chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm pain and tingling; left arm pain and tingling; fevers; nausea; heaviness of her head; This is a spontaneous from a contactable physician reported that.  A 64-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 intramuscular, administered in Arm Left on 04Apr2021 (Batch/Lot Number: EW0169) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 64 years). Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient past medical history included hypertension from an unknown date and unknown if ongoing, Allergies to Chamomile, codeine, latex, mango, Pineapple and shellfish. The patient's concomitant medications were not reported.  The patient previously took codeine and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On 13Apr2021 the patient developed left arm pain and tingling, fevers, nausea and what she describes as heaviness of her head. The adverse event results Doctor or other healthcare professional office/clinic visit. The patient received a treatment with Pepcid. The event outcome was Not recovered.  Device Date: 04Jun2021  Follow-up attempts are completed. No further information is expected.
This medically confirmed report (initial receipt 04-May-2012) concerns a female patient. The patient had an allergy to flu vaccine (manufacturer and batch number unknown). The patient sought medical attention and received treatment not specified. No further information was available. The event outcome was recovered.
male with history of CAD, COPD on home O2 and chronic prednisone, CHF, HTN, HLD, neurogenic bladder with chronic Foley in place, and CREST syndrome who presents as a transfer from hospital where he has been hospitalized for COVID pneumonia and was transferred after developing AKI.  Patient was tested for COVID-19 and was positive on 1/11.
It was reported that approximately 23 year old female received Fluzone SV '2002-'2003 (lot U0919AA) in the left deltoid on 10/17/02. Ten to fifteen minutes post-vaccination, the pt developed redness and itchiness on her left deltoid where the injection was administered. She then experienced nausea and vomiting. She was medicated with Benadryl, a shot of methodexozone and was given epinephrine within a half hour of receiving the vaccination. It was reported that the pt recovered and is doing well. Seriousness criteria: other medically significant (OMIC).  A 15-day follow up report received 9/9/2003 adds: From additional info received on 09/02/2003 from a registered nurse, it was reported that the pt is a 25-year-old female who had hay fever at the time of the vaccination. The pt received Fluzone SV '2002-'2003 USP on 10/17/2002 at 10:00 AM, which was her first dose. The pt did not receive any other vaccinations at that time. The onset of adverse events was noted to be at 10:01 AM, 60 seconds after the vaccine was administered. The pt's date of birth was provided. No further info is anticipated, this case is considered closed.
pt recv vax OCT96 & pt exp a fever myalgia, & arthralgia;MD indicated this was poss a serum sickness like rxn;MD also reported that pt went to hosp however it was not known if pt was hosp;
First Noted slight red area around vaccination site which has now grown to about a baseball size over 4 days.
Started out as a pink rash on chest. Was itchy. Responded to hydrocortisone  cream which stopped the itching and the rash disappeared only to come out on other body parts. This occurred for short periods of time, cleared up and the reappeared in other areas. Never a rash or itching during sleep. After wakening rash and itching started in various locations. After one week on doctors advice took Allegra a for 5 days and problem  went away while on the medication. The day after I stopped taking the meds. the rash reappeared in smaller areas and the itchiness was less sever. Each day the symptoms were gradually declining on their own. Total of days with symptoms from start to finish was 19 days.
I developed a slight rash under left armpit , as well as some pain in left arm . No other symptoms, rash was very  itchy  & after 4 days had NP look at rash  & was diagnosed with shingles. Previous history of chicken pox , never received shingles vaccine . Was out on 7 day Acyclovir x TID .  Have autoimmune disorder of type I diabetes.
This spontaneous report as received from a physician refers to an adult patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On 14-MAY-2014 the patient was vaccinated with RECOMBIVAX HB, 5/0.5 microgram-milliliter intramuscular. No concomitant medications were reported. It was reported that on 14-MAY-2014, the adult patient received 0.5 ml pediatric dose and no adverse effects reported. PQC was not involved. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, site of administration, lot number and expiration date were not provided) for prophylaxis while the patient was concomitantly taking valacyclovir (VALTREX). Other suspect therapies included sterile diluent (STERILE DILUENT) (lot # and expiration date were not provided). The pharmacist reported that the valacyclovir (VALTREX) medication was not stopped for two weeks prior to the patient receiving the ZOSTAVAX vaccine. No adverse effects were reported. No further information was provided. Additional information has been requested.
Presented with SOB x9 days; +Covid on 1/18; became more SOB on 1/23; CXR: bilat interstitial and alveolar infiltrates consistent with atypical multifocal PNA; CRP 17.43; D Dimer 0.55; Ferritin 3340  Tx: Zithromax, Rocephin, Decadron, Remdesivir, Vit C, Vit D3, Lovenox, Zinc; initially on 4 LPM with admission; up to 10 LPM and then back to2 LPM at d/c; home with home O2
Pt's arm has a wide rash around the injection site that appeared 3 days after the injection and is till present 8 days later.
Booster dose administered to a 15 year old patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to a 15 year old patient) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer shot (1st dose, with intramuscular route and Lot number was EWO151 with expiration date of 23-Jul-2021.) on 21-May-2021; for Product used for unknown indication: Pfizer shot (2nd dose and Lot number was EWO151 with expiration date of 23-Jul-2021.) on 14-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer shot and Pfizer shot.    On 23-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to a 15 year old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to a 15 year old patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's date of birth was reported as March 2007.  No concomitant medications information was reported. No treatment was given, as no AEs were reported.
I received the flu shot yesterday at a pharmacy. I have been getting an annual flu shot for the past 12 years. However, I had a fever and severe chills and shaking hours after taking the shot. I also had some nausea and felt dizzy a few separate times. I have never experienced anything like this before with a flu shot. I am concerned about the quality of the flu shot I was given. I usually don't get sick after taking a flu shot. However, I was really sick all of last night.
erythema at injection site, swelling, itching, swollen lymph nodes in R axilla
have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; 36 hours of left chest pain radiates to left arm; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; 36 hours of left chest pain radiates to left arm; This is a spontaneous report from a contactable Physician.   A 16-year-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in arm left on 12May2021 10:15 (Batch/Lot Number: EW0167) as single dose at the age of 16-year-old for COVID-19 immunisation, administered ad hospital.  Medical history included acne with no medications. The patient's concomitant medications were not reported.  patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in arm left on 21Apr202110:15 (Batch/Lot Number: ER8735) as single dose at the age of 16-year-old for COVID-19 immunisation. No past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient experienced ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis, 36 hours of left chest pain radiates to left arm on 13May2021.  The course of events was as follows: Previously healthy 16 year old male complaining of 36 hours of left chest pain radiates to left arm. Had Pfizer vaccine dose #2 about one day prior to chest pain onset. Found to have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis. Admitted to the Pediatric ICU for further management on 15May2021 7:00AM. The patient was hospitalized for the events, considered life threatening. Since the vaccination, the patient has been tested for COVID-19: Sars-cov-2 test: negative on 15May2021 Nasal Swab. Therapeutic measures were taken as a result of events, treatment in process. The outcome of events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I have a tickle and rash over my face; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single 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 "unknown", described as "I have a tickle and rash over my face".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough COVID infection in fully vaccinated patient. Positive date 10/06/2021.
Dizziness. Started about 1 hour after the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 23Sep2023 at 16:15 as dose 1, single (Lot number: WAG36183) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DIZZINESS (non-serious) with onset 23Sep2023 at 17:30, outcome "not recovered", described as "Dizziness. Started about 1 hour after the vaccine.". It was unknown if therapeutic measures were taken as a result of dizziness.  Additional information: The patient had no other vaccine in four weeks. The patient did not have Covid prior to the vaccination, was not tested for Covid post-vaccination, and has no known allergies.
Fever of 101.3 Ache all over  I am on the second day and the effects are subsiding
Shot at 3pm....By 8pm had a very sore arm and was moderately fatigued by 10pm mild joint aches and moderate fatigue. 8am next morning moderate joint pain - in particular one ankle felt very stiff. Arm was more sore could not lift this continued until around 4pm now mild joint pain arm still painful but much less so appears to be resolving. Still mild fatigue as of 7pm as well as random pain in joints off and on.
Rash on B neck; looks like 2 oval red patches, minimal itchiness at base of neck, but not at rash. She feels fine otherwise. Rash has not resolved yet.
Patient has not experienced any adverse reactions. This vaccine was the booster dose, however, it was given at 0.5mL instead of 0.25mL
Within about 36 hours I noticed the biggest herpes outbreak I have ever experienced. I did not seek medical attention as I have been living with herpes for over 35 years.  72 hours after the herpes presented, it is quickly subsiding and should resolve in a few more days.
Information has been received from a physician concerning an 8 year old patient who received a second dose of varicella virus vaccine live (Oka/Merck) and developed break through chicken pox. A product quality complaint was not reported. Additional information has been requested.
Information has been received from an 84 year old female with hypertension and an allergy to cephalexin Keflex who on 10/18/05 was vaccinated SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included amlodipine besylate Norvasc. On 10/18/05, the pts arm became very sore and red. The flab on the underside of her arm also became very swollen. No medical attention was sought and no diagnostic lab test were performed. At the time of the report, the pt had not recovered. A product quality complaint was not involved. No further information is available.
Caller indicates he takes "epifen 10mg and no hematoma formation".; This is a spontaneous report from a contactable consumer or other non hcp.  A 71-years-old male patient received dose 1 of bnt162b2 (BNT162B2, Solution for injection, (Batch/Lot Number: EL3302), via an unspecified route of administration on an unspecified date as SINGLE DOSE for an unspecified indication. Medical history included disability from an unknown date and unknown if ongoing. Concomitant medications included epinephrine (EPIPEN) taken for an unspecified indication, naproxen sodium (ALEVE), Aleve (Lot no NAA92FK expiry:Jun2023) taken for disability. Patient was responded by caller when vaccinating Persons with Increased Bleeding Risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection. He just wanted to find out if the things he did affect the potency. He said he did take a blood thinner. Secondly, the local station said one should not take any over the counter medication or pain killer, pain relief pills like aspirin, Ibuprofen, and it did not mention Aleve. The patient had asked whether he could antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. He was responded, recently too the Pfizer vaccine tuesday saw the warnings on the news channel all the things he should have done or not done, daily habits included Aleve, Norco. He was responded the interim ACIP guidelines note that Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms was not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses was not available at this time and If you were a patient, you should discuss this with your healthcare provider. The patient took Epifen 10mg and no hematoma formation. The outcome of the event was unknown.  Follow-up attempts were completed. No further information was expected.
Patient received 1st dose of COVID vaccine (Moderna) IM in Left arm in medical facility on 1st floor here medical facility. Patient was brought by staff member to Allergy office area to wait due to history of anaphylaxis.  Patient utilized emergency phone outside of office at approximately 1:38pm.  Patient c/o of heart racing and chest tightness, face and arms noted reddish in color.  BP 144/100 P143 SpO2 99% doctor immediately assessed patient and 0.3 ml of Epinephrine SQ was administered in right arm.  1:42pm Benadryl 50 mg IM administered in right arm. 1:50pm Patient reassessed by doctor immeidately BP 141/85 P103 SpO2 98% patient stated she is feeling better, noted face and arms now paler in color.   Patient offered and accepted can of orange juice.  2:05pm Patient reassessed by doctor.  2:20pm BP 133/85 P107 SpO2 98% Patient reassessed by doctor 2:30pm Patient reassessed by doctor Administered Depo-Medrol 40 mg IM right arm BP 129/78 P102 SpO2 99% Patient stated she is feeling better however feels a bit cloudy.  3pm BP 129/74 P 74 SpO2 99%  3:15pm BP 124/80 P 101 SpO2 98%  Patient was assessed by doctor and left office in no apparent acute distress.  Patient advised not to drive after dose of Benadryl, patient in agreement, patient's father gave patient ride home
Fever, chills, tiredness, headache, face feels swollen/punched in face
Patient developed rectal temperature of 101.5 degrees F.  The temperature decreased on 10/21 to 98.9 degrees F.  She had no further temperatures on 10/22/09 or thereafter. This serves as inital/15 day report as it is a mild AE.  This temperature is possibly related to the vaccine, but may be due to other vaccinations received on this day.
increased redness; increased fussiness; had a fever of 99.8 F; Initial information received on 17-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA103059 and 2020SA103147 via same reporter.  This case involves a 2 months old female patient who experienced increased redness and fussiness (erythema and irritability) and  fever of 99.8 Fahrenheit (pyrexia) , while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR).  On 16-Apr-2020, the patient received first dose 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ164ABA and expiry date 16-Feb-2021) via intramuscular route in the right thigh for prophylactic vaccination.  On 17-Apr-2020, the patient developed a non-serious increased redness and fussiness (erythema and irritability) and  fever of 99.8 Fahrenheit (pyrexia) 1 day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Laboratory test results included: Body temperature - 99.8 Fahrenheit   Final diagnosis were pyrexia, erythema and irritability.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not reported.
Case number PHEH2016US032832, is a spontaneous report initially received from a medical assistant on 13 Dec 2016. This report refers to a 29 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185887) at a dose of 0.5 ml, intramuscularly on 12 Dec 2016. It was reported that, the first temperature excursion was reported with FLUCELVAX pre-filled syringe (PFS) as 18.0 degrees Celsius (maximum temperature) for 6.5 hours. One of the pre-filled syringes might have been given after the temperature excursion on 12 Dec 2016. Upon follow up it was reported that, the patient had no adverse reaction following this medication error. The case was assessed as non serious by the medical assistant. Follow up report received from a medical assistant on 10 Jan 2017: Updated reporter's comment.
I started having a headache on the day of the vaccination. I thought it would just go away, but I had it for 7 days. I took Advil initially. Then the 2nd day, I took an Imitrex. The headache still did not go away. I took Advil over the next couple of days. I went to Employee Health on 10/7/13, because the headache would not go away. I was given Phenergan which I took on the 7th at bedtime. The headache ws dulled but still there. It went away on 10/9/13.
Very sore arm x 2-3 days. Then red, raised area on shoulder increasing in size. After 5 days. Oval shaped. 06/02- Benedryl and ibuprofen given. watching pt as of 05/30/05.
reports late in the evening that day experienced pain to right arm with swelling  from shoulder to forearm. States placed warm compresses to site and took  Bendaryl PO. States called nurse triage line, which advised him to do the same.  Patient states all syptoms have resolved, but wanted facility to be aware. Denies  further needs/concerns.
Red, raised, itchy rash. It is not so much ON or AROUND the injection site, but a few inches under it. It does not touch the injection site at all.
Approx 10 minutes after vaccine administration, patient reported headache, sore throat, tingling in arms, difficulty breathing, and dry throat. At 10:45 am administered 0.3ml of EPI to left thigh. At 10:50 am patient reported less tingling in hands/arms, started feeling better. At 11:15am resting comfortably, no distress noted.