chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OFF LABEL DOSING FREQUENCY; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included: pneumonia (30 years ago had pneumonia real bad like for a year), and concurrent conditions included: ex-smoker (Quit smoking). The patient had no history and was pretty healthy overall. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A expiry: unknown) dose was not reported, 1 in total was administered on 03-MAY-2021 to right arm for covid-19 prophylaxis. No concomitant medications were reported. The patient received non-company booster of Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, administered on 07-NOV-2021 for covid-19 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2).  The patient additionally received second booster dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 3) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was an off label dosing frequency (dose number in series 3). The drug was associated with Off label use. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that on 03-AUG-2022, the patient tested positive for covid-19 (confirmed clinical vaccination failure, dose number in series 1) and also mentioned on the same day, a little earlier the symptoms had begun. The patient mentioned the symptoms was just not feeling well (confirmed covid-19 infection) (dose number in series 1 and dose number in series 3). Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of off label dosing frequency was not reported. This report was non-serious.  This case, involving the same patient is linked to 20220807187 (dose number in series 1).
My doctor told me to report that I had an overwhelming metallic taste immediately after recieving the vaccination. It lasted for about a day and a half.
Pt. was hospitalized for cellulitis in arm that both the flu and the PPV vaccinations were administered. Right arm started hurting within a few hours of the injections.  Client woke up next a.m. with chills and had a fever of 103 degrees, headache, nausea and severe pain in right arm.  Client on Vancomycin, Unisyn and Amoxicillin.  Cultures are pending at this time. 1/24/06 Review of 1-page d/c summary confirms diagnosis of cellulitis of R arm with associated fever, and leukocytosis.
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 70-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: CH9402) at the age of 69 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: NDC 59267-1000-1), in left arm, on 28Mar2021 as dose 2, single (Lot number: NDC59267-1000-1), in left arm, on 04Nov2021 as dose 3 (booster), single (Lot number: FF3592), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: 33130BA), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test for 2 more weeks; Positive, notes: positive test for 2 more weeks; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID from 07Sep2023 to 11Sep2023.
This spontaneous report was received from a medical assistant refers to a 20 year old male patient. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On 02-JUN-2016, the patient was vaccinated with a pediatric dose of VAQTA (dose: 0.5 ml, lot # L023232, expiry date: 25-FEB-2017). No adverse effects were reported. Additional information has been requested.
around 6:30 pm patient started having symptoms of  dizziness and nausea and was not feeling well, went to sleep and woke up the next morning out of it and still had nausea and dizziness, with burning in her eyes and heart palpitations. she also experienced blacking out throughout the day.  these symtoms continued for 3 days. today, on day 4 patient is still feeling dizzy, the injection site is still swollen with pain.
w/in 6-8 hrs p/vax pt to be constantly twirling wrist & looking @ hand; very rhythmic, 90% of waking time spent doing this; no during sleep; gradually subsided over next 5-7 days;
Inflammation roughly the size of a golf ball at injection site starting a few hours after injection - It is still there 7 days later but emitting; redness roughly size of baseball persisted in past 48 hours but is not worsening - advised patient to see primary physician.
Onset late 3/28 with c/o pain, 3/29 edema down to knee and c/o pain with walking. Dx'd with cellulitis and started on Keflex 250mg TID for 7 days.
Two days after shot my bottom lip started to swelling, this happened fur more times on random days  each time getting worse and spreading on my face. Dr put me on steroid, pepcid and allergy pills for a week . Not getting swelling anymore but still have tingling in lip often ?
A few minutes after injection felt a quick electric-like shock across top of head and momentary faintness. A few minutes more, I began to have a tight feeling in my throat and swallowing was difficult. Felt the need to swallow frequently.  Got nervous so stayed past 15 minutes. At 30 minutes, it wasn't getting worse and my breathing felt fine so I left (foolishly) the vaccination site. Throat felt tight the rest of day. Kept feeling the the need to clear my throat. Sore. Hard to swallow. At 10:15pm, the tightness and swallowing issue abruptly stopped. Throat felt sore for next 2 weeks. Asked pulmonologist if my allergy and asthma medication could have suppressed a more insidious reaction. Did not know. Saw allergist. She did not know either but gave me an epi-pen if I was going to try shot 2. Also suggested J&J as an alternative. Ordered blood tests for reactivity to 2 chemicals close to PEG. (no blood test for it). Results not back. Noted that I was taking lisinopril which is an ACE inhibitor. Said they can cause swallowing problems. Cardiologist did not think so but changed my medication to a calcium channel blocker instead. Called Pfizer. They classified my reaction as an immediate adverse event and took a record of it. I canceled my second Pfizer shot appointment because the CDC site says not to take second shot if you have an immediate adverse reaction. Very disappointed and confused how to proceed. Mixed advice from doctors. Really wanted to be vaccinated. Really don't want to have a worse anaphylactic reaction which my pharmacist could happen if i tried it again. Don't feel safe trying it at the mass vaccination site at the beach.
between 7-8 days after the vaccination, itchiness occurring near the injection site. Within 12 hours after initial itchiness, large (2.5" diameter) hive like spot appearing: red splotchiness, raised skin, hard to the touch, round, warm, extremely itchy. Still in the process of symptoms; this reaction started less than 24 hours ago.
low grade fever (99 F); Sore arms; Overall exhaustion; This is a spontaneous report from a contactable nurse. An (12-17 Years) adolescent female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: EW0187), dose 2 intramuscular, administered in arm left on 12Jun2021 as dose 2, single for covid-19 immunization at Public Health Clinic/facility. The patient medical history and concomitant medications were not reported. Historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: EW0176), dose 1 Intramuscular, administered in arm left on 15May2021 as dose 1, single for covid-19 immunization. It was unknown whether the patient was pregnant. On 12Jun2021, the patient developed low grade fever (99 f), sore arms and had overall exhaustion. On 12Jun2021, the patient underwent lab tests and procedures which included low grade fever: 99 fahrenheit on 12Jun2021. The patient received Tylenol and ibuprofen as a treatment for the events. The outcome of events was recovered on an unspecified date in Jun2021.  Follow-up attempts are completed. No further information is expected.
Hives. One hive on day 1 then covered in hives from head to toes and still not resolved at time of filing report
Patient received vaccine.  Had patient sit in waiting area to monitor for adverse events.  A couple of minutes later, I heard the gate rattle and rushed over to lower him to the floor gently.  I called out to employee and customer to call 911.  Then he woke up probably within 30 seconds.  I had him continue to lie there and talked with him.   He set up once for a couple of minutes and said he still felt light-headed so i had him lay back down and continued to talk with him.  Then paramedics came in and took over.  They placed him on a stretcher and took him, while he was still conscious while leaving.
Systemic: open sore at injection site-Mild, Additional Details: patient denied any allergic symptoms
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented emergency department reporting right inguinal pain one day after receiving vaccination. Vital signs stable- no fever.  Admitted to hospital for pain control and further workup. Patient improved and most likely diagnosis was musculoskeletal injury. Discharged medically stable with outpatient follow-up in place.
SM awoke with whole body pruritis and maculopapular red rash.  Recieved small pox and anthrax vaccine together two weeks ago.  No SOB/CP.  No other symptoms.  Only other contributory history is that last night he used his shampoo on his body as he was out of soap.
Pfizer-BioNTech COVID-19 Vaccine EUA: 57 yo F presented to the ED about an hour after receiving dose #1 of vaccine with c/o tongue swelling, itchiness and intermittent cough. Rash noted on bilateral arms. All symptoms resolved. Patient discharged from the ED with instructions to follow up with PCP.
This spontaneous report as received from a physician and a nurse practitioner via a company representative refers to am unspecified (reported as a "few") number of patients of unknown age. It was reported that when GARDASIL first came out on the market (reported as many years ago) the doctor and a working with her nurse practitioner had a "few" unspecified patients faint after receiving a doses of GARDASIL (dose, route not reported) on unspecified dates. It was unspecified at which dose within the series the patients experienced the fainting. The outcome of the faintings was unknown. The relatedness between the faintings and GARDASIL was not reported. Additional information is not expected, because the reporters stated that it was so many years ago that they do not remember the details.
Pt devel uncontrollable crying episode 4 hrs p/vax administered for a period 6-7 rhs; t100.4, vomited x 1 about 12 hrs p/vax recvd;
This spontaneous report was received from a registered nurse referring to a 19 year old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 18-AUG-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB lot # L003193 (dose, route, anatomical site of vaccination and expiration date were not reported), then on 27-OCT-2015 the patient was vaccinated with the second dose of RECOMBIVAX HB lot # L003193 (dose, route, anatomical site of vaccination and expiration date were not reported). No adverse effects or product quality complain were reported. Additional information has been requested.
Mom reports that child broke out in a rash 3 days after receiving vaccines. Reports that child had increased temp 101 - 102. Was seen by her PMD 07/20/2005 for rash, 07/23/2005 tem was 98.4.
2-inch diameter red, painful rash/ raised circle centered around vaccine injection site. Treatment: 1 benadryl 25mg HCl at first sign, repeat 1 more, 6 hours later. Rash was resolved 80% by next day, 90% for following 2 days, and 100% by day 4. To note had localized pain in armpit and left chest for 3 days PRIOR to onset of rash, had resolved by morning of Jan 21 (day rash showed up in afternoon).
fever; chills; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) from 14-Jan-2021 to 15-Jan-2021 for Fever, at an unspecified dose and frequency and IBUPROFEN on 14-Jan-2021 at an unspecified dose and frequency. On 15-Jan-2021, PYREXIA (fever) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
After giving the immunization, while discussing the time frame of the second immunization, the patient said he was feeling a little dizzy. I called for assistance and took the patient's blood pressure but could not get an accurate reading. Once I had assistance we helped the patient over to the pharmacy bench and had him lay down and elevated his feet. The patient said he felt like he was going to pass out so I applied an ice pack to the back of his neck. The patient was asked if he wanted us to call an ambulance, but he said no he thought he was just hungry. I continued to monitor the patient and attempted to take his blood pressure again, but still could not get an accurate reading. The patient began shaking and holding his head. I asked him if he was okay or if he was cold? He said no, he was just trying not to pass out. Again I suggested calling 911 for an ambulance and the patient agreed at this time. EMS arrived and took his blood pressure, which was 108/70 then transported the patient to the hospital.
Pt recv vax on 1/27/99; on 2/3/99 pt exp itching, area red & feverish, soft ball size
Bump and red rash around it.  Started night after second shot.  Still theren48 hours later.  Painful to touch.
mild cellulitis at the injection site; supraclavicular lymph node swelling and general neck swelling above
Thrombocytopenia, was the result of getting this vaccine. Symptoms began during routine dialysis treatment with spikes in blood pressure and steady drop in hemoglobin values over a two week period. I was notified by my dialysis clinic that I was loosing blood some where. I went to the emergency room at Hospital  on 9-16-2021 and was given three blood transfusions. An esophagogastroduodenoscopy was performed  with no significant signs of bleeding and was told by Dr. at Hospital (Dignity )to schedule a colonoscopy as an outpatient
Information has been received from a physician concerning a female with a history of herpes zoster who on 23-FEB-2007 was vaccinated with a dose of Zostavax. On 29-MAR-2007 the patient experienced zoster like rash. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
This medically confirmed spontaneous report (initial receipt 06-Feb-2013) concerns a female patient. On an unknown date, the patient received AFLURIA (batch P50908A). After receiving AFLURIA, the patient developed severe pain in the arm and limited range of motion. The patient recovered 2 months after the vaccination.
SORE ARM AT INJECTION SITE AND FELT LIKE SOMEONE PUNCHED IN ARM; This spontaneous report received from a patient concerned a 60 year old female. 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 not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced sore arm at injection site and felt like someone punched in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm at injection site and felt like someone punched in arm on 12-APR-2021. This report was non-serious.
Had extreme pain in back, hips, knees; Had extreme pain in back, hips, knees; Extreme muscle spasms also at these sites; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 11Dec2021 at 12:30 (Lot number: 33030BD) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Fibromyalgia"; "Spondylitis", notes: Arthritis of the back; "Knee arthritis", notes: Arthritis of the back, knees, and hips,; "Coxarthritis", notes: Arthritis of the back, knees, and hips and "Latex allergy", notes: Known allergies: Latex; all (unspecified if ongoing). The patient received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6206; administration time: 14:00, vaccine location: left arm), administration date: 03Mar2021, when the patient was 49 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; lot Number: EP7534, administration time: 13:30, vaccine location: right arm), administration date: 24Mar2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021 at 12:30, outcome "unknown", described as "Dose number: 3"; BACK PAIN (non-serious), ARTHRALGIA (non-serious); with onset 12Dec2021 at 03:00, outcome "recovering" both described as "Had extreme pain in back, hips, knees" and MUSCLE SPASMS (non-serious) with onset 12Dec2021 at 03:00, outcome "recovering" described as "Extreme muscle spasms also at these sites". Therapeutic measures were not taken as a result of back pain, arthralgia and muscle spasms.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that pain was near unbearable. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
pt recvd vax & exp poss Bell's Palsy w/facial distortions & a constant h/a; pt exp asymmetric (decreased) movements of the rt side of face; addtl lacked control over the rt side of mouth;
Dizzness  from time of shot. Woke up at 130 am shaking and legs spasms, extreme thrist, body aches could hardly walk on feet, headache.
Pt was given 3 doses of rubella vax in MAR90 & had a low but protective antibody level; Pt was also administered measles virus vax 1963 & 1976 @ time of the report had no titer of antibodies (WAES 91030341);
pains in her stomach; Nausea; vomited; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (pains in her stomach), NAUSEA (Nausea) and VOMITING (vomited) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (pains in her stomach), NAUSEA (Nausea) and VOMITING (vomited). At the time of the report, ABDOMINAL PAIN UPPER (pains in her stomach) and NAUSEA (Nausea) outcome was unknown and VOMITING (vomited) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she vomited bunched of green liquid and had no food particles. Her temperature was 98.1. No concomitant information was reported. Patient didn't take any treatment.
Achy body, cough, wasn't running a fever, oxygen content was good. And that's when I called the doctor and she prescribed Molnupiravir 200mg 4 pills 2x day.
This spontaneous report as received from a nurse refers to a male patient of unknown age. Approximately on 02-FEB-2013(reported as 5 days ago), an unspecified patient was vaccinated with a dose of live ZOSTAVAX(lot number, expiry date, route and dose were not reported).Approximately on an unknown date in February 2013, the patient was having an unspecified surgery unrelated to live ZOSTAVAX. Action taken with live ZOSTAVAX was not applicable.It was unspecified if patient sought medical attention. The outcome of unspecified surgery was unknown. The reporter considered unspecified surgery as not related to live ZOSTAVAX. Additional information has been requested.
On 8/20/02, pt rec'd vaccines DTaP, IPV & MMR. Pt cam into office on 8/22/02 c/o itchy, red & swollen left arm from shoulder to elbow. Pt was referred to clinic  to be evaluated. He was seen by clinic. On 8/22/02 and was given Benadryl & Advil On 8/23/02, pt's swelling is going down.
Guillain Barre syndrome, Miller Fisher variant. Treated with IVIG at Medical Center.
Body aches; Unable to work; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on 07Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on unspecified date in 2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced body aches, fatigue and was unable to work. On an unknown date, after the vaccination the patient underwent lab test and procedure which included covid-19 test and the result was found to be negative. No therapeutic measures were taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events body aches, fatigue and unable to work was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.