chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My heart was beating very hard  and fast while laying down. I took ibuprofin and it helped but I thought you should know. My heart felt like it would explode and I was very dizzy and was experiencing intense vertigo as well. Playing a video game I turned the camera and nearly vomited.
Redness, swelling, induration of 4.3cm x 5cm. Warm to touch, tenderness, itching.
Patient felt that his throat was tightening 5 minutes after vaccination during his observation period. He was immediately pulled into a private exam room. Vitals were stable at that time. 50 mg of IM Benadryl was administered. Patient did not improve with this treatment and went on to develop a muffled sounding voice and mild swelling of his left posterior tongue 10 minutes later. At this point, 0.3 mg of epinephrine was administered.  Symptoms rapidly improved with treatment. EMS was contacted for transfer to the ER for further treatment as indicated and close observation.
10:45 pm - call received from a school stated a 9 y/o child rec'd nasal vaccine this morning and was now nauseous. No vomiting noted - Instructed child to lie down, place cool, wet cloth on forehead - Take V/S B/P - 127/79 P 88 - Instructed to call parents. 11:00 am -called school - spoke with mother.  She stated her other child did not feel well this morning but went to school anyway. Instructed mother to watch child today and if any other symptoms develop to contact family physician. Call placed to mother 3:10 pm - stated " pt went home with her father, ate lunch and felt a little better."
Patient received J&J vaccine. Within a few mins, patient was pale, weak, nauseous, and vomiting.  Patient was brought back to the exam room to lay down, evaluated by the physician, given water, and was monitored while resting for approximately 30 mins. Vitals were stable.  Patient was alert & oriented. Pt regained facial coloring, stopped vomiting, and felt better after some rest. Pt left the office ambulatory in stable condition.
Started with extreme pain at injection site, swelling, and inability to use my left arm. Then experienced chills, fever, muscle pain, extreme disorientation, total loss of appetite, more swelling of injected arm and red rash on upper portion of the injected arm. I would like it to be noted that I was given the PREVNAR13 injection one year earlier, on Feb 3, 2017.
Hearing issue; Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of hard of hearing in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced hard of hearing and drug dose administration interval too long. On an unknown date, the outcome of the hard of hearing and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the hard of hearing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient thought she might had been over the 6 month window for her 2nd dose of Shingrix, which led to lengthening of the vaccination schedule. The patient was experiencing some issues with her hearing. The reporter was in a rush and did not want to provide any information in regards to the adverse event and address.
3-4 days after receiving shots, developed fever <103. Irritability; generalized red bumpy rash developed around 6/7. Was taken to pediatrician 6/9. No treatment. Diagnosed as reaction to MMR vaccine received 5/28.
little sore on my arms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis and COVID-19 VACCINE (COVID19 VACCINE) for prophylaxis.   On 20-SEP-2023, the patient received RSV vaccine, INFLUENZA VACCINE and COVID19 VACCINE. On 20-SEP-2023, less than a day after receiving RSV vaccine and an unknown time after receiving INFLUENZA VACCINE, the patient experienced pain in arm (Verbatim: little sore on my arms).  The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 20-SEP-2023 This case was reported the patient via interactive digital media. The patient got 3 shots today (on the day of reporting) RSV, Infuenza flu and Covid-19 and had little sore on arm. Follow-up not possible as no contact details provided.
PT reported hives, and burning sensation in throat approximately 5 minutes after receiving her Pfizer booster dose. EMS was called. RN administered 50mL of Benadryl to right deltoid IM.  EMS arrived and took PT to local hospital. When PT left, pt was alert and oriented x3.
We returned from out of town on Thursday, June 30th.  On Friday morning I woke up with runny nose and I thought it was allergies.  We did testing, PCR, and it was negative.  On Saturday my chest felt tighter and I felt "off".  I tested at home and was positive.  As the day went on I felt worse and worse.  I did not have much energy.  It settled in my chest and cough was really bad.  I took a lot of fluids and basically slept.  My brain was like 'nothing' I couldn't think.  I had a hard time sleeping because of my coughing.  I had body aches and congestion in my nose.  I called the doctor on July 5, 2022.  He ordered an anti viral for me and decongestants.  Due to my asthma we were trying to be careful so I didn't have to be on steroids.  I tested positive all through the 11 days.  I began to feel better after the anti viral.  I am still fatigued more than usual and my brain fog is still here.  I will literally lose words from time to time.  My brain fog also will still cause me to lose train of thought and still causes mental exhaustion but not as often.
Sore throat; stuffed nose; ear congestion; 101 fever; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date: Not reported), via an unspecified route of administration into left arm on 29Apr2021 at 13:15 (at the age of 31-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included Anxiety, depression, and Bipolar II. The patient had no known allergies. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medications (in two weeks of vaccination) included: Citalopram at 20 mg once a day (QD), and Oxcarbazepine 300 mg twice a day (BID). The patient has received an unspecified vaccine on 29Apr2021. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection, Lot number: EW0158, expiry date: Not reported), via an unspecified route of administration into left arm on 08Apr2021 at 13:15 (at the age of 31-year-old) as dose 1, single for COVID-19 immunization and had Urticaria everywhere except feet and face on 20Apr2021 at 03:00 AM which lasted 24 hours. Patient did not receive prior vaccinations within 4 weeks. On 29Apr2021, the patient had Sore throat, stuffed nose, 101 fever, and ear congestion 7 hours after vaccination. Patient tested for COVID-19 post vaccination. The patient visited Emergency room/department or urgent care. The lab data on 29Apr2021 included: Covid tested post vaccination with Nasal Swab (Colour - through work) and results were pending at the time of reporting and body temperature was noted 101. The patient did not receive any treatment for adverse events. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swelling and Redness at injection sight from quarter coin size to half dollar with pain. Myalgia, Fatigue, fever 101.3 F. Nausea and diarrhea. dizziness. (main problems of fever and bodyaches) treated with tylenol, zofran, lomotil, rest. no appetite. facial swelling
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "not recovered", described as "migraine headaches". Additional information: It was reported that the patient experienced migraine headaches since receiving her first injection. These have persisted daily. The patient has received her 2nd dose and was seen by an HCP for these migraine symptoms. It was reported that the event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Small hives all over body with many on both arms, not specific to injection site. Also triggered larger acute urticaria throughout groin, thighs, and lower abdomen, which seemed initially to follow the same pattern as granular perakeratosis that was present in 2019. Granular perakeratosis in 2019 was verified by biopsy and was believed to have been caused by exposure to benzalkonium chloride. After stopping use of laundry sanitizer, the granular perakeratosis began to clear up and went away over time. It's been completely absent since then, but 12 days after Pfizer, acute urticaria followed the same pattern in groin, thighs, and lower abdomen. The worst seems to have subsided and no signs yet of lichenification as did occur in 2019 with the granular perakeratosis.
Seizure with fever ~8 hours after DTaP #4/ Comvax/ IPV
LITTLE TIRED; This spontaneous report received from a patient via a company representative via social media concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. 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 patient experienced little tired (dose number in series 1). It was reported that "I've had all the Coved shots and so for no reactions, no Covid. Only a little tired from the first shot. My family has been the same. I'm NOT suggesting anyone take it. I fully support the right to choice in THIS matter. God bless all. Stay safe and be fair". The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer), (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported for covid-19 prophylaxis. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20230107164.
flu; sick; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 12-Nov-2020 and live follow up received on 03-Dec-2020.  This case involves a patient with unknown demographics who reported flu (Influenza) and was sick (Illness), when received vaccine influenza vaccine (Flu shot).  Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) after administration of influenza vaccine, the patient was sick (Illness) for 2 weeks and had flu (Influenza).  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event sick was resolved while outcome was unknown for the event flu.  There will be no information available on batch number for this case.
9 PM that evening fever, chills, nausea, lightheaded, weak, headache, incoherent at times, very sore arm. Could not get out of bed til the 29th, several more days of fatigue.
shot was horrific, put me in the hospital. I have terrible reactions; This case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR139295   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: The pharmacist mentioned that the twin kids were sick and had Cholestasis and they advise her to did the vaccine for them agency reported by precaution as the pharmacist said that they were calling about the second dose so the twin kids already got the first dose of Rotrix. It was unknown whether this disease was related to the vaccine or not or if it was happen before the first dose or after. The second dose was not administrated yet. The pharmacist wasn't informed that he/she would report this PV case. No more information available the Rotraix formulation was unknown. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2022AMR139295:same reporter
BLOOD CLOT IN WIDOWMAKER; HUGE DAMAGE TO HEART; This spontaneous report received from a consumer (patient's wife) via company representative via social media concerned a 58 year adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. 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 patient had a blood clot in the widowmaker and died for 3 minutes with a huge damage to heart.  The reporter stated that "my husband's vaccine gave him a blood clot in his widowmaker and he died for 3 minutes and huge damage to his heart. He is only 58 and can never work again". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in widowmaker and huge damage to heart was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220801546..; Sender's Comments: V0: 20220801520-covid-19 vaccine ad26.cov2.s- Blood clot in widowmaker and huge damage to heart. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
small red dots from the neck down; itchier in the sun; itchier in the sun; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2023NVX-US-000000009.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 02Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), PHOTOSENSITIVITY REACTION (non-serious) all with onset 04Sep2021, outcome "unknown" and all described as "itchier in the sun"; RASH MACULAR (non-serious) with onset 04Sep2021, outcome "unknown", described as "small red dots from the neck down".  Additional information: On 03Jan2023, it was reported that a patient started treatment on 02Sep2021 with Pfizer BioNTech COVID-19 vaccine Dose 1. It was reported that on 04Sep2021, 2 days after the vaccine, the patient got small red dots from the neck down, and it was itchier in the sun. The individual did not get the second dose. The patient's primary care provider reported the adverse events to the database.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to a 39 year old patient of an unknown gender. No medical history was reported. On 04-SEP-2015, the patient was vaccinated with the expired PNEUMOVAX 23 (dose, frequency, route of administration were not reported) lot # K004542, expiration date: 19-AUG-2015. No concomitant medication was reported. The patient had not reported an adverse effect. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a unspecified number of patients of unknown age and gender. Nurse stated that on an unkonwn date, a provider may have vaccinated the patients with improperly stored ROTATEQ (lot#, expiry not reported). No adverse effects were reported. Nurse did not want to be contacted regarding this report. No PQC involved. This is one of several reports received from the same reporter. Additional information is not expected.
I had the PREVNAR 13 shot in Oct 2015. I usually have no reaction to any immunizations. But the P13 shot was followed by 3 days of excruciating muscle and joint pain. I could hardly sit or stand. In Dec 2015 I had another bout of excruciating joint and muscle pain that lasted 3 days. Again in Feb 2016 I had another bout of the same - again for 3 days. I am concerned that this will continue to recur indefinitely into the future.
White part of right eye has broken blood vessels. 1/2 of eye is bright red.  Eye is scratchy but no other problems. Has never happened before.  Noticed about three hours after injection
Patient received first COVID Pfizer vaccine on 3/12/2021. About 7 hours post vaccination, she developed a full body rash and facial swelling. No airway involvement. Rash started to improve in about 4 hours, at which time she went to the ER for evaluation and received benadryl. Her temp in the ED was 99.1, BP 145/98, HR 137. No other medication interventions (fluids, meds, etc) given. She reports arm soreness and itching for about 48 hours, but no other symptoms.
Deep Vein Thrombosis (DVT) in right lower leg.  Symptoms initially occurred about two days after feeling sick with a high fever.  Initially, the pain in the right calf muscle was thought to be a muscle or tendon strain.  On May 22nd, during a campout, there was pain along the entire right leg, but at the time I thought it was just related to lower back pain from sleeping on the ground.  On May 27 and 28th there was sharp pain at the bottom of my right foot, then on May 29th I noticed sweeling and a hard warm spot just above the inside right ankle.  I reported to a local urgent care clinic first  then was referred to Medical ER.
sever Sciatica pain; pain on my right side affecting my buttocks; difficult to walk; my lower back and legs making it very difficult to walk; legs making it difficult to walk; Sciatica pain; This is a spontaneous report from a contactable other HCP (patient). A non-pregnant 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Aug2021 at 13:00 (Batch/Lot Number: EVV0181) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history included diabetes mellitus. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. No known allergies. The patient did not have Covid prior vaccination. The patient was not tested Covid post vaccination. The patient received the shot on 19Aug2021 and on 21Aug2021 in the evening (16:00 PM) she began to have sever sciatica pain on her right side affecting her buttocks, her lower back and legs making it very difficult to walk and she had to use a wheelchair. On the 23Aug2021 it alternated to her left side and today (24Aug2021) it was back on her right side although today it was beginning to diminish slowly. The events onset date reported as 21Aug2021 at 16:00 PM. The events did not result in physician office visit or emergency room visit. The patient was recovering from the events. The patient did not receive treatment for the events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded.  The 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 notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a registered nurse via company representative refers to a 74 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated with M-M-R II (lot, expiry date, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date of 2018 (also reported as this week), the patient experienced titre negative. The outcome and causality assessment were not provided by the reporter. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1811USA001650.
Moderate fatigue and body aches started at about 10 AM the day after the shot and lasted about 2-3 hours
Pt recvd 2nd dose of Hep B vax on 27FEB92 & on 28FEB92 & exp h/a, stiff neck, & shoulder & neck pain; pt treated w/APAP & recovered in approx 2 days; No further details were provided;
Pt came for PPD reading ID with 9 x 9 circular red, hot area.
Epi auto injector refill of prescription on the same day as patient received the COVID vaccine.
Palpitations immediately after shot was given (Wednesday evening).. Approximately 17-18 hours after injection (by noon Thursday), muscle & joint aches began (hips, shoulders, hands, neck), with chills, fatigue, and low-grade temp (99.6).  Tylenol helped, but brain fog was severe. By  9:00pm, my temp was 101 and I felt severe body aches & miserable.  Only very mild symptoms the next day (Friday) and by Saturday I was fine.  It was like a 24-hr flu.