chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient describes feeling dizzy and hot through top of the body.  Patient had a low grade (99.8) temp and was advised by Physician to monitor temp for the next 4-6 hours. Consider a Covid test if temp goes over 100.4 degrees.   Advised Patient to rest.
This spontaneous case initially received on 06-Dec-2016, was reported by a health professional and concerns an adult patient of unknown age and gender. Weight: not provided; height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA (pre-filled syringe). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: WT52005 or WT56607. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date within a week of being dosed, the patient experienced fatigue (outcome: not reported), flu like symptoms (outcome: not reported), nausea (outcome: not reported), vomiting (outcome: not reported).
I am a board certified infectious diseases pharmacist and I have given lectures over hypersenstivites reactions. I noticed itching at the injection site a little more than 72 hours s/p injection with some minor itching. This progressed over the next 20 - 40 minutes to severe itching with large erythematous rash to the the left axillary region, then shoulder,  and chest. Then hives developed pretty aggressively to majority of body including neck, back, inner thighs, and bilateral legs. The next morning I woke up to severe myalgias feeling like I was hit by a truck with soreness this resolved after roughly 24 hrs. Pain worse in buttocks, quadriceps, and sharp left lower mandible pain.  On 01/02 around 7:30 pm took Hydrocorticone 100 mg PO x 1 and 50 mg of diphenhydramine q4h and the allergic reaction resolved over the next several hours.  Still having upper torso itching going on 3 days after allergic reaction and 6 days after injection. Continued diphenhydramine 25 mg twice daily keeps the itching tolerable.
A very, very bad, inflamed reaction to vaccine lasting several days - Wed - 1/1/14 I paced quickly to pharmacy for BENADRYL. Thur - 1/2/14 I rushed to emergency. On Mon. 12-30-13 got my Zoster vaccine at 3:15 pm at pharmacy - Wed. 1-1-14, back to pharmacy w. inflamed area to the vaccine so, pharmacist recommended diphenhydramine HCL 25 mg - (antihistamine). Thurs. 1-2-14, rushed to Emergency room, and doctor there said to continue the same diphenhydramine but, no change. Finally, Sat. 1-4-14, I went to my clinic - Doctor there prescribed me something called triamcinolone acetonide cream USP - 0.025% - gradually, I went getting better - sirs, not even the V.A.E.R.S. told me what I expected. I would like to add that, while making and trying to find out a solution to my problem on the telephone I was noticing and realizing that, everyone I spoke to never really told me, nor advised me on or, with the vaccine reaction itself. Of the few people who spoke to me, never told me what to do for this, right there on. I felt I was just getting switched fm. person to person, but no advice. No problem - I would still call the F.D.A. if I still have to in the future. Maybe I'll hear something from someone then. I'm glad I got someone that help.
the evening after receiving both vaccines patient experience shortness of breath but thought it was related to her asthma. Patient reports the next couple days she thought her face felt funny and "droopy" but when asking other family/friends they said she did not have any visible changes. Patient noticed visible facial change on 9/11/21 and went to ER for complete workup where they ruled out TIA, lyme disease etc.  Patient was given valtrex and prednisone tapers for treatment she is currently completing
Chills; fever; headache; weak; no appetite achy, all for 24 hours.
Pt felt stiffness & swelling in neck on 14JAN91 tx by MD on 15JAN91 temp to 103 developed headache & some diarrhea on 18JAN91. Dx acute viral synd possibly related to MMR vax. Pt saw neurologist no neurological abnorms. Cleared for work
5am on 11/17/05, awoke with severe dizziness, lightheadedness, nausea, sweaty/cold. She had difficulty walking, so she used a walker. Symptoms improved with time without treatment. 11/18/05 Still a little lightheaded in AM.
Legs became reddened, blotchy and black and bluish. Warm to touch. Pt recovered within 30 minute and leg went back to normal.
Blood pressure low (86/65) Heart Rate 89 Respirations 16 ; Became very cold and sweaty for 12 minutes and pale;  After 12 minute he was pink, dry and was alert and oriented the entire time.  He drunk fluids and at some chicken tenders and was discharge from the pharmacy at 6:30 pm.  He called when he got home at 6:40 pm and was doing great
I had nausea with stomach pain, diarrhea, fever of 99.5, and just a general feeling of blah. I started feeling better but now I feel bad again.  The doctor prescribed medication for me and I filled it but won't take it due to the side effects listed for the medication and I will just deal with the nausea.
patient received pentacel and prevnar vaccines in error with no reported adverse event; Initial information received on 31-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Child of unknown gender who received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVNAR 13] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] vaccines in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a Primary dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (lot: UJ799AA) via intramuscular route on left side and the patient also received an unknown dose of suspect PREVNAR 13 not produced by Sanofi Pasteur (formulation; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information regarding batch number will be requested in the case.  On an unknown date the patient received pentacel and prevnar vaccines in error with no reported adverse event (wrong product administered) (latency: same day).  It was reported, "This was a double scheduled visit with sibling, both children have same initals. Doctor requested vaccines for patient by circling vaccines on enounter (Pentacel and Prevnar-13) on both children, order was entered by nurse, Vaccines were drawn up, documented in chart prior to giving vaccines. Vaccines were given. A: After leaving exam room, I came out to nurses station and another nurse was questioning whether or not the older brother was needing these vaccines. Prompting her to look at the system, seeing that they INVALID. Dr. was notified and Manager notified: Dr. will document and contact parent. Drug rep/ manufacturer will be contacted to see if there will be any adverse effects."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 39 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Major depressive disorder", start date: Jun2013 (ongoing); "Graves' disease", start date: Mar2022 (ongoing); "Appendectomy", start date: 1987 (unspecified if ongoing), notes: Appendectomy; "Depression" (unspecified if ongoing); "Gallbladder removal", start date: 1993 (unspecified if ongoing), notes: Gallbladder removal. The patient's family history included: "Type 2 diabetes", start date: Nov2012 (ongoing), notes: Type 2 diabetes, Mother has asthma, diabetes, bipolar disorder (age 76 years old); "Asthma" (unspecified if ongoing), notes: Mother has asthma, diabetes, bipolar disorder (age 76 years old); "bipolar disorder" (unspecified if ongoing), notes: Mother has asthma, diabetes, bipolar disorder (age 76 years old). Concomitant medication(s) included: METFORMIN oral taken for diabetes mellitus (ongoing); GLIMEPIRIDE oral taken for diabetes mellitus (ongoing); LANTUS XR taken for diabetes mellitus (ongoing); PROZAC oral taken for depression (ongoing); METHIMAZOLE oral taken for basedow's disease (ongoing); PROPRANOLOL oral taken for basedow's disease (ongoing). Vaccination history included: BNT162b2 (Dose: 2, Time: unknown, Anatomical site of injection: upper right arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 18Feb2021, when the patient was 38-year-old, for COVID-19 Immunization, reaction(s): "felt sick"; BNT162b2 (Dose: 1, Time: unknown, Anatomical site of injection: upper right arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 29Jan2021, when the patient was 38-year-old, for COVID-19 Immunization, reaction(s): "felt sick", "very sore arm". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "felt sick".  Additional Information:11Oct2021 3rd dose of vaccine, felt sick 2 days. Complete only if a 3rd dose was administered. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complication). Specific relevant test for thromboembolic events with thrombocytopenia was none.  No follow-up attempts were possible. No further information was expected.
[Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA] This patient presented to our COVID clinic on 9/23/2022 to receive her 4th COVID vaccination with the Pfizer Bivalent Booster. She received this vaccine with no further events. It was reported on 9/28/2022 that this patient was brought to our ED from the nursing home she is employeed in cardiac arrest. Patient was found on the floor of one of the nursing home residents room by one of the CNA's. Last know well time could not be provided by the staff at the nursing home. Per EMS when they arrived at the scene no CPR was being done. EMS immediately commenced intubation and CPR for ~33 minutes. EMS indicated patient was pulseless and apneic when they arrived at the nursing home and remained so at every rhythm check during CPR. Patient is a never smoker; did not drink alcohol or use other illicit substances. Patient was dead on arrival at ED.
Tired, chills, slightly elevated temperature (99.6) day after vaccination for approx 24 hours. Soreness, swelling and redness of site during a period of well over a week after the injection.
laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain); horrible pain on left side (side of the injection); awful pain on left leg; could not raise leg; congestion in head, like a sinus infection; tiredness/fatigue; Headache; Chills; A spontaneous report was received from a consumer, a 79-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain), horrible pain on left side (side of the injection), headache, chills, tiredness/fatigue, awful pain in leg, could not raise leg, and congestion in head, like a sinus infection.  The patient's medical history was not provided.  Her allergies included sulfa, mycin, meloxicam and glycopyrrolate.  Concomitant medications included blood pressure medication (name not reported).  On 28 Jan 2021, approximately one day prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number: 028L20A) on the left side (anatomical location not reported) for prophylaxis of COVID-19 infection.  On 28 Jan 2021, on the night of the vaccination, the patient woke up with a horrible pain one her left side (side of the injection), headache, chills, fatigue/tiredness, an awful pain on her leg, and congestion in her head, like a sinus infection.  She got up thinking that walking would make the pain on her leg go away, but it did not.  When the patient tried to go back to bed, she could not raise her leg so she laid on the floor and she did not know if she passed out on the floor or fell asleep (she thought she could not have fallen asleep with such pain).  When the patient woke up, she could move her leg normally.  Treatment information was not provided.  Action taken in response to the events was unknown.  The events, laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain), horrible pain on left side (side of the injection), headache, chills, awful pain in leg, could not raise leg, and congestion in head, like a sinus infection were considered resolved on 29 Jan 2021.  The event, fatigue/tiredness was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 79 year old female subject, who experienced a serious unexpected event of loss of consciousness after first dose of mRNA1273 (Lot# 028L20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Information has been received from a nurse referring to a patient of unknown age. On 22-JUN-2016 the patient was vaccinated with VARIVAX and PROQUAD (lot #/expiration date unknown) together (overdose). No adverse effects reported. Additional information has been requested.
It has been 14 days since first dose - patient is going to military training on Monday and will not be able to get second dose any later. Patient is aware of risks and wishes to continue.
Initial report was received from a consumer, who was also the patient, on 26 October 2012. A 66-year-old female patient had received an intramuscular injection in the left arm of FLUZONE High-Dose, lot number not reported, in October of 2011 and an unspecified amount of time later experienced swollen lips, face, eyes, tongue and felt like her throat was closing. The patient was treated in the emergency room with IV's, Prednisone and BENADRYL. The patient was sent home after two hours and much improved. The patient had no illness at the time of vaccination, allergy to amoxicillin where she experiences hives and a history of high blood pressure and high cholesterol. Concomitant medications included lisinopril and CRESTOR. The patient's outcome was recovered. Documents held by sender: None.
No additional adverse effects reported; on 22-JUL-2020, a dose of properly stored GARDASIl 9 with expiration date 21-JUL-2020 was inadvertently administered to a male patient; This spontaneous report has been received from a registered nurse, concerning to 20-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was inadvertently vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N025429 with expiration date 21-JUL-2020 (dose, frequency, route and anatomical location were not provided) for prophylaxis. No additional adverse events were reported.
feels like there is a rod in her arm; proceeded to dry-heave; feeling abnormal; Vaccination site reaction; felt really achy in her hips; have not regained her normal level of energy; pretty good headache; felt like she was doing shoulder press for a month nonstop; A spontaneous report was received from a consumer concerning a 53-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pretty bad reaction, pretty serious vomiting, immediate reaction, massive rush up her chest into her neck, like an adrenaline sensation, felt high and buzzed up, felt a little funny, felt creaky and foggy, felt really achy in her hips, lethargic, vomited all over, 3 rounds of vomiting, didn`t feel great, arm was really sore, felt like she was doing shoulder press for a month nonstop, felt a little foggy, proceeded to dry-heave, was in bed for 2 and half days, pretty good headache, appetite been off, sleep been off, feels like there is a rod in her arm, have not regained her normal level of energy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026120A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) pretty bad reaction, pretty serious vomiting, immediate reaction, massive rush up her chest into her neck, like an adrenaline sensation, felt high and buzzed up, felt a little funny, felt creaky and foggy, felt really achy in her hips, lethargic, vomited all over, 3 rounds of vomiting, didn`t feel great, arm was really sore, felt like she was doing shoulder press for a month nonstop, felt a little foggy, proceeded to dry-heave, Was in bed for 2 and half days, pretty good headache, appetite been off, sleep been off, feels like there is a rod in her arm, have not regained her normal level of energy.Consent for safety to follow-up was received.  Treatment details included none  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pretty bad reaction, pretty serious vomiting, immediate reaction, massive rush up her chest into her neck, like an adrenaline sensation, felt high and buzzed up, felt a little funny, felt creaky and foggy, felt really achy in her hips, lethargic, vomited all over, 3 rounds of vomiting, didn`t feel great, arm was really sore, felt like she was doing shoulder press for a month nonstop, felt a little foggy, proceeded to dry-heave was in bed for 2 and half days, pretty good headache, appetite been off, sleep been off, feels like there is a rod in her arm, have not regained her normal level of energy was unknown.  Based on MSA comment, Anxiety, Feeling abnormal, Euphoric, and Malaise is deleted.
2-15-11 complained to mother of pain in neck and eye irritation. 2-16-11 noticed lazy lip. 2/17/11 twitching & crooked smile. Diagnosed on 2/18/11 with Bell's Palsy in the ER.
11 year old child was given the 0.3ml of the adult formulation of Pfizer
I had my third covid vaccine given in my left arm on 10/9 and started with what felt like a muscle pull on 10/10  under my left axilla. I noticed in the afternoon when changing that there is swelling under my left axilla. I cannot palpate any lumps or bumps , but it is slightly uncomfortable in that area when palpated and is swollen . No color changes noted and it is not hot to the touch . My injection site has no pain. Today is 10/11 and the swelling and tenderness are still present no changes  from yesterday.
Patient woke up on 12/24/20 with nausea, dry heaves, chills, headache, and general weakness.
The day after receiving my second dose of the Pfizer Covid-19 vaccine, I experienced minor side effects, including elevated temperature (99.8 F), headache, and soreness in my arm at the injection site. This lasted the whole day. The day after that, my temperature was back to normal (98.1 F), no headache, and the soreness had subsided significantly, but I am experiencing some swelling and soreness in my right armpit.
patient's wife called 4-24-21 to inform clinic that patient was taken to the ER for "breathing issues and inability to walk"; was treated by ER and sent home
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  It was reported that the data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients. The reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  Treatment information was not provided.
Vaccinator was only able to pull 4 doses from the vial. Likely too little diluent given. No adverse events during monitoring period. Pt notified.
ANXIETY; NERVOUS; SHORTNESS OF BREATH; CONDITION AGGRAVATED; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chest tightness. On 24-APR-2021, the subject experienced shortness of breath. On 24-APR-2021, the subject experienced condition aggravated. On an unspecified date, the subject experienced anxiety, and nervous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest tightness, shortness of breath, anxiety, nervous and condition aggravated was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Administration error only, no reaction. During injection, after a small amount given, the needle detached from the syringe and the vaccine ran down her arm. After review of the guidelines the person was given the full dose in the opposite arm.
1/12 had complaints of congestion, headache, stomach ache, chills and her right arm at the injection was very painful. She medicated herself with Tylenol on 1/13/21