chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient at Vaccination table, just received dose of vaccine when patient's arm went limp. Also developed generalized weakness. Mother stood in front of him and held his head with both hands. Patient then passed out with eyes rolling in back of head. Also had convulsions for a few seconds that mimicked seizure. Patient soon became alert. Vitals obtained with BP 92/52, HR 34, O2 96% on RA. Patient also diaphoretic to touch. EMS activated and arrived at 1:30pm. Placed in reclining wheelchair and taken to private area. Started to feel better after given cold water. Suggested ER due to having seizure first time. Declined ambulance but mother will take to ER in private car. Patient and mother left with no further incident.
On 04/20/21 at approx. 1:30 AM he awoke disoriented, lightheaded, "feeling funny" - knew something was different.  States he could not make works come out his mouth, make complete sentences.  This lasted for 7 or 8 minutes, then cleared up.  He called his PMD that morning and was told to go to ER. He went to Hosp. ER, but was then sent to another Hospital.  Hospitalized from 04/20/21 and discharged late afternoon of 04/22/21. Extensive blood work done, CAT scan, MRI, Carotoid ultrasound, Echo cardiogram. No signs of A-fib, cholesteral slightly elevated.  DX. with TIA.  Referred back to his cardiologist Has been under care of his cardiologist for 7 plus years -  Pt is an active runner - Runs approx. 6 days a week for 2 1/2 to 3 miles per day.  For the past few months he has switched to interval walk/run. After 1st dose of Moderna 03/03/21 - Reports no issues expect slight injection site discomfort. After his second dose of Moderna 03/31/21 - Reports chills 12 hours after injection, low-grade fever (99.0 - 100.0) started 14 hours after the injection. All symptoms resolved 30 hours after injection date and time.  Stated he kept notes of this.
Stroke; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of stroke in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix and received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the stroke and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the stroke to be related to Shingrix.     Additional Information: GSK Receipt Date:15-Jul-2022. Reporter's Comments: The patient's wife reported case on behalf of her husband. The patient received the first dose of Shingrix 3-4 years before the date of reporting. The patient had a stroke two years ago (adverse event -Symptomatic) and wanted to know if patient need to restart the vaccine series. It was also inquired if there was any assistance paid for Shingrix. The patient was provided medical disclaimer and referred to healthcare professional. The reporter consent to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
no adverse event; improperly stored vaccine administered intramuscularly; confirmed route of administartation was intramuscular; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. Information on patient's pertinent medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S002877, expiry date: 29-JAN-2021) (dose details, strength unknown) via intramuscular route for prophylaxis (incorrect route of product administration). The administered varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature of 8.1 degree fahrenheit within time frame of 20 minutes (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with sterile diluent (possible lot # S000130, expiry date: 23-AUG-2021) which was stored in correct temperature. The previous temperature excursions included were 8.1 degree fahrenheit for 17 minutes and 9.5 degree fahrenheit for 21 minutes. The digital data logger was involved. No adverse effect was reported.
Infant received 2 month immunizations (lot #'s below). Infant nonresponsive after 15 minutes despite vigorous stimulation. RR 20 moving air well 4hr. Epipen Jr administered (15 mg) IM in right thigh. Vigorous cry, MAE after administration of Epinephrine. Infant evaluated by PCN and monitored for 2 hours after episode without sequelae.
Rash; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 23-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: 1231) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of rash.  No follow-up attempts are possible. No further information is expected.
About a month after receiving recommended vaccinations for a trip, I developed chronic arthritis in my hands and feet.
When she got her vaccine, it was itchy, 10 days later it was inflamed, hot, itchy.  Put cortisone cream on it, by the next morning it had doubled in size and spread for the next couple of days up to her shoulder and down to her elbow.  She called her doctor and he gave her a prednisone cream.  She has been putting the cream on twice a day, and it is not nearly as red or itchy as it was.  It is still a little swollen close to the site of the injection.  It does not hurt or anything.
Pt reported pain discomfort in legs and interrupted sleep right after vaccine given. Temp (ear) 102 degrees down to 99 the next am. Pain relieved with OTC NSAID - Symptoms resolved next day 10/24/13.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2022 as dose 1, single (Lot number: FK9895) at the age of 72 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: History of asthma. Concomitant medication(s) included: TAMSULOSIN; ADVAIR HFA; LEVOTHYROXINE; FINASTERIDE; VALSARTAN; PRAVASTATIN; ALENDRONATE; ALBUTEROL [SALBUTAMOL]. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Therapeutic measures included, Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment started on 24Aug2022 and treatment stop date: 29Aug2022, Indication: Treatment of COVID-19. The reporter considered the events as non-serious. Hospitalization prolonged reported as no.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID from 05May2023 to 10May2023.  Clinical course: Other medication in 2 weeks was reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4/8 At 7pm that evening I started having skin irriation with a rash on both arms, chest and neck.  I also had hives on both arms about 4 on each arm. Also had fatigue and lightheadedness all afternoon and evening it would come and go. 4/9 The next day, I had a itching but hives were still there just not as intense of an itch.  Also had fatigue and and chills all day. Felt like I had the flu. 4/10 I had a faster heart beat when standing during the day, felt a little better and rash was almost gone.  Just fatigued all day.  That night at 2:00am I woke up with swollen hands and toes that felt like they were on fire and very itchy. Ankels were not swollen just toes.  Lasted for about an hour then went away. 4/11 hands still swollen and toes this morning and all day so far.  When I woke up my body was itchy all over, hands, feet, face, neck, chest, arms, torso, legs.  Feels like the same reaction I have had to medicines I am allergic to and get a rash from.   Hives are still on my arms and one is now on the back of my left thigh, very itchy.
Pt was given Pfizer bivalent dose of 0.5 ml.  Pt should have been given peds monovalent primary dose of 0.2 ml
Information has been received from a registered pharmacist concerning a 59 year old female consumer with arthritis, hypertension, diabetes, thyroid problems and several allergies to a lot of medications (unspecified) who on 27-JUN-2012 was vaccinated SQ with a dose of 0.65 mL of ZOSTAVAX (Merck) (lot # 672608/1715AA, expiration date on 02-FEB-2012). The pharmacist stated that after vaccination with the ZOSTAVAX (Merck) the consumer developed red and swelling at the injection site. The pharmacist indicated that the consumer presented to the pharmacy on 29-JUN-2012 with red, 2 inch round swollen area at the injection site that was warm to the touch. No treatment was given for the events and no laboratory tests were performed. The pharmacist stated the consumer tried to contact her doctor but the physician was not in the office. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Pt recv vax on 09/15/98; on 09/18/98 pt exp red circular raised areas on both legs; rash spread to chest &neck; pt tx=Benadryl PO, cortisone cream.  Rash imp 9/19/98.
Information has been received from a physician concerning a 10 month old patient (gender not reported) who on an unspecified date was vaccinated with the completed 3 dose series of Rotateq. Subsequently the patient experienced intussusception and was hospitalized. The intussusception was corrected surgically. On an unspecified date, the patient recovered from intussusception. Intussusception was considered to be immediately life-threatening. Additional information has been requested.  10/8/07 Patient demographics provided by CDC. 10/26/07 Received vax record & VAERS database updated w/same.  Also received tag 2 report from pcp which included AE onset.  Record faxed to CDC.  11/27/07 Reviewed hospital medical records which reveal patient experienced blood in stools, fever & vomiting x 2 days.  Seen by pcp who dx w/gastroenteritis & sent home.  Vomiting continued & taken to ER.  Admitted 9/5-9/18/2007.  He appeared dehydrated & ill. BE done revealed colocolic IS but not able to reduce.  Taken to OR where exp laparotomy with right extended hemicolectomy w/primary anastomosis & re-exploration laparoscopically with open reduction of IS was done.  Did well initially post operatively but on day 3-4 became distended & vomited.  Continued for several days & unable to tolerate oral feeds.  Taken back to OR where second IS was found & easily reduced.  Progressed well after 2nd surgery & d/c to home. FINAL DX: Intussusception, recurrent, surgically reduced x 2 with hemicolectomy. Records faxed to CDC.
Large red area where injection was given; 1-2 mm white raised area; NOT hot to the touch; NO pain.
He started having several seizures a day for 6 months. Referred  to neurology clinic for EEG- looked at for Epilepsy-ruled out.  Watched and waited for 6 months until seizures stopped.
Closed throat; Couldn't breathe; Swollen tongue; Right calm muscle pain; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number Fd8020 or f48020), via an unspecified route of administration, administered in Arm Left on 23Oct2021 13:30 (at the age of 35-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and within 2 weeks of vaccination patient received: Albuterol, Wixela, Xanax. Medical history included covid-19 from an unknown date and unknown if ongoing If Covid prior vaccination: Yes, irritable bowel syndrome from an unknown date and unknown if ongoing IBS, drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Sulfa, food allergy from an unknown date and unknown if ongoing Known allergies: Several food products. Concomitant medication(s) included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported; alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (WIXELA INHUB) taken for an unspecified indication, start and stop date were not reported. On 23Oct2021 13:45 the patient experienced closed throat (medically significant), couldn't breathe (medically significant), swollen tongue (medically significant), right calm muscle pain (medically significant), headache (medically significant), fatigue (medically significant). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was treated with Epinephrine, benadryl, solimetrol (Prednisone). Therapeutic measures were taken as a result of closed throat (pharyngeal swelling), couldn't breathe (dyspnoea), swollen tongue (swollen tongue), right calm muscle pain (myalgia), headache (headache), fatigue (fatigue). The outcome of event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I had a series of migraines after dose 1 of the vaccine; This is a spontaneous report from a contactable consumer. A 69-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261) via an unspecified route of administration, administered in left arm on 30Jan2021 at 10:15 at single dose for covid-19 immunization.Medical history included covid-19 from Jul2020 since having covid in july. The patient's concomitant medications were not reported. No Known allergies. No other vaccine in four weeks. No other medications in two weeks. She had covid prior vaccination. No covid tested post vaccination. On 04Feb2021 at 08:00 am, she had a series of migraines after dose 1 of the vaccine. Since having Covid in July she had more migraines than normal. She used to get 4 or 5 a year. She have probably had 10 to 12 since July. The event assessed as non-serious. No treatment was received. The outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
This is a 73y.o. female is medical history of cholecystectomy, type 2 diabetes mellitus, DVT (unspecified year not on anticoagulation), breast cancer with radiation treatment in 1999, glaucoma, ESRD s/p right kidney transplant 2009, essential hypertension, pancreatic insufficiency. Presenting to the emergency department with complaint of loss of appetite, nausea, low back pain, failure to thrive.   Patient's daughter present at bedside, providing information. Patient states that her mother went to doctor's appointment on Monday for a flu shot. States that Tuesday mom seemed little more tired and had some soup that day. Wednesday 11/24 she states that her mom started feeling very lethargic and worn out and stopped taking her medications. Thursday she had no appetite, stopped eating, and she needed help to move around the house. Her overall fatigue did not change and he decided to come to emergency department 11/27. Patient denied any chest pain, femoral discomfort, shortness of breath, loss of taste or smell.   Daughter states that 2 weeks ago he went to a doctor's appointment with Dr., her nephrologist. During that time. He started her on mycophenolate, due to "changed kidney numbers", unspecified of what the exact issue was. Patient states that since then she has been taking her tacrolimus, mycophenolate, daily prednisone daily. She endorses being on tacrolimus and daily prednisone since her kidney transplant in 2009. Patient was unsure why she got a kidney transplant back then, but she states both of her kidneys failed and she was on hemodialysis prior to kidney transplant. Patient endorses taking all of her medications daily, was unsure of the specific doses and changes to her insulin therapy.
IM given in left arm 3rd dose. (Booster). Moderna Covid-19 Vaccine Lot 045C21A given was removed from freezer on 10/6/21 @ 11:45 am. Given on 11/5/21, out of time range. Patient contacted that evening.  Moderan manufacturer called. Patients called the following Monday letting them know that Moderna was looking into this and would be getting back to us. Also let them know that Moderna was looking into this and would be getting back to us. Also let them know I would be following up with them once we heard back from them. Called patient today 11/17/21 and let him know that Moderan let us know the  vaccine was viable, no additional booster vaccine required.
Two months AFTER receiving the vaccination I developed pain in my right arm at the site of the vaccination. The skin around the vaccination site became numb. A self administered pin prick was not felt. Internal to the vaccination site I began experiencing random, what I can best describe as "lightning flashes" of extreme pain that felt, to me, as if I was being burned with a torch. The duration was very short, probably under 2 seconds. Had the duration been longer, it would have been unbearable.  The "flashes" were not correlated with any particular arm movement and would often present with no movement at all. Over the course of the last week or so, the "flashes" have ceased. The skin numbness is now replaced with a skin sensitivity. A light touch is mildly painful. I am due for my second shot but am having thoughts about not getting it. This experience is minor in the scheme of things but decidedly unpleasant.
Mother and grandmother report that patient began crying shortly after her vaccines were given and continued crying even after they got home.  She had been given tylenol in the clinic with her vaccines.  Mother gave 80 mg of tylenol at 12:30 pm, and patient continued to cry.  Mother called the clinic at 1:45 and was instructed to bring baby back to the clinic.  Baby was crying intermittently when she arrived.   She had missed a feeding due to crying.  Warm compress with heel warmers were applied to both side which appears to provide some relief of pain.  Patient went to sleep until she was examined again.  Initial HR in clinic was 198.  Pt took 2 ounces of her bottle and went to sleep.  She was observed in clinic for some time.  She was given 50 mg of ibuprofen at 3:30 pm.  HR was improved to 126.  Patient was resting well.  Injection sites were without erythema or swelling.  They were both noted to be tender.  She developed some mild papular rash (heat rash) to her upper chest.  No urticaria.  Patient was discharged to her home with instructions to continue warm compresses for comfort and tylenol every 4-6 hours as needed for fever or pain.
99.9 fever, fatigue, rash on lower extremities fever and fatigue gone in 24 hours Rash being treated with Eucerin cream and hydrocortisone 1% cream mixture.  Gradually improving after 6 days.  NO STEROIDS as per CDC caution.
It first started at just being light headed, then came nausea, a slight headache, tiredness. The progressed over a 12 hour span and lasted for about 36 hours. With that I also had extreme soreness in my right arm, weakness in the right arm, itchy, a red welp with a knot formed around the area I got the shot. This lasted for about 3 days, however, it returned about day 8. Going on day 9 and the itchiness is back with the redness and knot. I have contacted my doctor.
Information has been received from a 76 year old male with no known drug reactions/allergies who on 15-AUG-2007 was vaccinated with zoster vaccine live (Oka/Merck) by injection. No information was provided with regard to the patient's concomitant therapy. On 12-SEP-2007 the patient had a rash on his breast going around to his back. The patient sought unspecicifed medical attention and on 13-SEP-2007 he was diagnosed with shingles. As of 19-SEP-2007, the patient's shingles persisted. Additional information has been requested.
major pain in my arm that is getting worse, each day it gets harder to lift or grip anything,  Ive tried heat cold packs and wrapping it and ib profron and nothing is working. Its causing pain to go down my arm into my hand.  I have alot of discomfort.
bleeding stomach in the lower abdomen; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The wife was asking for her husband who will get the second dose of the Covid-19 vaccine on 18Feb2021 however the husband had recent surgery and a bleeding stomach in the lower abdomen on an unspecified date. The wife wants to know if the husband can take the second shot of the vaccine after getting the surgery. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Non immunocompromised patient received 0.5 ml (full dose) instead of 0.25 ml (half dose) for booster. No adverse events reported.