chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine dose 2 on 2/3/2021. 72 hours later a red, painful, and blistered rash appeared on my upper left torso, under my armpit and on my left breast, Shingles (Herpes Zoster).  A minor headache and soreness of the injection site were the only other symptoms I experienced.
pt had stat rxn w/redness all around inj site in rt leg & whelps just below inj site;no SOB or itching noted;called PMD office, they wanted to see pt;pt given DPH in PMD office;pt back to PMD office 15min later had vomited;given more DPH;
Treatment of COVID-19/I got covid again; Treatment of COVID-19/I got covid again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "Treatment of COVID-19/I got covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medications within 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
stiffening of her arm; This is a spontaneous report from a contactable Consumer report for self. A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization, arnica montana (ARNICA (PLANTA TOTA) "WELEDA") via an unspecified route of administration from an unspecified date to an unspecified date at unspecified dose for an unspecified indication. Medical history included hearing is not good. Concomitant medications not reported. Patient experienced no serious side effect other than stiffening of her arm, she took some Arnica before went for the shot and after, and she had practically no side effects, just a little stiffness but that just lasted a day. She is scheduled to take the 2nd dose on 29Jan2021 8am and is concerned that she may experience greater side effects and flu like symptoms after. She lives alone in an apartment and is asking if she should get someone to look her after the 2nd shot. Action taken for arnica montana was unknown. Event outcome was recovered.  Information on the lot/batch number has been requested.
Information has been received from a physician concerning multiple patients who were vaccinated with Gardasil.  Subsequently the patients experienced injection site reactions after receiving Gardasil.  The nurse reported that about 5-10 patients experienced a lot of heat and a knot under the skin for about a week after the vaccine.  The patients sought unspecified medical attention and their outcome was not reported.  Additional information has been requested.
Tinnitus and hearing loss in both ears. Persisted for 8 months. Right ear has improved, left ear persists. Treated with steroids (prednisone) for 2 weeks.
Left upper arm swollen, hot, states mom. Mom states took child to ER (Sat, Sun?) and obtained this form. 8/24/04 (Tues) read PPD. Arm con't hot and sl swollen. Mom states it is better.
pt exp an inject site react @ DTP site which included redness & swelling JUL92; dimpling @ site was recognized on f/u visit 9SEP92; reporter states pt given inject of Kenalog in same area 4 days p/DTP; dimpling & atrophy;
Patient developed erythema (2 days post-vacine) with swelling and redness.  Main involved area was approximately baseball sized with some diffuse smaller surrounding red areas.
The patient reported having Omicron; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient reported having Omicron) and DRUG INEFFECTIVE (Lack of efficacy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (The patient reported having Omicron) and DRUG INEFFECTIVE (Lack of efficacy). In January 2022, COVID-19 (The patient reported having Omicron) had resolved. At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high volume antibodies (High) high volume antibodies were found.         No concomitant medication details was provided. No treatment medication details was provided. The patient reported having Omicron for 5 days.  Company comment: This spontaneous case concerns a 81-year-old female patient with no medical history reported, who experienced the unexpected non serious AESI of COVID, approximately 9 months after the second dose of mRNA- 1273 vaccine and an appropriate schedule of vaccination. Additionally, Drug ineffective was considered. Omicron variant was reported, which resolved after 5 days. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-039332 (Patient Link).; Sender's Comments: This spontaneous case concerns a 81-year-old female patient with no medical history reported, who experienced the unexpected non serious AESI of COVID, approximately 9 months after the second dose of mRNA- 1273 vaccine and an appropriate schedule of vaccination. Additionally, Drug ineffective was considered.  Omicron variant was reported, which resolved after 5 days. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Delayed rash resembling a morbiliform rash on both thighs, calves and inner arms
swelling of the upper arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "hemophilia" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling of the upper arm". Additional information reported as after administering Prevnar 13 to a patient with hemophilia, there was a large area of swelling of the upper arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax in late July or early AUG & 2wks later pt exp a rash w/about 50 lesions;No further details were provided;
So about an hour after my vaccine I was ay a community event, outdoors. All of a sudden I got hit with a wave of nausea. I went into the shade and drank some water and sat down. After a couple of minutes I threw up. After a couple of steps I got dizzy and passed out and hit my head. It was a blackout, and I came to a couple minutes later. I was transported by ambulance to emergency room because I hit my head. When I came to I was feeling better and my nausea was gone. At the hospital they did lots of test, blood work, urine analysis, CT scan, EKG. Everything was normal, minus me being dehydrated. I advised them I received the vaccine earlier that morning. After a few hours I was released. The next couple of days I had extreme fatigue as well as a  low grade fever. Today is a little better.
Started with hives on my left hand, then hives on my right hand.  Put some cortisone cream.  Over 4-5 days the hives got increasingly worse and spread to my ears, nose, cheeks, eyebrows, face and neck.  Monday 2/15/2021 it was beyond uncomfortable and it felt like a pea sized lump was in my throat causing me to worry my breathing might be affected.  Went to the ER/Urgent care.  I was given a shot of solumedrol, and a predisone pack and given an ointment for the rashes, Triamcinolone.  I saw my PCP the following day as it was a scheduled appointment but wanted to see her to update her on this event.  I then developed allergies to the ointment worsening the rash.  She advised on 2/19/2021 I stop taking the predisone pack and gave me 7 days of 20 mg predisone instead and prescribed a different ointment that is not due to arrive until Monday 2/22/2021.  As of today 2/20/2021 the rash is still growing up my arm over my elbow and now I have some hives on my legs and back.
vomited immediately after receiving the ROTATEQ; vomited immediately after receiving the ROTATEQ; This spontaneous report was received from a nurse referring to a 2-month-old male patient. The patient's medical history included premature with 30-week-old gestation, apnoea at birth and hypoglycaemia at birth and the patient was fine at the time of this report. The patient had no concomitant medication or drug allergies.  On 06-JUN-2019 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ)( lot # R034878, expiration date 11-SEP-2020; strength and dose were not reported) in the series orally for prophylaxis. The patient vomited immediately after receiving rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (underdose). The events occurred during office visit. No treatment was given and no lab diagnostics or studies was performed.   Therapy with series of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was reported as continued. The outcome of vomiting was reported as recovered. The causality assessment was not provided by the reporter.
Irritated throat, felt like it was swollen  took benadryl, cough, flushed, pain in shot arm, hand and wrist on first day. congestion, coughing, body pains, day two Body pain, swollen ankles, pain in face and jaw. ear pain. disorientation day three Body pain all over day four Rash starts on lower back hive like bumps on right breast, left and right groin, terrible itching day five Went to local walk in clinic, lymph node swelling pain, under arms, groin, breast, larger rash on lower back a lot of hives. treated with antibiotics looked like breast had an infected center day six. itching continues for days, lump on left side of forehead forms causing pain, left eye pain scalp becomes sensitive all this lasts until 3/17/21 After second vaccine breast lump became violently infected and drained for at least 15 days. Back rash became bumps looking like multiple infections. multiple issues with inconsistent blood pressure lasting for weeks developed a mass on the left foot, saw a physician who suggested compression socks  still unresolved. developed a headache when breast was infected both sides of head, zingers on right side, scalp was sore, pain on right side of forehead into scalp  as breast lump  drained pain lessened but never went away completely July 17,2021 developed horrible disabling head pain and balance issues.  had MRI and neck X-ray  nothing significant unable to function. had ringing in the ears, photophobia, ears filled with fluid, was treated with prednisone. this excruciating pain  and symptoms lasted for 10 weeks until it became almost tolerable. This pain made it almost impossible to wash, or brush my hair. Pain would wake me up at night.Still have swelling on left side of forehead and scalp pain, balance issues, change in taste buds, weight loss, 11-13 lbs since first vaccine. Have an appointment with a neurologist on OCT 29 2021
Pt received Menveo and Trumenba on 3/9/2020. About 1' later pt. C/O severe chills. "Could not get warm". Mother did not take temp then gave Motrin. During night pt woke up in sweats. In am 3/10/2020 had temp over 101. Motrin given. No rash, No swelling redness at inj site. C/O general body aches. Had fever this pm as well. Mother not sure how high as thermometer not working correctly.
Patient was given a 1 ml dose of covid 19 vaccine (Moderna). This was his first dose. Correct dose is 0.5 ml. No adverse reactions have been reported. This was discovered shortly after the vaccine was given.
Mom states the next day, infant "lost control of head and had jelly limbs" and also red spots on lower left side and back. Mom held and infant "returned to normal". On 11/18/00, the same thing happened but also went into grand mal seizure. Was hospitalized on 11/18/00. On 11/19/00, had another seizure.
Woke up the next day and I felt like I had a really bad cold. I had a runny nose and a sinus headache. I didn't have a fever or chills. I went to the doctor for a routine appointment and was diagnosed carcinoma of the head and neck. I have a lot of fatigue and a lot of problems to stay awake.
Patient presented to the ED and was subsequently hospitalized for injury of left shoulder within 6 weeks of receiving COVID vaccination.
ARM RED AND SWOLLEN THE SIZE OF A TENNIS BALL, AND ITCHING, 4/30/2010 1:00 PM, COLD SORE ON UPPER LIP, HAD NOT HAD A COLD SORE IN 2 YEARS, 5/1/2010 ARM HOT AND ITCHING, RIGHT EYE SWOLLEN SHUT, DON'T KNOW IF THIS WAS ALL RELATED TO SHINGLES VACCINE OR JUST A COINCIDENCE.
Around 9pm after the vaccine I developed a severe fever and was sore all over. I was so fatigued and weak I took Tylenol 2 different times to help with the pain and fever all which lasted about 24hrs. Off and on I begin feeling feverish, but no fever developed. I developed extreme fatigue, brain fog and just the feeling of feeling very drained which lasted until around the beginning of February. I developed a couch which still lingers todays. About 2 weeks after the vaccine I noticed a lipoma on my left posterior shoulder muscle which was never there before and caused severe muscle and nerve pain causing me to have to start physical therapy in May. This did help with the severe pain. But still to date I have swollen lymph nodes above my clavicle that developed and the lipoma is still there. Dr's are unsure if this is long COVID or an actual AE to the vaccine.
This case was reported by a consumer and described the occurrence of pain in arm in a 71-year-ols female patient who received FLUARIX QUADRIVALENT (batch number 7A54E, expiry date 30th June 2016). Concurrent medial conditions included diabetes (no more details were provided). Concomitant products included PREVENAR. On 27th December 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb decreased were unknown. It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a consumer via a pharmacy via a pharmacy claims management company. The patient received the FLUARIX QUADRIVALENT vaccine in the left deltoid and the PREVENAR vaccine in the right deltoid. The patient experienced pain the entire left arm and limited movement on it.
Patient was vaccinated with VARIVAX on 6/27/12. He developed fever on 7/20/12 and a classic chickenpox rash - cluster of vesicles mid back which then transformed later to scabs - followed on 7/21/12.
can't taste anything/he had an Altoid mint and "it wasn't' strong at all"; smelling things differently; This is a spontaneous report received from a contactable consumer (patient) via Medical information Team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included altoid mint. The patient reported that after his first vaccine dose, he can't taste anything and he was smelling things differently. Patient reported that he had an altoid mint and "it wasn't' strong at all". The outcome of the events was unknown.  Information on Lot/Batch has been requested. Follow-up attempts are completed. No further information is expected.
9SEP96 pt recv vax for puncture wound to rt #3 digit (M.C.);devel t101 that evening w/shaking, chills;no other complaints;
No further AE/PQC reported.; patient received expired VAQTA; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 17-AUG-2020, the patient was vaccinated with a expired hepatitis a vaccine, inactivated (VAQTA) (lot # S018772, expiration date not reported, but upon internal validation established as 07-JUL-2020, 1 injection, intramuscular) for prophylaxis (expired product administered). The nurse questioned whether the patient need to be re-vaccinated or not. No further adverse event (AE)/ product quality complaint (PQC) reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S018772; expirationdate: 07-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
Information has been received from a physician concerning a 68 year old female with controlled diabetes who was vaccinated with a dose of Zostavax. On 29-JAN-2007 the physician reported that the patient "recently" developed shingles within four to five days of vaccination. The physician felt that it could be transmission from the patient's spouse who received his vaccination on an earlier unspecified date. Unspecified medical attention was sought. At the time of the report, the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/13/2007.  Information has been received from a physician concerning a 68 year old female with controlled diabetes who on 10-JAN-2007 was vaccinated with a dose ZOSTAVAX (Merck).  On 29-JAN-2007 the physician reported that the patient "recently" developed shingles within four to five days of vaccination.  The physician felt that it could be transmission from the patient's spouse who received his vaccination on an earlier unspecified date.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  There was no product quality complaint involved.  Additional information from the physician indicated on 18-JAN-2007 the patient contacted the physician's office with complaints of itchy, painful lesions on her back.  She was seen in the office on 23-FEB-2007 and diagnosed with shingles in an unspecified thoracic dermatome.  At that time the lesions and pain remained, however the itching had improved.  The patient continued to improve after that visit with the majority of lesions resolving.  On 02-FEB-2007 the lesions returned and the patient was seen in the office on 06-FEB-2007 again with shingles.  She was started on an unspecified antiviral therapy.  No further information was available.  Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 33-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 30Apr2021 as dose 2, single (Lot number: EW0167), in left arm and on 21Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) positive, notes: tested positive for COVID on antigen testing today; (06Jul2022) positive, notes: tested positive for COVID-19 on 06Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Treated with Paxlovid orally Treatment start date: 05Jul2022 and Treatment stop date: 10Jul2022. The reporter stated that patient became symptomatic and tested positive for COVID-19 on 06Jul2022, and was prescribed Paxlovid. He took his first dose that evening, and completed the course. He noticed quick and profound symptom improvement. Today, he felt sudden return of COVID symptoms (sinus pain, pressure, headache, fatigue) and tested positive for COVID on antigen testing today. This appears to be an instance of COVID rebound post Paxlovid therapy. The patient received no other medication in 2 weeks.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the lack of efficacy cannot be ruled out.
pt recv 1 dose of varivax 4/6/98 & 4/11 devel vesicles, redness, induration & itching at the inject site
Fever, Chills, Nausea, Headache - all started around 9:30pm on the day of the vaccine. The fever, chills, and nausea last until about noon the following day, while the headache persisted throughout the day.
VACCINE EXPIRED ON 4/28/23 AND WAS ADMINISTERED ON 5/2/23 BY CLINIC RN
Healthy woman taking oral typhoid vaccine in her private home prior to upcoming trip abroad. On 9/24 she took the first capsule. Within an hour she developed severe pain in the right neck and face. She was seen in UC on 9/25 and told not to take further vaccine, other than pain, exam was unremarkable per notes and she was managed symptomatically. I saw her on 9/27 w persistent severe pain, she had obvious swelling of the right parotid.  I treated her w vicodin for pain and dicloxicillin (for typical organisms) and cipro (bc of oral salmonella typhi exposure). She was seen in fu on 10/1 and improving. I saw her today on 10/8 and besides some residual fatigue her sx seem to have resolved.
Mom reported the site initially became red and firm, however over the next several hours the area had enlarged and redness was larger. Patient was treated for Cellulitis of the Right Thigh, treated with Cephalexin 250mg/5ml solution.
Right after the vaccination my left arm did not function like it used to. Since I received the vaccine and until now (70 days after) I?m experiencing pain in my left arm and limited range of motion. It hurts to do certain movements that I had no problem doing before the vaccine. The injection was done in the wrong place (too low) and damaged something in my arm.