chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My partner and I went on a five-day cruise. We flew down on 03/19/2023. The cruise was 03/20/2023-03/25/2023. We flew home on 03/25/2023. On our connecting flight, my partner started feeling unwell. We both tested for COVID-19 on Sunday. I was negative at that time. I tested again on Monday, and I was positive. We both wore masks on all of our flights. We did not wear masks on the cruise. I woke up with a headache and body aches on 03/27/2023. I spent all day that Monday in bed. I only got up to drink water. I wasn't able to eat until that evening. My main symptoms were the headache, body aches, and I was very fatigued through that whole week. It progressively got better. The first two days were the worst for me. We called a doctor on Sunday, for my partner. He was prescribed PAXLOVID. He began taking it that Sunday night. I began taking it the following day.
COVID arm:  4"x4" red patch on arm around injection site; itching spread across chest and in lymph nodes; lasted about 5 days
Swelling-large lump-red, blk and blue-hives, rash. Stye-in right eye, hard to breathe, itching. This lasted for a week or so-right eye is causing more trouble-scratching and feels irritated. Pharmacist said I might need surgery on my right eye.
some increased swelling in her hands; feeling numb in her right hand and fingers; but after the shot, it hurts more and swells more than it did; pain; This is a spontaneous report from a contactable consumer(patient). A 83-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 01Sep2021 (at the age of 83-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included breast cancer and lymphedema (on the left side, which was 23 years ago, and has had no problems) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that, on an unspecified date, about 3 days ago (on reporting date), while helping her granddaughter at her wedding, she noticed some increased swelling in her hands. It had gotten worse. Additionally, she was feeling numb in her right hand and fingers, pain and after the shot, breast cancer and lymphedema hurts more and swells more than it did (condition aggravated). It was reported that, on her left side, her arm, hand, and fingers were swollen. She was asking if that would be because of the vaccine. Therapeutic measures were taken as a result of events. She was scheduled for her second dose on 22Sep2021. She reported that she had been taking Tylenol for the pain. She had reached out to her doctor, but could not get a hold of them and was awaiting a callback. Outcome of all events were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
A report was received from a health professional on 11/23/01, concerning a 65 year old male patient who experienced an urticarial rash, swollen lips and swollen eyes, 1 day after receiving the Fluvirin vaccine on 11/13/01. The patient had no record of previous vaccination. At the time of report, the patient had recovered. There was insufficient information to determine the reporter's causality assessment.
Patient fainted immediately after vaccination administration, awoke approx 10 seconds afterward. No history of fainting/needle phobia. Pt was given candy and orange juice and monitored for approx 20 min. after the first 5 min pt said she felt back to normal.
Subcutaneous tissue defect-resembling gradual latent onset of fat necrosis 8 mm in diameter area 3.5mm deep.
Day 1:  dull headache Day 2: dull headache, injection site soreness, muscle soreness, joint pain, lower GI distress Day 3: intermittent dull headache, injection site soreness, muscle soreness, joint pain, lymph node pain under same arm of injection, fatigue Day 4:  injection site soreness, joint pain, lymph node pain, fatigue Day 5: Lymph node soreness
Headache migraine (date of event not listed) Narrative:  Treated with OTC tylenol
Pt recv vax on 10/12/98; on 10/13/98 pt exp warm/ itchy/ rash at vax site then to upper arm
This spontaneous report was received from a Certified Medical Assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient, the patients were vaccinated with and improperly stored dose (Merck) VARIVAX lot # K020758 with expiration date of 31-OCT-2016, lot # L034367 with expiration date of 08-SEP-2017 and lot # L024250 with expiration date of 30-JUN-2017 (anatomical route of vaccination and dose number were not provided). No adverse event was reported at time of vaccination with (Merck) VARIVAX. The Certified Medical Assistant (C.M.A.), reported the following temperature excursion for (Merck) VARIVAX: -10.6 degrees C for 1 hour and 26 minutes. The vaccine underwent an additional temperature excursion of -6.7 degrees C for 2 hours and 25 minutes on an unspecified date. No product quality issue was involved. Additional information has been requested.
Patient received a flu vaccine at her workplace and shortly afterward began to have severe pain in her upper arm. She was diagnosed with bursitis in the Emergency Dept. Pain has not improved since. She does not remember the manufacturer or the lot number of her vaccine.
light headed, head spinning, could not keep balance ,falling down ,especially getting up out of bed, and after every time a sat  down
Site: Pain at Injection Site-Severe, Additional Details: Patient claims she got the Influenza vaccine too high on her arm and developed "tendonitis" due to this. Went to the local Emergency Room and had extreme pain. Patient also has had recent shoulder surgery prior to the vaccine.
I developed tinnitus the evening i got a booster (4th dose - im immunocompromised). It has been 10 days and has not abated. I received the Moderna vaccine for all my vaccinations
Patient received COVID19 vaccine at 2:10pm 3/13/21. At 4am 3/14/21, she woke with painful, itchy rash described as big, long patches and also in sections that was like a bad sunburn, from chin to collarbone (bilaterally), also present on both eyebrows, one patch on left cheek on face, above right side of temple in hairline area, and she could feel top of head itches and burns but could not see there to see if a rash is present. Advised patient to go to the emergency room, but patient refused at time of triage call.
alternating feeling of hot and cold; two doses of Shingrix were 10 months apart; This case was reported by a consumer via call center representative and described the occurrence of feeling hot and cold in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in 2017, lot number 524S7, expiry date 12th February 2021, VAREs: CVS Pharmacy, Washington DC).   In August 2018, the patient received the 2nd dose of Shingrix. In August 2018, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced feeling hot and cold. On an unknown date, the outcome of the feeling hot and cold were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the feeling hot and cold to be related to Shingrix.  Additional details were provided as follows:  The patient reported for herself. The patient initially thought the shingles vaccine she got was Zostavax but she would check again because she received 2 shingles vaccine shots. Later on it was confirmed that the patient's first shingles vaccine was not Zostavax. The patient received 2nd dose 10 months after the 1st dose, which led to lengthening of vaccination schedule. The patient went to the emergency room for alternating feeling of hot and cold after receving 2nd dose of Shingrix. Emergency room provider said it was a reaction to the shingles vaccine.  The reporter did not consent to follow-up.
Woke up with mild flu symptoms (light fever, tired, sore all over, fluctuation between feeling hot then cold), lasted for most of the day, subsided completely after waking up the following day
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with M-M-R II lot number J014872 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in July 2015, the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, anatomical location, lot # and expiration date were not reported). Subsequently, the patient was vaccinated with the second dose of this vaccine on 09-MAY-2016. Despite this schedule, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Patient came to ED with worsening shortness of breath and weakness.  Patient admitted to hospital with hypoxia and pneumonia due to Covid.
pain, swelling and redness of arm; redness and numbness of face, redness and burning sensation of face persists.
Thirty minutes post vaccination the employee called to report that her throat was scratchy and tight. I advised her to come to the ER to be evaluated for anaphylactic reaction to the vaccines. She also reported a warm feeling that went up her neck when she received the Hepatitis vaccination. She was seen in the ER and given DECADRON 10mg IM x1 injection, and Rx for prednisone 20mg 3 tabs by mouth x5 days, and PEPCID 20mg 1 every 12hours daily x10 days.
Presneted with HTN, fever, chills, non productive cough, gen weakness; + Covid in ED; admitted to medical with Covid infection , possible PNA; tx with remdesivir, steroids, supplemental O2, Vit C, singulair, zinc
65-year-old female with past medical history of hypertension, asthma, diverticulitis and GERD presented to the ED after having tested positive for COVID-19 3 days prior to admission.  Patient has had altered mental status for the last 2 days prior to admission.  Per family, patient has had poor oral intake for several days as well. Per EMS, patient's initial O2 saturation was 50% on room air at which point they placed her on CPAP which improved O2 saturation to 75%.  Patient did not tolerate CPAP and remained persistently hypoxic and was therefore intubated in the emergency department.  She also arrived with a right upper extremity PICC line for outpatient antibiotics for a "groin wound." Laboratory results showed
Mom called clinic 21MAY92 stated had red area on rt thigh from shot; 22MAY92 red streaks going down thigh; low grade fever;  MD dx vax rxn;
A week after the first dose, I experience Tintinis.  I thought my hot water heat was amiss because I heard a gurgling sound like water rushing through the pipes.  I have heard a loud rushing sound and also a sound of high frequency.  The sound seem to rotate in a random order.  Today. I am experiencing a loud rushing sound.
It was a return of the same symptoms I had after the second dose. It was a very odd sensation that came over me like an aura. It started with a little change in my state of consciousness. It was almost like pins and needles. It's not painful though. It was all over my body after the second dose but mainly in the esophageal area after this third dose. It would last for different amounts of time and my blood pressure would go up while it was happening. I was also feeling dizzy and lightheaded more often and the feeling would wake me up at night sometimes.  My doctor ran a bunch of neurological tests and found nothing wrong in that regard. I also saw a Rheumatologist and Neurosurgeon and they did not find any issues either.
shortness of breath; hives on nouth; throat swelling; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 (Batch/Lot Number: ew0177) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included asthma. Concomitant medication included fluticasone propionate (FLOVENT); montelukast sodium (SINGULAIR); and cetirizine hydrochloride (ZYRTEC) and METHYLPHINATE. The patient previously took peanut, tree nut, coconut. The patient experienced shortness of breath, hives on mouth, throat swelling, and dizziness all on 19May2021 14:00 with outcome of recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment antihistamine was received for the adverse event. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.
RECEIVED 2ND BOOSTER DOSE WITH JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date in MAR-2021 for covid-19 prophylaxis. It was unknown whether the patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received first booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for covid-19 prophylaxis. It was unknown whether the patient had any adverse events following vaccination with first booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2).  The patient received additionally second booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for covid-19 prophylaxis which was associated with Off label dosing frequency (Off label use). 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 received 2nd booster dose with JANSSEN COVID-19 VACCINE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received 2nd booster dose with JANSSEN COVID-19 VACCINE was not reported. This report was non-serious. This case, involving the same patient is linked to 20230433428.
Patient came in for Moderna Bivalent Booster (0.5mL). It was discovered the next day that the patient had received the Primary Series Moderna product (0.5mL) instead. They had already received their first two doses and booster. Patient was notified that day and stated fatigue and muscle pain common with injections, but said he was feeling better and was not upset. The MD office was notified and per CDC guidance, the patient will wait 60 days and then receive the Bivalent Booster.
Pt had swelling & erythema from shoulder to elbow, severe malaise, chills and achiness.
Youth here today complaining of swelling, redness, pain, and itching over bilateral upper arms, where immunization shots were given yesterday. Pt states that she noticed some discomfort in the areas last night while sleeping when she would lie on her respective side. Then this morning she noticed the swelling and redness and has had intense itching in the area, worse over her R vs. L upper arm. Pt received immunizations yesterday and the affected area correlates with where her injections were given. Pt received the Tdap shot in her upper L (dominant) arm and a Hep A #1 and MENACTRA shot in her upper R arm. The more anterior shot appears to be the one reacting in her R arm, however, I am not certain if it was the Hep A or the MENACTRA that was given anteriorly in that arm. Pt also had a PPD placed in her volar R forearm yesterday. Pt has not tried any tx. She denies any fever, chills, or d/c. In further discussion regarding pt's vaccinations, she states she thinks she did receive some vaccinations, although she does not remember which ones, about a year ago. We have no record of these vaccinations on file. Pt's parents are currently out of the country and will not be returning until about 9/18/09. Pt states there is no other family members here who would know any further information on her vaccination status or who could obtain her previous medical records. She states she thinks she might have had a rxn to a vaccination in the past, but then she thinks it might have been a bee sting, she cannot remember which it was. Other ROS is WNL.
no additional adverse events were reported; received first two doses of GARDASIL in 2017 and did not receive the third dose / received first two dose in 2017 and got busy where he missed the third dose; This spontaneous report was received from a male consumer of unknown age who referred to himself. No information about the patient's pertinent medical history, concomitant medications or drug reactions/allergies was provided.  On unknown dates in 2017, the patient received first two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dose, route of administration, lot # and expiration date were not provided) for prophylaxis.  The patient stated that he did not receive the third dose of the suspect vaccine (also reported as "got busy where he missed the third dose") and wanted to know if he needed to start the series over. He was instructed by his doctor to call for this information. The patient refused copy of prescribing information. No additional events were reported and no additional details provided. No product quality complaint was reported. The patient was instructed to speak to healthcare provider in regards to starting series over.
Swollen lymph nodes, about the size of golf balls. Two at least we're swollen. After a day of swelling there was severe pain in my breast and side of my chest, and it felt heavy.
Information has been received from a licensed Practical nurse concerning a white 85 year old female pt with no report pre-existing medical conditions, who on 16OCT2003 at 15:30 PM was vaccinated IM in the deltoid with a second dose of pneumococcal 23v polysaccharide vaccine. The licensed practical nurse reported that the pt received 2 vaccines within 2 months of each other (also reported as may have received 2 doses of pneumococcal 23v polysaccharide vaccine within the last three months). It was noted that on 16OCT2003, the pt experienced a mild local reaction for 24 hours. The licensed practical nurse reported the pt recovered on 17OCT2003. It was noted that the pt did not have an illness at the time of vaccination. There were no laboratory or diagnostic tests performed and there was no product quality complaint reported. No treatment was required. No other information was available. Unspecified medical attention was sought. No further information is expected.
Extremely sick with high fever. After a couple days of not talking he began to recover but his speech was slowed and he went from quick efficient speech patterns with multiple syllable words (before illness) to single syllable words and great pauses before speaking his thoughts. He eventually (over the course of months) regained his vocabulary and ability to express himself normally but it was just a different way of talking than he used to..a little more reflective. Grandparents and daycare providers asked about what brought about the change.
Shakes, chills, hot flashes, extreme soreness throughout entire body, headaches,fever, muscle pain, lightheaded ness, increased anxiety,
A week after immunization started with lower leg itching which then included the abdomen/torso. Rash-full body after @ 2 weeks with cont. itching, burning & pins & needles discomfort from neck down.  Went to numerous M.D.s & also phoned PCP who admin.
Pt recvd Hep B vax on 8OCT91 & about 20 mins following vax exp flushing of the face, arms, chest, & back which resolved p/a short while;
Developed rash on her right side of the abdomen; Patient never received Shingrix second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and chickenpox.   On 15-SEP-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In SEP-2022, 2 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash (Verbatim: Developed rash on her right side of the abdomen). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Patient never received Shingrix second dose yet). In SEP-2022, the outcome of the rash was resolved. The outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-MAY-2023 The pharmacist reported that an adult female patient received Shingrix first dose and 2 or 3 days after the shot she developed rush on her right side of the abdomen.  It was just on one side but it have never blistered. The rash lasted for 3 or 4 days.  Prior to this Shingrix vaccine, patient also had shingles before and chicken pox twice.  Patient never received Shingrix second dose yet, although it has been more than 6 month since the first dose.  The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.