chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of asthma in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced asthma. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of the 11 cases (B0643778A, B0667867A, B0667865A B0667866A, B0667868A, B0667869A, B0667870A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. The case referred to 52 subjects who onset asthma. This literature article summarizes the results of an open, prospective, observational study that was carried out in a Health Maintenance Organization. The primary aim of this study was to estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions and new onset of chronic illnesses) following administration of a single dose of BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcomes among 13,427 10 to 18-year-old adolescents who received TDAP vaccination as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematological events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of TDAP vaccination by comparing with historical TD controls matched for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the TDAP and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following TDAP vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of TDAP, compared with 0 events within days 30 to 59. When compared with matched historical TD recipients, no increase in new onset chronic illnesses was seen after TDAP. No deaths occurred in the TDAP cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with TDAP.
3 days after shots, mother noticed redness and swelling at site of injection and child complained of itching.  Area is still red and indurated, by 4 cm.
Headache, Pain @ injection site, fatigue Narrative: Reported pain @ injections site, HA & fatigue
On 5/10/12 patient had one day irritability and tactile temp. Next day patient had weakness in (L) arm and presented to hospital. Patient was admitted with diagnosis of post infectious encephalitis of unknown cause and transient erythroblastopenia of childhood.
Case had surgery on 03/15/2023 and tested positive in hospital on 03/24/2023 in preparation for going to Rehab facility. Only symptom was a fever.
Vasovagal episode for a few seconds. Took vitals but was WNL. Patient lied down on a mat and felt fine after. AOx4.
Severe General malaise, palpitations, GI upset (severe), esophagitis, muscle and joint ache for 21 days.  Severe dehydration  Visited urgent care clinic 11/09/09 and Hospital ER on 11/12/09 for 6 hours.  Diagnosed severe dehydration and received multiple IV Saline/Dextrose over a 6-hour stay.  Gastroenterologist appointment 10:30 a.m. on 11/16/09.  Upper GI Scope on 11/17/09 6:45 a.m., GI Ultrasound on 11/18/09 8:00 a.m. Hida Scan on 11/19/09 10:00 a.m.  12/1/2009 ED records for 11/12/2009, patient with c/o's nausea and myalgias. TX: IVF, Phenergan and pepcid. Dc Dx dehydration. F/up with GI MD 12/1/2009 Outpatient dx studies 11/17-11/19/2009 received
Splenic Infarct, Thrombocytopenia, Pancreatitis, disseminated intravascular coagulopathy
HIB dose was given to patient with an expired diluent. Per health dept, instructed to reimmunize patient.
About two weeks after second Covid vaccine, I developed pain in both thighs (quad and hamstring muscles). It was unexplained cause of inflammation.  The pain got worse over a three week period.
Symptoms: pain over injection site, severe ecchymosis over injection site (8.5 x 5.0 cm area), bronchial infection, dyspnea with bronchospasm requiring treatment with albuterol (the patients is not a known asthmatic).  Additionally, extreme fatique, muscle aches, headaches, nausea and emesis.  Treatment was done twice in the emergency room with albuterol.
Patient comes in with left-sided weakness and facial droop; incidental finding of COVID-19, asymptomatic
Pt started on 10/07/2002 with rash, Positive chicken pox. Confirmed by doctor. Pox on head, face trunk
He had swelling, pain and redness yesterday and came ;home early from preschool Mom treated him wtih benadryl and ibuprofen and he slept well last night This morning was still complaining about it hurting No fevers
Swelling, redness over entire arm length - slight pain. Received cortisone injection from doctor. Symptoms subsided after 2 days.
Area of injection, swelling red warm to touch => Cellulitus, LEVAQUIN.
MAJOR ARM PAIN LASTING FOR MONTHS.  NOW PATIENT CLAIMED THAT HE COULD BARELY MOVE HIS ARM.
Redness, warmth, and swelling at injection site 8 days post injection.  Increased swelling, warmth, and itchiness day 10 post injection.
6 patients administered with expired vaccines; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients administered with expired vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 012H21B) for an unknown indication.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients administered with expired vaccines). On 13-Apr-2022, EXPIRED PRODUCT ADMINISTERED (6 patients administered with expired vaccines) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.  The reporter stated that they administered expired vaccines to 6 patients on 13Apr2022. Lot number from expired vials is 012H21B, and expiry date from this vial is 18Mar2022.  No AEs were reported.
Within a few hours I experienced severe stomach cramping. The cramping has turned into chronic gut pain, possibly ovarian/uterus. Its become uncomfortable for me to even walk, which is surprising because I'm very active and fit. I can press into my lower right gut and feel isolated pain, like the vaccine put a hole in my intestines. It doesn't hurt to digest food, but when my bowel is activated I feel jolts of pain in the localized spot.
Report 2001028862-1 describes hives in a 19 year old female who received hep B vaccine. Medical history, concurrent conditions, and concurrent medications were not specified. On unspecified dates, the vaccinee received her first and second injections of hep B vaccine. Following her second vaccination with hep B vaccine, she experienced hives. As of 12/4/01, the hives had resolved.
2-3 hr p/vax mom noticed a bulging fontanelle & irritability; taken to hosp ER where LP & Ct scan done; sent home; f/u neurologic exam 22APR & scan 21APR95 nl; mom stated pt completely well by 4 days;
mom reported rash 15MAY97;mom states pt was miserable began to have a fever that noc 103;highest temp 104-relieved by APAP;
Pt vaccinated with Fluzone developed facial swelling seen on 19OCT90 face was red with periorbital swelling. Benadryl 25 mg 1 or 2 caps every 8 hours.
arm was slightly sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was slightly sore at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was slightly sore at the injection site). At the time of the report, VACCINATION SITE PAIN (arm was slightly sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was provided.   Reporter did not allow further contact
On 5/19/08 - came in c/o rash to upper (L) arm and (R) arm, forehead. Also had mouth sores. Was prescribed abx (BACTRIM).
patient came to get Pfizer 5-11 years bivalent booster, but was given Pfizer 5-11 mono-valent  booster vaccine
Patient given Moderna 1st dose booster on 4/26/2022. Vial expired on 04/24/2022. Denied adverse reaction. Moderna and CDC notified. Advised to re-vaccinate patient.
Ache is annoying; Pain is currently deep into shoulder and left hand; Deep muscular pain in left deltoid; Bad stiff neck, couldn't turn it; Pain travelled to vaccine arm/shoulder/back/elbow; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Bad stiff neck, couldn't turn it), PAIN IN EXTREMITY (Pain travelled to vaccine arm/shoulder/back/elbow), PAIN (Ache is annoying), ARTHRALGIA (Pain is currently deep into shoulder and left hand) and MYALGIA (Deep muscular pain in left deltoid) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 0ZZMZ0A) for COVID-19 vaccination.     Concomitant products included MELOXICAM (MOBIC) for Pain in hip.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Bad stiff neck, couldn't turn it) and PAIN IN EXTREMITY (Pain travelled to vaccine arm/shoulder/back/elbow). On 24-May-2021, the patient experienced PAIN (Ache is annoying), ARTHRALGIA (Pain is currently deep into shoulder and left hand) and MYALGIA (Deep muscular pain in left deltoid). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Bad stiff neck, couldn't turn it), PAIN IN EXTREMITY (Pain travelled to vaccine arm/shoulder/back/elbow), PAIN (Ache is annoying), ARTHRALGIA (Pain is currently deep into shoulder and left hand) and MYALGIA (Deep muscular pain in left deltoid) outcome was unknown.            Action taken with mRNA-1273 in response to the events were not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Followup received on 23-Jun-2021 contains: The reporter still had slight neck, shoulder and arm pain over a month later.
pt recv vax 1JUN98 & same day exp stiffness & pain in the inj site arm;
Constant headache blurred vision dizziness pain in back of head numbness in left leg  bp very high weakness tightness in right arm and pain in left arm where the shot was given sore throat  face numbness
Pt called 2 days after vaccine. 24 hours after vaccine, 4 fingers on arm that received vaccine went numb and are still numb. Advised pt to call PCP.
Expired ZOSTAVAX was administered to a patient. Expired 08/06/2010; Administered 8/23/2010. No additional treatment given. No adverse effects noted.
T of 104 (R) & an unusual cry, seemed irritable, developed diarrhea.
Pt became irritable and restless post vax. Pt's mother had a history of latex allergy. No further info was available at the time of this report. Pt experienced restlessness and irritability following second dose of Prevnar. See HQ1482831MAY2001.
19 y/o male received primary Smallpox Vaccine (SPV), Anthrax (AVA#1), Typhoid VICPs o 06JUN11 in preparation for deployment in SEP 2011. He experienced a syncopal episode & nausea during PT on 21JUN2011 (Day #15 s/p receipt SPV). SM reports presyncopal episode & nausea the next day (22JUN11) while doing inventory at work- on feet, bending, lifting, etc. Went to ED for evaluation. Treated for "Possible Heat Exhaustion" with IV 2L NS IV fluids and ZOFRAN. No cardiac enzymes, ESR or CRP drawn. CBC and CMP WNL. EKG obtained in ED interpreted as "normal" NSR, normal p axis, V-rate 50-99, " consider left atrial abnormality- wide or notched P waves, PR 120 with baseline wander in Lead V4. SM experienced a recurrent sensation of presyncope & nausea after participating in 4-mile run on 01JUL11. SM also reports a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes w/o radiation to jaw, throat, neck or left arm, accompanied by SOB and sensation of heart "skipping a beat". Cardiac Panel (08JUL11) with + CK of 524 U/L (55-170); CKMB of 5.0 U/L WNL (2-16); CRP 0.1 WNL (Ref. 1.0 mg/dl) and ESR was 6 WNL (0-15 mm/hr). SM initially denied positional worsening of CP/SOB in supine position, but reported  a recurrent episode of similar CP on SAT 09JUL11 when lying down on bed in barracks, which last 5-10 minutes. Cardiology Consult to r/o underlying cardiac dysfunction, valvular dz, or dysrhythmias. Clinical presentation of SM's CP does not seen c/w Vaccinia Myopericarditis, but this must be considered in Differential Dx, as SM's sx occurred w/in a 30-day window of primary SPV immunization & other vaccines mentioned. Therefore, could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the SPV. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of SPV, but by presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram.
Angry, Red, swollen area around the injection site. Approx size of an orange and sticking out about one inch. Nausea, fever reported on 07/23/15. Saw primary care physician on 07/24/15. Given rx's for zpak and cetirizine.
On 7/31/2018 Child was here for his Kindergarten Physical. He received KINRIX to cover his 5th DTaP, and 4th IPV intramuscularly to his right deltoid, and PROQUAD to his left arm. On 08/01/2018, his mother brought the child in for a swollen, warm, red right arm where the injection site occurred. She noted that it started 07/31/2018, and doubled in size from yesterday to today. She denies fever, pain or itching. Upon exam, the area of redness was oval in shape, approximately 4x5 inches, with an area of firmness and heat approximately 2-3 inches in diameter near the injection site. The child denied pain or itchiness, he noted it just feels "hot".
PATIENT HAS A KNOT IN HER LEFT ARM WHERE THE SHOTS WERE GIVEN. PER PATIENT DESCRIPTION IT IS WARM TO THE TOUCH AND HAS BEEN PUTTING ICE ON IT. WILL SEEK MEDICAL ATTENTION IF SYMPTOMS GET WORSE.
This case was reported by a consumer and described the occurrence of headache in a female subject of unspecified age who was vaccinated with Influenza vaccine (GlaxoSmithKline), DTP (A or W not known). A physician or other health care professional has not verified this report. Concurrent medical conditions included hypothyroidism. There were no concurrent medications. On an unspecified date "in the past', the subject received unspecified dose of Influenza vaccine (unknown), unspecified dose of DTP (A or W not known) (unknown). At an unspecified time after vaccination with DTP (A or W not known) and Influenza vaccine, the subject experienced headache and diarrhea. At the time of reporting the outcome of the headache and diarrhea were unspecified. The subject reported a case for her son, see A0883807A.
It was the same symptoms as the 2nd dose except it happened quicker and within 3 hours. I started feeling like crap with severe headache, severe fatigue, arm soreness, 100-101 fever, and the palsy I had and restless legs were more intense but lasted 2 days instead of 3. The muscle pain was much more painful to the point where I cried and I would wake up in the middle of the night and my husband would have to calm me down. I've just felt really tired and my hair is falling out but all of my labs are coming back fine. My doctor said I am healthy and so I had my labs drawn by my Gynecologist and they were negative and my PCP drew that again in March 2022 and, they were positive. The only health change I've had is getting the booster in November. I was diagnosed with ADHD and I've been taking medication for that for 5 years and my blood pressure has always been normal and actually low if anything. Starting in January, my blood pressure was 135/85 and they thought it was weird and kept an eye on it and monitoring it and my doctor prescribed me HCTZ which gave me terrible headaches. I kept a log of it and it would reach much higher at the Doctor's office. I was having edema in feet and lower extremities as well. My doctor changed my medication to Spironolactone and I've been on that for a week. I will follow up with her the week of the 20th. I experienced significant hair loss and the density of my hair is 50% of what it was and I was pulling out handfuls of hair when I was in the shower. My doctor checked my vitamin D, thyroid, and hormones and the most recent ANA that came back positive but there was 1 tier and 2 that came back negative. I also never got COVID. She's going to do some labs in a couple of weeks and see if I'm a super responder and check my antibodies.
Patient denied having any side effects from vaccine; Patient is 49 years old and knows he is older than the recommended age but his doctor chose to do it anyway; This spontaneous report was received from a 49-year-old male patient, reporting on himself.    The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-DEC-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   On 28-DEC-2021, the patient stated he knew he was older than the recommended age but his doctor chose to do it anyway (off label use).  Patient denied having any side effects from vaccine (no adverse event).
pt had high fever 105 ax;pt had sz, diarrhea, & was non responsive;29SEP97 pt was still in hosp as of 26SEP97;
body aches, sore arm, stomach ache, lost her voice. Symptoms lasted for 2 days.
Golf ball size lump in armpit that began during the same night the vaccine was given and lasted several days. 9 days after vaccine a severe rash and hives developed. Rash still persists after three weeks.
Patient had physical exam done on 4/7/03 then with returned check on 4/9/03 for local vaccination. Reaction cellulitis, treated with Cephalex in 250mg/5hl for ten days.
post menopausal vaginal bleeding; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 21Apr2021 16:45 (Lot Number: EW0161) at the age of 56-year-old as single dose for covid-19 immunisation. The patient was not pregnant. Medical history included hypertension, anxiety, depression, COVID-19 (Prior to vaccination, the patient was the patient diagnosed with COVID-19). The patient had no known allergies.The patient previously received first dose of bnt162b2(lot number: ER8732) at arm left on 31Mar2021 04:30PM at the age of 56-year-old for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included venlafaxine hcl; metoprolol tartrate; multivitamin; hydrochlorothiazide (HCTZ); all taken for an unspecified indication, start and stop date were not reported. One week after the second dose (28Apr2021), the patient began to have post menopausal vaginal bleeding. It lasted for 8 days and ended on 08May2021. The bleeding was similar to a menstrual cycle. Her last menstrual cycle was in Sep2017. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Covid test post vaccination covid test type post vaccination(Nasal Swab) on 03May2021 was negative. No treatment received for the event. The event was recovered on 08May2021.; Sender's Comments: Based on the information currently available, the reported event post menopausal vaginal bleeding one week after the second dose more likely represented intercurrent illness, but not related to bnt162b2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and investigators, as appropriate.
She is not feeling really well; She is feeling like dizzy from last three days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "She is not feeling really well"; DIZZINESS (non-serious) with onset 28Aug2021, outcome "unknown", described as "She is feeling like dizzy from last three days".  Additional information: The patient got the vaccine and she was not feeling really well. She was feeling like dizzy from last three days and she said about the Pfizer vaccine was approved and licensed. Is that true?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
There is a large circular area around where I receive the typhoid shot that is extremely painful, swollen, itchy, hot to the touch and very hard (it's a firm raised circular spot that is visibly swollen and red). I've felt very tired and my arm and joints hurt.
Began eight days, 3/14/2021, after first dose of Moderna vaccine.   Large, warm, raised, red, slightly sore, very itchy area appeared at injection site.  Lasted about two days, then went away.  Then, on 3/19/2021 the itching began again, and I have another red spot on my left arm at injection site just like before.
Around 8:00pm I started experience ear fullness and tinnitus (pulsing with my heart beat) in my right ear along with a mild headache on that side.  At 11:00pm I woke up with one of the worst migraines of my life and I was shaking uncontrollably.  Only a mild temperature of 99.2.  I took two Extra strength Tylenol and 30 minutes later the shaking subsided by the temperature did not.  The headache persisted until 11:00am on Friday.  Migraine symptoms included aching and shooting pains on the right side of my head near my temple, neck pain, light and smell sensitivity.  I also smelled things that were not there--like the smell of burnt toast and garlic.  I regularly get migraines and have seen a neurologist for these, but do not take prescription medication.  I had tinnitus in the same ear about 12 years ago, but have not experienced symptoms since.