chrisvoncsefalvay/vaers-outcomes huggingface dataset:
major bleed; GI bleed; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 25Feb2021 (at the age of 77-year-old) (Lot Number: EN6200) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Medical history included first time she experienced bleeding was in 2013 because of aspirin. Stated that she decided it was a good idea to take baby aspirin so she took it on her own. She was told don't ever take aspirin ever again and she didn't have any problem until Nov2020. That was the first incident, in 2013, that told her she should not take blood thinner. They took her off the blood thinner in Nov2020. She had been taking aspirin. She lost half her blood; she lost it two settings. She sat down to take a bowel movement and was told she lost half of her blood. Not sure when she started Aspirin but she stopped it in 2013. It was mentioned that she could take aspirin. She was on a low dose of Eliquis for atrial fibrillation for prevention of a blood clots or heart attack.  she had bleeding in the last year. The one that was the most was back in Nov2020; it was more pronounced. Mentioned that she went in on 12Nov2020 for the bleeding and then had to go back in because her legs were swelling. She stopped taking Eliquis in Nov2020 and from then until Apr2021 she had no bleeding. It was several years ago when she was diagnosed. She was riding her bike in the neighborhood, and felt too tired so she stopped at the doctor and went in and told them she felt weird, they couldn't get her BP and took her to the hospital and her heart rate was sky high like 250. They said she might had to have electric. She didn't have any pain but states she was psychologically freaked out by everyone running around. Mentioned that, she was first placed on dronedarone (MULTAQ) 400mg twice daily to treat her atrial fibrillation; she can't remember the year. After taking it as prescribed for some time she got atrial fibrillation again. She was told by the doctor it had lost its efficacy. Concomitant medications included Fenofibrate taken for blood cholesterol, Metoprolol succinate taken for blood pressure, Vitamins NOS, Ferrous Sulfate taken for anemia, Vitamin D3 all are ongoing. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EL3246) on 06Feb2021 in arm left for covid-19 immunization. It was reported that, On 25Feb2021 she received her second dose of the Pfizer-BioNtech Covid-19 vaccine, on 19Apr2021 she had a major bleed and GI bleed (Hospitalization) on 19Apr2021. The patient was hospitalized for major bleed and GI bleed from 19Apr2021 to 21Apr2021. Outcome of the events was unknown.  No further information expected.
Immediate pain with injection, none with first injection. Progressively worse and now can?t lift arm without extreme pain
Severe stomach cramping, diarrhea for 24 hours, then bleeding from anus , red currant jelly blood
8 days p/vax given c/o h/a, sore throat, vomiting, t102-103F, dx sinus infect; Glands became more swollen back to MD;
At 10 am, checked on patient, stated she was unsure how she felt, throat is kind of itchy. BP 124/84 P 71 O2 99%. Reviewed with Dr, added an additional 15 minutes of observation time. No additional orders at this time.   At 1037 am, Patient assessed by Dr. No additional orders. Patient cleared to leave and in stable condition.
she got deathly I'll every time she took one of those shots; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional.  This case involves an unknown age female patient who got deathly i'll every time she took one of those shots (illness), while she received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.   On an unknown date, the patient received influenza vaccine (Strength, formulation, dose, frequency, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date (unknown latency), after started therapy with suspect vaccine, she got deathly ill every time she took one of those shots (illness).   Action taken with the suspect drug was not applicable.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted roughly 2 minutes after receiving COVID 19 vaccination
breaking out in hives, in my lip, top lip first then it went to my bottom lip around the injection site and on my butt; breaking out in hives, in my lip, top lip first then it went to my bottom lip around the injection site and on my butt; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 81-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration on 24Mar2021, last wednesday (at the age of 81-year-old) as dose 2, single for covid-19 immunization. Medical history included hives, he had these hives when he was a kid, 75 years ago from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (solution for injection) via an unspecified route of administration, administered on an unspecified date, as dose 1 single for COVID-19 immunization. On an unspecified date in 2021, past few days the patient experienced breaking out in hives, in his lip, top lip first then it went to his bottom lip around the injection site and on his butt. He was calling to report this. Should he take something, or should he call his doctor. Had anything like this been reported before. Caller wanted to know how long this report was going to take. He wants to be transferred over to get his question answered. Outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Child given flu shot on Wednesday. On Thursday she developed high fever and had convulsions. She was sent to another city and then to another. Had severe anemia. According to grandmother she returned home the week of 18th - Has to go for frequent Dr visits.
Dear Sir,  I went to the wellness center (health center) in March 20 to check for my eyes after taking an appointment before one hour. When I arrived they told me at the reception you have to take vaccine MMR and you need to sign this form, so I asked them I submitted the required forms for the vaccines before enrollment in the class, so they told me you have to take it (Receptionist) I signed the form, and then the physician told me that you need to take vaccine, and the nurse took information about my eyes and then another one came to make an oppintment to me in private clinic, so I told her I need to take the medication from the center then I will go to private clinic. then she got out the room then she came back with syringe already loaded out side with the material as she told me it is vaccine (MMR), she injected me in the right hand. Next day I got urine problem for four days, difficult to urine, go to the bath a lot of time daily. I got pain because of a lot of urinaty. I got headache, fever, redness skin particulalry under fingers. I called the
This spontaneous report was received from a registered pharmacist concerning a male patient who on an unknown date was vaccinated with a dose of PNEUMOVAX23, intramuscular (dose not provided) (lot # 0709AE, expiration date on 04-JAN-2014). On an unknown date, the patient came down with fever and rash around injection site with color of scarlet red. No treatment was given for the events. The patient spoke to pharmacist. At the time of the report, the outcome of the events was unknown. A lot check investigation was initiated. This is one of several reports received from the same source. Additional information has been requested.
Sent to ER then admitted to Medical, then sent to rehab, then back to ER, then back to rehab.
This spontaneous report as received from a nurse practitioner via a company representative refers to an around 55 year old female patient. On an unknown dates, about 5 or 6 months before, the patient was vaccinated with two doses of ZOSTAVAX which was other than indicated in the Prescribing Information. It was not confirmed whether both shots were given on the same unspecified date or on different dates. The patient sought medical attention: visited an office. Additional information is not expected as there is no consent to contact the reporter.
Severe anxiety and panic attacks; Severe anxiety and panic attacks; covid vaccine details administration date 13Apr2021 / other vaccine same date vaccine date 13Apr2021; covid vaccine details administration date 13Apr2021 / other vaccine same date vaccine date 13Apr2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0162, at the age of 38-year, on 13Apr2021 11:00, and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8732, at the age of 38-year, on 13Apr2021, both at single dose in left arm for COVID-19 immunisation. Medical history was not reported. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received Penicillin. On 06May2021 13:00, the patient experienced Severe anxiety and panic attacks that has lasted over 2 weeks. Both events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the events included Therapy and prescription. The outcome of Severe anxiety and panic attacks was not resolved.
weak; soreness in the left (injection) arm; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA, VACCINATION SITE PAIN, and FATIGUE in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (Began using Humira on 13-May-2021, paused between 24-Jun-2021 and 23-Sep-2021).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA, VACCINATION SITE PAIN, and FATIGUE. At the time of the report, ASTHENIA, VACCINATION SITE PAIN, and FATIGUE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and treatment medications provided.   This case was linked to MOD-2021-381984, MOD-2021-382083 (Patient Link).
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 3:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 3:08 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient received Moderna vaccine on 11-Mar-2022 15:08:34, past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
CHEST PRESSURE/CONGESTION, HEAD CONGESTION.  SYMTOMS SUBSIDED WITHIN 36 HOURS.
Headache, NauseaVomiting, Localized pain; fatigue Narrative:
A report has been received from a Health Professional concerning a 24 year old, female subject, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 14-Jan-2014. The Registered Nurse reported that they inadvertently administered expired FLUMIST QUADRIVALENT to the patient (Preferred Term: Expired drug administered) which started on 14-Jan-2014 and not reported any symptoms. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
Break through varicella with less than 50 lesions, 13 papules and 2 vesicles complicated by cellulitis. Rx'd Augmentin.
didn't receive 2nd dose, first was given two years ago; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 8-JUN-2022 Reporter's comment:The reporter stated that that a male patient did not received the 2nd dose of shingrix and first dose was given two years ago. The consent to follow up was given. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which lead to Incomplete course of vaccination.
I had the Covid Vaccine happily and as I walked out of the building into my car something scary happened. I was in a call with my grandmother and my mother was with me. About 20 minutes later I felt dizzy then fainted and my muscles twitched causing my body to jerk around. It lasted a couple of seconds but it hurt a bit.
2 days after DTaP and VARIVAX in R shoulder, 7x7 cm bright red area, with heat, 2x2 induration where DTaP given; No fever. 4 days later, less red - No fever, Non tender
Information has been received from a physician concerning a patient with an egg allergy who between January and May of 2005 was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live (date unspecified). Concomitant suspect vaccination given on that same day included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, on the same evening thee patient experienced an trouble breathing also reported as allergic reaction and was taken to the hospital for possible adverse reaction following vaccination. It was reported that the patient was hospitalized for 1-2 days for further testing. The outcome was reported as recovered. No further information was available. No product quality complaint was involved. Additional information is not expected.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant were not reported. On 12-MAY-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K018528, expiry date: 14-APR-2016) (route and dose not provided). No adverse effects were reported. No Product quality complain (PQC) involved. No further information provided. Additional information has been requested.
Patient complained of feeling dizzy, seeing floaters in her vision, and pain to her left arm where vaccine was given. EMS responded. Vitals were within normal limits. Refused transport. Dizziness resolved with snacks and water. Patient referred to contact her PCP.
Patient experienced an upset stomach after getting her first dose of the pfizer vaccine. She ended up throwing up but felt better afterwards.
A lot of arm pain, aches, 102 fever, chills, cough, headache - went to ER 6/21/12 - given VICODIN, ZITHROMAX.
Patient reports swelling of lymph nodes behind both ears, in neck, axillae, behind right knee. Painful left wrist and heart palpitations also reported.
Patient reported feeling "flushed, hot, and a little lightheaded" with a slight headache about 10 minutes after receiving her second dose of Moderna Covid Vaccine.  Pt given ice packs for face and given water to drink.  Pt reported symptom improvement and resolution within a few minutes of writer evaluation.  Pt denied any facial swelling, tongue swelling, throat swelling, difficulty speaking, shortness of breath, chest pain, nausea, vomiting, diarrhea, abdominal pain, fevers, chills, palpitations, dizziness, sore throat, or weakness, .  Pt's vital signs were stable: BP of 122/82 mmHg, 79 bpm pulse, SPO2 97% on room air, respirations 16 breaths per minute.  Pt alert and oriented x 3 and able to speak in full complete sentences.  Physical exam only revealed some minor facial flushing, no wheezing on auscultation, or audible stridor - airway patent.  Pt was observed by writer and staff for a total of 45 minutes from the time of receiving her second dose of Moderna.  No other adverse events observed by staff or reported by the patient during that time.   No medications were administered.  Pt disposition was home after completion of 45 minute observation period, patient went home with family member.  Additional information: Pt stated that after she got her first dose of Moderna Covid Vaccine one month prior, she experienced: "nausea, vomiting, diarrhea, fever, body pain, and rash for 7 days", she stated she went to "walk-in clinics 3 times for the body pain".  She also stated the symptoms completely resolved "after 7 days".  Pt denied needing to be hospitalized after her first dose of Moderna one month ago, or receiving any injections of epinephrine.
Pt reported waking up the next morning with a headache and sore throat, and a quarter-sized bruise at the injection site. She also voiced concern that bleeding occurred from the injection site for ~20 minutes after the injection.
received the first dose of the vaccine and 2 weeks later came down with the COVID virus; received the first dose of the vaccine and 2 weeks later came down with the COVID virus; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the vaccine and 2 weeks later came down with the COVID virus. The patient wants to know when he can get the second dose of the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
blood pressure dropped really low; pulse went really high; heart rate went up; atrial fibrillation; his blood pressure and pulse have remained erratic; his blood pressure and pulse have remained erratic; This is a spontaneous report from a contactable consumer.   A 76-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm on 05Mar2021 10:30 (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021), at the age of 76-years at vaccination, as SINGLE DOSE for COVID-19 immunisation  .  Medical history included congestive heart failure, aortic valve replacement couple of years ago. Concomitant medication includes aspirin 325mg once per day by mouth. On 05Mar2021, the patient went into Afib, his heart rate went up and the next day on 06Mar2021, his blood pressure dropped really low but his pulse went really high and carried it that way for a few days and then he went pretty much back to normal.  On 05Mar2021, the patient experienced atrial fibrillation for 22 hours and since that time his blood pressure and pulse have remained erratic. The reporter stated that the patient has returned to normal and his pulse is still a little high and his pulse used to run in the 70's and maybe 80 but today (15Mar2021), the pulse was still 95; on 06Mar2021, the patient took his blood pressure twice and is not sure at what time he checked it but one time it was 98/65 and the pulse was 114 at that time and the other time the blood pressure was 88/59 and the pulse was 115. States the patient's blood pressure pretty much turned back to normal on 10Mar2021 and the blood pressure started being normal on 10Mar2021. On 15Mar20021, the patient's blood pressure was 140/76 and the pulse is still real high at 95 today and he weighs himself, takes his blood sugar and blood pressure every day. Regarding the treatment, the reporter and the patient saw the patient's cardiologist this past Friday 12Mar2021 and put the patient on Metoprolol and the blood thinner Eliquis; states the patient was just taking a whole Aspirin and had previously had aortic valve replacement a couple of years ago and the HCP reduced his aspirin dose down to a low dose of Aspirin and then put him on the Eliquis at the HCP appointment. The reporter stated, for the Metoprolol and Eliquis she does not know the dosages or frequency of how the patient takes them at this time; states she has no lot numbers for the Metoprolol, Eliquis or Aspirin to provide as they are not with her at this time. The outcome of the event his blood pressure and pulse have remained erratic was not recovered; while the other events was recovered. Treatment has been given for the events.
No Adverse reaction  Expired IPV 7/16/21  given 8/2/21 IPV will be reoeated 30 days after 8/2/21  vaccines Mother Ntfd.
Systemic: Flushed / Sweating-Mild, Additional Details: pt states heatness/flushing and went away after drinking water
Patient developed rash cheek, wrist, back of neck 3/14/21. Had received 1st dose of Moderna Covid-19 3/12 but also took her 1st dose of Aricept this same day.