chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; red, slight swelling and hot to touch at vaccination site; red at vaccination site; slight swelling at vaccination site; hot to touch at vaccination site; itchy at vaccination site; vaccination site rash; Initial information was received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (office staff).   This case is linked to cases 2020SA231242 and 2020SA241448 (same reporter)  This case involves an adult patient (gender unspecified) who had headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash, when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2008 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.
When I received the injection, I had a sharp pain (more than usual for a deltoid injection in the past).  I had extreme fatigue, some lightheadedness, and a small amount of nausea the morning after I received the injection.  I needed to return home from work around mid day and slept for about 2 hours.  Some minor lighheadedness lasted through the following day (10/4) but all adverse symptoms were gone by 10/5).
6mo Female with mild laryngomalacia and recent URI received routine 6 months vaccines and first Flu vaccine today. A few minutes after receiving vaccines and leaving the office she was brought back by caretakers unresponsive. Patient was assessed and had normal VS, open airway, breathing spontaneously, and hemodynamically stable but minimally responsive to noxious stimuli. Finger stick glucose was 95. She developed a rash on the face and was given epinephrine due to possible anaphylactic reaction.  She was taken to the emergency room at Medical Center
Patient stated beginning 1-2 hours after receiving vaccination they experienced nausea, tightness in throat, moderate/severe uncontrollable body shaking. Patient rested for several hours; said 24 hours later they felt much better. Patient notified and discussed with primary care physician.
Lower right extremity raised rash beginning from ankle to groin. Lower left extremity raised rash localized on calf.
TDAP vaccine (unsure of brand) given at 28 week pregnancy visit.  Severe pain starting one hour later. Difficulty moving arm/shoulder back and outward. Today is day 7. Not able to sleep due to pain, limited range of motion. Was seen at urgent care. Informed of bursitis, vaccine given high.
myocarditis; pericarditis; SOB; Chest pain; troponins as high as 25; BNP of 150s; This is a spontaneous report from a contactable pharmacist. A 14-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 26May2021 (Lot Number: EW0197) at the age of 14-year-old as 1st dose, single dose for covid-19 immunisation.  Medical history included Autism, asthma and COVID-19 which was diagnosed prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced pericarditis/myocarditis with "SOB" and Chest pain and troponins as high as 25 and BNP of 150s. All the events occurred on 27May2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19  IgM (Nasal Swab): negative on 29May2021, COVID-19 IgG (Blood test) positive on 29May2021. The patient received NSAIDS and Opioids as treatment.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be fully excluded. There is limited information  available, which precludes a more meaningful assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug 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
(L) deltoid area swollen-started a little nite of injection. Next day the same, worse the night after injection given. Area is warm, red, tense and painful.
pt presented to Er seizing for approx 1 hr; sz were focal in origin w/rt side shaking & eyes deviating upward; pitched t103 R; no hx of sz; father had sz in childhood which resolved;
Tongue & throat tingling & numbness. Took 2 Benadryl that helped. Heart racing & blood pressure got high. Chest tightness. Feeling nauseous off & on. Went to ER they completed EKG & several blood tests. Gave Ativan to settle heart racing down & a short term blood pressure pill for high blood pressure.
Vaccine on Friday afternoon, spiked 104 fever by Saturday night. Body aches and swelling at the injection site.,
Extreme pain at injection site, swelling redness. Cold chills, terrible Headache, hallucinations , fatigue the next day and general malaise. Redness and swelling lasted 5 days at injection site.
I had a fever blister i got a tingling feeling on my upper lip and it got larger.
itching on her back and sides; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 71 years 3 months and 25 day old female patient who experienced itching on her back and sides, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Jul-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in the right arm.  On 16-Jul-2019, the patient developed a non-serious itching on her back and sides (pruritus) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Final diagnosis was itching on her back and sides.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for itching on her back and sides.  Information on the batch number was requested  List of documents held by sender: none.
My right eye lens clouded over very soon after the shot.   Eyesight deteriorated from 20:30 to 20:150 Didn't clear for six months so ended up getting surgery to replace the lens.
I had a sore throat that felt like it was closing off,  muscle aches, pains. Received Dose 2 on 01/12/2021.
flu; Initial information was received on 06-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from patient.  This case involves Adult female patient who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported, "the only time patient got the flu was when got the flu shot. Same with hubby so no coincidence there!! Never again. Plus my mother & her sister for years would get the flu shot, only ones that ended up with dementia! Sorry no! Nothing beats your immune system, learn what to take to stay healthy."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Complain of arm hurting and sore red hot area approximately 4cm. Prescription for medrol dose.   Use benedryl oral care.
Started out as muscle ache at injection site.  By 9:00 PM, temperature increase to 99.3.  Injection site had hot red marble-size lump developing.  10:00 PM temperature increases to 101.2 with chills. I can't seem to get warm.  Took more Advil, added more blankets and finally went to sleep. Oct 19th, 4:00 Am temp rises to 102.3.  Went in to see nurse @ 10:30 AM.  Injection site now has hot redness that spread out in a line from injection site toward inside of arm.  Temp still at 100.8 even though Advil taken.   Dr. gives me a perscription for anti-biotic in case of infection to take if the redness spreads.  Oct 20 still have temp of 101.3 all day and night. Muscle pain down the injection site arm to elbow.  Oct 21, redness has spread to just below elbow in the same unusual angle toward inside of arm where the muscles had been sore the day before.  Oct 22, fever finally breaks.  Starting to feel better but very weak still.  Oct 23 feeling much better today and redness is fading.
Very sleepy 4 hours after second dose; This is a spontaneous report from a contactable healthcare professional (patient herself). A 60-year-old female patient received the second dose of bnt162b2 (lot number: Ek9231), intramuscularly on the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient was not pregnant. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (lot number: Ek5730) intramuscularly on the right arm on 22Dec2020 at 08:00 AM. On 11Jan2021 14:00, the patient became very sleepy four hours after second dose. The patient was recovering from the event. No treatment was given in response to very sleepy 4 hours after second dose.
administration of vaccine that expired with no reported adverse event; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of unknown age and demographics who was administered expired Influenza Quadrival A-B High Dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Oct-2023, the patient received an unknown expired dose of suspect Influenza Quadrival A-B High Dose HV vaccine of lot UJ773AA and expiry: 30-Jun-2022 (formulation and strength: not reported) via unknown route in unknown administration site for influenza, with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   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 Directive and Regulatory Authority Practices. 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.
palpitation; This case was reported by a nurse via call center representative and described the occurrence of palpitation in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2020, the patient received the 1st dose of Shingrix. On 12th June 2020, less than a day after receiving Shingrix, the patient experienced palpitation. On 12th June 2020, the outcome of the palpitation was recovered/resolved.   It was unknown if the reporter considered the palpitation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced palpitation on the same day and resolved on the same night. The reporter consented to follow up. This case has been linked with case CA2020097732, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020115724:same reporter
to the ED on 4/30, with an ECG and symptomatology consistent with pericarditis, no official diagnosis sent home on indomethacin. Cardiology 5/4 with the ongoing diagnosis of atypical pericarditis sent home. return to the ED 5/9. No definitive pericarditis diagnosis R/T vaccine admin. did experience Left sided numbness upper/lower extremity which was worked up with unclear etiology
Experiencing full body urticaria hives and rashes  . They are spontaneous and worse at night .  Dermatographia noted .
Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 17 year old female who on 30-APR-2007 was vaccinated IM with a first dose of Gardasil lot # 657621/0387U. Concomitant therapy included prenatal vitamins (unspecified). The nurse reported that the patient became pregnant sometime after her first injection. Patient was positive over the counter pregnancy test. In follow up it was reported that on 16-AUG-2007 ultrasound showed 7 weeks pregnancy and the expected date 04-MAR-2008. The patient's outcome was unknown. In follow up information from doctor's office it was reported that patient was treated with prenatal vitamins starting from 15-AUG-2007 for pregnancy. On 16-AUG-2007 she was diagnosed pityriasis. On 05-SEP-2007 patient was treated with 10 mg REGLAN for nausea every 6 hour as needed. Fetal arrhythmia was detected at 20 weeks of her pregnancy. She saw maternal Fetal Medicine (MFM) doctor and her fetal cardiac ultrasound was normal. It was reported that she had threatened preterm labor and on 08-NOV-2008, she was treated with magnesium sulfate intravenous (IV) in the hospital for it. After she was off magnesium sulfate she was treated with PROCARDIA 20 mg every 6 hour for preterm labor. On 08-NOV-2008 she was noted to be positive ureaplasma of the vagina/cervix. Other laboratory tests included biophysical profile, Amniotic fluid index (AFI), Non stress test (NST) was done weekly starting 27-DEC-2007 and then twice weekly till 28-JAN-2008. It was reported that patient had a normal female baby on 12-MAR-2008, 41 weeks from her last menstrual period. The baby weighed 8lb 1oz and her Apgar score was 8/9. There were no abnormalities reported. Additional information has been requested.
Fever 102.8 starting 7/23/2013. Rash developed 7/27/2013. Morbilliform pink rash involving entire body.
Itchy Body, itchy mouth, trouble breathing started about 10:00 am, 10 minutes after getting the shot.  Went to Hospital Er and was intravenously  given: diphenhydramine 50 mg, ND (0.9 % sodium chloride) bolts 1,000 ml, and methylprednisolone sodium succinate 60mg at 11:19 am. I was also injected with EPINEPHrine 0.3 mg at 11:20 am, and an albuterol nebulizer solution 5mg at 11:18 am. Stayed at the ER until 2:30 pm, got sent home and feel much better now.
He states that 3 days after he got his second vaccination his wife says that he started to talk "funny" on Saturday and that was what took them to the emergency room, they were not able to be seen secondary to the wait being too long.    He states that he was shivering yesterday and feels that this was worse than he's had previously like with the flu. His right scalp was feeling sensitive as well. concerned about shingles he'd had in the past as that distribution. The cognition decrease seems like slow decrease. He will lose the sentence in the middle of it, not know what he was going to say. He does take THC and CBD at night and he will do this more at that time. Feels that when he is going to sit down, he is plopping down more than sitting. Now the sensation is crossing the midline of his head.  - From my knowledge of him, he does feel a little bit slower and less "with it" than usual.  - He says that he does feel weak, but has really been falling a lot more this last week as well.  - Today he seems to be walking well today, but this is the first day. When he was in the emergency room Saturday, he was not able to walk well.  - Has had some new urinary incontinence, states that this comes and goes with him, but does seem to be more recently.
Patient received first dose of Pfizer around 7:43 AM. Patient observed after vaccine and on her way out felt "her throat feeling thick and itchy". RN brought patient back to med bay. Patient was having difficulty swallowing, and reported throat and tongue itchiness. 50 MG IM Benadryl given at 0813. DOC on call notified at this time. Patient reported symptoms improved after Benadryl, but about 6 minutes later, they came back and felt "worse". Patient was holding her throat, was struggling to swallow, was coughing, and felt SOB. Patient was having difficulty completing a full sentence. Epi pen given at 0823 and 911 called. Patient hospitalized in the past due to anaphylaxis with shellfish. RN monitored patient until EMS arrived at 0837. During that time, patient reported improved symptoms, but still felt it was a little difficult to swallow. Patient awake and alert speaking in full sentences at this time. Denies SOB and VSS. When EMS arrived, patient's symptoms returned and she stated "my throat and muscles in my neck feel swollen and tight. My lips and tongue are itchy and thick". EMS gave another EPI dose at 0847 and transported patient to hospital. Patient was awake and alert prior to transport. EMS arrived on scene at 0837, administered another dose of EPI and transported patient to Hospital.
her bottom lip went numb.; right eye twitched for about 0.5 minute; This is a spontaneous report from a non-contactable consumer (patient herself) of 53-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for Injection, Batch/Lot number were not reported, Expiration date: unknown) via an unspecified route of administration on 22Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. About 11.5 hours after vaccination the patient experienced right eye twitched for about 0.5 minute and her bottom lip went numb. She reported her lip continues to remain numb on 23Mar2021. The outcome of events was unknown.
33 year old male c/o dizziness post first pfizer vaccination at 1330  He became diaphoretic and clammy 1330 VS 77/49 44 16.  99% O2 SAT ON RA.  A+OX3 THE WHOLE TIME.   PLACED IN SUPINE POSITIION  DIZZINESS RESOLVED WITHIN 30 SECONDS.  F/U VS AT 1335 112/72 61   REMAINED SUPINE FOR FIVE MINUTES AND THEN SAT UP AND THEN STOOD UP  VS THEREAFTER OF 113/73 68 20  AND PATIENT REPORTED BEING ASYMPTOMIC.  AMBULATED  TO BR WITH STEADY GAIT, DENIED ANY SYMPTOMS .  DRANK TWO BOTTLES OF WATER (16.9 OUNCES EACH) AND ONE BAG OF FRITOS.  STEADY GAIT MAEW, DENIES ANY SYMPTOMS AND STATED HE WAS ABLE TO DRIVE HIMSELF HOME.  ADVISED TO WAIT 30 TO 60 SECONDS BETWEEN ANY POSTURAL CHANGES.    REPORTED PREVIOUS VASOVAGUEL EPISODES X 4 IN THE PAST.  REPORTED TAKING NO MEDICATIONS AND NO ALLERGIES.    PATIENT ADVISED TO F/U WITH PCP AS NEEDED AND/OR 911 AS NEEDED  AND RECORD 3 OR 4 SETS OF VS PRIOR TO NEXT VACCINATION FOR COMPARISION.  HE WILL ALSO CHECK IN WITH OBSERVATION NURSE PRIOR TO THE VACCINATION.    (SITE SUPERVISOR) INFORMED
2 days of occasional diarrhea.  2 days of mild nausea. 3 days of fatigue.
About 2 or 3 weeks after the second does I started to break out in a rash or hives, it was itching a lot and has continued for the last 5 months. I was given an antihistamine and a course of prednisone for 6 days. After the prednisone, it started itching and breaking out again. I was given another course of prednisone of 12 days, during that time I didn't have any break outs or itching at all. I saw my hematologist, internist and dermatologist. My dermatologist diagnosed it as seborrheic dermatosis and discovered squamous cell skin cancer. I have 2 of those spots removed. I am now taking a 7-week course of prednisone and gradually as I have cut down on the dose each week, the itchy has come back gradually and small wart like out breaks have occurred. The antihistamine is taken as needed for itching; I do take more now than I did in the beginning. I will be seeing an allergist this Thursday 09/09/2021. I have been really bothered by the itching. The middle of April I was diagnosed with CLL (chronic lymphocytic leukemia). I was also given a topical steroid cream, triamcinolone acetonide.
Patient states that she was told by physician that pneumovax was given too high up and has affected shoulder. States joine is frozen.
This non-serious initial spontaneous case, was received from a pharmacist on 15-Aug-2017, concerning a patient of unspecified age and gender. On an unspecified date, (reported as years ago), the patient was administered with INN Flu Vaccine Seasonal (influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination the patient developed redness and selling at the injection site. The outcome of the events was not reported.
rash all over body; started at neck/shoulder and worked it's way down to ankles; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over body; started at neck/shoulder and worked it's way down to ankles) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over body; started at neck/shoulder and worked it's way down to ankles). At the time of the report, RASH (rash all over body; started at neck/shoulder and worked it's way down to ankles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
4-26-08 Mother noticed "little red dot" on L leg where varicella had been given on 4-19-08.  The red area became larger & tender & more red as time went by.  Came to clinic where shots were given.  Area was approx 7 cm diameter.  Was advised to see her MD which she was.  No treatment recommended.  Area started to diminish 4/30/08 & on 5/2/08 is almost gone.