chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 days after the 2nd dose, I started having dizziness, heart rate increase and I almost passed out.  I also started getting numbness in my right hand.  I worked at the hospital and I was brought downstairs.  I was given fluids and they did an EKG which detected tachycardia.  I was discharged with  instructions to follow up with PCP.   The next couple of days, I felt tired and a couple of episodes of nausea.  I decided to go back to work on 7/12/2021.  At around 8PM I felt my heart rate increasing and I sat down and my co worker took me downstairs to the ER. I felt nausea and felt like I was going to pass out.  I was given fluids and my tachycardia did not go down.  My heart rate was as high as 120-150.  I was admitted to the hospital for rapid heart rate.  I was given Metoprolol to bring down my heart rate.  Currently, I am still in the hospital.  I still have tachycardia, fatigue, SOB and numbness in my right hand.  I will be here another night to run more tests and more blood work.
Initial report received via a search of the scientific literature on 11 March 2014. The literature article provides information for two patients who experienced similar events after receiving smallpox vaccine. This case pertains to one of the two patients; information for the other patient is captured in case number 2014SA033333. Abstract: "Post-vaccinial non-viral folliculitis has been recognized in the past decade as a new adverse cutaneous reaction to smallpox vaccination. Contrary to more serious smallpox vaccine reactions, post-vaccinial non-viral folliculitis has a benign course and resolves spontaneously within approximately 7 days. We describe additional histopathologic findings associated with post-vaccinial non-viral folliculitis, which has only been described once previously. New findings include the presence of a neutrophilic or lymphohistiocytic infiltrate that is concentrated around the hair follicles. We compare our findings to the follicular nature of varicella and herpes zoster infections, generating the hypothesis of deposition of vaccinia protein within folliculosebaceous units as a potential pathophysiologic mechanism behind post-vaccinial non-viral folliculitis." A previously healthy 43-year-old male received a left arm injection of ACAM2000 (lot number and date of vaccination not reported). Seven days post-vaccination he noted the appearance of pruritic lesions. Ten days post-vaccination he presented to the local emergency room, where he was noted to have over one hundred pink papules and papulovesicles on the trunk and upper extremities. Skin biopsy of a papulovesicle revealed the following: a mixed inflammatory infiltrate with abundant lymphocytes and histiocytes in a perifollicular distribution, with exocytosis of lymphocytes into the follicular epithelium with follicular spongiosis. No fungal organisms, follicular mucin, or vial cytopathic changes were seen. Immunohistochemical stains showed a predominance of CD3-positive cells, with CD4, CD8, and scattered CD68-positive cells. The patient was determined to have post-vaccinal non-viral folliculitis. According to the authors, the event was possibly as "classic lymphocytic hypersensitivity reaction". Outcome was not reported. Follow-up information received on 20 June 2014: The patient's outcome is recovered. Documents held by sender: None.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt was sitting in monitoring area for observation after vaccine. tech noticed pt leaning and nurse who gave vaccine immediately responded, layed her down and elevated pt legs. pt had pulse and was breathing but not responding to  verbal commands. EMS was called. pt responded and opened her eyes and was alert shortly after laying down. Ambulance arrived, evaluated pt. pt declined to go to hospial. Pt stayed at the pharmacy for another 30 min. pt has history of fainting after lab draws.
patient received first dose of menactra at the age of one but did not the complete series/No AE; Initial information was received on 21-Aug-2020 regarding an unsolicited valid non-serious case received from the other health care professional (pharmacy intern).  This case involves 12-months-old female patient who was vaccinated with first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE but did not complete the series (batch number and expiry date not reported) via unknown route in unknown administration site on an unknown date in Feb-2003 for prophylactic vaccination (incomplete course of vaccination).  At the time of report, patient was 18 year-old and wanted to know if she needed to restart series.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due incomplete course of vaccination.  At the time of report no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  There will be no information available on batch number for this case.
Chest tightness upon activity that has continued for past 2.5 months. Diagnosed as asthma due to a dust mite allergy. Treated with inhalers -- Alvesco and Albuterol and is now mostly manageable.  Recent dust mite mitigation efforts -- covers for mattress and pillows, frequently washing of bedding and frequent vacuuming.
Pt was administered a first dose of Pfizer COVID Vaccine 0.3ml into her right deltoid muscle. This vaccine given after the BUD. Vaccine was originally punctured 07/13 at 10:10am with a BUD of 10:10pm on 07/13. The vaccine was maintained in the fridge at a temperature if 39 degrees celcius up until dose was drawn approximately at 03:20pm 07/14. Vaccine was given 07/14 at 3:25pm. After 15-20 minute monitoring, patient reported no serious side effects besides a slight itch at the injection site (and no where else). Pt was notified of the administration mistake and advised to monitor for any serious side effects and usual symptoms that last longer than 1-2 days and report to PCP or hospital. No additional dose was provided to patient.
Pt recv vax on 3/12/99; on same day pt exp crying & pain, red/ swollen area on left buttock & left thigh; tx=ice, Tylenol, Codeine, Motrin
Patient presented to the clinic after receiving her second dose of the Pfizer-BioNTech COVID-19 vaccine at an outside facility.  The patient has several skin grafts present on both arms, and stated that after receiving her second dose a large clear bubble presented on the outside of her skin.  She presented a photo of the skin and bubble.  While impossible to estimate accurately, it appeared to be a significant amount of clear fluid consistent with apparent leakage of the Pfizer-BioNTech vaccine potentially due to administration into skin grafts/scar tissue that has built up.  She asked whether or not she should receive a 3rd dose since she was not sure if she even got the second dose.   211 was called by myself and stated they could not provide an answer, and they transferred me to the Vaccine Direct Live line.  Vaccine direct stated that a definitive determination could not be made, and that the affected patient should consult with a primary care physician or the local health department.  They did advise that if a 3rd dose was clinically indicated, that we were permitted to register and administer the vaccine to the patient.   Information was relayed to the patient.  As a student, the patient was able to be seen by the student health clinic in order to make a determination as to the appropriateness of a 3rd dose.  The CDC guidance document for vaccine administration errors (updated 5/18/21) was consulted (Available at: https://www.cdc.gov/vaccines/covid-19/downloads/covid19-vaccine-errors-deviations.pdf).  According to this document, when a subtherapeutic dose is administered - including vaccine leakage - and "the proportion of the dose cannot be estimated" providers are to "administer the authorized dose immediately (no minimum interval)".  The patient was referred back to the clinic with permission to receive a 3rd dose by the provider.  3rd dose administered, with no apparent leakage.
One day after receiving one dose of varicella virus vaccine live the pt experienced a fever of 105F. Pt was treated with lukewarm baths and Tylenol. The next day the fever dropped to 102F.
When they injected me with the shot, I felt a quick electric shock rush through my arm that went away instantly. I am still experiencing this till this day. It happens randomly. I feel it 4 times a day and I notice it more often when I am active during the day. I began to experience very bad pain injection pain at the injection site 3 to 4 days. Around 10:30 I had trouble raising my arm above eye level. Pain in my legs. 5 days after the vaccine, I began to develop a cough pain in my chest, trouble breathing and wheezing in the lungs.
mild arm soreness at the injection site (none with 1st shot) small unformed/ soft bowel movements for several days at end of second week after 2nd shot (similar but shorter/ day plus symptom after 1st shot)
pain in left arm; Muscle weakness; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis, PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On 6th October 2022, the patient received Shingrix, Flu vaccine, the 1st dose of PNEUMONIA VACCINE (intramuscular) and COVID VACCINE. On 6th October 2022, 1 hr after receiving Shingrix and Flu vaccine, the patient experienced pain in arm, muscle weakness and muscle pain. On an unknown date, the outcome of the pain in arm, muscle weakness and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, muscle weakness and muscle pain to be related to Shingrix and Flu vaccine.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's comment: The patient self-reported this case. The patient received doses of a Covid vaccine and Flu vaccine in her right arm and she received a Pneumonia vaccine and Shingrix vaccine in her left arm.  One hour after the vaccines were administered she reported pain in her left arm along with muscle weakness of that arm.  The muscle pain and weakness had continued on and off since the injection and was still not completely resolved. The lot number and expiration dates of vaccine were not available. The reporter consented to follow-up. Consent to contact HCP given. Additional supportive information: It was unknown if the reporter considered the pain in arm, muscle weakness and muscle pain to be related to Pneumonia vaccine and Covid vaccine.
Had influenza vaccine #2 on 1/2/08.  Later that day possible seizure.  To ER, temp 104, diagnosed with UTI, not admitted.
each of them feeling sick; aching all over for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2023 as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "Aching all over for a day or two"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "Aching all over for a day or two"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "Aching all over for a day or two"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "Aching all over for a day or two"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "Aching all over for a day or two". The following information was reported: PAIN (non-serious) with onset 2023, outcome "recovered" (2023), described as "aching all over for a day or two"; MALAISE (non-serious) with onset 2023, outcome "unknown", described as "each of them feeling sick".  Additional information: Caller reported receiving 6 Pfizer COVID-19 vaccine injections in the past (dates and formulations not provided) and after each of them feeling sick and aching all over for a day or two. Caller's last Pfizer COVID-19 injection was in May.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300313159 Same patient/vaccine/event, different dose;US-PFIZER INC-202300313160 Same patient/vaccine/event, different dose;US-PFIZER INC-202300313161 Same patient/vaccine/event, different dose;US-PFIZER INC-202300313162 Same patient/vaccine/event, different dose;US-PFIZER INC-202300313163 Same patient/vaccine/event, different dose;
Information has been received from an Health Professional referring to a 4 year old male patient. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 06-APR-2017, at 16:01 the patient was vaccinated with a third dose of PROQUAD, subcutaneously on the left leg lot # M042500 (expiration date was not provided), for prophylaxis. On that same date, at 14:04 the patient experienced that his lef thig leg was slight swollen with lesion that looked like and was treated like an insect bite. At the time of reporting, the outcome of the events injection site swelling and arthropod bite was unknown. Additionally, the reporter did not provided causal relationship between the events and vaccination with PROQUAD. Additional information has been requested.
29 yo male had first smallpox vaccination to left shoulder with 3 jabs on 6Jan2007.  This did not take.  Had second vaccination with 15 jabs on 13Jan2007.  On 22Jan2007, Day 9 post-vaccination, had onset of chest pressure with radiation to left arm, associated with diaphoresis, vomiting, and chills.  Reported for evaluation on 23Jan2007 and electrocardiogram showed mild ST elevation and PR depression in leads II/III/F/V3-V6.  Pain relieved with nitroglycerine and oxygen.  Patient started on meds to treat an MI by doctors at hospital.  Echocardiogram reported to show EF of 54% with inferior hypokinesis.  Labs were positive for cardiac injury with positive troponins: Troponin T's, in order, were: 1.27, 1.24, and 0.94.  Normal range 0-0.1.  By the time he arrived to hospital on 29Jan2007 he had been symptom free for 6 days.  On 29Jan2007 his cardiac enzymes were negative (toponin I < 0.1 twice, CK 64 and 44, and MB 0.5 and 0.4).  His ESR and CRP labs were also normal at 5 and <0.5 respectively.  A repeat echocardiogram showed an EF of 65-70% with no wall motion abnormality.  His cardiac meds were stopped with exception of the baby aspirin and low dose lopressor, and NSAIDS were not used given the normal objective studies and prolonged absence of symptoms.  He will be sent for convalescence back home.  A stress test is recommended in 4-6 weeks.  Very unlikely that he had ischemic myocardial infarct.  Very likely that he had smallpox vaccine related myopericarditis.  Records received from VHC for 2 day hospital ICU stay (Jan 29-31, 2007) for episode of chest pain, diaphoresis, vomiting and chills which began 9 days s/p smallpox vaccination. Pt. experienced "pressure in his chest" which radiated into the left arm.   Txd with Nitro, O2, Plavix, Lopressor, and ASA. DX:  Smallpox vaccine associated Myopericarditis.
Developed "a hive" within 24 hours; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. Patient received the first dose of the COVID 19 vaccine and developed "a hive" within 24 hours. Is it safe for them to get a second dose? He has no other information on the patient. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Right arm red, swollen, itchy. Evening after vaccination, body felt chilled, shivers rest of the evening. Shook all night, no appetite the next morning, body aches. Symptoms lasted about a week. Took about 7 days to feel better. Patient stated your breathing was stable. Patient uses FITBIT and feels that her body has recovered, but slowly. Patient thinks she has flu shot more then a month before shingrex administered
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 03-JAN-2020, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
SORE THROAT; FELT OUT OF SORTS; SORE ARM; CHILLS; HEADACHE; FELT MILD QUEASY; This spontaneous report received from a patient via an unspecified company representative concerned a female of unspecified age. 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: Unkown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced chills, headache, felt mild queasy, sore arm. On 07-MAR-2021, the patient experienced felt out of sorts and sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, felt mild queasy, sore arm, sore throat, and felt out of sorts. This report was non-serious.
Heat/flushing from injection site to neck to face to upper body x 20 minutes; sweating
mom states pt adm to hosp 11NOV94 for t105, sz, paralyzed on lt side;
Patient was given between 10 to 12 IMOVAX rabies vaccines during a 4.5 month time frame with no reported adverse event; Initial information was received on 30-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age male patient who reported patient was given between 10 to 12 imovax rabies vaccines during a 4.5 month time frame with no reported adverse event after receiving rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history included Animal bite. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect rabies (HDC) vaccine (Powder and solvent for suspension for injection) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient had a non-serious event patient was given between 10 to 12 imovax rabies vaccines during a 4.5 month time frame with no reported adverse event (incorrect dose administered) (unknown latency) following the administration of rabies (HDC) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Woke up in severe pain in shoulder and could not move arm. Progressively worsened throughout the day. Injection was accidently given in the very top of arm on the bony portion of shoulder joint. SIRVA EVENT.