chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IPOL were exposed to highest temperature of 25.26 degrees C for 3 hours due to unknown reason with no reported adverse event; IPOL were used post excursion with no reported adverse event; Initial information received on 16-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health Care professional   This case is linked to case 2022SA512590.  This case involves a 6 years old male patient and  it was reported ipol were exposed to highest temperature of 25.26 degrees c for 3 hours due to unknown reason with no reported adverse event and were used post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (daptacel),measles vaccine, mumps vaccine, rubella vaccine (mmr),varicella zoster vaccine (varicella vaccine) and hepatitis b vaccine (hepatitis b vaccine) for Prophylactic vaccination  On 29-Nov-2022 the IPV (VERO) [IPOL]. Vaccine were exposed to highest temperature of 25.26 degrees c for 3 hours due to unknown reason with no reported adverse event (product storage error), were used post excursion with no reported adverse event (poor quality product administered).  On 08-Dec-2022, the patient received a (series: unknown) suspect IPV (VERO)(Formulation- Suspension for injection)( Strength = standard) (Lot Number- V1B901M)(Expiry date-Jun-2024)( Dose: unknown) via unknown route in unknown administration site for Immunization  It was reported This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.Reporter was the one who administered the vaccine Caller mentioned that IPOL was used to 5 patients. Patient information not available at the time of call, future follow-up for other 4 patients accepted.   Action Taken : not applicable.  At time of reporting, the outcome was Unknown for the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  case 01410480 for GENERAL VACCINES:
almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on arm it is little bit blotchy; itchy on arm it is little bit blotchy; Migraine; This is a spontaneous report from a contactable consumer.   A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 05Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported.   The patient had unspecified concomitant medications; unspecified allergy medicine and unspecified vitamins.  On 05Apr2021, the  patient experienced the following events:  almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine. Details were as follows: patient had a reaction after the vaccination. She got really dizzy, almost passed out. Then her heart started racing. It took about 10 minutes to go normal and then she got like a super dry mouth and a metal taste after that, elaborated as like she had penny or something in her mouth like metal. After that,  it was little more hard to swallow and just started to get itchy on arm, it is little bit blotchy. Therapeutic measures were taken as a result of  migraine, and included treatment with sumatriptan (MANUFACTURER UNKNOWN), at 100 mg ( take half every time). The outcome of events, almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine was unknown.
No adverse event; administered to patient during the excursion; Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 10-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S026371, expiration date on 01-APR-2022, 0.5 milliliter (administration route and anatomical location were not reported)for prophylaxis.  The reporting nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion, the excursion were as follow: Two times temperatures below 2 Celsius degrees (C) (1.3 C) for 24 minutes and previous temperature excursion below 2 C (1.6C) for 24 minutes.No adverse events were reported. It was confirmed that a digital data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026371; expirationdate: 01-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I had a rash, it wasn't to bad and it would come and go. Now it is everywhere on my torso and coming back with a vengence. I saw my physician and he gave me a mederal dose of steroids and an antihistamine pill to take. I had to half it because it made me dizzy and slightly sob. It's under my breasts on my stomach, on the top of my legs and behind my knees and on the inside of my arms.
mild localized erythema 7 X 5.5 cm with central more erythematous area about 3 cm
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L014429 with expiry date 15-MAR-2018 and lot # M014925 with expiry date 16-FEB-2019 (dose and route of administration were not reported) for prophylaxis. The doses were exposed to 51 Fahrenheit (F) for 14 hours 23 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of 4 reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014600: US-009507513-1612USA014444: US-009507513-1612USA014599.
Mother noticed redness to left deltoid.  Presented to clinic on 8/21. Erythema noted to left deltoid and left arm. Warm to touch.
Patient had several ED visits: on 2/24, 2/25, and 4/8. On 3/6, patient presented to the ED and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.
Immediate numbness on top of left hand, tachycardia, flushing, dizziness, dry/numb mouth, feeling faint, lethargy. Was wheeled to ED where they left me in the waiting room for two hours, not seen by a provider, before being told I was "fine" and sent home.  On 1/9/2020 I began experiencing widespread bodily itch, no hives or swelling that included in and around my mouth. Took cirtirizine and symptoms were alleviated.
Presented to office with overnight fever, lethargy, vomiting, nonspecific exam. Admitted to hospital and had positive spinal tap for Streptococcus pneumoniae type 19A.
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 18-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 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, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 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 1407USA01304 (same reporter link).
Nose Bleeding 4 times a week lasting between 6 minutes to 10 minutes each time; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose Bleeding 4 times a week lasting between 6 minutes to 10 minutes each time) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced EPISTAXIS (Nose Bleeding 4 times a week lasting between 6 minutes to 10 minutes each time). At the time of the report, EPISTAXIS (Nose Bleeding 4 times a week lasting between 6 minutes to 10 minutes each time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications not reported.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient was inoculated with ZOSTAVAX on or about 02-AUG-2012, at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JUN-2013, the patient was treated by a physician at a clinic for a blistering vesicular outbreak which was then diagnosed as herpes zoster. The patient has been prescribed VALTREX, tramadol, and lidocaine topical cream for management of her painful symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored MMR II (lot# M004889, expiration date 25-JUL-2017, dose not reported) subcutaneously and a dose of improperly stored VAQTA (lot# reported as L02374, expiration date 04-NOV-2016, dose not reported) intramuscularly. Two vaccines were improperly stored in 33 degrees Fahrenheit for 600 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Lot number L02374 is an invalid lot number for hepatitis a vaccine, inactivated. Additional information has been requested.
Pt experienced a firm, warm, erythematous area measuring 60 - 80 mm in diameter local to injection site.
Went blind on right eye for 5 minutes; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (Went blind on right eye for 5 minutes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS UNILATERAL (Went blind on right eye for 5 minutes) (seriousness criterion medically significant). At the time of the report, BLINDNESS UNILATERAL (Went blind on right eye for 5 minutes) had resolved.            No concomitant details were provided by reporter. No treatment details were provided by reporter.  Patient got her sight back about after 5 minutes.  This is a spontaneous case concerning  a female patient of unknown age with no relevant medical history, who experienced the unexpected serious event of Unilateral Blindness. The event occurred approximately on an unknown day after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-439924, US-MODERNATX, INC.-MOD-2022-440018, US-MODERNATX, INC.-MOD-2022-440019 (E2B Linked Report).; Sender's Comments: This is a spontaneous case concerning  a female patient of unknown age with no relevant medical history, who experienced the unexpected serious event of Unilateral Blindness. The event occurred approximately on an unknown day after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. US-MODERNATX, INC.-MOD-2022-439924:MOD22-000708(Reporter first dose)/same reporter different patient US-MODERNATX, INC.-MOD-2022-440018:MOD22-000708(Reporter second dose)/same reporter different patient US-MODERNATX, INC.-MOD-2022-440019:MOD22-000708(Reporter booster dose)/same reporter different patient
Presented to Clinic on 8/3/06 with c/o L neck and axilla swelling, achiness and HA. Diagnosed as smallpox reaction/flu like symptoms. Quarters x 48 hours, push fluids and f/u prn.
The doctor's office did not report giving vaccines to the State. They then looked up his State record only not his medical chart. He had finished his series or hepatitis b and chicken pox vaccines. They had the records in the office-the only office I go to for vaccines-they did not check the records. They only checked the State records which were not correct because of their failure to report giving vaccines in the first place. They gave him extra doses of these two vaccines. The medical assistant realized the mistake when reviewing his records
THROBBING PAIN UNDER ARMPIT; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included vitamins nos for drug used for unknown indication. On 12-APR-2021, the subject experienced throbbing pain under armpit. Treatment medications (dates unspecified) included: amlodipine besilate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throbbing pain under armpit. This report was non-serious.
Tiredness; Headache; chills; joint pain; fever; nausea; feeling unwell; weakness; stomach upset; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EM9809) via an unspecified route of administration on 26Feb2021 (at the age of 73-year-old) as single dose for COVID-19 immunization. Patient had no medical history and was not taking any other products (concomitant). On 28Feb2021, two days after vaccination patient experienced tiredness, headache, chills, joint pain, fever, nausea, feeling unwell, weakness, upset stomach. Patient stated she had no injection site reactions but had all the other ones. She used 1 Tylenol 2 days after the shot that was because she was trying to lessen the severity of the symptoms. Patient asked why she had so many symptoms that were very severe. She mentioned that they gave a list after the shot of things you might have, and she had them all. The only she didn't have was pain in her arm, which she did ice her arm, but she has had all the other symptoms on the whole list. She clarified she has had tiredness, headache, chills, joint pain, fever, nausea, feeling unwell, weakness, all of that. She said everything began 2 days later, she was fine for 2 days on Sunday 28Feb2021. She said she still has an upset stomach which was not listed as one of things that could happen. The nausea part was but not upset stomach, she still has bits of the nausea and upset stomach. The other symptoms have gone away. She clarified the tiredness, headache, chills, joint pain, fever have gone away. She said the chills was more like shivers through the night like if someone was hypothermic but all of that has subsided. Patient asked if other people reported things like this where they have had a lot of symptoms. Treatment included Tylenol. Outcome of the event nausea and stomach upset was not resolved, for unwell and weakness was unknown and for all other events were resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Developed rash in the mid and upper part of back and on chest; This is a spontaneous report from a contactable consumer.  A 7-month-old male patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: W51943 and expiration date: Jul2020), intramuscular on 07May2019 at 0.5 ml, single for childhood immunization.  The patient had no medical history and concomitant medications.  The patient previously took PREVNAR 13 for immunization.  The patient developed rash in the mid and upper part of back and on chest on 07May2019. The outcome of the event was recovered on an unspecified date.
Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the jaw line to under the chin, malaise, large muscle spasms and cramps, chills and shaking, soreness and swelling at injections site, burning in face and lips, and severe unexplained drop in blood sugar (56) that was very slow to bring back up.
O2 sats down from 99% to 90%; Shortness of breath; Chest pain; Dizzy; symptoms lasted around 3 weeks
Itchy, red rash on her right arm; red rash; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itchy, red rash on her right arm) and RASH ERYTHEMATOUS (red rash) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Pacemaker insertion (cardiac). Concurrent medical conditions included Diabetic, Hypertension, Thyroid disorder NOS, Acid reflux (esophageal) and Penicillin allergy. Concomitant products included METFORMIN, HYDRALAZINE, PANTOPRAZOLE, RIVAROXABAN (XARELTO), LEVOTHYROXINE, PRAVASTATIN and SOTALOL for an unknown indication.    On 25-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced RASH PRURITIC (Itchy, red rash on her right arm) and RASH ERYTHEMATOUS (red rash). At the time of the report, RASH PRURITIC (Itchy, red rash on her right arm) and RASH ERYTHEMATOUS (red rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product include "magnoxside".  Treatment information was not provided.
Parent was emailed link to register for the 9/15/22 clinic for children to receive their 3rd doses. Parent erroneously registered for the 9/9/22 clinic, which was one week too early for the last vaccine. This date discrepancy was not noted by clinic staff and vaccine was administered one week earlier than recommended.
Skin around the eye area feels like it us burning. No outward signs or rash, no swelling. Just burning feeling and face feels like it's cracking when blinking or squinting. No fever or rash.
7 Days after 1st  shot - I woke up  at 0600HR with slight swelling at injection site on right arm. By 1800HR size of swelling had increased to cover all of upper arm, from elbow to shoulder. Extreme heat and pain followed. Use of Arm limit. Fever increased to 100°; Nausea; Fatigue.
I had a heart attack, anterior wall heart attack. I received cardiac catherization and I had two coronary artery stents placed on 02-10-2021.
My first periods after both vaccine shots came a week earlier than usual (unusual for me), had odd spotting/bleeding/cramping (compared to normal), and accompanied by lower back pain (sometimes too stiff to stand straight), bloating that doesn?t go away, and my first period without the shot came two weeks late, was shorter than usual, and accompanied by the same unusual symptoms as the periods after the shots (odd spotting, bleeding, and cramping). The back pain is not as bad after some time, but it comes and goes, and some days I still cannot stand straight without pain. The bloating has also been consistent since vaccination; it doesn?t go away (where before vaccination I only bloated during my period).