chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had 'cold' for 1.5 weeks, then right ear and head pain for which he was given Septra.  Approximately 2 days later, he awakened with partial right facial weakness (on 10 Nov 2007).  Also had right hyperacusis, tinnitus and decreased hearing on right.  No taste changes, but had drooling from right side of mouth.  No extremity weakness/numbness, although he had the sensation of pain from right face down right anterior chest and right shoulder.  He reported to an ER that evening, where blood work and a head CT were normal.  He was given a prednisone taper dose over 10 days and Vicodin for pain.  Approximately 3 days later, he developed right ear pustules, erythema and swelling, and was given Valtrex for 7 days.  His symptoms improved until 1.5 weeks later when the pain again increased, and he was given a second prednisone taper, this time for 5 days.  He again improved until approximately 1 week ago, when his right facial pain worsened and he was given a combination of Tylenol #3 and Motrin 800mg tid.  Currently, he estimates his pain level to be 50% improved compared to when it was at its worse.  His facial weakness is mildly better, as he can now more fully close his right eye.  He used a patch for 4 days initially, and continues to use eye drops during the day.  He also initially had mild veritgo, which now only occurs rarely, for short durations.  Later diagnosed as Ramsay-Hunt Syndrome. 9/18/08-records received-Office visit 11/13/07-Seen in ER for right sided Bells' palsy, symptoms began on 11/10/07. Dry cough and right ear pain for 5 days.  Office visit 12/7/07-symptoms improved and not returned including ear pain. Right ear pustules, erythem and swelling. 12/9/07- resolving sinusitis.
Patient received shingles vaccine on 10/25/07. On approximately 04/22/08 identified recurrence of shingles rash. On 4/24/08 patient went to private physician for treatment of herpes rash - Famciclovir - herpes rash subsided 1st week of June. This is in follow-up to report (s) previously submitted on 9/24/2008. The patient recovered from shingles. The patient sought medica attention. The reporter did not express interest in the VZV analysis by PCR. No further information is available.
Severe headache, rash, dizziness, severe swelling and muscle pain at injection site, breaking into sweats, increased heart rate and blood pressure.
Intense Nose Bleed; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Apr2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), turmeric pills (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN) all started on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 12:15, the patient experienced intense nose bleed. The clinical outcome of the event intense nose bleed was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
acute onset of rash yesterday evening. Rash is red, itchy, raised, waxing and waning. No treatment to date Patient had vaccines on 8/3/21. Patient also diagnosed with RSV 7/23. Had cough and diarrhea--both have resolved for the last week Was prescribed amoxicillin on 7/26/21 for otitis media but only tolerated one dose. no reported new foods, no new detergents or soaps no previous episodes of hives mom reports that she had chronic hives for 2 years--allergy testing was entirely negative.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 29-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
a few weeks after he received the 2nd dose of the vaccine he started vomiting and continued to vomit through out the night. He was instructed by his Dr to call 911. He went to the ER and was admitted into the ICU for diabetic ketoacidosis. to this day, it is very difficult to control his blood sugars.
Initial report received from a health care providers on 22 October 2007. A female patient with no pre-existing medical conditions, had received an intramuscular left deltoid injection of FLUZONE, lot number US444AA on 18 October 2007 and within 24 hours, she experienced chest pain which radiated to her back. The patient had no difficulty breathing. The patient was evaluated by her physician and diagnostic testing was performed. "Echo and EKG - WNL"; dates of testing were not provided. The reporter stated the patient had recovered from the evnet and no further information was provided at the time of the report. Follow-up information received on 26 November 2007 from a health care provider. There was no illness at the time of vaccination although other medications included ibuprofen. The date of the echocardiogram and electrocardiogram was 19 October 2007. The patient had a history of congenital absent pericardium of the left side of the heart and cardiomegaly secondary to absent pericardium (previously reported as no past medical history). The reporting facility in this case is the same as in case 2007-03559.
Shortness of breath, post vax, lasting 1/2 hour, soreness in joints, no hives, pain in leg where a vaccine injection was given years previously.
erythema, swelling @ site over 48hr period w/o fever, urticaria;
PASSED AWAY; HIGH BLOOD PRESSURE; DIZZINESS; THROWING UP; HEADACHE; This spontaneous report received from a consumer concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: unknown) dose was not reported, 1 total  administered on 16-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient received covid-19 vaccine ad26.cov2.s on 16-MAR-2021. On 17-MAR-2021, the patient's only complaint was that she experienced headache. On 14-APR-2021, she complained about dizziness and throwing up that was getting worse and high blood pressure on same day the reporter called the patient's doctor's office at 14:30 p.m. and doctor saw the patient's blood pressure was returned to normal and she underwent  laboratory data included: systolic blood pressure (NR: not provided) 113 mmHg, 170 mmHg, 190 mmHg. After few hours, 7 or 10 hours she passed away in her sleep, no pain at the time of death between 12:00 a.m. or 15:00 p.m. on 15-APR-2021. It was unspecified if an autopsy was performed. The reporter was unsure about the true time of death. The reporter did not complaint for a lawsuit as the doctor of the patient did not know if the death was correlated with the vaccine. The patient did not had no other disease, except high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient passed away on 15-APR-2021, recovered from high blood pressure on 14-APR-2021, and headache on an unspecified date in  2021, and the outcome of dizziness and throwing up was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: - covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).   covid-19 vaccine ad26.cov2.s-High Blood pressure . 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: UNDERLYING DISEASE; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 16:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 80 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 19Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2593), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing). Concomitant medications included: COLACE, start date: 18Nov2022, stop date: 08Mar2023; MAGNESIUM CITRATE, start date: 15Dec2022, stop date: 08Mar2023; METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID], start date: 06Dec2021, stop date: 08Mar2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Mar2023) Positive, notes: Return of positive covid test and symptom worsening after 5 day course of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient has no known allergies.
Raised red rash with itching in the genital and buttock area of the child.  Treated with diaper rash cream, but it keeps coming back.  Pediatrician told mother to phone us.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient started Paxlovid as treatment of Covid-19 from 25May2022 and stopped on 30May2022. The patient had rebound of COVID-19 5 days after completing treatment with Paxlovid. No other medication in 2weeks. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the close temporal association the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out
Complains or "soft tissue" pain in her left shoulder area. She says it does not hurt when she relaxes the arm. However, when she raises or lifts the arm, there is persistent pain.
Experienced body aches, chills, fever nearly 12 hours after receiving the vaccine. Symptoms carried on for 36 hours but were resolved/reduced with ibuprofen.
Headache; Body Aches; Fever; Fatigue; Loss of balance; Brain fog; This is a spontaneous report from a contactable consumer (patient). An adult patient (44-45 years) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via intramuscular route of administration in the left arm on 03Mar2021 at 08:15 as dose 2, single for COVID-19 immunization. Medical history included diabetes mellitus from 02Nov2010 and ongoing, Bg well controlled, A1C 5.4 (Nov2020), anxiety from 2018 and ongoing, obsessive-compulsive disorder from 2018 and ongoing, attention deficit hyperactivity disorder from 2020 and ongoing, on medication/CBT well controlled and panic attack from an unknown date and unknown if ongoing. Patient parents were vaccinated - no side effects. They were in their 70's. Patient was an only child. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via intramuscular route of administration in the left arm on 10Feb2021 at 08:15 as dose 1, single for COVID-19 immunization and experienced headache, body aches, fever, fatigue. Concomitant medication(s) included empagliflozin (JARDIANCE) from 2012 and ongoing, metformin (METFORMIN) from 2012 and ongoing and semaglutide (OZEMPIC), injection from 2019 and ongoing, all taken for diabetes mellitus, sertraline hydrochloride (ZOLOFT) taken for anxiety, obsessive-compulsive disorder from 2018 and ongoing, propranolol taken for anxiety from 2018 and ongoing, buspirone taken for anxiety, obsessive-compulsive disorder from 2020 and ongoing, lisdexamfetamine mesilate (VYVANSE) taken for attention deficit hyperactivity disorder from 2020 and ongoing and alprazolam (XANAX) taken for panic attack from 2020 and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced headache, body aches, fever, fatigue, loss of balance and brain fog on an unspecified date in Mar2021. Patient took 2.5 days off from work, a weekend to feel normal. The patient underwent lab tests and procedures which included glycosylated haemoglobin: 5.4 % on an unspecified date in Nov2020, Bg well controlled A1C 5.4. The clinical outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: fc3184), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: fp4554), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (unspecified date) Negative, notes: covid home test came our negative; (08Jul2022) Positive, notes: home test was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
A BRUISE AND SMALL BUMP DEVELOPED IMMEDIATELY AT INJECTION SITE. THE BUMP GREW IN SIZE TO APPOX 2-3 INCHES IN SIZE IN A MATTER OF 60 SECONDS. THE PATIENT FELT FINE AND DOES NOT HAVE AN EGG ALLERGY. SHE TOOK A ZYRTEC WHILE IN THE PRESENCE OF ME. I ADVISED TO ICE AND MASSAGE ARM. I ALSO TOLD HER SHE COULD TAKE TYLENOL TO HELP WITH ANY PAIN THAT MAY HAPPEN. WILL CALL PATIENT IN 2 HOURS TO CHECK IN WITH HER.  PATIENT RECEIVED PREVNAR 13 IN HER LEFT ARM IMMEDIATELY PRIOR TO THIS VACCINATION.
PERICARDIAL EFFUSION. PERIMYOCARDITIS, ELEVATED TROPONIN
At 4:30am on Sunday early morning, 3/7/2021, roughly 42 hours after receiving my 2nd dose of the Moderna COVID-19 vaccine,  I was awoken out of sound sleep by a light coughing as something was in my throat.  Upon waking, I realized that it was blood that was from a fairly significant bloody nose that I was having.  Even though I used facial tissues to deal with the bleed, it took nearly 25 minutes or so to subside as it was quite severe.  The situation is/was HIGHLY unusual as I haven't had a bloody nose for at least a decade (or perhaps even 2 decades) and when I earlier did, I was usually able to deal with it and get it to stop within a minute or two.  In this case, the bleed was significant, flowing quite heavily, when standing straight up (with blood dripping out of my nose) and even when lying in a prone position, wouldn't stop for 25 minutes.  Additionally, in my life, I have never had a bloody nose be the source of being woken out of a sound sleep.
Fever, chills, rapid heartbeat, body aches, headache for 2 days, 3-4th  day very tired.
From telephone contact received  on 08/15/2002, it was reported that a female, born on 11/28/1999, received a dose of ActHIB, MMR and DTAP on 04/27/2002.  The patient developed seizures within 24 hours of vaccination.  On 08/08/2002, she received third dose of ActHIB and also developed seizure within 24 hours of vaccination and was rushed to the hospital on 08/09/2002.  No other vaccines administered on this occasion.  The patient appears fine at the present time.  From additional information received at AP on 12/18/2002, it was reported that the 2 year old patient also received a dose of MMR (manufacturer Merck, Lot # 0587K) given in the left upper arm and DTAP (manufacturer SKB, Lot # U0299AB) given in the right upper arm on 04/27/2001 at 10AM.  The patient was not taking any other medications or had any illnesses at time of vaccination.  The case is closed.
Rash to injection sites, itchiness.  BENADRYL allergy. Cephalexin.
Patient came in to get a vaccine and patient said she has a history of fainting when getting vaccines.  She said she really wanted to get the vaccine even though she might faint again.  I gave the patient a shot and she said she did not immediately have any dizziness or lightheadedness.  About 10 minutes later, the patient was waiting in the waiting area when it was reported that she might have been having a reaction.  When I went to check on her, her skin looked pale and she had her head drooped.  She said she felt hot and it looked like she was sweating.  I offered the patient some water and told her to drink the water and stay seated.  She did not have any trouble breathing or swelling of the mouth or throat.  When I checked on her again a couple of minutes later, the color in her skin came back and she said she felt a lot better.  I asked if she might have fainted and she said she did not know.  I told her to stay seated and rest.  I checked on her every 5 minutes after and she looked better so she left.
Injection site pain; urinary tract infection (UTI); This is a spontaneous report from a contactable consumer or other non health care professional.  A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration, in Left Arm on 23Feb2021 at 15:45 (at the age of 65-years-old) as 1st dose, single for Covid-19 immunisation. The patient medical history included depression, arthritis, post-traumatic stress disorder (PTSD). The patient was diagnosed with all the medical history in her twenties. The patient concomitant medications were not reported. The patient had no other recent vaccinations or started any new medications. On 24Feb2021, the patient had experienced urinary tract infection and injection site pain on an unspecified date. The patient reported that the first symptoms she had only a very small pain where she got the shot. She informed that her main concern is that last night she had a UTI, so she wondered if it could be because of that, clarified to being a side effect. She reported that she got her first dose late in the afternoon, about 03:45PM. She took over the counter AZO yesterday for the UTI since it was horrible yesterday. No further details provided about the AZO. The patient received treatment for the event urinary tract infection. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I received the J&J vaccine on 3/24, and by that evening I had a headache, and my tinnitus was louder than normal. I had mild barely perceptible tinnitus prior to the vaccine. I would normally never notice it during the day, but lying down and going to sleep in a quiet room I would hear it. Constant high pitch but not loud, in the background more. I always run a fan in my bedroom so that I have some white noise and don't hear it. I had the flu like headache from the vaccine for two days and then it slowly started to subside into the weekend. I was tired as well from the immune response.  Five days out, I get out of the shower in the morning, and go to put underarm deodorant on, and notice my left armpit is all bright red. I check my right armpit, just as red.. Took photos of the red armpits and shared with some family and friends, as I read on the Internet that there were all kinds of crazy side effects that were possible. The red skin like rash is one of them, although my armpits never itched or burned. I could feel that they were warmer than normal, that was it. It was the 2nd day after my red armpits that my tinnitus ratcheted up to the current level that I am really unhappy with. The red armpits went away within 48 hours, never did anything about the redness, just didn't put underarm deodorant on until it passed. Sadly, the Tinnitus has remained and it is at a level that is distracting and persistent.
She got her vaccine, she started itching and had hives on her neck and started itching it.  It then went to her arms, legs and then was all over her face and neck.  Mother noticed that there was a circle of bumps around the injection site, indication that the shot caused the allergic reaction.  She has had no other symptoms than the itching and hives.  She was taken to the ER and was kept for a few hours for observation and was given Benadryl and Epinephrine and saw her PCP this afternoon who referred her to an allergist.   The Benadryl did not help her symptoms, but the Epinephrine did and started taking some of her symptoms.  You can see minor red marks throughout her stomach and neck and they want her to continue to take the Benadryl.
Patient developed significant mental status decline starting 2 weeks after his third booster.  The decline accelerated and became profound within 3-4 months.  Developed balance issues as well.
swelling of deltoid muscle w/pain into neck & finger tips w/tingling of finger tips
Chills, fever, chest congestion, ear ache, nasal congestion, immediate within 4 hours.
Patient received vaccination at 7:35pm, and about 10 minutes later, the patient reported burning in her throat, and a feeling of lumpiness in her throat. The patient was administered Benadryl 50mg po as one dose.  Symptoms improved within 30 minutes. No other side effects reported or observed.