chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Side effects experienced are injection site redness and swelling, arm pain radiating across chest, nausea, diarrhea, severe headache, fever, loss of appetite, fatigue, shivering, and whole body aches. Headache has improved after day two.
Pt presents with syncopal episode 5 minutes post vaccination of 1 dose Janssen vaccine to left deltoid. Pt was in his vehicle when he started to feel lightheaded and had +LOC. His girlfriend who was sitting next to him states that he was unconscious for about 15 seconds before regaining consciousness. He had no head injury or other trauma. On immediate evaluation he is conscious and endorses diaphoresis and lightheadedness. He states that he has had similar episodes of syncope in the past following vaccinations. He denies medical problems, medications, or any Hx of allergies. Pt denies swelling of the face, throat tightness, difficulty swallowing, itching of the skin, SOB, CP, nausea or vomiting.  Following evaluation by EMS, Pt refused medical transport and signed out AMA. Pt felt improved and was driven home by his girlfriend.
Information has been received from a physician concerning a 61 year old male patient who in January 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). The physician stated that in June 2010, the patient experienced a bilateral rash on his thigh but the physician did not think it was shingles. The physician stated that "the rash seems to be controlled by 400 mg of acyclovir (manufacturer unspecified)". At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Evening p/vax 103 AX temp w/some n/v; mom gave APAP; notified MD next AM, t101 AX, c/o LA tender & diff to move; 29AUG91 temp x 3 day MD - rx APAP;
administered subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number J7J4X, expiry date 31st January 2023) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details provided were as follows: The age at vaccination was not reported. The pharmacist reported that the patient received a dose of Shingrix subcutaneously which led to intramuscular formulation administered by other route. The reporter consented to follow-up. The case was linked with case US2021209477 and US2021AMR210335, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209477:Same reporter US-GLAXOSMITHKLINE-US2021AMR210335:Same reporter
A few hours after his vaccine patient reported very sore knee joints and did not want to walk. The next day he woke up with very swollen lymph nodes underneath his left arm and the left side of his neck was visibly swollen as well. He received his shot on a Saturday he was unable to go to school on Monday because of the pain. He missed his activities for five days. 6 days after his shot he was diagnosed with strep throat. Doctor noted his left tonsil was more swollen than right.  Today his left tonsil is still very large and the left side of his neck is swollen and  I can feel his lymph nodes.  As the symptoms have continued to persist we did not receive his second vaccination and are unsure what to do about the second shot.
severe chills; fever; muscle aches; headache; fatigue; intense pain near underarm and shoulder on injection site side; intense pain near underarm and shoulder on injection site side; intense pain near underarm and shoulder on injection site side; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jan2022 (Lot number: FL3209) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 2, Lot EW0186, administered in right arm), administration date: 20May2021, when the patient was 23 years old, for Covid-19 immunization; Bnt162b2 (dose 1 , Lot EW0170, administered in left arm), administration date: 29Apr2021, when the patient was 23 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Jan2022, outcome "recovered", described as "severe chills"; PYREXIA (non-serious) with onset 18Jan2022, outcome "recovered", described as "fever"; MYALGIA (non-serious) with onset 18Jan2022, outcome "recovered", described as "muscle aches"; HEADACHE (non-serious) with onset 18Jan2022, outcome "recovered", described as "headache"; FATIGUE (non-serious) with onset 18Jan2022, outcome "recovered", described as "fatigue"; AXILLARY PAIN (non-serious), ARTHRALGIA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 18Jan2022, outcome "recovered" and all described as "intense pain near underarm and shoulder on injection site side". Therapeutic measures were not taken as a result of chills, pyrexia, myalgia, headache, fatigue, axillary pain, arthralgia, vaccination site pain.  Additional Information: The patient received the vaccine at a pharmacy or drug store. The patient did not received any other vaccine within four weeks of the vaccine.   No follow-up attempts are possible. No further information is expected.
syncope; This spontaneous report as received from a nurse refers to her sister of unknown age.There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On an unknown date, the patient was vaccinated with 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (dose, route of administration, lot number and expiration date were not reported), unidentified Merck hpv vaccine administered (name not provided).      On an unknown date, the patient experienced syncope. No treatment was given for the adverse event. The patient did not seek medical attention. The outcome of syncope was reported as recovered, on an unknown date.  The causal relationship between the aforementioned event and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), unidentified Merck hpv vaccine administered (name not provided) was not reported.No further information was provided    Upon internal review the event syncope was considered to be medically significant.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of VARIVAX (merck) in December 2008 (four years ago). No other co-suspects were reported. No concomitant medications were reported. The nurse stated on an unknown date the patient came into office with a case of chickenpox. The outcome of chickenpox was unknown. Additional information is not expected.
Generalized hives, nausea, extreme malaise, headache, pain in left shoulder and neck, body aches involving multiple joints. This occurred within ten minutes of receiving the vaccination.
Information has been received from a retired physician concerning a 72 yr old male with a medical history of arthritis in shoulder and penicillin reaction (took 6 months to recover) who was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy included simvastatin (10mg). Subsequently the pt experienced extreme pain, left arm very swollen from injection site to fingers, cellulitis, tingling sensation and felt horrible. The pt was treated by his own family physician with prednisone and diphenhydramine HC1 (Benadryl) IM.  The pt was recovering. The physician stated that the pt also on simvastatin (WAES 0502USA03454) and experienced muscle pain, unk when this occurred, but the muscle pains were attributed to arthritis and not simvastatin. No product quality complaint involved. Additional information has been requested.
Expired Menactra vaccine was administered to the patient / No AE; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case from a health care professional.  This case involves a patient (with unknown demographics) who received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported and Expiry date 25-May-2020) via unknown route in unknown administration site for prophylactic vaccination on 14-Jul-2020 (expired product administered).  The patient's medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  It was an actual medication error case due to expired vaccine used.  Reporter wanted to know if this was okay as the vaccine was used within 60 days of expiration.  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 the batch number for this case.
nurses gave an expired Daptacel vaccine/no adverse event; expired Daptacel Vaccine was given to 1 yr 7 mo old female/3rd dose the series/no adverse event; Initial information received on 13-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 months old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 08-May-2019, the patient received 0.5 ml third dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in the leg.  It was of actual medication error case due to Inappropriate age at vaccine administration and Expired vaccine used.  It was reported that no adverse event was experienced.  Information on the batch number was requested  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.  List of documents held by sender: none.
Required vaccination under threat of job termination. Received at occupational health. The afternoon after vaccination, experienced moderate to severe headache, nausea, fatigue and blurred vision. Headache and nausea persistent 4 days after, decreased slightly day of this report.
This is a spontaneous report from a contactable physician reported via a Pfizer sales representative. This physician reported similar events for six patients. This is the fifth of six reports. A child (age and gender unknown) received a dose of PREVENAR 13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unspecified date approximately five to six days after vaccination, the patient had large, raised, dark red swelling about 4 inches in diameter at the vaccination site and fever. Outcome was unknown. Follow-up (04Aug2011): Follow-up attempts completed. No further information expected.
Broke her hip; 3 Major arthristis flare ups; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Broke her hip) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (Broke her hip) (seriousness criterion medically significant) and ARTHRITIS (3 Major arthristis flare ups). At the time of the report, HIP FRACTURE (Broke her hip) and ARTHRITIS (3 Major arthristis flare ups) outcome was unknown.            It was reported that patient has been prescribed with steroids 3 times since she got the vaccine. Reporter did not have the lot or vaccine.  No concomitant drugs were reported. Action taken with mRNA-1273 in response to the events was not Applicable.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-116328 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
It was reported that the pt experienced pain at injection site, discomfort to left arm, sweating at night, feeling hot and cold that has lasted for a week after the flu shot was administered.
prolong pain in lt arm of inj-to date 4 wks;pain is worse @ noc, also terrible lying on rt side;pain so bad on sitting especially in chairs w/arm rest;pain inc on activity eg getting dressed, putting on deoderant, reaching w/lt rm;
Case number PHEH2013US014736 is an initial spontaneous report from the health care professional (patient who is a veterinarian) received on 10 Jul 2013. This report refers to a 45-year-old female patient. She was vaccinated with the booster dose of RABAVERT (batch number: not reported) intramuscularly in the arm on unknown date. It was reported that "vaccine booster doses were administered in each arm" (no information regarding the other booster doses). On 06 Jul 2013 (approximately 8 weeks after vaccination), she had numbness and tingling in the right foot. On 08 Jul 2013, the symptoms continued all day long and during night, symptoms migrated to the right thigh. On 10 Jul 2013, she noticed tingling in the right arm. It was reported that she had perfect strength and had no weakness or lack of coordination. The patient called the neurosurgeon about the symptoms and the physician stated that she might had symptoms of Guillain Barre and told her to observe the symptoms for the next 48 hours and if it continued or worsen, she was requested to consult the physician. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
A little bit of arm pain - mild; went away in a day or two. That night about 7 or 8 pm I felt muscle achy and tired. Next day I was really tired and spent the whole day in bed. I was feeling feverish. I took my temp. and it was around 100.1 degrees f and that is high for me as I am around 96-98 usually. I took Advil and Tylenol which helped but still didn't feel great and I was still muscle achy. I stayed home from work the next day as well because of the fever. Went back to work the following day, I was functional but not feeling great - felt brain foggy and my forgetful. I ended up taking Thursday off work because I didn't feel functional or with it. Loss of appetite started day after vaccine and it lasted a good week or so. No abdominal pain this time. Muscle aches cleared my by Monday the third day after the vaccine  and so did the fever. ALl my coworkers got second dose the day after I did and we all agreed it felt it like we got hit by a busy.
Posterior circulation CVA, elevated D-Dimer, no afib, no carotid dz . Acute posterior cerebellar CVA initially eval and airlift transfer to Hospital admission on 7/15/22 to 7/18/22, and tx within 74 minutes with alteplase and CT and CTA showed basilar artery CVA and left splenium left corpus collosum and left posterior cerebral and left parieto-occipital CA s/p thrombectomy. He has right homonomous hemianopsia, but no residual weakness or expressive aphasia. His TEE and carotid and telemetry showed no source and he had LINQ placed, follows with cardiology and neurology. His d-dimer was elevated again at 5.35,  Previously following his covid vax his d-dimer was high and we used eliquis for 6 weeks and in 12/21 d-dimer had normalized to 0.33 so we had stopped his Eliquis.
Shots given 4:10 pm - patient passed out 4:20. Awakened, but having vision problems, patient taken to E.R. approx 420-440 pm per Dr. Check on patient in ER 4:50 - awake doing fine.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Expired DTaP vaccine. No adverse effects reported. Vaccine re-administered at a later date.
One day after receiving the her first dose of the vaccine, my daughter was not eating and vomited; One day after receiving the her first dose of the vaccine, my daughter was not eating and vomited. Thus far she has only had one round of vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 2-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jun2022 as dose 1, single (Lot number: FT9142) at the age of 2 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DECREASED APPETITE (non-serious) with onset 22Jun2022 at 18:00, outcome "recovering", described as "One day after receiving the her first dose of the vaccine, my daughter was not eating and vomited"; VOMITING (non-serious) with onset 22Jun2022 at 18:00, outcome "recovering", described as "One day after receiving the her first dose of the vaccine, my daughter was not eating and vomited. Thus far she has only had one round of vomiting". Therapeutic measures were not taken as a result of decreased appetite, vomiting.  Additional information: It was reported that other medical history and known allergies were noted as no. Facility type vaccine was noted as pharmacy or drug store. The patient did not experience covid-19 prior to vaccination and the patient was not tested for covid-19 post vaccination. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. One day after receiving the her first dose of the vaccine, the patient was not eating and vomited. Thus far she has only had one round of vomiting. Up to this point no one else in the house had been sick so a stomach bug seemed less likely. Reporter's other daughter (age 4) received her first shot on the same day and has not had any symptoms.
pt recv vax 30MAR98 & grandfather brought child to clinic 2APR98 w/ c/o swelling @ inj site;area was swollen, sl red area, warm to touch;father stated swelling was noticed 1APR98;no ice for warm compress were given when initially noted;
Left hand became cold and numb while waiting in post-vaccination observation room. Denied any other symptoms. Had not had any food or drink all day. Took fruit juice p.o. States she feels like this when she is anxious. Stayed additional 10 minutes and numbness resolved on its own. Able to leave facility independently and feeling well.
Information has been received from a physician assistant (P.A.) concerning a 24 months old female patient with no known drug reactions/allergies and medical history who on 09-JAN-2009 was inadvertently vaccinated intramuscularly on the thigh with a 0.5ml dose of PNEUMOVAX instead of PREVNAR.  Concomitant therapy included HAVRIX.  The physician's assistant reported that on 09-JAN-2009 the patient experienced swelling and rash on the injection site area.  The patient sought medical attention saw the P.A.  At the time of reporting the patient was not recovered.  This is one of two reports received from siblings.  Additional information has been requested.
had a "bad reaction"; wants to know the definition of anaphylaxis as that may be what happened; This is a spontaneous report. A contactable consumer (patient herself) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were unknown), via an unspecified route of administration on 31Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, caller received first dose on 31Jan2021 and, on an unspecified date in 2021, the patient had a "bad reaction"; wants to know the definition of anaphylaxis as that may be what happened. Feels she was unable to get second shot because of reaction to the first. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Patient had chest pain, non-cardiac. Onsite EMS was called vitals BP  150/100  99% O2 HR 89. Patient Treated, Transported by the EMS to the hospital.
More than a month Later still have pain in arm that started AFter vaccine. Much swelling, For 2-3 days. Suffered pains that seemed Like an injury. Used cold pack and Tylenols As Told to. Pain persisted. Saw primary care doctor. Took Tylenol-Codeine No. 3. NO Help. Doctor ordered Ultra-sound For 11-4-2019   Second vaccine To be given Two to six months LateR
Red, itchy patch, 1.5" by 4", extending down from injection site.  Also extreme tenderness in underarm area.
typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the fourth (4th) of the seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not provided), 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. The reporter stated that multiple friends (unspecified number of patients) had the regular side effect of soreness in the arm on an unknown date. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient