chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bloody diarrhea, super bloody diarrhea; had severe ulcerative colitis; bad gas; diarrhea; dehydrated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). .  A 17-year-old male patient received BNT162b2 (BNT162B2), on 26May2021 as dose 1, single (Batch/Lot number: unknown) and on 16Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA HAEMORRHAGIC (hospitalization, medically significant), outcome "unknown", described as "bloody diarrhea, super bloody diarrhea"; COLITIS ULCERATIVE (hospitalization, medically significant), outcome "unknown", described as "had severe ulcerative colitis"; FLATULENCE (hospitalization), outcome "unknown", described as "bad gas"; DIARRHOEA (hospitalization), outcome "unknown", described as "diarrhea"; DEHYDRATION (hospitalization), outcome "unknown", described as "dehydrated". The patient was hospitalized for flatulence, diarrhoea, dehydration (hospitalization duration: 35 day(s)). The patient underwent the following laboratory tests and procedures: Intestinal resection: remove his large intestine, notes: He had 3 surgeries. Therapeutic measures were taken as a result of diarrhoea haemorrhagic, colitis ulcerative, flatulence, diarrhoea, dehydration.  Clinical course: On 16Aug2022, it was reported that a he started treatment on 26May2021 (dose1) and 16Jun2021 (dose 2) with Pfizer Biontech COVID-19 Vaccine. It was reported the he had bad gas, diarrhea, bloody diarrhea, super bloody diarrhea and was dehydrated. He was in hospital for 35 days. They gave him IV and said he had severe ulcerative colitis. The only option was to remove his large intestine. He had 3 surgeries. They put in a J pouch instead of an ostomy bag.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna Vaccine given first dose to 16yrs old pt on July 2nd with no adverse reactions and was instructed by CDC to adminster 2nd dose with same vaccine, Moderna and report to VAERS same as first dose. No adverse events  encountered.
By 6:00pm I had severe tinnitus in both ears. Noticed hearing loss next morning which has continued to date: 03/02/2021. Tinnitus also continues but not as severe.
Injection site was sore, as time went on, the site became more sore and itchy; it has become progressively more sore and itchy at the injection site; also red and warm to touch at the injection site; warm to the touch, (as if fever) itch and increase in size at injection site; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198; Expiration Date: 30Jun2021), via an unspecified route of administration in left arm, on 24Feb2021 at 11:00 (at the age of 78-years-old) as dose 2, single for COVID-19 immunization in a facility reported as other. Medical history included diverticula. No allergies to medications, food, or other products. Concomitant medications/other medications received within 2 weeks of vaccination included paracetamol (TYLENOL) 1 hour prior to the vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265; Expiration Date: 31May2021), via an unspecified route of administration in left arm, on 28Jan2021 at 03:15 (at the age of 78-years-old) as dose 1, single for COVID-19 immunization and experienced a little soreness in her arm at the injection site. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. After the second dose of vaccination, on 24Feb2021, the injection site was sore like the first time. The patient's injection site was sore but it had become progressively more sore and itchy as time went on, also red and warm to touch at the injection site, the redness is now the size of her palm. Injection site continued to be red, warm/hot to the touch, (as if fever) itch and increase in size about the size of my hand. She only has fever on the spot, the rest of her body (her forehead) is not feverish. She does not know when it started getting red. She said that the area feels like it has fever. She put ice packs on it occasionally. It was reported that no treatment was received by the patient for these events. The patient wanted to know if there were any recommendation on what she should do about these events and how long these symptoms supposed to last. The outcome of the events was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
One week after injection arm developed rash at injection site measuring 4? by 3?.  Very itchy.  No other symptoms. Applied Benadryl cream.  Notified doctor. Rash for 3 days.  Still waiting for rash to clear.
pt recv vax & approx 15 days p/vax pt devel a low grade fever 102 which was tentatively dx as fever of unk origin;pt hosp;dx was autoimmune hemolytic anemia;tx w/pred;relevant lab data 12NOV98 WBC 5.4;RBC 2.8;
Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient complain of tachycardia, sweating, left neck soreness, dry mouth and numb tongue approximately 10 minutes after administration. Recovered after 30 minutes. Per patient possibly anxiety induced.
10/06/2021 dizziness, nauseous, low blood pressure, low pulse, headache.
Herpes zoster rash which fully erupted on 11/17/13; there were a few skin papules present the day after vaccine.
Patient called at 10:35AM on 12/13/2017 to inform RPh that she had noticed inflammation and bruising at the injection site when she woke up on 12/8/17. Pt didn't call pharmacy previously to this. While talking with pt she informed the RPh that the inflammation had gone down and that the bruising was going away. Pt also mentioned that she had bilateral numbness from her waist to her toes. Pt was encouraged to contact MD and be evaluated. RPh called Pt at 3PM on 12/13/2017 to see if pt had made an appointment with PCP and to confirm information contained in the VAERS. Pt confirmed information and that Pt had made an appointment with PCP for Monday 12/18/2017.
Pt recvd DTP/OPV/HIB 6AUG91 & woke up from nap @ 3PM screaming for 2.5-3 hrs, lt leg red & swollen, APAP & cool compresses & triaminic liquid given;
near syncope, got dizzy and pale BP: 107/58 @ 9:23am HR 66 provided water. within a few minutes patient felt fine. BP rechecked @9:36am was 117/68 HR: 90  patient recovered and ready to go home.
Patient received MMR vaccine on 7/6/09. Pt did not know if she was pregnant. She stated there could be a chance of her being pregnant. Pt was returned to clinic in city for prenatal care.
This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 26-JUN-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) and first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J014584, expiry date: 16-JAN-2016) which were stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA01902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013, and 1407USA013014 (same reporter link). Additional information has been requested.
Hardly work or get dressed Muscles tender to touch Shoulder & hip joints are stiff very tender with ROM
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies, or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L045711, expiration date 08-MAY-2017; exact doses and route of administration were not provided). It was reported that the vaccines was exposed to temperature of 1.1 Celsius (C) degrees for 1 hour and 45 minutes and then for 1 hour and 17 minutes (cumulative 3 hours and 2 minutes at lowest 1.1 C) before administration to the patients. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
PATIENT COMPLAINED OF TIGHTNESS BUT THINKS IT MAY BE FROM COLD WEATHER 4:10 BP 122/68, HR 83, RR 18, O2 SAT 98% 4:15 DIPHENHYDRAMINE 25MG PO GIVEN 4:22 BP 118/68, HR 75, RR 18 4:40 BP 120/70, HR 72, RR 18 4:50 BP 122/64, HR 78, RR 18; PATIENT LEFT SITE IN STABLE CONDITION
Patient developed maculopapular rashes to the extremities.  He was administered the flu vaccine on 09/15/2009 and he is also on CLOZAPINE and Valproic Acid.
brachial neuropathy; This is a spontaneous report from a contactable consumer.  A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 16:00 (Batch/Lot Number: Pfizeren6206) as single dose for covid-19 immunisation (age at vaccination: 48 years)  .  Medical history included asthma,  drug hypersensitivity (allergy to Penicillin). Concomitant medications included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for an unspecified indication, start and stop date were not reported.  The patient experienced brachial neuropathy on 12Mar2021 with outcome of not recovered. The reported event was considered an Important Medical Event. (IME).  Course of the event: Initial pain subsided in 3 days, then returned with right shoulder joint pain, burning sensation in right side of neck, limited mobility in shoulder joint and severe pain. Dr. Diagnosed as brachial neuropathy. Its 2 weeks now, and still in severe pain. The patient is being treated with Pain meds  No follow-up attempts are possible. No further information is expected.
Feb 25, 2021 had dry heaves, severe headache, same thing next day and my eyes are sensitive to light and giving me a constant  headache and sick to my stomach.  Have called my doctor but she has no information for me other than go to the hospital.  The symtoms  are still going on today  March 9, 2021.  I do not have dry heaves but sunlight gives me a constant headache and nothing over the counter works for my headache or my stomach.
HEMATOMA; This spontaneous report received from a patient concerned a male of unspecified age. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced hematoma. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hematoma was not reported. This report was non-serious.
After the usual expected side effected after the vaccine. I felt good after a few days . But on Monday November 1 I woke up very tired, high heart rate, dizzy and was just not well. The following days I have been developing muscle fatigue, pain and twitching .  I also experience pins and needles that seems to be getting worse or same and not better.
COVID 19/ tested positive; COVID 19/ tested positive; This is a spontaneous report from a contactable consumer and a nurse. A 56-year-old male patient received first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified routes of administration on unspecified dates (lot numbers and expiry dates: unknown) at single doses for COVID-19 immunisation. Medical history were not reported. It was unknown if the patient was diagnosed with COVID prior vaccination, unknown if the patient received other vaccines within four weeks prior to COVID vaccination, and unknown if the patient received medications within two weeks prior to COVID vaccination. Facility where vaccine was administered was also unknown. The patient's concomitant medications were not reported. On 31Mar2021, the patient was 'ill'. On the same day, the patient tested positive and was diagnosed with COVID-19. The nurse noted that the patient was "fully vaccinated" however, they were unable to find evidence of vaccination in the Pfizer medical record. The events were considered serious due to other medically important condition and due to hospitalization on unspecified dates. It was unknown if the patient received treatment for the events. The patient was recovering from the events.  Information on lot/batch number has been requested.
Information has been received from a physician and a certified medical assistant concerning a 68 year old female patient with high cholesterol who on 06-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 665925/0932Z) and a dose of FLUARIX in the other arm. Another concomitant therapy included LIPITOR. The physician reported that on 07-OCT-2010, the patient experienced swelling and warmth on the arm the dose of PNEUMOVAX 23 was administered in. The certified medical assistant reported that the patient experienced no injection site reaction on the arm that was vaccinated with FLUARIX. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The physician's office requested a lot check. This is one of two reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665925/0932Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
About 45 min after injection, started with exanthem with several small papular urticarial lesions, a little itchy. mild facial flushing. felt like she was "bouncing." Symptoms resolved within 30 minutes of diphenhydramine administration.
Patient received dose 1 of the COVID vaccine (lot EW0150, exp 7/2021) at 1637. At 1650, patient was sitting in the observation area when she told PHN that she was experiencing left arm numbness at the injection site. Vital signs: blood pressure 128/90, respirations 18, O2 99%, pulse 83. Allergy to sulfas. Patient denied medical conditions. Medications: multivitamin, iron, vitamin B12. At 1655, patient noted the numbness in her left knee additionally. At 1704, PHN offered Benadryl but patient declined. Vital signs: blood pressure 130/92, O2 98%, respirations 18, pule 73. PHN encouraged patient to follow up with her provider and when to call 911. At 1710, patient reported she wanted to go. Patient left walking with steady gait at 1711.
Patient was given QUADRACEL on 11/14/17. Came back to the Clinic on 11/16/17 due to having a reaction on the Lt thigh. Per chart notes this was the reaction: Legs: rt lateral thigh with quarter size redness and warmth at site of imm. Left thigh is 2/3 red, swollen, warm, no fluctuance, +serous drainage from small puncture sites.
sore muscles and stiffness neck thru shoulder blades and upper left arm: which is red and slightly sollen. I  had a negative Covid-19 test on Monday morning, 9/25/2023.   I contacted my PCP who prescribed 20mg prednisone/day for 2 or 3 days as needed in addition to my daily antihistamine (Zyzal/Claritin/ Zyrtec)  & Tylenol.
COVID-19 (FEVER); SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 66 year old female of unknown race and ethnicity. The patient's weight was 69.1 kilograms, and height was not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included macitentan for primary pulmonary hypertension, selexipag for primary pulmonary hypertension, and riociguat non-company.  On an unspecified date, the patient experienced covid-19 (fever), and suspected clinical vaccination failure, was hospitalized. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F, and SARS-CoV-2 test (NR: not provided) positive. patient was hospitalized from 03-JUN-2021 to 04-JUN-2021, for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 (fever) and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210115804.; Sender's Comments: V0: 20210630934 -Covid-19 vaccine ad26.cov2.s-Covid-19(Fever). This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210630934 -Covid-19 vaccine ad26.cov2.s-Suspected Clinical vaccination failure .This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
8-16-17 Rec'd shot 10:45 AM no pain-4 PM pain onset 10/10 scale could not move R.A.-no fever, rash, little swelling. 8-17-17 Pain 24 hrs, contact MD office-cannot drive pain 10/10 use wife's TYLENOL codeine 120/12 for relief 8/10. 8-18-17 Pain 24 hrs, contact MD office, cannot drive, make appt. for 8-21-17 (Monday)-use total 75 mls TYLENOL/codeine. 8-19-17 Less pain all 24 hrs-lose sleep-more swelling, R. A. 8-20-17 Less pain all 24 hrs. 8-21-17 Visit Dr.-never seen in 50 yrs-no complaints-master vial OK. RN remarked vaccine came in pre-filled syringe.
Hives 6 hours after and vomiting and extreme fatigue and migraine for 2 days
Arm began to have pain in it 9 days after vaccine administration. On day 10, it began to be itchy, red, raised, and the pain continued. At the time of reporting, symptoms continue despite ibuprofen, tylenol, antihistamines, and topical antihistamines.
Paxlovid:Treatment of COVID-19; Paxlovid:Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Nov2020; LISINOPRIL, start date: 01Nov2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid:Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.   Clinical course: The patient took Paxlolvid as treatment from 26Apr2022 to 01May2022. The patient had cold like systems, head congestion from 03May2022.  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 information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Left chest pain no MI, PE....acute crisis with clot ruled out CBC showed giant platelets and variant leukocytes which have not been present before
HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported.; Sender Comments: Keywords : US-009507513-2306USA011972:
Case number PHHY2013US136193 is an initial literature report received on 23 Nov 2013. A retrospective cohort study was done using large surveillance datasets to evaluate the effect of receiving the influenza vaccine during pregnancy on fetal health outcomes, small for gestational age (SGA) and prematurity among births between 01 Jan 2005 to 31 Dec 2008. This report refers to multiple pregnant patients of unknown age. A total of 8393 women with a live birth over a 4-year period were included in this study. On an unknown date, 916 pregnant patients were vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) during pregnancy. It was reported that women with a higher risk for influenza related morbidity demonstrated higher vaccine benefits against a small for gestational age (SGA) births. The authors concluded that the impact of vaccines on birth outcomes may vary with the underlying influenza epidemiology and maternal demographic characteristics.
The patient states it was her 1st time receiving the flu shot and had Red patches occur around the area of administration and not at the site. She states feeling fatigue for several days after as well. No problems breathing nor shortness of breaths.