chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Pfizer pediatric dose of 10 mcg/0.2 mL at the age of 12, instead of the indicated 30 mcg/0.3 mL. No adverse events reported at the time, no symptoms during 15 minute observation period.
have a stroke; I'm partially blind; Destroyed my right occipital lobe; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on [02Dec2021], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "have a stroke"; BLINDNESS (medically significant) with onset 2021, outcome "not recovered", described as "I'm partially blind"; SKULL FRACTURED BASE (medically significant) with onset 2021, outcome "unknown", described as "Destroyed my right occipital lobe". The patient underwent the following laboratory tests and procedures: investigation: unknown results, notes: After months of testing with every test that modern medicine has, there's no explanation as to why it happened. Additional information: Three weeks after patient's first Pfizer shot in Sep2021, patient had a stroke that destroyed his/her right occipital lobe. After months of testing with every test that modern medicine has, there was no explanation as to why it happened. The only common denominator. Pfizer. Now patient's career was ruined because patient was partially blind.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This is a literature case, initially received on 19-Feb-2019, concerning a 75-year-old, elderly male patient. This is a review of safety profile of aIIV3 vaccine by analysing the reports of aIIV3 submitted from 01-Jul-2016 through 30-Jun-2018 to the vaccine adverse event reporting system (VAERS). On an unspecified date, the patient was administered FLUAD (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported] for an unknown indication. On an unspecified date, after vaccination, the patient died due to Sjogren's syndrome. Autopsy was performed and the cause of death was reported as Sjogren's syndrome. The reporter assessed this case as serious (death).; Reporter's Comments: A 75-year-old, male patient developed fatal Sjogren's syndrome, on an unspecified day after administration of FLUAD (TIV) Vaccine. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported event, vaccination details, concurrent medical conditions and investigations to provide alternate aetiologies, the causal role of suspect vaccine was assessed as unassessable. The case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Sjogren's syndrome.
77-year-old obese male with history hypertension, hyperlipidemia, COPD, DM2, chronic hypoxic respiratory failure dependent on 3 L nasal cannula oxygen at bedtime, Parkinson's disease, depression, paroxysmal atrial fibrillation on Xarelto, coronary artery disease (s/p CABG x 2 (LIMA to LAD / SVG to RCA) in 2012 and stenting x 2 on 02/12/2021), valvular heart disease (s/p bovine AVR in 2012), AICD/pacemaker, Chronic systolic CHF/Ischemic cardiomyopathy EF less than 20% with severe global hypokinesis and mild LVH. Patient presented to the ED via EMS due to altered mental status for approximately 9 hours prior to arrival per ED documentation with associated slurred speech reported.  Patient was unable to provide this history for me due to confusion.  ED workup significant for hyperglycemia, elevated beta hydroxybutyrate.  Urinalysis pending.  CT brain without acute intracranial abnormalities.  Chest x-ray with chronic bilateral opacities however however, final read pending  7/28/2021 tested positive 8/7/2021: patient discharged.
persisting subcutaneous nodule on right shoulder; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Lot number: EM9809) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pre-ventricular contractions" (unspecified if ongoing), notes: Pre-ventricular contractions; "headaches" (unspecified if ongoing); "FSAD" (unspecified if ongoing); "degenerative disc disease" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: METOPROLOL. Vaccination history included: BNT162b2 (lot number: EL9261, dose number: 1, vaccine location: Right arm), administration date: 20Jan2021, when the patient was 30-year-old, for COVID-19 immunization. The following information was reported: SKIN MASS (non-serious) with onset 01May2021, outcome "not recovered", described as "persisting subcutaneous nodule on right shoulder". Therapeutic measures were not taken as a result of skin mass.  Additional information: The patient had covid prior vaccination. It was unknown covid tested post vaccination, patient was not aware about known allergies.
Nurse received telephone call from client's parent stating child woke up with "rash and swelling on face" the morning after vaccines were administered. Parent took child to pediatrician, was given hydrocortisone cream and Tavist prescription. 4-9-08 TC from mom. Client much improved. Nurse advised mom to follow up with ped for future vaccines. Bring note from doctor if returning to clinic.
The pt developed multiple myalgias, arthralgias, lower extremity weakness and swollen and painful joints.
mom reported pt had fever of @ least 103.8 ax p/vax 23JUN93; pt also exp episodes of prolonged/constant crying for 4-5 hrs; no tx by FMD @ that time, but mom did contact FMD prior to 23MAR93 appt & MD recommended ped DT instead of DTAP;
pulmonary problems; 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 73-year-old female patient received BNT162b2 (BNT162B2), on 08Sep2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG DISORDER (hospitalization) with onset 2022, outcome "unknown", described as "pulmonary problems". The patient was hospitalized for lung disorder (start date: 2022). The event "pulmonary problems" required emergency room visit.  Additional information: The patient stated she was supposed to have booster doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022. However, she had pulmonary problems and other health problems during 2022 and early 2023; she was hospitalized 5 times and wasn't able to get her boosters shots. She was in urgent care in Mar2023.  The last dose she received was on 08Sep2021. She wanted to know if she should receive a dose of the Bivalent vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt stated that the day after the covid vax she had the dry heaves and body aches and pains.  The second day she shaking and jerking, couldn't hold on to anything.  Her blood pressure was up and down that day. She said she felt like she was dying and then she vomiting where she bruised both elbows on the toilet bowl due to the jerking movement she was experiencing.  She took a nap and woke up confused.  She was hallucinating saying she felt like she went from a small box to a blue box to red box and didnt recognize her room.  Her sitter said her eyes were glazed but was able to recognize her sitter at that time.  Blood pressure dropped so the sitter then called EMTs where they checked her out.  Vital signs were good but she declined to be transported to the hospital via ambulance.  The third day she was feeling some better where she was able to eat and get a sponge bath.  Fourth day she was better so was able to shower.  She states she is better now with just a little soreness and redness around the injection site.   Pt has contacted her PCP and spoke with the nurse about her symptoms.
13DEC98 cough, earache;mother tx for cold;30DEC cough, ears bothering pt;seen by MD & given sinus med;4JAN99 chest bothering pt x-ray done showing past bronchial irritation;dx viral bronchitis;seen by MD irritation of lungs, allergy
Immediatley after receiving vaccinations, child developed hives on face and both arms.  No respiratory distress or itching was present.  Child was seen by Emergency Room physician just after hives appeared as vaccinations were given at satellite clinic being held at hospital.  Child was released without treatment and hives resolved within approx. 45 minutes.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 30-DEC-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 72, 29 and R; 104, 33 and R; 24, 32 and R; 24, 31 and R; 112, 30 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Dtap shot (L) arm 4/20/11. 4/22/11 onset AM of 7 1/2 x 8 c red, slight firm, warm, not hot, afebrile.
This spontaneous report as received from a consumer refers to a 61 year old female patient with no pertinent medical history and allergy to hay fever and penicillin. On an unspecified date in April 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). Concomitant therapy included blood pressure medications (dose and manufacturer unknown). The patient stated she had a mild case of Shingles over 20 years and recognized the symptoms, so she got the ZOSTAVAX vaccine to prevent having an extremely bad case. The patient was experiencing burning and discomfort in her back and under her armpit. No distinction was made to which side of her body was being affected. The patient did not receive any treatment and did not seek any medical attention. Routine quarterly blood work was performed and no result was given. On approximately 07-JUN-2013 (currently), the patient was still experiencing the symptoms. Additional information is not expected.
onset approx 930PM fever up to 103-vomit x2;APAP given;
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. The registered nurse reported that on 13-AUG-2013, one patient was vaccinated with an improperly stored dose of VAQTA (lot # H012673 expiration date 27-FEB-2015) (dose and route not specified), that was exposed to 31F for 72 hours, which is an unsupported excursion noted by in-house stability data. No adverse symptoms reported. The nurse also reported that another patient was vaccinated with improperly stored VAQTA (MARRS 1308USA009656), another patient was vaccinated with improperly stored PEDVAX (MARRS 1308USA009657), another patient was vaccinated with improperly stored ROTATEQ (MARRS 1308USA009659), and another one was vaccinated with improperly stored GARDASIL (Intramuscular Injection) (MARRS 1308USA009658). This is one of several reports from the same reporter. Additional information has been requested.
Two days post vax, the pt developed a rash early AM. By that evening the pt had a full body rash, large areas even on palms, feet, face, ears, largest area at site of injection. Diagnosed with erythema multiforme.
Patient received vaccine in afternoon and said in the evening she had fever, aches, cough, fatigue, elevated heart rate and elevated blood pressure
Patient received first COVID19 Pfizer vaccine on 4/18.  At that time, had about 3 days of cough and chest tightness.  Subsequently began having neck pain on 5/8 and received second Pfizer vaccine on 5/9.  Then began having fevers (Tmax 103F), cough.  Admitted to Hospital on 5/15 with respiratory failure and shock.  Unclear etiology of pneumonia vs multisystem inflammatory syndrome in children (MIS-C).  Did not initially respond to antibiotics so treatment for MIS-C was initiated.  Now slowly improving but still hospitalized.
Pt received HPV, then Tdap, then Hep A - before last IM MENACTRA was given - Pt stiffened, had stiffening of legs, eyes closed, unresponsive - had mouth movements, then urinated. Given whiff of ammonia with much result, after approx 2 minutes pt became responsive.
A rash in her belly on her left side, now it's just steadily all over her belly, now it's just steadily all over her back/bloody red, big as her hand; she can't move; Very painful, she thought it was shingles, it hurts like shingles; It's awful, can't wear a top; Can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (A rash in her belly on her left side, now it's just steadily all over her belly, now it's just steadily all over her back/bloody red, big as her hand), HYPOKINESIA (she can't move), PAIN (Very painful, she thought it was shingles, it hurts like shingles), DISCOMFORT (It's awful, can't wear a top) and INSOMNIA (Can't sleep) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included METOPROLOL, RIVAROXABAN and PREDNISONE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH ERYTHEMATOUS (A rash in her belly on her left side, now it's just steadily all over her belly, now it's just steadily all over her back/bloody red, big as her hand), HYPOKINESIA (she can't move), PAIN (Very painful, she thought it was shingles, it hurts like shingles), DISCOMFORT (It's awful, can't wear a top) and INSOMNIA (Can't sleep). At the time of the report, RASH ERYTHEMATOUS (A rash in her belly on her left side, now it's just steadily all over her belly, now it's just steadily all over her back/bloody red, big as her hand), HYPOKINESIA (she can't move), PAIN (Very painful, she thought it was shingles, it hurts like shingles), DISCOMFORT (It's awful, can't wear a top) and INSOMNIA (Can't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information regarding corrective treatment was reported by the patient.
No adverse event; The patient received dose 1 on 29-Jan-2021 and dose 2 on 19-Feb-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received dose 1 on 29-Jan-2021 and dose 2 on 19-Feb-2021) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had no allergies to medications, food and other products. The patient had no acute illness at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions.  The patient's past medical history included COVID-19. Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received dose 1 on 29-Jan-2021 and dose 2 on 19-Feb-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received dose 1 on 29-Jan-2021 and dose 2 on 19-Feb-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received dose 1 on 29-Jan-2021 and dose 2 on 19-Feb-2021).    The patient received dose 1 and dose 2 of Moderna vaccine in P.M hours.  Dose details of Fluarix was reported as pre-filled syringe, quadrivalent.  No treatment details was reported.   This case was linked to MOD-2022-665705 (Patient Link).
Site of the injection. Arm was very swollen, red, warm, and painful to the touch. It lasted for a week. Used hydrocortisone cream and antihistamine for the duration of the event.
Patient had a large amount of swelling and pain, felt like she couldn't move her arm. She also broke out into hives. The injection site became very itchy and painful.
Site: Bruising at Injection Site-Mild, Systemic: Bleeding after administration of the vaccine- about 2 cc, no other events-Mild, Additional Details: Administered vaccine in left deltoid- patient had approximate 2 cc of bleeding after the fact. Another dose of vaccine was administered in the right deltoid- this was unremarkable
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (strength unspecified) (lot# L040181 with expiration date: 18-AUG-2017), route unspecified. The suspect product was exposed to 50.2F for 36 minutes detected by a data logger. No adverse effects reported. No product quality complaints involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
This case is part of 4 cluster cases and it's is linked to cases 2012-12607, 2013-06243 and 2013-06234 (same reporter, FLUZONE HIGH-DOSE No Preservatives 2012-2013 lot number U4496AA). Initial report received from a healthcare professional on 20 MAY 2013.  A 72-year-old male patient had received an intramuscular dose of FLUZONE HIGH-DOSE No Preservative 2012-2013 (lot number U4496AA, dose number was not reported) in right arm on 20 SEPTEMBER 2012. Chronic problems included dyspnea (used oxygen, had DOE with minimal activity, had trouble sleeping without oxygen), arthritis, diabetes mellitus (PCMR, location was endocrine, symptoms began a year ago, managed by diet and oral medication, sugars at home had been int he low 100s), abdominal aortic aneurysm,  chronic pancreatitis; congestive heart failure, hypertension, COPD, CAD and diverticulosis.  Location of arthritis pain was low back, right shoulder, bilateral wrist, bilateral hand, bilateral knee and bilateral ankle. Symptom was aggravated by activity and rest. Patient denied relieving factors and had activity limitations and fatigue. Pertinent negatives included rash and paresthesias. Past medical history included pulmonary embolism in 1999, chronic gastritis, compression T8, DVT, GERD, hyperlipidemia and myocardial infarction with stents. Surgical history included trigger point injections, appendectomy, cholecystectomy, abdominal herniorrhaphy in 1999. The patient was a former tobacco use5r. Patient had history of diarrhea due to Levothyroxine sodium. The patient received Pneumococcal vaccine in 08 SEPTEMBER 2010 and Tdap on 22 NOVEMBER 2011. Patient's concomitant medication included Lidocaine 2 percent and Celestone Soluspan 10 mg (1ml injected in right deltoid) during arthritis assessment, Metformin HCL 500 mg tablet oral 2 times morning and evening with meal, Imdur (Isosorbide Mononitrate) 20 mg orally every day before meal, Tramadol HCL 50 mg every 8 hours PRN for pain, Xanax (Alprazolam) 0.25 mg tablet orally 3 times a day OS, Nitrostat (Nitroglycerin) 0.5 mg to be taken as directed, Advir Diskus (Fluticasone propionate/Salmeterol) 250 mcg-50mcg 1 puff inhalation 2 times a day (morning and evening) and Suboxone (buprenorphine/Naloxone) 2mg +0.5 mg 1 tablet daily (started before visit). On 21 September 2013, the patient developed pain in right arm and right shoulder pain. Corrective treatment was not reported. On 15 MAY 2013, review of musculoskeletal system was positive for back pain and bone/joint symptoms; vital signs included blood pressure 141/73 mm/Hgh, pulse 92/mi and pain score 10/10; physical examination showed the patient had decreased ROM of both shoulders, right mid lateral should was tender to palpation. As of 20 MAY 2014, the patient had not recovered from the events. Documents held by sender: Patient hospital records. Follow-up information received from healthcare professional on 26 JUNE 2013. It was reported that, the patient was still having problems i.e. shoulder pain and vaccination site pain. The patient did not report this adverse event previously. As of 26 JUNE 2013, the outcome was not recovered.
arm very sore with limited range of motion; White blood cells in the bursa; arm  very sore; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves female patient of an unknown age who experienced arm sore with limited range of motion and white blood cells in the bursa, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ044AB via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious arm very sore with limited range of motion  (mobility decreased) and arm  very sore (pain in extremity) 2 weeks following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed non-serious bursa (bursitis) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Relevant laboratory test results included: Aspiration bursa - On 29-April: positive for white blood cells.  Final diagnosis was arm very sore, white blood cells in the bursa and arm very sore with limited range of motion.  It was not reported if the patient received a corrective treatment.  The outcome of the events was Unknown.  Documents held by sender: none.
Patient said her arm was sore and hard and she felt she had a slight fever since she got the shingles shot. The symptoms started the day after she got the shot.
Vaccine failure as subject developed varicella on 03-21-03.  This event is consistent with vaccine failure.
Nausea and some dizziness. Onset was at 15 minutes and lasted about 10 minutes. Patient was given 50 mg of BENADRYL as a precaution. Felt better after 10 minutes and left feeling better. Felt like she needed something to eat.