chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 hours after vaccination the tinnitus started/Tinnitus got louder by the day, waking me up in the night; stomach pain; diarrhea; vomiting; my nose were dripping blood; weak; On day 10 my jaw locked up in the morning; Pain in left side, radiating towards the ear; Face is swollen on left side; tongue is tingling; This is a spontaneous report from a contactable consumer or other non-health care professional (patient reported for herself). A 45-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6206, Expiry date: not reported), via an unspecified route of administration, administered in arm right on 10Mar2021 at 16:00 (04:00 PM) (at the age of 45-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included breast cancer survivor, pulmonary embolism survivor, and known allergies: CT contrast. The patient concomitant medication included anastrozole taken for an unspecified indication, start and stop date were not reported. No other vaccine was administered in 4 weeks. No COVID prior vaccination. No COVID tested post vaccination. On 10Mar2021 at 21:00 (09:00 PM), the patient experienced 5 hours after vaccination the tinnitus started/tinnitus got louder by the day, waking me up in the night. In Mar2021, patient also experienced 26 hours later stomach pain, diarrhea, vomiting, my nose was dripping blood, weak for 3 more days, on day 10 my jaw locked up in the morning, pain in left side, radiating towards the ear, face is swollen on left side, tongue is tingling. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. Outcome of all the events was not recovered.  Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a medical assistant referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 07-DEC-2015 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot# K026803 with expired date 05-DEC-2015, route and dose were unknown). No concomitant therapy was provided. No adverse effect was reported. Additional information has been requested.
Late preterm infant, 35 week gestation.   Birth weight: 2950gms  female infant who was preterm at 35 weeks, has a bicuspid valve and coarctation of the aorta. The Patient received Anthrax Vaccine anthrax #1 10/27/20 (lot # 300070A) while 23 weeks pregnant . Infant has a bicuspid valve and coarctation of the aorta.  history of respiratory distress ; admission to NICU observed a self-limited, 40 second run of SVT occurring at night.  The SVT had no provoking onset, resolve spontaneously, and had no evidence of hemodynamic compromise.  Following this event, she was observed for 2 more days as an inpatient and had no further recurrence.   breast fed 1 month old with exam and echocardiographic findings of mild/borderline coarctation of the aorta.  The ductus arteriosus is closed and she is warm/well perfused below the diaphragm with symmetric upper and lower extremities pulses. Cardiology following, considering intervention.
The day after the recipient received the vaccine, she presented to the emergency department with complaints of severe abdominal pain.  The pain began to subside within 6 hours after receiving IV pain medications but did not completely resolve for 4 days.
a 17 year old patient that received his first dose of Moderna COVID-19 vaccine on 04/14/2021.  Reporting due to patient being under 18.
flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 5544H, expiry date 15th May 2021) for prophylaxis.   On 18th February 2019, the patient received the 1st dose of Shingrix. On 18th February 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On 19th February 2019, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had flu-like symptoms within 8 hours. The symptoms resolved the following day.  He also reported that he had a similar reaction to the 2nd shot.  No additional details were available as the patient's cell phone disconnected in a remote location.  The reporter can follow up directly with the patient. The reporter called back and provided additional information. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019149401. This case linked with US2019149405, reported by same reporter.
Breakthrough case admission after 4 vaccines Moderna 2/5/21 Lot# 032H20A;  Moderna 3/6/21 Lot# 027L20A;  Moderna 12/5/21 Lot# 058H21A;  Moderna 6/3/22 Lot# 059M21A
Vomiting started on 8/11/02. Taken to ER. Was put on Amoxicillin. Mother reported ears were pink, but not infected. Continued with vomiting, fever, irritable, weak and diarrhea. Again to ER on 8/14/02. Now has rash on neck and chest and behind ear.
No symptoms child was given a 3rd dose of Moderna and it is a 2 dose series
Localized reaction at site of inj. swollen and red/mom gave her Benadryl.
sore throat, achy, fatigue, headache, stuffy nose, congestion, - developed on day after the shot and continued for three days
Patient received first dose of Moderna Vaccination at 15:32. Approximately 30 minutes later patient began feeling itchiness in her throat and anxious. Pt was placed on a Non-rebreather at 15 L. Pt's vitals were BP: 134/81, HR: 113, O2: 100% on 15 L NR, RR: 26. PA at bedside with verbal order for Epinephrine 0.3 mg. EpiPen give to left upper thigh at 16:32. Pt's heart rate increased to 110's-140's. Pt's itchy throat remained the same. Pt began having symptoms of a dry throat as well. Pt administered Benadryl per PA at 16:40. Pt began experiencing nausea at approximately 16:50. Zofran 4 mg ODT administered sublingual at 16:50. EMS was activated and arrived approximately 16:55. Report given and pt transferred to ECRMC for further workup and assessment. Vitals remained stable throughout.
No swelling - very painful in R shoulder - difficult to raise arm. Feels hot and cold. Using Tylenol PRN and a cold pack during the night.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 3:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 3:49 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 49.67 for dose administered on 24-May-2021.  No concomitant medications were reported.  Batch number 026C21A underwent temperature excursion on 24-May-2021 with temperature 35 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 18-May-2021 and beyond use date for the vial was reported as 17-Jun-2021. Product moved to clinic on 24-May-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
PATIENT HAD RASH OUTBREAK SIMILAR TO CHICKEN POX ON HER WHOLE BODY, THE RASH WAS  ITCHY AND BLISTER LIKE. TODAY SHE HAS SCABS OVER THE AREAS WHERE SHE PREVIOUSLY HAD RASH ALTHOUGH COMPLAINING OF ITCHING.
10 hours after: rigors, chills, headache, L arm soreness 24 hours after: headache, chills, fatigue, muscle/joint pain, L arm soreness 72 hours: swollen lymph nodes L axilla, L neck
My joints are so swollened and inflammed, and sore; My joints are so swollened and inflammed, and sore; My joints are so swollened and inflammed, and sore; This is a spontaneous report from a Pfizer sponsored program. A contactable Health care professional (Nurse) reported for a female patient.  A 70-year-old non-pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication included hydroxychloroquine sulfate 200mg tablet (PLAQUENIL SULFATE), atorvastatin calcium 10mg tablet, Tizanidine hcl 2mg capsule, Gabapentin 300mg capsule. The patient stated that (on an unspecified date) my joints are so swollen and inflammed, and sore. I have missed 3-4 day of Xeljanz because of covid. The outcome of events was not recovered.  Follow-up activities closed. Batch/lot number not available.
SORE THROAT; BODY ACHES; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced sore throat, body aches, headache, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache, fever, body aches and sore throat was not reported. This report was non-serious.
Round rash area at injection site.  Pt was advised to take a dose of benadryl and report to ED if symptoms continue to worsen
pt with hx of spontaneous chronic urticaria, cleared by allergist to receive covid vaccine on 3/12.  24hrs post vaccination, hives developed.  allergist contacted and given Zyrtec, Claritin, and Medrol pak
A little achy. Numbness in spot where shot was given. Still numb to present.
This is a spontaneous report from a contactable physician (patient herself). A 53-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications.  The patient experienced a sore arm (added that she cannot move it from the pain) for 24 hours on an unspecified date. The patient did not receive any treatment of the event. The outcome of the event was recovered on an unspecified date.
PT WENT TO ER FOR SEVERE ABDOMINAL PAIN, APPENDICITIS WAS RULED OUT VIA CAT SCAN.  PT WAS GIVEN IV THERAPY AND REST TO TREAT SYMPTOMS.
Large reaction at site of injection (red and raised) and small bumps around neck (front and back) and chest area. Patient states they itch.
I had diarrhea on October 28th, I'm on day 13 of liquid stools. I have never had diarrhea. I have isolated hives in my knees and intense itching with hives. Two days later I had intense itching on my knees. I haven't had any further issues with hives.  I saw a doctor and they noted that I had an inflammatory response in my intestines. I had a positive Leukoderma.  I've been taking over the counter Imodium.
Heart palpitations; This is a spontaneous report from a contactable consumer (patient reported for herself). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 (at the age of 69-year-old) (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included hypertension and blood cholesterol increased. The patient had no Covid prior vaccination. The patient had Known allergies to beta blockers. Concomitant medication(s) included TRIAMTERENE, DILTIAZEM, ATORVASTATIN, CALCIUM and colecalciferol (VITAMIN D), all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient had not been covid tested post vaccination. The patient experienced heart palpitations on 09Feb2021. The outcome of the event was not resolved at the time of this report.  Information on Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
episodes of electrical, burning and stabbing pains now diagnosed with MS; 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), in Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunisation. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "episodes of electrical, burning and stabbing pains now diagnosed with MS". The events "episodes of electrical, burning and stabbing pains now diagnosed with ms" required physician office visit. Therapeutic measures were taken as a result of multiple sclerosis. Clinical course: Inquiry: Patient received Pfizer booster in Mar2022 with no history of medical issues until 2-3 weeks after started having episodes of electrical, burning and stabbing pains now diagnosed with MS after a long painful year of suffering. Patient believe the shot that was mandated turned his life for the worse and Patient would like to know whom patient can speak with. Patient have been in and out of the hospital seen numerous doctors with no relief. Patient need help and would kindly ask for someone to get back as to what patient can do.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My pulse increased. About 45 to 50 minutes my pulse went through the roof. I started feeling really lightheaded. I felt like I could not breathe. Then I pulled off the road and seat out in the cold without a jacket for about 15 minutes until I could control my breathing. Then I went to the urgent care to check my vital sign. It was normal at that point. That night, I got a fever and ache arms for two days. I started to feel better on the March 4th, I had to much energy. Where I could not sleep. Then day, I started having heart problems. So, I went to the ER. They did blood work, but everything was normal. I only sleep for 2 hours between Friday and Saturday. I had severe insomnia for 6 to 8 weeks. I took medication for it. Once or once of every other week, I will still have that boost of energy where I could not sleep. They went away. Then in June, the insomnia came back worst. I had stomach problems, the heart problems and breathing problem came back as well. On June 25th, I experience my pulse sky rolling, and lightheaded again. I struggled to eat meals. I continued to have heart problems and insomnia. August 5th, I lost 15 lbs. because I could not eat anything. On August 8th, I went to ER because of my heart rate was high. I had a CT scan. I been dx with serve gastritis. They also discover endometriosis and access on my ovaries'.  They are unsure what is causing my gastritis. At this point I can't eat, sleep and got endometriosis..
Patient had a bout of syncope after vaccine was given - approximately 15 sec after injection.  Patient turned white, rolled over, and had stiffened body and started to twitch x 10 sec.  Patients eyes were glossed over and she was temporarily unresponsive, but eyes were opened.  Patient recovered quickly.
ER visit 7-28-22 diagnosis Acute deep vein thrombosis (DVT) of left peroneal vein-severe pain. Prescription Eliquis started. Adverse vaccine report created at 41 hours of pain constant.
Loss of control of movement of limbs on both sides, delirious, cold and hot sweats, left side facial droop, trouble swallowing by Friday the following day.
I started having heart racing, difficulty breathing and a swollen feeling in throat, minutes after the COVID-19 booster vaccination.
Several hours after patient received vaccine, reported pain with movement of the Right arm, patient also states he had a difficult time with movement in his arm. Patient is being seen by physical therapy for his arm pain and will continue to do so until he has relief of symptoms. If no relief, patient will seek higher echelon of care.
10/28/09 day after shot Rt. leg warm, indunated and very tender to the touch. Was worse on second day after shots. Mom intends to take to doctor. (Have made many attempts to contact mom Re. dr visits - no answer and no voicemail 11/5/09)
This case was reported by a consumer via call center representative and described the occurrence of generalized arthritis in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized arthritis (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the generalized arthritis and pain were unknown. It was unknown if the reporter considered the generalized arthritis and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The caller was a consumer who heard from an acquaintance that she received 1st dose of SHINGRIX and experienced feeling very achy and went to see physician and was diagnosed with arthritis all over her body and was in constant pain. The caller declined to provide address or other identifiers for the patient. No further information was available. This case has been linked with case US2018158686, reported by the same reporter.
Fever; Headache; warmth across back; achy; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6204), via an unspecified route of administration in left arm (left shoulder) on 18Mar2021 at 09:45 (at the age of 76 years old) as single for covid-19 immunisation. Medical history included diabetes mellitus, under control, always does the A1C with primary care provider and diagnosed about 15 years ago, left breast where she had her surgery from Apr1997 to an unknown date, heart attack from 14Feb2011 to an unknown date, left her with 35% of her heart muscle died, osteoporosis diagnosed years ago, arthritis diagnosed 30 or more years ago, right leg knee replacement from 2013 to an unknown date. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not have any additional vaccines on same date of the Pfizer suspect. She had her first dose of the vaccine and then had a bit of a headache on 18Mar2021 at 09:55 then there was like a warmth across her back in her shoulders on 18Mar2021, and that only lasted about 10 minutes, it was like she had a fever go across her back. The headache lasted about 10 minutes, it has gone away but she feels kind of achy on 18Mar2021. She had headache started within 10 minutes of the shot. She was feeling achy but it could be due to the weather. Second dose scheduled for 08Apr2021. The patient underwent lab tests and procedures which included weight: 215 to 225 lbs. The patient did not visit emergency room or physician's office. No family medical history relevant to adverse events was provided and no relevant tests were performed. The outcome of headache, warmth across back was recovered on 18Mar2021, achy was recovering, fever was unknown.  No follow-up attempts are possible. No further information is expected.
Headache; joint and body aches; joint and body aches; fever; fatigue; This is a spontaneous report from a non-contactable other HCP(patient). A 25-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Er8737) via an unspecified route of administration, administered in Arm Left on 03Apr2021 as DOSE 2, SINGLE for COVID-19 immunization (age at vaccination 25 years). The patient medical history and concomitant medications were not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6203) via an unspecified route of administration, administered in Arm Left on 13Mar2021 at 08:30 AM as DOSE 1, SINGLE for COVID-19 immunization and the events occurred are Headache, arm soreness, fatigue. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.On 03Apr2021 16:15 the patient experienced headache, joint and body aches, fever, fatigue. No treatment was received for the events. The outcome of the event was reported as recovering.  No follow-up attempts are needed. No further information is expected.
Dizziness the following morning, could not drive or work, head spinning, ears ringing, vision blurring