chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse regarding an unknown age and gender patient. On 12-DEC-2012 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to -13 C for an estimated total time out of range of 10.5 hours and on 16-JAN-2012 at 7:30, the vaccine was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 16-JAN-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Right deltoid/arm with approximately 2 cm area of erythema and tenderness. No induration. No fever. Rx: Ibuprofen 400 mg prn, BENADRYL 25 mg prn.
TEMPERATURE OF 103.3; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient 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: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced temperature of 103.3. On 08-APR-2021, the subject experienced pain at the injection site. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.3 deg. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from temperature of 103.3, and the outcome of pain at the injection site was not reported. This report was non-serious.
since October he start to feel cramps on both legs and arms.  By December 17 paralysis start on left arm, then it progress to paralysis on both legs and arms, cramps, headache, stiff jaw, eye mouth and neck tic. weakness.  Immunoglobulin treatment for Guillain Barre Syndrome was given during hospitalization and physical therapy.  To the date he is still paralyzed on both legs after treatment.  he recovers only partially on arms.
Inside that arm; It makes it hard to sleep at night; Pain within left elbow/ joint pain; Muscle pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Inside that arm), INSOMNIA (It makes it hard to sleep at night), ARTHRALGIA (Pain within left elbow/ joint pain), MYALGIA (Muscle pain) and PYREXIA (Fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20/2A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Inside that arm), INSOMNIA (It makes it hard to sleep at night), ARTHRALGIA (Pain within left elbow/ joint pain) and MYALGIA (Muscle pain). The patient was treated with MELOXICAM at an unspecified dose and frequency. On 12-Feb-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Inside that arm), INSOMNIA (It makes it hard to sleep at night), ARTHRALGIA (Pain within left elbow/ joint pain) and MYALGIA (Muscle pain) outcome was unknown.            Concomitant medications included blood pressure medication, multivitamins. Action taken with mRNA-1273 in response to the events was not applicable.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Urticaria chronic" (unspecified if ongoing), notes: Other medical history= Chronic urticarial. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Had multiple days of negative tests prior to rebound; (11Aug2022) Positive, notes: Tested positive on rapid COVID test on day 11 (6 days after completing paxlovid). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received vaccine and did not had other medication in 2 weeks. The patient was treated with Paxlovid for COIVD-19 from 01Aug2022 to 05Aug2022. Tested positive on rapid COVID test on day 11 (6 days after completing paxlovid). Had multiple days of negative tests prior to rebound. No Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
20 y.o. female with no prior past medical history, presents to the Emergency room after 3 weeks of worsening respiratory symptoms.  Medical work-up on admission reveals an acute pulmonary embolism patient reports completing GARDASIL vaccine series in August 2008.  2/2/09 Received multiple medical records for 11/4/2008-1/6/2009. 11/4/2008 ER records. FINAL DX: pneumonia Only records were CXR which was WNL.  11/14/2008 Hospital medical records for 11/14-11/22/2008. FINAL DX: hypercoagulable state; venous thrombosis embolic disease w/bilateral LE DVTs & pulmonary embolus w/lung infarct & pleural effusion; s/p IVC filter; sinus tachycardia; anemia; hemorrhagic ovarian cyst for outpatient w/u; possible mood disorder Records reveal patient experienced cough, chills, fever, yellow sputum & worsening difficulty breathing x 3 weeks.  Had been on oral antibiotics for pneumonia w/worsening s/s.  Heme, Pulmo, GYN & surgery consults.  Improved slowly & d/c to home on continued anticoagulants w/outpatient f/u.  12/11/2008 ER records Only records were CXR which revealed bibasilar subsegmental atelectasis; lung VQ scan which revealed large perfusions defects bilateral lung bases, unchanged; and duplex scan of bilateral LEs which revealed resolved thrombus of right common femoral vein.  2/12/09 Received PCP vaccine records & office notes of vaccine visit dates.  2/21/08 #1 was well except for dry hands/feet & allergic conjunctivitis.  4/24/08 pt dx w/chronic sinusitis & recurrent abdominal pain.  9/16/08 #3 pt dx w/URI.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster),single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "generalized anxiety disorder" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: Feb2001, stop date: 08Aug2022; BUSPIRONE, start date: Mar2000, stop date: 08Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19 and the patient was given Paxlovid, treatment start date 02Aug2022 and stop date 07Aug2022(lot number GD8784.Clinical course:The patient reported after 7th dose of BID Paxlovid she experienced novel panic attack upon awakening from overnight sleep. Pt. had never previously experienced this. Later, uncharacteristic restlessness.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
elevated heartrate for 3 days following vaccine. Rash and lump on arm, fever and body aches
Information has been received from a female nurse (also reported as a pharmacist) who on 4/22/03 reported that on approximately 4/15/03, about one week ago, was vaccinated with a dose of varicella virus vaccine live. On approximately 4/15/03 the patient developed pain, redness, and swelling at the injection site. The reporter noted that these reactions lasted 2 days, and that she is now fine. Unspecified medical attention was sought. Additional information has been requested.
patient gets flu shot every year, gets the flu every year too; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves female patient of unknown age who INFLUENZA VACCINE every year, gets the flu (influenza) every year too.  The patient's past vaccinations included flu shot and gets flu every time.  Medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was not reported for the event influenza.  There will be no information on the batch number for this case.
a large red welt. itchy and sore. the welt is about 3 inches around at injection site and very itchy and red.
This spontaneous report as received from a licensed practical nurse refers to over 40 unspecified patients of unknown age (no patient information provided). On an unknown date, the patient was vaccinated with, improperly stored outside temperature conditions listed in the product insert, RECOMBIVAX HB injection, (dosage regimen and indication were not provided). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
2 weeks post inoculation developed burning sensation/tingling /pain from armpit to thumb; some tingling in thumb - sensation more like nerve pain vs muscle pain.  After two days gradually improved.  Muscle strength not affected, but movement in most directions elicited sharp pain coursing down arm.  Gradually improving to pain over the deltoid near injection site;  as of 19 days since initial pain motility much improved but still periodically throbs and sensitive to pressure and certain movements.   No treatment except restricting use of arm and time.  10 hrs post inoculation developed chills, myalgia and headache.  Chills and myalgia resolved in a few hours; an aspirin the next day resolved the headache.    This reaction was not unexpected.  Did not have pain at injection site until 2 weeks post injection.
21 yo pregnant woman, at 28 weeks gestation. EDD: 9/10/21. No complications in pregnancy. Completed series of Moderna covid vaccine. Two days after vaccine she started experiencing new onset chest pain and dizziness. Presented to ED on 6/22/21 and found to have spontaneous coronary aortic dissection (SCAD), with elevated troponin levels (3.180). No evidence of myocarditis. Transferred to hospital, with cardiologist. Currently being treated with  blood thinner and beta blocker.
Second dose was administered at 4 months and 1 week, 3 weeks early. Patient was observed for 20 minutes after injection. No adverse reaction.
Information has been received from a physician concerning a 12 month old male with no pertinent medical history and no drug reactions/allergies, who was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included Prevnar. The physician reported that the patient experienced a full blown case of the chickenpox after receiving vaccination. No additional adverse event information was provided. There were no lab diagnostic studies performed. Unspecified medical attention was sought. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested.
he received his 1st booster (3rd shot) he started experiencing heart complication; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (he received his 1st booster (3rd shot) he started experiencing heart complication) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (he received his 1st booster (3rd shot) he started experiencing heart complication). At the time of the report, CARDIAC DISORDER (he received his 1st booster (3rd shot) he started experiencing heart complication) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient received 1st & 2nd primary dose and said that he did not experience any side effects. Patient said that when he received his 1st Booster (3rd shot) he started experiencing heart complication.  The patient received 2nd booster (4th shot) in December 2022 and has since experienced fatigue, energy loss, accelerated heart rate. Advised that stress accelerated his symptoms.  Patient was not asked about consent to follow up.   This case was linked to MOD-2023-702488 (Patient Link).
a mild sore arm; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 09Apr2021 as a single dose for COVID-19 immunization. Medical history included allergic to shellfish, clams, and mussels, Raynaud's and a heart murmur. The patient's concomitant medications were not reported. In Apr2021, the patient did not have any reaction other than a mild sore arm. The patient was scheduled to take the second dose on 30Apr2021 which would have been 3 weeks after the first dose. She asked if she could postpone receiving her second vaccine. She did not have any reaction other than a mild sore arm. The outcome of a mild sore arm was  unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
clammy, swollen left cheek, difficulty swallowing, upper arm (site of injection)  had no feeling
high blood pressure, vomiting, low potassium. hospitalized from 2-27-2021 till 3-2-2021
Hives all over body started feeling itchy on scalp on 1/8/2022, no symptoms right after injection other than sore arm the next day, hives were very painful for first week but still getting occasional less frequent and not painful hives as of now (2/13/22). The hives non seem to be spontaneous and no treatment really made them subside.
Rash torso same evening ache all over body. Fever Rash lasted less than 24 hrs
15 min after vaccine, pt began to have urticaria to left arm spreading to left trunk, nasal itching, felt dizzy. no angioedema or wheezing
rash and itching below the injection site; rash and itching below the injection site; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for covid-19 immunization. The patient experienced rash and itching below the injection site on an unspecified date. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Presented with diarrhea x3d, also CP/weakness; + covid in ED; CXR no change from previous exam; Dx: Covid infection, CHF exacerbation,  COPD;  D-dimer 1.12; CRP 1.88 Ferritin 592; Tx: started on Vit C, Vit D3, Zinc, singulair, decadron; Rocephin for cysititis; room air initially; Required O2 via NRB x1 night, then weaned back down to room air
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 29-MAY-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, on or about 29-MAY-2010, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
Patient received a boostrix shot & said she did not feel not herself afterward. She went to see our nurse practitioner on site, her blood pressure was high. Her son took her to the local ER. Followup call I spoke to patient & she said she is ok now. She got IV medication for the allergic reaction.
has not felt well since last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 86 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "has other health problems" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "has not felt well since last night".  Additional Information: It was reported that the patient could not go to the vaccination appointment because she has not felt well. Furthermore, the reporter mentioned that the patient's condition is not related to the Pfizer-BioNTech COVID-19 vaccine. The reporter was not sure if it would be advisable to receive the first vaccine again, in case the second dose of the COVID-19 vaccine was not administered 3 weeks later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist concerning a 45 year old female who on 4/21/2006 was vaccinated route unknown with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651321/1036P). The pt went back to the clinic 10 hours later, on 4/21/06 with severe pain and could not move her arm. At the time of the report treatment was unknown. Unspecified medical attention was sought. No product quality complaint was involved. Out come was not reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Sep2022) Negative, notes: Rebound Covid after 10 days of testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 13Sep2022 to 17Sep2022. The patient had Rebound Covid after 10 days of testing negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.