chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of tingling lips in a 28-year-old female patient who received SHINGRIX for prophylaxis. On 12th April 2019, the patient received SHINGRIX. On 12th April 2019, less than a day after receiving SHINGRIX, the patient experienced tingling lips, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the tingling lips was recovering/resolving and the outcome of the inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the tingling lips to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) called on behalf of self. The reporter stated that while reconstituting SHINGRIX all the contents of the second vial sprayed them in the face and around their mouth, which led to inadvertent exposure to vaccine and exposure via skin contact. The HCP reported they washed their face with soap and water for several minutes. The HCP reported they began to experience tingling around their mouth, which was reported as beginning to improve. The reporter was consented to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Spiked 103 fever), NAUSEA (Nausea), ASTHENIA (weakness) and HYPERHIDROSIS (sweaty all night) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, LIRAGLUTIDE (VICTOZA), CANAGLIFLOZIN HEMIHYDRATE, METFORMIN HYDROCHLORIDE (INVOKANA DUO), SIMVASTATIN, OMEPRAZOLE, SERTRALINE, HYDROCHLOROTHIAZIDE, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (Spiked 103 fever), NAUSEA (Nausea) and HYPERHIDROSIS (sweaty all night). On 26-Feb-2021, the patient experienced ASTHENIA (weakness). The patient was treated with NAPROXEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PYREXIA (Spiked 103 fever), NAUSEA (Nausea), ASTHENIA (weakness) and HYPERHIDROSIS (sweaty all night) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MESTINON. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive, notes: Return of symptoms and positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt is a 49 y/o female who had received Pfizer vaccination as booster to J&J initial. Pt was in observation as she was being fanned by her husband near syncope. Pt stated having reaction to initial J&J but subsided within 5 minutes. This time, elapsed time was 30 min with acute nausea. EMS was activated and pt was transported to hospital. COAx4,GCS14. Peripheral muscular spasms were advised and general weakness. Pt being evaluated for neurological deficits.
Dizzy. Can't walk. Blurred vision nausea, headache. I have missed 5 weeks of work and everything is getting worse. I cant walk without falling or running into walls. I think I got another auto immune disease from this.
I had my Pfizer Covid 19 Booster shot at Hospital on 8/31. Within 1 hour, I felt fatigued and lightheaded/dizzy. On 9/1, I woke with severe soreness in left shoulder, which I was forewarned that it was likely to happen. However, the fatigue and dizziness from the day before was worse, and stayed with me all day. On 9/2, I still was fatigued and loopy feeling. Around midday, I started getting heart palpitations. Late afternoon I felt as if I was burning up. My eyes were bloodshot and glassy. My temperature was 99.3. I noticed rashes had developed on both knees. I had sweats all night. On 9/3, woke with runny nose, sneezing, coughing and totally fatigued. The rashes remained. Was totally fatigued all day. Felt like I head a head & chest called. On 9/4, woke with much the same symptoms as day before. Still had knee rashes.
Pale skin, fainting spell with shaking approxiamtely 30 seconds unresponsive.  Oxygen administered via non-rebreather at 15 LPM. Physician evaluated and vitals were reassessed prior to release to escort.
Day 1: fever and chills Day 2: fatigue Day 3: red streak appeared on arm for several days then dissapeared
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot # not reported) (strength and total daily dose not reported). It was reported that the patient received the dose of GARDASIL in a buttock. No adverse effect was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
"I started to feel strange". "Funny taste in mouth, dizziness, difficulty swallowing, and not thinking clearly, history of reaction to high dose flu shot, HTN
This spontaneous report was received from a physician via a company representative and refers to a 4 month old patient, of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On 13-SEP-2018, the patient was vaccinated with ROTATEQ orally, lot # R007991, expiration date 18-OCT-2019 (strength, dose and anatomical location were not provided) for prophylaxis; PREVNAR 13 and PENTACEL (strength, dose, route, anatomical location, lot # and expiration date were for both not provided). On 22-NOV-2018, the patient experienced intussusception and was hospitalized due to the event on the same date. The treatment included a barium enema. The patient was discharged from the hospital on 23-NOV-2018. Therapy with ROTATEQ was discontinued, as it was stated that the patient had not and would not receive any additional doses of ROTATEQ due to the adverse event. The outcome of intussusception was reported as recovered. The causality between the event intussusception and the suspect therapies was not provided. Upon internal review the event intussusception was considered to be medical significant.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:12 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 63.26.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 34 and 37 respectively, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials was sent to clinic. Vaccine BUD dates was 08-Apr-2021.  Vial was stored on cooler 1, on 20-Mar-2021, Excursion duration At 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM : 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient was given an expired vaccine the date of 6/10/22 and the vaccine expired 5/24/22. Patient has not yet reported any symptoms therefore no treatment was given.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2022 as dose 1, single (Lot number: EP7533) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21May2022, outcome "unknown", COVID-19 (medically significant) with onset 21May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: The vaccine was received. Patient received other medication in 2weeks: product- Albuterol inhaler, brand- ProAir. Anti-viral details product- Paxlovid, COVID 19 Treatment, treatment start date was 18May2022, treatment stop date was 22May2022 for indication Treatment of COVID-19. Symptoms returned after taking Paxlovid. Took Paxlovid on Day 2, and symptoms resolved shortly after. Tested negative on Day 9, then tested positive again on Day 12. Symptoms include runny nose, sore throat and some chills. No known allergies.
7:30pm unusual restlessness in both legs; by 8:30pm dull constant pain increased, legs were weak, knees wobbly, hands shaking.  Pain in legs became intense; I could not sit on the toilet.  Went to emergency room of Hospital at 9pm; no medications given.  Pain calmed by 10pm, but sensation in legs returned at 11pm and continued until  discharge at 1:15am on 3/6.  Took Tylenol PM at home for moderate pain in legs and went to bed.  Awakened next morning to no pain, had breakfast and went back to bed until noon.  Feeling fine since that time.
"Unusual" Shingles; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program,. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date, as a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was diagnosed with an unusual Shingles on unspecified date after receiving first COVID vaccine. Therapeutic measure was taken as a result of the unusual shingles and the patient was advised to put on antiviral medication and asked if it would affect the efficacy of second COVID vaccine. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Received flu vaccine in left deltoid muscle at approximately 2:30 PM. At approximately 3:25 PM, reported red spots and itching of both arms. Minimal site swelling (approximately 3cm), non raised rash on inner right antecubital area and similar on left arm. Denied difficulty breathing. Benadryl 25mg given with resolution of rash in 40 minutes. BP and P stable. BP 150/100 and Pulse 68.
Vaccinated wednesday, symptoms of exhaustion and dizziness appeared friday night/saturday morning. Symptoms of exhaustion continue today [monday].
Redness in arm/hot to touch 4 to 5 inches below injection site starting on Saturday 09/08/18 and No balance, shakes, and diarrhea (Sat. Only). As of today Monday 09/10/18 - patient stated arm is a little red, hot to touch and sore, but not as bad as it was. Balance is still not normal, but better than it was. Tremors decrease in frequency but still come and go. Spoke to patients physician and they set up an appointment with patient on 09/11/18 at 4:30pm.
Patient name and DOB identified and verified what we were doing today (Flu vaccine and Shingles vaccine). Patient agreed with plan. Here with family if needed help understanding my questions. Flu shot administered and then family said he only needed the Shingles vaccine and that he had already had the flu vaccine. Patient told family it was in September but it was given in October 2022. Had patient wait in clinic for 20 minutes. No adverse effects noted. Patient advised to go to ER if he experiences anything overnight. Patient in agreement with plan.
Pt became lightheaded and dizzy. Pt's vitals were evaluated and within limits. Pt's symptoms resolved without intervention. Pt refused transport to ED.
I (the patient) requested a walk-in COVID-19 booster vaccination from pharmacy staff (the pharmacy accepted walk-in COVID-19 vaccination requests). I was told by staff that I would be vaccinated for COVID-19, and I was given, and filled out, paperwork for a COVID-19 vaccination. I then saw the doctor, who informed me that the vaccine I was to be given was "quadrivalent." I said, "I don't know what that means," and he did not respond. I then asked if the vaccine included protection against Omicron, and he told me that the vaccine was an Influenza vaccine. I verbally consented to the Influenza vaccination and was administered that vaccination. Afterwards, I asked for the COVID-19 vaccination. The doctor refused, stating that I needed to make an appointment.
Patient arrived for dose 2.  Noted dose 1 given in L arm just under and to the right of deltoid muscle and appears SQ.  Initial bruising and swelling noted by patient for 2 weeks- now present with a left hard area and quarter size redness.  PCP for follow-up as needed.
I did not have an adverse reaction to the vaccine but contracted Covid 19 and tested positive May 24, 2022. I took ibuprofen and Mucinex for three days to alleviate the discomfort.
Headache, fatigue, muscle aches, swelling, redness and pain at sight of injection.
chest pain; breast lumps; pain in chest wall; covid like symptoms - shortness of breath; lung obstruction; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EW0191), via an unspecified route of administration on Jun2021 (at the age of 38-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included Penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Jun2021, the patient experienced chest pain, breast lumps, pain in chest wall, covid like symptoms - shortness of breath and lung obstruction seen on chest xray. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19- Nasal Swab with unknown result on unspecified date in 2021. The patient underwent lab tests and procedures which included chest x-ray on 15Jun2021 which shows lung obstruction. Therapeutic measures were taken as a result of the adverse events which included antibiotics, nebulizer, pump, albuterol, steroid. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
pt recv vax; devel chicken pox;f/u indicated that MD stated pt recv 2nd dose of vax & devel varicella type rash;
SHINGLES; FEELING LIKE CRAP; ITCHING ON LEFT ARM; NECK WAS VERY STIFF; NECK WAS SORE; HEADACHE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s on left arm (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced feeling like crap. On MAR-2021, the subject experienced itching on left arm. On MAR-2021, the subject experienced neck was very stiff. On MAR-2021, the subject experienced neck was sore. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced muscle pain. On 23-MAR-2021, the subject experienced shingles. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck was very stiff on MAR-2021, was recovering from headache, had not recovered from shingles, muscle pain, itching on left arm, and neck was sore, and the outcome of feeling like crap was not reported.  This report was non-serious.  Additional information was received from patient on 30-Mar-2021. The following information was updated and incorporated into case narrative: Reporter (details), due diligence, events (neck was sore and neck was very stiff), outcome (shingles and headache), shingles, muscle pain and neck was sore (treatment information),  product (neurontin), labeling and causality updated, narrative updated.
Swelling of right undereye area the morning after COVID-19 vaccine (approximately 23 hours after vaccine). History of dermal fillers in mid-face area one year ago.
Pain in left shoulder, radiating to axilla and elbow with painful swollen lymph node.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm 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 Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive, notes: Treatment for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had my 2nd shot on Monday., April 19. On Tuesday morning I had the blahs, a bit queasy, mild chills. By noon I didn't join a Zoom meeting because I was not feeling well and shivering. My temp never went over 100.6 that I am aware of. However, my normal temp is 97.5.  I crawled into bed to try and get warm. By then I was shivering, shaking badly. It became so intense that I couldn't call out to my husband. I couldn't use my cell because of the violent shaking. I don't know if I fell asleep or passed out. There were about 2 hours I could not account for. I still had chills and slight shivering when I woke up. I had fever for 3 days  and felt exhausted. It was so scary. It was so extreme and totally unexpected. I feel like I need to report this reaction.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/15/21,Pfizer ,Lot#EL3247 2nd dose:  02/05/21.pfizer,Lot#EL9264  Diagnosed covid positive:04/03/21 Exposure:Home Symptoms:Chills,runny nose,headache.
6MAR96 seen @ clinic n/v, fever x 2 days, ? rxn to ATB;7MAR96 chang to another ATB;9MAR96 seen by ER MD-hx fever x 4 days w/diarrhea, facial trunk rash-sl raised in cheeks, conjunctiva injected, SOB, cough, t105.3R;CXR-bilat pneumonia
Patient reviewed Menquadfi in error instead of Prevnar. When I called parents upon realization of error made, parents report patient has no reactions at time of call/this reporting. Advised to call for any concerns or side effects right away.
vertigo; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for three patients. This is the first of three reports.  A 70-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:15 (not pregnant patient), single dose for covid-19 immunization. Medical history included Multiple Myeloma, stem cell transplant on 02Feb. In remission, Known allergies: sulfa drugs, all from an unknown date. The patient had her first dose of BNT162B2 on 05Mar2021 10:15 on left arm for Covid-19 immunization. Concomitant medications included acyclovir [aciclovir]; folic acid; pravastatin, all taken for an unspecified indication, start and stop date were not reported. The patient experienced 8 days after receiving 2nd dose of the Pfizer vaccine (03Apr2021), a severe attack of vertigo and was hospitalized for 3 nights. The outcome of the event was recovering. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 03Apr2021. No other vaccine in four weeks.Treatment for the adverse event were CT scan, brain MRI, drugs. No covid prior vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021402492 same drug, different patient, similar AE;PFIZER INC-2021402493 same drug, different patient, similar AE
Student states she developed fever and vomiting 10/03/06 after receiving the vaccine earlier in the day. Came to student health on 10/5/06 to report symptoms. Fever of 100.1 on 10/3/06. Temp 98.6 on 10/5/06.
Had redness that appeared a few days after injection and lasted a few days. I even had a rash in the shape of the bandaid as well as a blotch below. No pain or itchiness
Vomiting - one time  Sweating while feeling extremely cold- for 1 hour Fatigue- 12 to 36 hours after injection