ""she's having major back pain since sunday, after she got the 2nd covid shot."'  Additional information: It was reported that, Case is from Marketing program but suspect product(s) are not part of the case Suspect product Xeljanz XR updated to  Pfizer covid 19 Vaccine as per the events reported and Xeljanz XR considered as Concomitant product coded via CDD. spouse reported md discontinued xeljanz "about 2 weeks ago, "because it just wasn't working, her inflammation seemed to be getting worse".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she received the first COVID (coronavirus) vaccine and she was sore for three days after/her arm still hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "she received the first COVID (coronavirus) vaccine and she was sore for three days after/her arm still hurt".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache every day post Covid vaccine a week ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: 2020 (unspecified if ongoing), notes: Patient had COVID last year with a lot of sequelae. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache every day post Covid vaccine a week ago".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.