chrisvoncsefalvay/vaers-outcomes huggingface dataset:
44 year-old male with a PMH of anxiety, and migraine presented to the ED 1 hour after receiving first dose of COVID 19 vaccine in the medical clinic. 5-10 minutes after receiving the vaccine, patient began to report pruritic in left wrist that increased to his head, back, flanks, and stomach. Patient then began noticing pain in right leg. He was given cetirizine 10 mg and orange juice without any reliefs. Then, the patient developed gives and redness appearing on left forearm. He was then sent to ED for further evaluation since his symptoms were not improving. In ED, patient states itching has improved, hives have resolved, and has mild pain to lateral right leg. Denies chest pain, palpitations, shortness of breath, chest tightness, headache, abdominal pain, N/V, prior vaccine reaction. Vital signs were stable in the ED and no signs of distress or anaphylaxis. The ED provider recommended if the patient would like to get the second dose, he should take benadryl beforehand. Additionally, the patient was discharged home with diphenhydramine as needed for itchiness.
Hospitalized with Bilateral Pulmonary embolism.  Blood clots in each lung, causing severe pain, high blood pressure, and heart rate,  being prescribed blood thinners for life.  Damage was done to lungs, possible terminate damage
Bell's Palsy; This is a spontaneous report from a contactable consumer. This consumer reported same event for three patients. This is the third of three reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345756 same reporter, product, and event; different patient.;US-PFIZER INC-2021345757 same reporter, product, and event; different patient.
I got really sick, I threw up, I was vomiting and I was wondering if it is side effect; I got really sick, I threw up, I was vomiting and I was wondering if it is side effect; This is a spontaneous report received from a contactable consumer or other non hcp. A 70-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EI9264, Expiry Date: unknown) via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunisation. Medical history included High blood pressure  from an unknown date and unknown if ongoing and Diabetic from an unknown date. Upon probe, the patient confirmed that she received the first dose of the vaccine. The patient's concomitant medications were not reported. The patient experienced she received the vaccine (unspecified vaccine) on Tuesday the 2nd (Feb2021) and everything was fine but last night she got really sick, she threw up, she was vomiting, and she was wondering if it is one of the side effects, so what was going on. The patient did not received any treatment for the events. The clinical outcome of the event was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.  No follow-up attempts are possible. No further information is expected.
BEFORE MY FIRST VACCINE SHOT, I HAD A MENSTRUAL PERIOD STARTING 3-27-21. FIRST VACCINE SHOT 4-14-21. WAS SUPPOSED TO START MY NEXT MENSTRUAL PERIOD 4-23-21. GOT MY SECOND VACCINE SHOT 5-18-21. FINALLY GOT MY PERIOD ON 5-20-21. MY PERIOD WAS 28 DAYS LATE. I AM NOT SEXUALLY ACTIVE. I AM NOT ON THE PILL.   WONDERING IF MY FERTILITY IS AT RISK BY THE VACCINE?
I had a dinner guest on Monday 05/16/22 she had tested positive (this person also tested negative on 5/16) on May 17,2022. I had a home test that was negative 05/18 and on the 19th it was positive.  I felt bad I had a headache and cough.  21/22  I called my doctor and told them I tested positive, and they told me to isolate and was given Paxlovid. It didn?t get any worse. I naturally have bad lungs, so I took the medication as instructed.
fever, chills, fatigue, headache, reactive arthritis, body aches, vomiting, insomnia, shakes.
Got the vaccine 09:30 am at 09:30 pm I started vomiting. For 7 to 10 I couldn't keep anything thing down. Dry mouth and sore throat, dehydrated, severe vomiting. Extra pain in the right back side of my head. A tremor developed. I was completely fatigue and weak. I vomited non stop for 3 months I lost 100 pounds.
pt had six episodes of eye rolling back, arms flexed & stiff back lasting about 20-30sec;this occurred 9 hr p/vax;went to ER for eval including blood tests & CT scan-all nl;
Sx: anorexia, low grade fever, HA, weakness sx of paresthesias in upper and lower extremities. Dx: Guillain-Barre Tx: NIG, non-responsive to tx, transferred to tertiary hospital. Note: Vaccine administered (outpatient) prior to hospital admission.
This is a prospective pregnancy case. This 36-year-old female subject was enrolled in a study. The subject received BOOSTRIX .5 ml on an unknown date. The subject's estimated date of delivery was 19th January 2015. The subject received BOOSTRIX at week 38 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: A pharmacist was considering administering BOOSTRIX in a pregnant patient who is currently 38 weeks pregnant. She knows it is recommended between 27 and 36 weeks but was wondering if it would be okay at 38 weeks. The patient was at the pharmacy but an administration had yet to occur.
pt recv vax 11FEB97 & suffered stiffness of the back of neck (lasting 4 days) & a h/a;no tx or ER or MD visit required to treat these events;took dose 2 on 14MAR97 p/which had no adverse rxn;
7/29/2021 admitted to hospital; Pfizer on 4/10 and 5/3. Positive on 7/30
Pt vaccinated with DTP followed by fever 103, vomiting for 24 hrs & a severe headache lasting 5 days. Also, had redness inferior to the injection site. 6 X 4 tender indurated area below injection site.
pain at site/ muscle soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. In September 2019, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was unknown.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by the patient's sister. The age at vaccination was not reported. The patient received a dose of Shingrix and the flu vaccine last week from the date of reporting on the same day in the separate arm. The reporter stated that, the patient experienced pain and muscle soreness in the Shingrix arm. This was the only information she had on the vaccine. This case has been linked with cases US2019172789 and US2019173375 reported by the same reporter.
Client Received on 10/11/2019 FLu and Zoster vaccine and PPD skin test Client reports the day after( 10/12/2019) having vaccines she had all over aches and took Ibuprofen. Reports her Left eye was read and swollen. On Sunday(10/13/2019) she noticed a sharp pain to her jaw and reports she has partial dentures that were not fitting into her mouth as normal. Reports she took Ibuprofen again for the pain.Went into work on Monday( 10/14/19) with eye swelling and redness and co-worker noticed a droop to clients mouth ( drooping to the right). Client contacted employee health who directed client to an Urgent Care Center. Was informed they would not be able to help and was sent to Hospital for follow up.
Information has been received from a physician concerning patients who were vaccinated with the first dose of Rotateq past 12 weeks of age. It was unknown if medical attention was sought. No further information is available.
celiac disease; developed dermatitis, which is immune mediated; hemolytic anemia; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 78-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose number unknown, single (Lot number: HF9275) for covid-19 immunisation. The patient's relevant medical history included: "immunologic problem" (unspecified if ongoing); "allergic to sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient reported that he had an immunologic problem, that's why he was making sure he was up to date with his COVID vaccines. When he got the latest booster vaccine, there was no package insert that was found in the box of the vaccine. It did not mention in the labeling that the vaccine was a monovalent formulation. He developed celiac disease and then developed dermatitis, which was immune mediated. First choice of drug was Dapsone, and anti-leprosy drug, but he developed hemolytic anemia. The second choice of drugs were sulfa drugs, which he can't take because he was allergic to sulfa drugs. They were trying to find something to work. States the vaccine he got would cover omicron variant was his main concern. The subvariants bothering humans right now were EG5 and BA286. Outcome of the events was unknown.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported events and suspect BNT162B2 omi xbb.1.5 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Improperly stored vaccine administered; This spontaneous report as received from a registered nurse refers to a 17-month-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 23-FEB-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T017688, expiration date: 21-MAY-2022), 0.5 ml (route of administration was not provided). The vaccine was stored in temperature -13.3 degrees Celsius for 4 hours and 15 minutes. There was no previous temperature excursion. Digital data lodger was involved.  This is one of 23 reports from the same reporter.; Sender's Comments:  US-009507513-2012USA013093: US-009507513-2012USA013095: US-009507513-2012USA013524: US-009507513-2012USA013532: US-009507513-2012USA013533: US-009507513-2012USA013584: US-009507513-2012USA013585: US-009507513-2012USA013592: US-009507513-2012USA013594: US-009507513-2012USA013596: US-009507513-2012USA013598: US-009507513-2012USA013601: US-009507513-2012USA013603: US-009507513-2101USA000121: US-009507513-2101USA000122: US-009507513-2101USA000144: US-009507513-2101USA000214: US-009507513-2101USA000235: US-009507513-2101USA000261: US-009507513-2101USA000265: US-009507513-2101USA000266: US-009507513-2101USA000307:
A report was received from a health care professional on 10/30/03, concerning a 62 year old female vaccinee who inadvertently received a sub optimal dose of Fluvirin on 10/30/03. On 10/30/2003, the vaccinee inadvertently received a dose of Fluvirin where some of the vaccine dripped down her arm. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
pt recvd vax 9JAN93 & ER visit; dx contusion knee; pt returned to ER 21JAN93 for cellulitis due to inject; hard red area on lt deltoid; MD statement probable acute small subcutaneous abscess;
Red hot welt on right thigh size of a half dollar.  Red hot welt on left thigh size of an orange.  Can't touch the area.  School nurse called me about the size of the left welt. Have been using ice pack, pain reliever, and benidryl.
the products reached 30.9 Fahrenheit  for five hours with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (MI) (Reference number- 00833419) and transmitted to Sanofi on 28-Oct-2021.  This case involves an unknown age and unknown gender patient for whom it was reported the products reached 30.9 Fahrenheit for five hours while receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for Prophylactic vaccination.  It was a of actual medication error due to product storage error [Latency: on the same day].   It was reported "Caller reporting a temperature excursion caused by human error; facility employee thought she was making the temperature warmer and turned the temperature down instead; the products reached 30.9 Fahrenheit for five hours".  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  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 the 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.  There will be no information available on the batch number for this case.
vaccinator felt that the syringe didn't feel right upon administration.  assessed the vial of vaccine.  it was determined that the syringe was likely empty and an additional injection was given with vaccine
Increased pain from cramps when menstruating requiring time off work; Headaches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history included celiac disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. On 19Apr2021, the patient experienced headaches, nausea and increased pain from cramps when menstruating which required time off work. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, nausea and increased pain from cramps when menstruating which required time off work were not resolved at the time of this report.
Moderate to severe pain in left arm at injection site, ongoing for 2 days. Feel like flu symptoms, have fever, achy, tired, no appetite, have been in bed for 2 days. Hope tomorrow is better.
Infections: in throat and mouth, trouble remembering recent information, short-term memory loss, depression, mood swings, irritable, nose bleeds, runny nose & neck rigid, sleep problems, skin discoloration. Skin turns funny color skin rash, thirst increased, acid reflux, stomach problems, neurological staring spells.
I developed a massive GI bleed suddenly 16 days after receiving my second COVID shot.  While I am a UC patient, I have had this disease for over 15 years, and this has NEVER happened before.  Even when in a flare, and even on blood thinners, I have never had a bleed like this.  It required a trip to the ER and a hospital admission for testing and treatment.  In the course of my stay, I learned that Ulcerative Colitis patients are now reporting massive GI bleeds after recovering from COVID itself.  The doctor couldn't rule out the possibility that the vaccine caused the bleed.  I was admitted May 15th and am expected to be released home to recover on May 18th or 19th.  A pelvic/abdominal CT on May 16th showed inflammation in the colon, but a colonoscopy on May 18th showed the evidence of UC was chronic / old disease, while a single significant ulcer was found as the source of the bleed and cauterized.  This occurred while the disease was well controlled on medication, literally out of the blue with no other symptoms besides the bleeding.
Local reaction at injection site: redness pain, blisters, warmth, itching.  No treatment.
This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 18-FEB-2014, the patient was vaccinated with first dose of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Feel so heavy every time I close my eyes; I'm feeling so sleepy; Itchy at the place where I got the vaccine; Sore at the place where I got vaccine; I'm feeling so tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENOPIA (Feel so heavy every time I close my eyes), SOMNOLENCE (I'm feeling so sleepy), VACCINATION SITE PRURITUS (Itchy at the place where I got the vaccine), VACCINATION SITE PAIN (Sore at the place where I got vaccine) and FATIGUE (I'm feeling so tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS and IBUPROFEN for an unknown indication.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ASTHENOPIA (Feel so heavy every time I close my eyes), SOMNOLENCE (I'm feeling so sleepy), VACCINATION SITE PRURITUS (Itchy at the place where I got the vaccine), VACCINATION SITE PAIN (Sore at the place where I got vaccine) and FATIGUE (I'm feeling so tired). On 09-Feb-2021, VACCINATION SITE PRURITUS (Itchy at the place where I got the vaccine) and VACCINATION SITE PAIN (Sore at the place where I got vaccine) had resolved. At the time of the report, ASTHENOPIA (Feel so heavy every time I close my eyes), SOMNOLENCE (I'm feeling so sleepy) and FATIGUE (I'm feeling so tired) outcome was unknown.            Reporter did not allow further contact
2) "Stoned" From 8:15pm 2/5 thru 12:00 pm 2/7 1) Sporadic vibration of entire body 3) Constipation
A report has been received from a Health Professional concerning a 40 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 5-Dec-2013. It was reported that four patients were inadvertently administered expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered) which started on 05-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST QUADRAVALENT to four patients is unknown. The report was considered to be non-serious. Corrected report 06-Jan-2013; Formulation corrected. Start date added to FLUMIST.
This spontaneous report as received from a Medical assistant refers to a patient of unknown age and gender. On 09-JUL-2013 the patient was vaccinated with VARIVAX (INJ) (0.5 ml) (lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. The medical assistant reported that the patient received a dose of VARIVAX (Merck) instead of ZOSTAVAX. No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
Administration error: Pt had history of Guillain-Barre syndrome and received Fluzone HD. No symptoms  that we are aware of so far.