chrisvoncsefalvay/vaers-outcomes huggingface dataset:
then tested positive; then tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "Walnut" (unspecified if ongoing); "shrimp" (unspecified if ongoing). The patient took concomitant medications. There were other medications in two weeks.  The following information was reported: No adverse even to vaccine. But tested negative day after finishing Paxlovid treatment, then on 26May started feeling symptoms worsen, then tested positive of 27May. Patient was still tested as positive and still have symptoms but they are improving. COVID-19 (medically significant), outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "then tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: tested positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant and refers to unknown number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history and concomitant medications was provided. On unknown dates in 2017 (reported as "on or after 20-FEB-2017"), the patients were vaccinated with improperly stored VARIVAX lot# M023382 and expiry date: 11-MAY-2018, lot# reported as: L046837, expiry date 23-NOV-2017 (dose and route of administration were not provided). Properly stored sterile diluent (manufacturer unknown) was used to reconstitute the vaccine. VARIVAX was improperly stored in temperature from -9 to 8 Celsius degrees for 8 hours. Digital data logger was involved in detecting the temperature excursion. No previous temperature excursion took place. No adverse event was reported. Additional information has been requested.
Swelling to the left eye that has the eye almost swelled shut.  This started on 07/28/2021.  Some left side facial swelling. Sore/painful left arm, pain in left leg. Fatigue. Headache.
Did my COVID rapid and PCR (both positive); Did my COVID rapid and PCR (both positive); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 15:45 (Lot number: 301458A) at the age of 37 years as dose 3 (booster), single, administered in arm left, administration date 08Mar2021 08:45 (Lot number: EN6203) as dose 2, single and administered in arm left, administration date 15Feb2021 13:00 (Lot number: EL9267) as dose 1, single for covid-19 immunisation. Relevant medical history included: "minor gastrointestinal discomfort" (unspecified if ongoing); "constipation" (unspecified if ongoing); "received PRK eye surgery", start date: 11Jan2021 (unspecified if ongoing), notes: received PRK eye surgery. No known allergies were reported. The patient took concomitant medications. Past drug history included: Prednisone, start date: 2021, for weakened my first vaccination. The following information was reported: VACCINATION FAILURE (medically significant) with onset 05Mar2022, outcome "unknown", COVID-19 (medically significant) with onset 05Mar2022, outcome "not recovered" and all described as "Did my COVID rapid and PCR (both positive)". The event "did my COVID rapid and pcr (both positive)" and "did my COVID rapid and pcr (both positive)" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Mar2022) positive; (05Mar2022) positive. Therapeutic measures were taken as a result of covid-19.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired Moderna vaccine given as a third dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 004C21A) for COVID-19 immunization. No medical history reported. On Sep 21, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 21, 2021, patient administered expired product (expired Moderna vaccine given as a third dose). On Sep 21, 2021, administered expired product (expired Moderna vaccine given as a third dose) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The expired Moderna vaccine administered as a third dose to the patient on Sep 21, 2021, at 2:40 pm. This case linked to MOD-2021-326571 (patient link).
Left arm SQ swelling, local reaction with redness. Tender to touch. Treatment: cool compress and MOTRIN prn for soreness.
Started out as cold like symptoms, but continued to get worse. Lost 30-35 lbs over 2 weeks. Has extreme muscle weakness. Was admitted to hospital, where he was diagnosed with Guillain-Barre syndrome. Was in the hospital for 2 weeks. Still has significant muscle weakness and is currently seeing therapy and specialists. Still trying to get answers. Started getting sick before Thanksgiving and was admitted to the hospital X-mas day.
April 29, 09 - Injection given R shoulder. Client describes pain in R shoulder joint, trouble lifting arm. Pain was immediate after shot then next day, went away 2 days, pain back, not as bad.
second dose 46 days later; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 46 days later) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 46 days later). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 46 days later) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment details was not reported by the reporter.
I initially had the standard "pain, swelling, and redness at the injection site," but it went away after a few days. Suddenly about four days after that, my arm was red again in the same spot, swollen, very hot, and ITCHY. I have not noticed any rashes anywhere else (so far!).
Heart rate increased from 71 to 158 (captured on apple watch) within two seconds post administration, and experienced shortness of breath, flushing and palpitations.
shot hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient reported that the shot hurt but did not want shingles.
Information has been received from a health professional concerning a 6 year old pt who was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine at 3 years of age. Subsequently, at 6 years old, the pt died from pneumococcal disease. The physician indicated that she believes the child did not get a second vaccination.  Additional information has been requested. Discharge Summary rec'd 06/21/2005 states additional terms as abdominal pain, tachycardia, photophobia, headache, distended abdomen, pulse absent and hypotension.
Experienced mild chest pain and elevated heart rate in the days following the second vaccine dose. Also experienced discomfort in the heart when lying down. Received medical attention from ER department and was found to have heightened troponin levels and irregular EKG readings. Was given potassium pills to help support healthy blood flow and was prescribed a "healthy" low sodium diet during my time there. Discharged after 3 days of testing and was diagnosed with an enlarged heart and mild hypertension. During a follow-up visit with the cardiologist, he informed that symptoms aligned very well with those of pericarditis and believed that I may have experienced an overactive immune response to my second vaccine dose.
Flu shot - 09/28/2012. Sore shoulder - 09/30/2012. Very painful frozen shoulder - 10/15/2012. Tramadol - 04/16/2013 - couldn't take got sick ibuprofen (6 per day) and acetaminophen (6 per day) - 04/23/2013 - current. Feldenkrais practitioner - 05/20, 05/24, 05/29, 05/31, 06/02, and 06/05. Chiropractor - 05/31 and 06/05.
Received flu shot, walking across parking lot to return to work approx. 15 min. after shot left side of face began to tingle, & then became numb (numbness - included eyelid, eyebrow & forehead as well as entire left side of face).
THROBBING IN MIDDLE FINGER; DIARRHEA; JITTERS; FELT LIKE DYING; LEG PAIN AND NUMBNESS, LEFT ARM AND RIGHT ARM PAIN; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was 160 pounds, and height was 64 inches. The patient's concurrent conditions included spinal stenosis, lumbar deteriorating disc disease, deteriorating disease, alcohol user, smoker, cholesterol, and blood pressure, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included tramadol for cholesterol, gabapentin for epilepsy, and fentanyl citrate. On 10-APR-2021, the subject experienced jitters. On 10-APR-2021, the subject experienced felt like dying. On 10-APR-2021, the subject experienced leg pain and numbness, left arm and right arm pain. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced throbbing in middle finger. On 11-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throbbing in middle finger, diarrhea, jitters, felt like dying, chills, and fever on 12-APR-2021, was recovering from leg pain and numbness, left arm and right arm pain, and had not recovered from headache. This report was non-serious.
7 PM-feeling cold & body aches. Took Advil PM at 9 PM.  At 11:45 PM -6 AM next morning intense shivering (could not get out of bed to check temperature) and dull headache. Fatigue & body aches continue. By 4 PM next day only periodic chills and body aches....much improved. I had called and left message at my MD office yesterday, and nurse from the office called back this morning to say that since my side effects were 'common', they said that the doctor's office would not report the side effects I informed them of.
PT FELL TO THE FLOOR, DID NOT HIT HIS HEAD, THEN PT REGAINED CONSCIOUS. DID NOT EAT LUNCH PRIOR, VSS, REFUSED TRANSPORT.
Childhood BCG vaccine scar redness and pain. Muscle/arm pain under the BCG vaccine scar about half an inch far from the covid vaccine. No pain at the moderna booster vaccine site after 1 day of vaccination. No treatment.
body aches about 20 hours after shot soreness and itching at injection site lump at injection site itchy rash appeared  10 days after injection
nauseated /queasy; Heartburn; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAUSEA and DYSPEPSIA in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA and DYSPEPSIA. The patient was treated with ZOFRAN for Nauseated, at an unspecified dose and frequency. At the time of the report, NAUSEA and DYSPEPSIA was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. symptoms are lasted for 4 days now. Her HCP wrote a prescription for Zofran and she would like to know if she can take it before her second dose.
Cellulitis on right thigh, 8cm X 10cm of redness, hot to touch and swelling.
Swollen left thigh, warmth and redness for 3 1/2 days. Mild discomfort.
On 03/14, I had a slight headache all day, a sore left arm where the injection was given. The site was warm and a large red, itchy spot beneath the injection site appeared. My normal temp is 97. I felt flushed all day and my temp was 98.6 at its highest.  I took 1 tylenol 500 tablet at 3pm and another 1 tablet at 9 pm. On Monday, 03/15, all symptoms were gone except for my slightly sore arm and the red spot which was lessening.  On 03/16, my left arm is almost back to normal.
Blanching erythema 8x4.5 (L) lateral upper arm, no induration, not tender. No fever, moving  (L) arm normally. Advised ibuprofen and cool compresses. By next day 2-16-18, parents reported improvements.
Patients arm around injection site was red and the size of a baseball. It was raised in swelling around 1/8 of an inch and 3 inches in diameter. It was warm to the touch for the first 8 hours but not warm to the touch when she stopped by the pharmacy.
This spontaneous report was received from a physician and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patients were vaccinated with VARIVAX (lot# M010482 with expiration date: 01-MAR-2018, lot# L049536 with expiration date: 08-DEC-2017 and lot# M025870 with expiration date: 24-MAY-2018; dose and route of administration were not provided) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
A report has been received from a study investigator concerning a 37 year old, female subject, height: 172.0 centimeters; weight: 59.0 kilograms, enrolled in study. FLUMIST QUADRIVALENT (intranasal) started on 28-Oct-2013. The patient became pregnant on 15-Jul-2013. The date of last menstrual period was 01-Jul-2013. FLUMIST QUADRIVALENT (intranasal) was discontinued on 28-Oct-2013. The patient gave birth. The outcome was reported to be a healthy baby. The report was considered to be non-serious. The investigator considered that there was no causal relationship between pregnancy and FLUMIST QUADRIVALENT.
I received the 5th dose and I started having something like a head cold. I went to see my doctor and I was given Ardizone and a that didn't help. The doctor had me come back in and had a cocktail of different medicines, FLONASE twice saline and brand name AIR and it took me two weeks to see improvements. I then started seeing tremors in my had and as time continued, I noticed it was a full body of tremor. I have some brain scans and other test scheduled. I don't know if these things are connected but it's been a rough 6 months. I took the other shots and had no issues this is just very weird to start having all these issues after the 5th dose.
Tender and sore under arm; Dime/quarter sized lymph cyst under right arm; This is a spontaneous report from a contactable other healthcare professional, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Apr2021 at 10:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa drugs. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and minerals nos, vitamins nos (PRENATAL VITAMINS); both for unspecified indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Mar2021 at 10:15 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient previously took sulfamethoxazole;trimethoprim (SEPTRA) for unspecified indication on an unknown date and experienced drug allergy. 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 06Apr2021 at 17:30, at 2 days post 2nd vaccine, the patient experienced dime/quarter sized lymph cyst under right arm and tender and sore under arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event dime/quarter sized lymph cyst under right arm and tender and sore under arm was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever to 101 x 3 days 10 days past 12 with rash to upper back and right thigh.
Patient called from home stating she has a rash all over her arm that she received the vaccination in. She was instructed to take Benadryl. If she gets worse to go to the emergency room. Patient arrived at the emergency room about an hour later with c/o her tongue swelling. Patient was treated and released.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number- 00303291) and transmitted on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310354, 2020SA277871, 2020SA310901, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770  (same reporter)  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
SUSPECTED COVID-19 INFECTION; EXACERBATED ASTHMA; RASH BROKE OUT ON BODY AFTER COVID INFECTION; This spontaneous report received from a patient concerned a 58 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, underlying conditions Shellfish allergy, and overweight. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total administered on 18-MAR-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 57 years old. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin not reported, batch number: 211091A expiry: UNKNOWN) dose was not reported, 1 total administered on 01-DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 57 years old. No concomitant medications were reported. The patient also received Non-company suspect vaccine included: influenza vaccine (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. On unspecified date around beginning to middle of SEP-2022, the patient experienced suspected covid-19 infection (Omicron variant) (along with symptoms of breathing issues and extreme fatigue) (Dose number in series 2). On an unspecified date in 2022, the patient experienced exacerbated asthma (breathing from - exacerbated asthma) and rash broke out on body after infection (Dose number in series 2). The patient still had breathing issues from exacerbated asthma, some long term covid effects of breathing issues, rash that broke out on body (after infection), and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s, and influenza vaccine was not applicable. The patient had not recovered from exacerbated asthma, rash broke out on body after covid infection, and suspected covid-19 infection. This report was non-serious.