chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact dates, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 22-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # K016966, expiration date: May 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Patient passed out, after vaccine. Patient complained about sever back pain before vaccine, but insisted on recieving the vaccine on 6/2/21. Patient was transferred to clinic, and placed under care and then transported by ambulance from pharmacy.
Received Proquad 4/11/07 one week later had fever to 102.8-Developed "tiny dots" on trunk and face-too numerous to count-sleeping more than usual. Lasted 3 days (1 day fever per mom "didn't quite form blisters" 2 days rash
Since vaccine, chronically tired, spike in cholesterol, constant dry cough, dizziness, problems with eyes focusing.  Have not been given medicine as they try to figure out cause of cholesterol spike, leg and knee pain
Muscle aches, fatigue, pains, vision trouble, shoulder and back and neck pains, ringing in ears, tinkling burning-hands, feet, etc.
Moderna  COVID-19 Vaccine EUA Heart palpitations, elevation of blood pressure.  Not yet treated, symptoms have not resolved. Contacted Physicians office this morning. Waiting for a return call.
Pt recvd 3 doses of Engerix-B 18JAN91, 18FEB91 & 17JUL91 & reporter indicated due to neg HBSAB titer result, 4th dose of vax required 29SEP91;
This spontaneous report as received from a physician refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 08-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M044717, expiry date: 1 dose (route, anatomical location were unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 32F to 35F for a duration of 35 minutes and 47F to 77F for a duration of 29 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA007252.
Headache, Myalgia, L ARM PAIN, TIRED, FATIGUE, CHILLS Narrative:
Janssen COVID-19 - grade 3 fever-- 102.1 maintaining with tylenol and ibuprofen - chills - aches/sore joints - headache - fatigue - nausea (dry heaving, can't eat)
Developed hearing loss eventually resulting in tinnitus.  Visited audiologist 2 weeks after symptoms began. The audiologist referred me to an ENT specialist, I saw Dr. 2 weeks later. He administered a steroid shot. Some hearing regained but tinnitus has persisted.
5 days after vaccination had febrile seizure. Pt admitted for observation overnight at hospital ICU.
1 day p/vax pt devel an inj site rxn characterized by a lump & pruritus;pt was seen by Md who prescribed DPH & applications of ice;
Itching all over; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3248; Expiration Date: unknown), via an unspecified route of administration, administered in Arm Right on 02Feb2021 at 10:15 as 2nd dose, single for COVID-19 immunization; Historical vaccine included bnt162b2 (lot number=El3248) via an unspecified route of administration, administered in left arm on 12Jan2021 at 10:15 as 1st dose, single for COVID-19 immunization. The patient medical history was not reported. Other medications the patient received within 2 weeks of vaccination included vitamins. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 10:45, the patient experienced itching all over. Patient had not received treatment for the adverse event. The clinical outcome of the event was not resolved.        Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of contusion in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced contusion. On an unknown date, the outcome of the contusion was not recovered/not resolved. It was unknown if the reporter considered the contusion to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced permanent bruise. She had fear that the bruise would not go away.
Total loss of motor control in that arm for 2 days, slowly regained to normal in 6 weeks. Still experiencing occasional pain after 3 months. Can feel lump in arm.  If that can happen to an adult, what would it do to a child? Contribute to autism? Also extreme agony the first few days.
Broke out in a rash all over her neck down to her abdomen; This spontaneous case was reported by a nurse and describes the occurrence of RASH (Broke out in a rash all over her neck down to her abdomen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B211A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced RASH (Broke out in a rash all over her neck down to her abdomen). The patient was treated with PARACETAMOL (TYLENOL) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Broke out in a rash all over her neck down to her abdomen) had resolved. Not Provided      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.   After receiving 1st dose of vaccine patient had a broke out in a rash all over her neck down to her abdomen. Patient took Tylenol and it went away.  Concomitant medications were not reported.
Redness and swelling around site. Warm and tender to touch. Ice and Motrin - watch for day, then call if not resolving or worse.
lt upper arm erythema area 110mm x 70mm pt states pain in area; t101.8 oral;
booster; I think I have Covid; I think I have Covid; headaches; chills; muscle soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I think I have Covid"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; CHILLS (non-serious), outcome "unknown", described as "chills"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness".  Clinical course: Patient took both Pfizer shots and the booster. Patient think that have Covid and patient currently waiting in a line over a hour long for rapid testing. Patient had headaches, chills, muscle soreness. Patient breathing has been alright.  The lot number for bnt162b2 was not provided and will be requested during follow up.
pt c/o SOB; dyspnea inc to need for 911 cal to ER given INIS & breathing tx observed for 2-3hrs & released;10 days later 27OCT had virus w/cough;ER dx 17OCT95 bronchospasm r/o rxn to flu vax;allerg to avacado & PCN type med
Case number PHEH2014US025072, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 61 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 07 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Date of refrigeration of the vaccine was 07-May-2021.
Patient was feeling lightheadedness, dizzy after vaccine. Site of injection had very minimal blood (which is normal uptn needle insertion). Pt was instructed to sit for 10-15 minutes. Pt was given water and orange juice, patient was feeling better 15 minutes.
Redness in right eye, no swelling, itching. Passed after 3 days.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 71-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Reporter stated that no adverse reactions were reported by any patients. No treatment medication information was provided.
rash at the injection site; swelling at the injection site; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 77-year-old female patient who had rash at the injection site (vaccination site rash) and swelling at the injection site (vaccination site swelling), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.7mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date the patient developed non-serious rash at the injection site (vaccination site rash) and swelling at the injection site (vaccination site swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "Pharmacist calling on behalf of a patient that received FLUZONE HIGH-DOSE QUADRIVALENT and is reporting a potential adverse reaction of a rash and swelling at the injection site and states she was not properly administered the vaccine."  Details of laboratory were not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for both the events.  There will be no information available on the lot number for this case.
Had full body aches the night after getting the vaccine that improved with Tylenol. Then they returned midday the next day so I laid down to rest and took Tylenol but after an hour or so found that I couldn?t lift my neck or get out of bed without extreme pains. The pain has improved in the nearly two weeks since but is still there and was not much helped by a massage.
Erythema with induration at injection site. Advised to cold compresses and Tylenol.
Shortness of breath, rapid heartbeat, high fever, chills, nausea, pain all over body
Started feeling congested and feverish and was coughing a lot. On 02/27/2023 took home COVID-19 test and it was positive. Called doctor and was prescribed PAXLOVID. Tested negative on 03/07/2023.
Symptoms: Redness, pain, itching, swelling, and a blister which is getting bigger and painful over time (All symptoms are  below the injection site). Medications: Tylenol, Benadryl (tablet & cream), cold patches Note: I have documented the infected area with daily pictures if you need
Hi i just want to start by saying I'm not sure which TDAP vaccine I got, it isn't listed on my patient information sheet I got with the warnings at the time of vaccination. I felt ok when I got the vaccine on Tuesday and then after about an hour and a half arm pain began then radiated up my neck. Then I started feeling sick to my stomach. The next few days I became very nauseous and had trouble eating. I felt awful. My arm really hurt quite badly and raising it above my head or using it caused a lot of pain. My neck stiffened and I developed a headache. Then on September 29th I noticed my armpit hurting. On October 1st I went to the hospital for terrible pain in my armpit and my upper left arm was very swollen, as well as the armpit and the area above my left breast. The pain aggravated my Vasovagal Syncope. The hospital said it was my lymph nodes. After two days the pain stopped but the swelling was still present, but not as bad. I continued to have trouble eating and feeling very sick and feverish. I never developed a fever over 99.4 though. I sweated and became very weak. I also developed some emotional issues during this. I cried one night for three hours and felt very depressed and said I wanted to die. This is abnormal for me and not usual behavior. I became agitated and moody. I also lost 6 lbs after getting this vaccine from all of the side effects. I developed strong pain in my low back that started on October 2nd which I took TYLENOL for, and then also got diarrhea with severe cramping that made me very nauseous and sweat profusely. I almost stopped eating entirely until October 6th when I started to feel better. October 9th now and I am feeling better.
Patient became unconscious the evening of 4/14/21.  This event occurred five days after his second Covid vaccination. Patient had just gotten up from a living room chair and was walking over to the stairs to go to the second floor when he became rigid, lost consciousness and fell backward.  911 was called by his girlfriend.  He was unconscious for a couple of minutes.  When EMT's arrived he was conscious but very groggy.  His blood pressure was 250/157.  He knew his name and year and SSN but did not correctly answer several other questions.  He was taken to ER.  After numerous tests over the course of several days, he was diagnosed as having a stroke.    In the ER, they performed CAT scans, EKG, blood work, urine test and chest xray.  Blood pressure remained high.  Complained of headaches.  Patient was also having trouble voiding urine in the ER so a foley catheter was inserted.  He was admitted to the hospital.  After admission, an MRI, echocardiogram and EEG were performed.  The MRI showed three small blood vessels had burst in his brain.  Echocardiogram showed functions were normal.  The EEG showed some slowing but no signs of seizure.  The conclusion was a stroke.  Physical and occupational therapy examined patient.  No need for further therapy.  Blood pressure remains slightly elevated but he does not appear at this time to have lost any physical or mental functions.  Patient does NOT have a history of high blood pressure or heart issues.  Tests showed his heart was functioning properly.  Per his family doctor, his BP ran approximately 124/64 when tested during the previous 12 months.
102.8 fever, diarrhea, shaking, nausea, body aches, fast pulse, high blood pressure.
1 y/o pt devel H. Influenzae Meningitis on 31DEC91; On third day of Ceftriaxone pt still only semi responsive but is stable; H. Influenzae grown from spinal fluid; recvd HIBTITER 2FEB91, 26APR91, & 26JUN91;
Fever night of getting PREVNAR 13 as a 5th dose. On next day - 24cm circumference area of cellulitis w/ lymphangitis.
Client was to get his 2nd COVID 19 Pfizer immunization and was given the Pfizer Bivalent immunization.
Pt recvd 3 doses of Engerix-B AUG90 & SEP90 & JAN91 & DEC91 titer result was 0.1;
~10 days after 2nd Pfizer dose, she developed  nightly fevers for 2+ weeks, joint pain, macular itchy rash. WBC 2.0, ALT 78, AST 226, Hgb 6.9. After lab results treated with prednisone 40mg, admitted for 3 days, symptoms completely resolved, now on ferrous sulfate for anemia
Same evening started freezing cold. tired. went to bed to try to get warm.  Woke 3 a.m. so dizzy I had to hold furniture to get to bathroom, Headache, achy, feverish but too unsteady to take temp or aspirin. Woke after daylight to 101 fever, usually 97. headache, took aspirin. Mild upset stomach. achy. mildly dizzy. Not clear-headed; filling out this report was too much. By Sunday fever almost gone. A blister inside top lip. Sunday evening well enough to dress & discovered arm sore, red, hot & swollen.  I removed bandaid, and it got better over the next few days.   Headache continued a few more days but not as bad. I was still very tired; slept most of Friday, Sat & Sunday. That improved but was still unusually tired for a while.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; SYNTHROID. Past drug history included: Keflex, reaction(s): "known allergies: Keflex"; Bacteria ds, reaction(s): "Known allergies: Bacteria DS". The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected Covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At site: soreness, later that night soreness and swelling increased, site hot, redness an inch below injection site. Size of redness/induration: 2 x 3 inches.
mom reported child was breaking out in a rash, t inc, crying;referred to PMD or clinic;16JUL97 states took child & gave shot for allerg rxn;MD also told was underweight & given too many immun;some rash still present;
Patient collapsed to the floor-15 min. after shot given. C/O runny nose/shortness of breath/tongue felt swollen and hard time moving legs (both). 911 called after vitals taken and she went to ER. She was discharged and went home from ER. Time frame from shot to symptoms 15 minutes.
Administer expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) in an 81-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 07-APR-2022.  The vial did not undergo any temperature excursions.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information- reporter address updated.