chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had full severe hearing loss; tinnitus/ ringing in the right ear.; She then experienced some pain overnight that second night after in one ear, the right ear; she started developing a feeling of fullness or pressure in the right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (COMIRNATY), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2,  MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER),  MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: EAR DISCOMFORT (non-serious) with onset 05Apr2022, outcome "unknown", described as "she started developing a feeling of fullness or pressure in the right ear"; EAR PAIN (non-serious) with onset 06Apr2022, outcome "unknown", described as "She then experienced some pain overnight that second night after in one ear, the right ear"; DEAFNESS (medically significant) with onset 07Apr2022, outcome "unknown", described as "she had full severe hearing loss"; TINNITUS (non-serious) with onset 07Apr2022, outcome "unknown", described as "tinnitus/ ringing in the right ear.". Clinical course: the patient received second booster dose for patients over 50 on Monday 4Apr2022.  Within the next day (26-27 hours) she started developing a feeling of fullness or pressure in the right ear.  She then experienced some pain overnight that second night after in one ear, the right ear.  When she woke up the next morning she had full severe hearing loss in her right ear and tinnitus/ ringing in the right ear. She read a short course of corticosteroids can be very helpful and is very hopeful can be resolved. Have these side effects been reported?  Will a corticosteroid help decrease inflammation?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm became red, swollen, and hot to touch from shoulder to elbow x 3 days. Ice to arm, Benadryl, and Ibuprofen given.
Pain to palm of (R) hand 15 min after injection. Pt to take OTC analgesia f/u with Dr if prob persist.
Patient was vaccinated with the firsts dose of Pfizer COVID vaccine at around 11:20 am on Oct. 14, 2021.  Approximately 5 minutes after vaccination patient began feeling hot/flushed and light headed and moments later he began to pass out so an Epi Pen was quickly administered and  the patient quickly became more stable.  EMT was at the clinic and immediately began monitoring the patients.  While the EMT moved the patient to a gurney the patient seemed very rigid and needed help to sit on the gurney but then became relaxed again once he was lying down.  Once the EMT verified the patients vitals were stable he was immediately transported to the Emergency Room and left the clinic at 11:35 am.  Update on the patient at 4:00 pm was that the patient is being discharged for ED with a vasovagal diagnosis.
Fever 1 day after vaccine, to 104 degrees F resulting in febrile seizure. Treated & released from ER.
Late June I started experiencing pain in my right shoulder, specifically when I would pick things up or if I put my hand behind my back. I went to an orthopedic and they prescribed physical therapy, which ended up making my pain worse. I experienced clicking and popping with some motions. They did an MRI and x-ray and both came back normal. I am supposed to have exploratory surgery to see what is going on with my shoulder.  They gave me a steroid injection at one point to see if that could bring down the inflammation. That helped for a few days but not long term. In the past few weeks I have experienced pain in my left shoulder as well.
Swelling, erythema left deltoid within 48 hours after receiving vaccine, followed by cellulitis 72 hours after administration.
Getting sick; continous nausea and vomiting; delayed nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Getting sick), VOMITING (continous nausea and vomiting) and NAUSEA (delayed nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced ILLNESS (Getting sick), VOMITING (continous nausea and vomiting) and NAUSEA (delayed nausea). At the time of the report, ILLNESS (Getting sick), VOMITING (continous nausea and vomiting) and NAUSEA (delayed nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  It was reported that patient went to emergency room and was treated with anti-nausea medication.
Extreme hives all over/full blown hives that itch and hurt; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 72-year-old male patient (age at vaccination: 72 Year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL1283 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 21Feb2021 at 11:15 AM, as a single dose for COVID-19 immunization at public health clinic/veterans administration facility. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9264 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 31Jan2021 at 11:15 AM, as a single dose for COVID-19 immunization at public health clinic/veterans administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included atrial fibrillation. Concomitant medications included Warfarin 5mg, Metoprolol Tartrate, and Terazosin HCL. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on an unknown date in Feb2021, he had extreme hives all over, concentrated in his midsection. He had started feeling itchy about 3 days before his second shot and once he got that it turned into full blown hives that itch and hurt. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment received for the adverse event. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
burnt rubber taste and smell (both); burnt rubber taste and smell (both); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 14:30 (Lot number: EW0217) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Endometriosis", start date: 2018 (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if_covid_prior_vaccination Yes. The patient took concomitant medications. Past drug history included: Ceclor - when i was a baby i got a rash, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0217, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 13Oct2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset 12Nov2021 18:30, outcome "not recovered" and all described as "burnt rubber taste and smell (both)". Therapeutic measures were not taken as a result of taste disorder, parosmia.  Additional Information: On 12Nov the patient had a kale salad and thought it tasted strange, like rubber. At the time she thought it was just the taste of kale, because I'd never had raw kale before. But since then, she had noticed the same very weird burnt rubber taste and smell (both) whenever she had coffee, white wine, kale, turkey, and a few other foods, those were just the ones she was most certain about because she drink coffee every day and have wine a few times a week. She had never tasted or smelled this particular taste/smell before and was concerned that it was parosmia from the vaccine. It had not gone away yet as of today 21Nov2021. There was no other vaccine in four weeks. The other medications in two weeks includes women's multi vitamin, probiotic qummy, fish oil. She had covid prior vaccination. And post vaccination not tested for covid. The known allergies includes ceclor, when I was a baby I got Rash. Other medical history includes endometriosis since 2018 / UTI (I got this 16 days after the first dose of the vaccine and it took 23 days to go away also concerned that was from the vaccine)  No follow-up attempts are possible. No further information is expected
breast hurts a little; left arm swollen; Booster; fell; doesn't feel that good; The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting. Upon receipt of follow-up information on (20Dec2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Dec2021 11:30 (Lot number: FD7218) at the age of 71 years as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing), notes: had it for a long time, took medication and is ok, has been under control for years; "thyroid" (ongoing), notes: had this condition for over 20 years, took medication; "Little overweight" (ongoing). There were no concomitant medications. : Hasn't taken any new mediations in a long time. Vaccination history included: BNT162B2 (dose 1), administration date: 2020, for COVID-19 immunization, reaction(s): "didn't feel any reaction"; BNT162B2 (dose 2), administration date: 2020, for COVID-19 immunization, reaction(s): "didn't feel any reaction". The following information was reported: IMMUNISATION (medically significant) with onset 18Dec2021 11:30, outcome "unknown", described as "Booster"; FALL (medically significant) with onset 18Dec2021, outcome "unknown", described as "fell"; BREAST INJURY (medically significant), outcome "unknown", described as "breast hurts a little"; PERIPHERAL SWELLING (medically significant), outcome "unknown", described as "left arm swollen"; MALAISE (non-serious) with onset 18Dec2021, outcome "unknown", described as "doesn't feel that good". The patient stated that she thought she got the booster dose, however, when looking at the papers, it says to come back for a second shot, she didn't think there was a second shot for the booster. She was already given the two vaccines last year, already had the first two doses of the COVID-19 Vaccine. She went to the pharmacy at the grocery store, asked for the booster and was given a shot she already had, received it on 18Dec2021. She fell Saturday, 18Dec2021, evening when she went home and was going up the stairs, fell, hit her knee, and the breast, and shoulder, was in bed all day Saturday night and Sunday. Her left arm was now swollen, and her breast hurt a little. Had not gone to the doctor. Her left arm was swollen after the fall. She got the Pfizer COVID-19 Vaccine, came home, fell, hit her left arm, and right knee. She didn't feel that good from Saturday. Couldn't believe it. She took two of the COVID-19 Vaccines last year and didn't feel any reaction. She was given this extra dose. She asked for the booster and was given the wrong one.  No follow-up attempts are possible. No further information is expected.
Entire upper arm became swollen, red and hot to the touch. It was very tender. This lasted for 5 days.  The site was raised about 1/2 inch. Very painful.
Headache and fever up to 101.4 axillary that last 1 1/2 days.
fever 101, chills,  lasting the full following day   Went back and forth taking ibuprofen and acetaminophen  No fever the 2nd day following the shot....but tired.
pt states after getting his 2nd covid vaccine his right arm went numb. He had tightness in his chest.  Hew felt like he was having a stroke or a hear attack.  He went to an urgent care.  He was told he was having a reaction to the vaccine and was sent to the local ER hospital.  He was given test and all came out normal.  He saw his Cardiologist at his local office.  He was having  heart defibrillations and was given Stress Test, EKG, and US.  BP was 200/90 and pulse was 160.  He was scheduled a FU end of  October to run more test.  Heart does not show any damage but is still having heart palpitations. He had a car accident on 6/16 that caused his arm to go numb so now he has complications along with the other symptoms.
Systemic: Allergic: Rash Generalized-Mild, Systemic: Fever-Mild, Additional Details: patient reported to pharmacy today 6/17 that he had a fever after getting the vaccine second dose on 6/7 starting the next day on 6/8 through 6/12, when he started to get a generalized rash in a few small areas. He reported to the ER (unknown what treatment or dx at ER)and reported in today with his Rx from that visit for steroid oint and epipen but did not want the meds filled despite recommendation to fill to have on hand. Patient wanted the report of his adverse reaction submitted and meds on hold
sever nausea; vomiting; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: el3246), in left arm, on 09Feb2021 as dose 2, single (Lot number: el9269), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: ff2590), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: fk9893) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing). Concomitant medication(s) included: FISH OIL, stop date: 06Jun2022; VITAMIN C & ROSEHIP, stop date: 06Jun2022; IBUPROFEN, stop date: 06Jun2022; CALCIUM CITRATE, stop date: 06Jun2022; ACETAMINOPHEN, stop date: 06Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; NAUSEA (non-serious) with onset 18Jun2022, outcome "not recovered", described as "sever nausea"; VOMITING (non-serious) with onset 18Jun2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: COVID-19: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19, nausea.  Clinical information: After 4 doses, patient experienced sever nausea and vomiting. Dr. office suggested she was continue taking the product and try eating toast with it. She seem to experience the nausea pretty continuous, but only vomit after 5 hrs. After ingesting each dose of paxlovid. No known allergies.  No follow-up attempts are possible. No further information is expected.
Fever and body aches one day after. I had nasal congestion and pain two days after, illness continued. I took a Covid test five days later due to continued illness and was positive.
I developed "influenza-like-illness" in the days immediately following vaccination. On the day following vaccination (day 1), I had a headache and felt miserable. On day 2, I was physically weak. A fever developed on day 3, which continued into days 4 and 5. Gastrointestinal symptoms presented on day 4, with projectile vomiting and diarrhea.
pt recv vax 24SEP97 & went colorless, had 103 fever, knot in leg;took to after-hr clinic;MD there said probably rxn from pertussis portion of DTP & should never recv this again;
felt fatigued; Dull headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt fatigued) and HEADACHE (Dull headache) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Immunocompromised.  Concomitant products included METHOTREXATE for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced FATIGUE (felt fatigued) and HEADACHE (Dull headache). On 30-Mar-2021, FATIGUE (felt fatigued) and HEADACHE (Dull headache) had resolved.      The patient felt fatigued with a dull headache which lasted about 24 hours after the second dose of vaccination.  No treatment medication was provided.   This case was linked to MOD-2021-339391, MOD-2021-339370 (Patient Link).
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race, ethnic origin. Initial information received was processed along with the additional information received on 20-JAN-2022. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient 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, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced cough, sneezing, cold and scratchy throat (coded as suspected covid-19 infection and suspected clinical vaccination failure) (dose number in series 1). On 11-JAN-2022, patient tested positive for covid with Binax Now antigen test.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. The patient received Pfizer vaccine (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 04-JAN-2022 for prophylactic vaccination. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000213233.; Sender's Comments: V0 - 20220126312- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
tiredness, flu-like symptoms, achey, generally feeling like I was getting sick.     lasted 36 hours.      then 4 days later - right leg muscles on either side of my shin were painful to touch for at least 36 hours.
Right arm pain, red, hot, and lump at injection site. Redness and pain spread from site to 2"-3" below elbow. Patient treated with ES Tylenol, cold compressions until doctor's appointment. Doctor treated with Rocephin IM, Zyrtec for 10 days and Keflex for 10 days.
Admitted to medical center from 12/13/09-12/15/09 for dizziness, nausea, vomiting.  Transferred to another medical center, then to a third medical center and diagnosed with Guillian-Barre syndrome.
Patient received 3rd dose, was sitting in chair next to wife. Patient slumped over, at which point wife called for assistance. Patient was quickly roused and was responsive, but a bit weak for about a minute. Offered to call 911, patient declined. Accepted request for water. Pharmacist sat in chair next to patient and wife for about 5 minutes after event. Patient quickly recovered and was advised to continue to sit for about 30 minutes inside of pharmacy to ensure no further adverse event occurred, and inform pharmacist before they left. Sat for about 20 minutes before leaving. Wife had mentioned previously no adverse reactions to previous vaccines, but issues with passing out in past not related to immunizations.
15 mo old with MMR given 2/5/13, on 2/14/13 had a febrile sz at daycare (T 39.3) seen in ED. Sent back to ED 3 hours later with another sz / fever (38.1). Admitted overnight for observation, EEG nl - has. OM persists.
pt recvd vax 7MAR95 inc temp 102; small redness devel 8MAR95 w/inc swelling & redness to elbow by 8MAR95 evening; cont pain, erythema & swelling 9MAR95;
Nausea 10 minutes after injection at 4pm. Continued Nausea all day, followed by chills and vomiting 9 times throughout the night.
Patient complained of radiating pain from shoulder to hand starting 24 hours after shot. Patient had prednisone and took some which did provide relief. Pt visited md on 11/28/2017 and was issued a new script to continue prednisone. No diagnosis given but patient did say pain could also be related to some type of autoimmune disorder she has. Pt also stated, she felt shot was given more towards the tricep area.
Numbing of tongue, possibly  mild Bell's Palsy, and occurred about 7 minutes after vaccination
This spontaneous report was received from a pharmacist refers to a 84 year old female patient. The patient pertinent medical history included high blood pressure, low thyroid and high cholesterol. On 11-MAR-2014, the patient was vaccinated with ZOSTAVAX Lot # J013138 (Expiry: 17-JAN-2015) 0.65 ml, subcutaneous. Concomitant medications included pravastatin sodium, lisinopril, ZETIA, sotalol, levothyroxine sodium, hydrochlorothiazide and amlodipine. On 11-MAR-2014, 40 minutes after the patient was vaccinated with ZOSTAVAX experienced the neuropathy in the feet was reactivated. The patient was sought medical attention. The pharmacist also reported that the patient received the ZOSTAVAX which was exposed to 42F for 81 hours. The outcome of the event neuropathy in the feet was reactivated was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
I contracted COVID-19 on 06/06/2022 with symptoms of runny nose, sneezing, hiccups, a-fibrillation, fatigue, and cough. I was prescribed Paxlovid and Dexamethasone on 06/08/2022. My symptoms were very mild until the Dexamethasone caused my blood sugar to rise to 800 on the 3rd day of taking the medications, which caused me to be hospitalized for the effects of the drug interaction not COVID-19 symptoms. I never had a fever. I was hospitalized for 6 days, and 2 days after leaving the hospital I was still experiencing mild symptoms. I was ill for 14 days before my symptoms began to resolve. I am still experiencing lingering symptoms of fatigue and cough.
FEVER, VERY DEEP RASPY HEAVY COUGH, RUNNY NOSE, LETHARGIC
Infant was found expired in her crib on the morning following vaccination.  Mother reports that she had a tactile fever on the evening prior to her death.