chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US022363, is an initial spontaneous report from a medical assistant received on 05 Nov 2014, with the follow-up received on 16 Dec 2014. This report refers to a 52 years old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 29 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error. Follow-up received from medical assistant on 16 Dec 2014: Report type changed from other to spontaneous, updated patient demographics (initials, DOB, age and gender), vaccination date, dose, route and site of vaccination.
"Approximately 1 year ago", the pt received his 1st, 2nd and 3rd doses of Lymerix. About 4-5 months ago, he experienced muscle and joint pain. This included right shoulder bursitis-type pain, pain in the back of his legs from his heels up to middle upper calf, and aching feet from time to time. A doctor visit was required. Physician told the pt that he "did not have arthritis". The most recent information, received on 6/5/00, reports the condition of the vaccinee is ongoing.
09/15/22 presents to ED for "SOB". PMHx of "CHF (LVEF 10% with ICD), HTN, sarcoidosis"
large red area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (large red area) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (large red area). At the time of the report, VACCINATION SITE ERYTHEMA (large red area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment details were not provided.   Reporter did not allow further contact
Swelling,redness, warmth,Pain at site.   Chills,Bodyaches.  Headache,Major. Generalized Weakness.  Lasting three days. Ice compresses continuously.  Tylenol OD.   Decreased gradually.  Today the 5th Day still visible redness, and slightly painful.
2nd day after shots, mom noticed kept scratching his lefty arm. Mom noticed red area red raised, spread thru-out day, kept scratching, entire left upper arm red
SORENESS; HEADACHE; This spontaneous report received from a patient concerned a 25 year old. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-APR-2021 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 APR-2021, the subject experienced soreness. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness and headache was not reported. This report was non-serious.
Area of induration appeared day after vaccine. Grew larger over 24 hours. Presented with area of warmth & induration approximately 12 cm diameter. No fever, no distress.
This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 12-JUL-2014 the patient was vaccinated with third dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K0050583, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. 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, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012657, 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.
Patient received immunizations today and immediately fainted with a brief seizure episode. He also hit the back of his head. After the episode, he was incoherent for approximately 30 minutes. The patient slowly became more alert over the next hour. His oxygen saturations have always been good.
Due to reaction to 1st I took loratadine prior to vaccine and Benadryl approx 8:00 am. At approx 10:00 am. It was difficult to breathe. I kept self monitored for approx 5 min as SOB and chest tightness throat tightness increased significantly I immediately got to the ER. I where I assessed by the Dr. He asked if I had tonsils, I shook my head no because I was unable to due speak due to throat swelling and SOB. I was medicated with IV Benadryl, steroids, Epi, Pepcid and a breathing treatment. After approx 10 min later I started to feel a little better. Within seconds of stating this breathing started to become difficult again and the reaction started over my throat was tightening and I could.t breath. I was given another dose of Benadryl and epi. The reaction began to lessen. I was informed that if the kept continuing as it had I would need to be inhtubated. Ativan was given at this time. At approx 1:30 pm I was discharged home as long as I was supervised.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 18-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Woke up the following day with pain in shoulder - somewhat relieved by ibuprofen. Has pain from neck to fingers. calls it a throbbing pain that never goes away. Went to clinic to see nurse practitioner and described it as nerve pain.
Kept shaking the limbs and head terribly for at least 20 -30 minutes (Like people who have convulsion/seizure or shake their limbs like having extremely terrible Parkinson's disease). Heart rates increased and became much faster than usual. Could not control but kept shaking my limbs and head as well as repeatedly smacking my lips or grinding my teeth even I was conscious.  After it passed (20-30 minutes), all symptoms went away.
Very disoriented  he was like he was looking into space, shaking, very nervous, panicky,  afraid to drive, seeing things,  felt like he was having a heart attack.  Hosptial did tests for his heart everything was fine with his heart. They said it may be from the shot.  For him to go to his primary doctor. The doctor said not to get the second shot.  Patient's first shot was 2/12/2021 and he still has the effects  it?s going on two weeks .
Information has been received from a 61 year old female patient with no pertinent medical history and no known drug allergies who on 09-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not provided) 0.65ml subcutaneously. There was no concomitant medication at the time of vaccination. Reporter stated that right after getting the vaccination she "just didn't feel right". She developed weakness in her legs and hands. She "shuffled" when she walked and "had trouble holding things". Her fever goes up to 102 degrees "3 times every day" and went up to 103 "yesterday". Patient sought unspecified medical attention. She was admitted to the hospital for 4 days and had all kinds of laboratory work done, as stated "you name it, they did it". A test done there showed a small blood clot. She now has "about 75% of my strength back". She is now taking COUMADIN and Ceruroxime (unspecified) 500mg. At the time of this report, the patient was recovering. No further information is available.
flushed; hot and cold; Feeling face was on fire; feeling achey; legs and knees felt like they were on fire; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (feeling achey), FLUSHING (flushed), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and BURNING SENSATION (Feeling face was on fire) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tylenol, sulfa, -toprolol). Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), MONTELUKAST, ATORVASTATIN and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Apr-2021, the patient experienced CHILLS (chills), MYALGIA (feeling achey), FLUSHING (flushed), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), BURNING SENSATION (Feeling face was on fire) and ARTHRALGIA (legs and knees felt like they were on fire). At the time of the report, CHILLS (chills), MYALGIA (feeling achey), FLUSHING (flushed), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), BURNING SENSATION (Feeling face was on fire) and ARTHRALGIA (legs and knees felt like they were on fire) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068271 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068271:First Dose.
Patient received an UNDILUTED dose of the Pfizer COVID-19 Bivalent booster vaccine. Parent reports that no signs or symptoms were observed from the patient.
swollen lymph nodes @ neck, rapid heart rate dizziness, weakness, headache, shake, nervious feeling feeling, nausea, rash, body aches, tiredness.
fainted; shaking uncontrollably to the point she couldn't walk; shaking uncontrollably to the point she couldn't walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 17-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, 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: SYNCOPE (hospitalization, medically significant), outcome "unknown", described as "fainted"; TREMOR (hospitalization), GAIT DISTURBANCE (hospitalization), outcome "unknown" and all described as "shaking uncontrollably to the point she couldn't walk". Reporter stated that, this was the only vaccine approved for patient age group. After the vaccine was administered, withheld faint she slept the rest of the day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Felt like what I believe pleurisy would feel like.; Chest pain that went thru to my back, started about the same time my arm started to feel sore.; Chest pain that went thru to my back, started about the same time my arm started to feel sore.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Don't have card with me), for Covid-19 immunization. The following information was reported: PLEURISY (non-serious) with onset 11Oct2021 13:30, outcome "recovered" (Oct2021), described as "Felt like what I believe pleurisy would feel like."; CHEST PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 11Oct2021 13:30, outcome "recovered" (Oct2021) and all described as "Chest pain that went thru to my back, started about the same time my arm started to feel sore.". Therapeutic measures were not taken as a result of pleurisy, chest pain, pain in extremity.  Additional information: Patient had known allergies: Sulfa. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Device Date : 24Oct2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 27FEB96 & denies any problems w/1st or 2nd vax & had no problems immed;problems began 8APR96 w/muscle soreness & weakness in both upper arms;though it was arthritis but MD feels it is vax rxn;c/o weakness, sore muscles
Patient was noted to be sitting on the floor and not responding to staff.  Right sided facial drooping was observed by RN. Patient was unable to stick tounge out and was only able to open left side of mouth. Patient was unable to squeeze RN hand with right hand, only the left.  Vital Signs were taken T 99.1 P 104 R 16 BP 133/88 SpO2 97%.  She was taken to the hospital for further work up
Information has been received from a licensed practical nurse for GARDASIL and MMR II, Pregnancy Registry products, concerning a female patient with no known drug allergies who on 11-FEB-2009 was vaccinated with the first dose of GARDASIL (lot# 659184/0843X), 0.5 mL, intramuscular administration. Concomitant therapy administered on 11-FEB-2009 included MMR II (lot # 662817/1366X) albumin status rHA, and Tdap (unspecified). It was reported that the patient was pregnant. LMP was in January 2009, EDD was 08-OCT-2009. No adverse effect was reported. The patient sought medical attention at the physician's office. Follow up information was received from a licensed practical nurse. She reported that the patient received the GARDASIL, MMR II and Tdap (manufacturer unknown) early in her pregnancy. The licensed practical nurse stated that this patient had her pregnancy confirmed at the health department (urine hCG test) and after a few weeks, she called to report that she had a miscarriage (specific date not provided). The licensed practical nurse reported she requested that the patient come in for follow up, but she had not seen or heard from her since the phone call. Upon internal review miscarriage was determined to be an other important medical event. No further information is available. Additional information has been requested.
Immediately after the vaccination, I asked the pharmacist to test my blood pressure machine to see if it was working properly. He placed the blood pressure cuff on my left upper arm just below the vaccine site and he took my blood pressure. The next morning my upper arm began aching. That night there was a red streak on my upper arm. The next day (1/23) the redness had spread from upper arm to elbow. I saw my doctor and she said I had a huge hive and prescribed over the counter BENADRYL.
Symptoms that started within 2 minutes of receiving the vaccine, but cleared up in about 1 hour included: (1) Soreness in the tongue and a sensation that felt like I could taste the vaccine, (2) pressure behind the eyes, (3) chest tightening, (4) need to concentrate on breathing, (5) burning sensation (felt similar to the sensation when getting a CT scan), (6) sensation of something washing over entire body, and (7) sharp pain in right calf.   Symptoms that started within 5 minutes of receiving the vaccine and lasted for 36 to 72 hours included: (1) nausea (~36 hours), (2) headache (~36 hours), and (3) pain at the injection site (~72 hours).  No treatment for any symptoms. All cleared up on their own in the timeframe indicated.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 20-FEB-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R019391 with expiration date 05-JUL-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Developed a rash; it looks like hives; Developed a rash; it looks like hives; This is a spontaneous report from a contactable consumer (patient's parent). A 16-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0162, Expiry date: not reported) (age at the time of vaccination was 61 years), administered in Arm Left on 20Aper2021 as dose 2, single for COVID-19 immunization. The patient's medical history included pre-diabetic. The patient's concomitant medication was not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, on 01Apr2021 as dose 1, single for COVID-19 immunization. On 03May2021, the patient developed rash it looks like a hives. Treatment received included benadryl. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.