chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful arm at injection site, next day fatigue, 4 days after injection no longer having arm pain. but over this past weekend 1/16/21 I noticed I had reddening of the skin on the right arm near the injection site, rash like, hot to the touch, and spread out on the skin about 7 or 8 inches, and is now slightly itchy.
Information has been received from a physician concerning a female with a history of idiopathic thrombocytopenia purpura who at 16 months of age, in approximately 1993, was vaccinated with MMR (second generation). The patient's idiopathic thrombocytopenic purpura was treated with steroids and IVIG. The patient's idiopathic thrombocytopenic purpura cleared at approximately 3 years of age. Upon medical review, idiopathic thrombocytopenic purpura was considered an other important medical event (OMIC). Additional information has been requested.
pt recv vax & w/in 2hr post vax exp urticaria & rash on hand, thigh & trunk;ER or MD visit was required;tx DPH;sx resolved in 3 days;
Right arm pain, weakness, and numbness from upper arm to pinky. Intensity varies with position. Started couple days after vaccine. Got worse and then is starting to get better. Patient use aspirin to treat pain. Patient has physician appt. 9/27/16. Patient believes only ZOSTAVAX in right arm despite documentated otherwise.
In study a 45 yr old female subject born on 18Mar1960 was vaccinated IM with 0.5ml of investigational drug on 08Nov05. The subject was seen at the investigative site clinic on 03Mar06 for influenza like illness including aching all over, sore throat, fever, cough. Temp taken at the clinic was 100.5F. Onset of symptoms was on 01Mar06, 113 days after immunization. Subject took ibuprofen starting on day of onset (1 March). Rapid influenza test was positive for influenza A. And the subject was given Tamiflu. Viral culture was positive for influenza A/H3N2. Resolution was on 06Mar06 was complete recovery. The investigator considered the event as not related to vaccination. Seriousness criterion: Medically significant (OMIC). Possible for vaccination failure. The reported events, except for vaccination failure, are not expected. On a case level, the case is considered expected due to vaccination failure. Follow up 23Mar06: We just received the completed documentation. No further relevant new information reported. The reported events, except for vaccination failure, are not expected. On a case level, the case is considered expected due to vaccination failure. Follow up 27Jun06: Today we received the information that the study has been unblinded on 26Jun06. Subject received Fluvirin (lot 61122). The reported events, except for vaccination failure, are not expected. On a case level, the case is considered expected due to vaccination failure.
Itching at injection site, large red rash, swollen arm 7 days after shot. Rash grew for 7 days. Cream lowered the swelling and redness.   Second dose, redness and rash immediately. Rash grew. Chest became tight and difficulty breathing. Received cream and steroids.
NONE. No adverse event occured. We were instructed to file thi by our local DPH immunization manager because Boostrix not Adacel.
I have been fatigued and thyroid has been acting up worse than usual, congestion, headaches, muscle aches and pains/spasm. Increased thyroid medications 3 times in last 3 months.  Meeting with endocrinologist in December
Temp 100.5, headache, full body aches, dizzy, flushed
No reaction to dose #1.  Reaction to dose #1 started at roughly 11:00 PM 10 hours after injection. Slight fever 100, some chills, slight achiness. Went to bed and woke up the next day not feeling well. Took a tylenol. Slight fever, aches, chills, no appetite and fatigue. Adverse reaction was fully gone by Monday evening. And by Tuesday felt back to normal.
I had no symptoms 4 days post-vaccine.  Then, 8 days after receiving the vaccine, the injection site swelled again, and became red and itchy.  It looks like a giant bug bite.
Acute onset transverse myelitis with lower extremity paralysis and loss of bowel/bladder control 4 days after high dose flu vaccine FLUZONE High Dose.
12/20 fever to 105. 12/20-12/28 continued fever, increased irritability. 12/28&29 To Dr. 12/30 Fever to 105, rash on trunk, hospitalized. 12/31 rash is covering entire body and eyes. 1/3 rash is fading, but can still be felt.  01/08/2007 Verified with reporter that vaccination and AE occured in December of 2006 (not 2005).  Child would have been approximately one year of age at the time. 01/16/2007 MR received from vaccine provider which included vax. record, photos of rash, and labs from hospital visit. 02/16/2007 MR received for ER visit of 12/24/06 for c/o fever, cough, runny nose. Clinical Impression: Fever, Pharyngitis.  02/21/2007 MR received for one night admission of 12/30/2006 for c/o dehydration and fever.  Child also had a diffuse papillary rash over the torso and extending to the extremities.  Mom states rash is similar to one he had in response to Zithromax.  D/C 12/31/2006. Assessment:  Dehydration.  Fever- most likely viral.  The rash can be explained by one of 3 things. 1) reaction to antibiotics-highly probable. 2) reaction to MMR or Varicella vaccine.  3) Viral exanthem. Seen again in ER 12/31/2006 for rash. Clinical Impression:  1) Fever  2) Diffuse rash, Drug reaction. Follow up: Verification requested per Dr. at FDA.
Dizzy; Felt like something popped up in my head; Lymph node was swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: DIZZINESS (non-serious) with onset 02Apr2021, outcome "unknown", described as "Dizzy"; HEADACHE (non-serious) with onset 02Apr2021, outcome "unknown", described as "Felt like something popped up in my head"; LYMPHADENOPATHY (non-serious) with onset 02Apr2021, outcome "unknown", described as "Lymph node was swollen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. developed rash, 12 hours after vaccination. Vaccine given (9/22), pt. saw M.D. on 9/27 and was given med.
R testicle pain, radiating into lower R abdominal pain. Daily. 9/10 pain at its worst. Started the week off after receiving 2nd Pfizer shot. Certain positions make it worse. Been to the ER once already. Have had all tests and blood work done including scans. Primary care still has no idea what the pain and issue is.
Patient received vaccines and then 1 hour later started with itching and red lesions on neck, chest and abdomen.  The rash appeared as a wheal with lots of itching.  Patient was treated with Prelone.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions and concomitant therapies provided. In approximately February 2013 the patient has received first dose of PNEUMOVAX 23 for prophylaxis. In approximately May 2017, the patient was vaccinated with second dose of PNEUMOVAX 23 lot # M022947, expiration date 12-NOV-2017 (dose and route of administration were not reported) for prophylaxis. Additional information has been requested.
A lot of pain when shot given and it only increased. Also heat and a little raised area all the way to the elbow. Today the heat is still there and raised area not as bad. She could not sleep on that arm for the first few days due to the pain.
Swollen glands on left collarbone on injection site side Narrative:  Other Relevant History:
Vaccines were exposed to 31.5f upto 2 hours 45 minutes and These vaccines were administered to 40 patients over a span of 1 week with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 11 years old male patient where MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] vaccines were exposed to 31.5f upto 2 hours 45 minutes and these vaccines were administered to 40 patients over a span of 1 week 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 5-component, tetanus vaccine toxoid (Adacel) for Prophylactic vaccination.  On 15-Jun-2023, the patient received 0.5 ml dose of suspect meningococcal A-C-Y-W135 (t conj) vaccine Solution for injection lot number not reported via unknown route in unknown administration site (strength and expiration date: not provided) for immunization and (poor quality product administered) (latency- same day). Information on the batch number was requested.  Products involved? ADACEL, DAPTACEL, IPOL, MENQUADFI, PENTACEL, QUADRACEL, TENIVAC, VAXELIS Product activated/prepared? NO Ask how the situation occurred? POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached? 31.5° FAHRENHEIT How long did the excursion last? 2 HOURS 45 MINUTES Did it occur due to a human error? NO Does extended stability data cover the excursion: NO And in case of negative advice: Was the product used by/ administered to the patient: YES. First time product used : No Still using product : Yes  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Arm sore; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer reported that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 07Jun2021 as dose 2, single for COVID-19 immunisation; medroxyprogesterone acetate (DEPO-PROVERA, Formulation: Suspension for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 16Jun2021 as dose number unknown, single for birth control. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. No investigation assessment was provided. It was reported that she got a second dose on 07Jun2021 and had a doctor appointment "today". She said that the doctor injected a medication, in the same site, that she got her vaccine. She reported that the area hurt a little more "today", then when she got her vaccine. She confirmed that she was calling about the Pfizer vaccine for COVID virus. She reclarified that she got the second vaccine on 07Jun2021, and "today", she went to the doctor for her birth control, for the Depo shot (medroxyprogesterone acetate). She didn't think about anything, until later. She asked if it was alright, that she got the vaccine and her Depo shot, in the same site and if there would be an interaction. She clarified that her arm was sore, originally, from the COVID vaccine and stated her arm is also sore, from the Depo shot. The outcome of event was reported as unknown.  Information on lot/ batch number has been requested.
Initial and follow up has been received from a pharmacist concerning her 15 year old daughter who on 03-AUG-2007 at 2:00 p.m. was vaccinated with her 3rd dose of Gardasil, and experienced pain with injection (did not have any pain with previous 2 shots).  At 6:00 p.m. she started having joint aches/pain plus fever of 102.4-102.  The reporter was concerned that her daughter had got a bad lot, since she had been asymptomatic with other doses.  Correct lot information was not available.  The reporter stated that the patient had been taken to the emergency room and was treated with 2 liters as she had passed out twice.  She further stated that her daughter had been nauseated, had arthritis and pain in every joint, but that she was fine the next day.  She believed the events occurred due to her daughter being dehydrated as she had not had anything to drink.  The reporting pharmacist agreed to provide lot number information if available from the Nurse Practitioner who administered the injection.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 09/17/07. Additional follow up information has been received from the pharmacist concerning the student with a sulfa energy. The pharmacist stated that the injection of GARDASIL administered on 03-AUG-2007 stung and hurt a lot more than other shots and that her daughter started running a fever of 102-104 most of the night. She said that all of her joints ached and felt terrible. On 04-AUG-2007 she blacked out twice and was taken to the ER where she received 2 L of normal saline. CBC and chemistry were normal, they were unable to obtain urinalysis. The patient recovered on 05-AUG-2007. Additional information is not expected.
28FEB92 mom reported giving pt APAP was crying & felt warm temp of 99 ax pt became limp, pale, lethargic @ approx 2PM, threw up @ 4PM;
Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Mild
Could not move arm. For 3 months suffered severe exhaustion and lethargy, pain in arm continued for 4 weeks into end of September.  Nausea continued for 2 months.
Day following vaccination I experienced bilateral hand swelling along with drowsiness, hot flashes and diarrhea. Bilateral hand swelling was noted to have started on 10/1 and I am still experiencing it along with pain/weakness in entire right arm and burning sensation in right foot.
9hrs after 1st DTP shot 11MAY90 pt turned pale & weakness & lethargia for one hr.
Initial solicited report received on 22 November 2017 from a Consumer. This is a prospective pregnancy registry case. This case involves a 33 year-old- female subject who had vaccine exposure during pregnancy and had red, sore area at injection site, also experienced headache, tiredness, hives across chest area, and did not feel any fetal movement that night following vaccination, and had decreased fetal movement. The medical history included: had previous flu vaccines and had developed hives after those vaccinations father's health status and age was not reported. The date of LMP was not reported. The estimated date of delivery was reported 17 December 2017. The subject's previous pregnancies were not reported. The subject maternal exposure drugs were not reported. The subject received a dose of FLUZONE INTRADERMAL QUADRIVALENT (route, site of administration and batch number not reported) on 20 November 2017. The subject stated that the reaction started the day of vaccination. She mentioned that she had red, sore area at injection site, also experienced headache, tiredness, hives across chest area, and did not feel any fetal movement that night following vaccination, and had decreased fetal movement the next day. This case was serious with the event of "did not feel any fetal movement" as considered as IME. It was not reported if the subject had treatment for infertility. The subject's family history of congenital abnormality was not reported. Prenatal testing included the subject was 36 weeks pregnant at the time of vaccination. On 22 November 2017, Ultrasound done and stated both were normal. The pregnancy was ongoing at the time of report. The outcome of events red, sore area at injection site, headache, tiredness, hives across chest area, and did not feel any fetal movement that night following vaccination was unknown at the time of report. List of documents held by sender: none. Sender's Comments: A 33-year-old female subject received a dose of study vaccine at 36 weeks of gestation. She had not felt fetal movements on day vaccination and decreased fetal movements the next day. On Ultrasound baby was normal. Based on data available, the sponsor assesses this event as not relate to study vaccine. The subject was followed as a part of pregnancy registry commitment. Company causality taken as associated for reporting purpose.
At the time of both shots  flu like symptoms and fatigue.  On 4/2/2021 developed a shingles like rash on my left ear ear and left side of neck and head.  on 4/12/2021 I was diagnosed with shingles.  I had been vaccinated against shingles with Shingrix.  I don't know if the Moderna vaccine has anything to do with my case of shingles but my doctor suggested I should submit this.  For information my husband received the second dose of Moderna approximately one month after me and he was diagnosed with shingles the same week that I was.  He had also received Shingrix.  I am improved but not completely recovered.
(L) leg swollen about the size up 1 1/2 x 2 1/2 in.
FOGGINESS; RUNNY NOSE; WATERY EYES; DROWSINESS; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included never had allergies before. 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced fatigue. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced fever. On APR-2021, the subject experienced fogginess. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced watery eyes. On APR-2021, the subject experienced drowsiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fogginess, runny nose, and watery eyes on APR-2021, and chills, and fever on 2021, and the outcome of fatigue and drowsiness was not reported. This report was non-serious.
2mo infant rec'd shots on 23APR91; following day child was feverish but temp was not taken; 25APR infant not breathing well; Taken to Hosp temp 107.9 & sz noted; Blood sugar 5; Hospitalized; placed on Ventilator;
hardly sleep/I sleep about 3 hours a night; can't get comfortable; if I'm not freezing to death, then I'm roasting alive; extremely sensitive to bright light/if I go out in the sun, I'm blinded; it hurts bad; He hasn't gone to work since then. He can't drive his truck, which is what he does for a living; joints are killing me/shoulders, lower back, hips; feeling like crap; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling like crap), INSOMNIA (hardly sleep/I sleep about 3 hours a night), DISCOMFORT (can't get comfortable), FEELING OF BODY TEMPERATURE CHANGE (if I'm not freezing to death, then I'm roasting alive) and PHOTOPHOBIA (extremely sensitive to bright light/if I go out in the sun, I'm blinded) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced MALAISE (feeling like crap). On an unknown date, the patient experienced INSOMNIA (hardly sleep/I sleep about 3 hours a night), DISCOMFORT (can't get comfortable), FEELING OF BODY TEMPERATURE CHANGE (if I'm not freezing to death, then I'm roasting alive), PHOTOPHOBIA (extremely sensitive to bright light/if I go out in the sun, I'm blinded), PAIN (it hurts bad), IMPAIRED WORK ABILITY (He hasn't gone to work since then. He can't drive his truck, which is what he does for a living) and ARTHRALGIA (joints are killing me/shoulders, lower back, hips). The patient was treated with PARACETAMOL (TYLENOL) on 28-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (feeling like crap), INSOMNIA (hardly sleep/I sleep about 3 hours a night), DISCOMFORT (can't get comfortable), FEELING OF BODY TEMPERATURE CHANGE (if I'm not freezing to death, then I'm roasting alive), PHOTOPHOBIA (extremely sensitive to bright light/if I go out in the sun, I'm blinded), PAIN (it hurts bad), IMPAIRED WORK ABILITY (He hasn't gone to work since then. He can't drive his truck, which is what he does for a living) and ARTHRALGIA (joints are killing me/shoulders, lower back, hips) had not resolved.            No concomitant medications were reported. The patient had driven trucks for 40 years, that all took away from him. The patient could no longer do what he was doing. The thing had got him terrified.
Fell and blacked out briefly; Dizziness; Fell and blacked out briefly; This is a spontaneous report received from a contactable consumer (patient). A 32-years female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8735, on 15Apr2021 07:45 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The patient had no known allergies. The patient had Dizziness on Friday in the evening (16Apr2021). Fell and blacked out briefly at evening.  No treatment was received for the events. The outcome of the events was unknown.
Fever, body aches, nausea, chest tightness, difficulty taking deep breaths,  painful lump in armpit.
30 mins p/shot mom called clinic stating could not wake the baby up; no difficulty breathing & pink color; instructed to come in for eval; on arrival pt was arousable w/effort;
Presented w/ weakness, cough, sore throat, fever & tested + COVID two days prior. On oral chemo. Tx w/ IV, Remdesivir, steroid, Vit C and Zinc.
Extremely weary and tired. Slept 18 hrs after vac. Still sleeping many hours during the day. Congestive heart failure
This spontaneous report as received from a certified nurse practitioner (C.N.P.) refers to an adult female patient. It was reported that on an unknown date the patient who was to have received ZOSTAVAX and instead a medical assistant gave her VARIVAX (Merck) (dose, route and lot# not reported). Additional information has been requested.
This spontaneous report as received from health department Alert of 01-APR-2014, refers to 4 adult patients. On an unknown date the patients experienced measles. The patients were previously vaccinated with measles, mumps, and rubella virus vaccine, (manufacturer unknown) (lot#, dose and route not reported). The outcome of measles was unknown. Total 25 measles cases were reported in the Alert. Six cases had been hospitalized. Five cases (including this case, the other case was captured in MARRS 1404USA005179) were confirmed as vaccinated with MMR vaccine before. It was not reported which cases among the 25 cases the hospitalized cases refer to. Additional information has been requested.