chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Licensed practical nurse (LPN) concerning a 26 year old female patient, with concurrent condition of asthma and sulfonamide allergy who on 20-OCT-2008 was vaccinated with the first dose of GARDASIL intramuscularly into the right deltoid (lot# 0947X). Concomitant therapy included rescue inhaler. On approximately 27-OCT-2008, the patient experienced systemic rash, redness at the injection site, systemic itching and asthma attacks. She was prescribed BENADRYL, used her rescue inhaler, and had a steroid injection. After two weeks, the patient recovered (2008). The LPN considered the systemic rash, redness at the injection site, systemic itching and asthma attacks to be Other Important Medical Events. Additional information has been requested.
reported seeing lines going up & down in both eyes lasting 45min & sharp pain lt head;resolved spontaneously;also reported later that day of chills, fever & diarrhea;resolved the next day;
Lot of pain at injection site immediately after the IM Flu shot in upper arm. Around 11/25/2012, severe flu like syndrome developed with low grade fever, cough, cold, running nose, body-ache and headache.  It lasted for two weeks. Gradual development of intense pain in right shoulder and arm and restriction of movements of right arm and shoulder akin to frozen shoulder from 11/15/2012 until 07/24/2013. Extreme pain and disability and weakness of the arm persists.
Within 5-10 mins of vaccination, started experiencing flushing, tachycardia, jitteriness, and slight confusion.
Fatigue, weakness, nausea, dry heaves, sore neck, myalgias.
light headed (airy/helium head feeling); hard to concentrate on more than one task at a time; Flushed; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular on 22Dec2020 at 11:30 at a single dose on the left arm for COVID-19 immunization in a workplace clinic. Medical history was reported as none. The patient's concomitant medications were not reported. The patient had no known allergies. The patient also did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 at 15:00, the patient was light headed (airy/helium head feeling), hard to concentrate on more than one task at a time, and flushed. No treatment was given to the patient. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date. The events were considered non-serious.  No follow-up attempts are possible. No further information is expected.
(R) tricep area with 6.5 x 4 cm erythema and mild swelling - (L) tricep area with 13 x 9 outer erythema/swelling and central 4.5 x 3cm red/indurated area, tx with KEFLEX.
received the Vaccine on 31Dec and on 04Jan was tested positive; received the Vaccine on 31Dec and on 04Jan was tested positive; Low-grade fever; slight loss of smell and taste; slight loss of smell and taste; This is a spontaneous report from a contactable Consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the Vaccine on 31Dec2020 and on 04Jan2021 was tested positive prior to having surgery. Minimal symptoms. Low-grade fever, slight loss of smell and taste. Outcome of events was recovering.   Information on the Lot/Batch number has been requested.
Patient was given an undiluted (not yet reconstitutued) 0.3 ML dose of COVID vaccine; Patient was given an undiluted (not yet reconstitutued) 0.3 ML dose of COVID vaccine; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 11:45 (Lot number: FH8030) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Simvastatin for myalgias, reaction(s): "Known allergies: Simvastatin". Vaccination history included: Bnt162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand_unknown=True,, prev_dose_brand_name_unknown=COVID19 Vaccine,, prev_dose_lot_unknown=True,, prev_dose_lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, prev_dose_dose_number=2},), for COVID-19 immunization; Bnt162b2 ({prev_dose_product=COVID 19,, prev_dose_brand_unknown=True,, prev_dose_brand_name_unknown=COVID19 Vaccine,, prev_dose_lot_unknown=True,, prev_dose_lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, prev_dose_dose_number=1}]), for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 01Dec2021 11:45, outcome "unknown" and all described as "Patient was given an undiluted (not yet reconstitutued) 0.3 ML dose of COVID vaccine"; IMMUNISATION (non-serious) with onset 01Dec2021 11:45, outcome "unknown", described as "booster". Therapeutic measures were not taken as a result of overdose, product preparation error, immunisation and the patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.   No follow up attempts are possible. No further information is expected.
SMALL AMOUNT OF HEAT FELT ON RIGHT DELTOID INJECTION SITE. COLD COMPRESS PLACED. 2 MIN LATER NOTICED REDNESS AND HEAT AT THE LEFT DELTOID FRONT INJECTION SITE. COLD COMPRESS PLACED.
A report has been received from a Health Professional concerning a 1 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 21-Oct-2013. The reporter stated that the patient had FLUMIST administered to 23 month old which started on 21-oct-2013. The outcome of the event of FLUMIST administered to 23 month old is unknown. The report was considered to be non-serious.
Information has been received from an approximately 23 year old emergency medical technician (EMT) with no allergies and no medical history who in January 1991, was vaccinated with a single vial intramuscular dose of RECOMBIVAX HB in the deltoid (manufacturer unknown).  It was noted that it may have been possibly RECOMBIVAX HB  (MSD).  Concomitant therapy included birth control.  Sometime in 1991, after the series of vaccinations, the patient had negative titers and believed that the vaccine did not absorb properly as it may not have been administered deep enough.  The EMT completed the series and blood work revealed negative titers.  The EMT had 2 additional vaccinations of RECOMBIVAX HB.  Another titer was done with negative results.  It was reported that at the time of the report the patient had not recovered.  No further information is available.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
received an expired 1st dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number H2HM2, expiry date 29th August 2021) for prophylaxis.   On 22nd November 2021, the patient received the 1st dose of Shingrix. On 22nd November 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Office manager reported the case. The patient received a dose of an expired Shingrix, which led to expired vaccine used. The reporter consented to follow up.
Rash/Swelling at injection site with some shortness of breath and chest pain - Lasted 30min. and resolved
Right leg - 1 inch red, warm but not tender nonfluctuant nodule on Rt. thigh at injection site of flu and varicella w/overlying 1-2mm papule x 2 - remainder of skin without rash. Noticed by parent 2-3 days prior.
as soon as needle went in patient's arm patient turned white and sweaty. never lost consciousness. pt said ears were ringing and that he couldnt see  patient's mother wanted us to call squad. we did.  they arrived shortly after. they determined it to be an allergic reaction and administered epi and gave pt IV fluids  patient was stable enough to leave a little before 7 pm
Next morning after taking the vaccine the pain in his arm was unbearable, he couldn't his arm it became very sore for days.  At injection sight got a red spot that was sensitive to touch and a knot under it that has grew to the size of a ping pong ball.
swelling redness rt hand & rt side of face jaw ache/swelling-bilat;
Missed 2nd shot and asking for 2nd shot which will be passed 42 days; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (Missed 2nd shot and asking for 2nd shot which will be passed 42 days) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (Missed 2nd shot and asking for 2nd shot which will be passed 42 days). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (Missed 2nd shot and asking for 2nd shot which will be passed 42 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Client states she received flu shot at about 08:30/AM on 10/9, Rt arm was sore after shot. By 4AM, client states she had acute pain in her Rt shoulder with radiation down her Rt arm into her hands with decreased mobility in hands. She states she feels a "jumping" nerve like sensation in the inner aspect of her RT arm 10+. The area is painful to touch and she cannot move well. She has been taking Ultram since the inj secondary to the pain and immobility thinking it would get better and it has not. Client was given ice and BR and referred to her PMD.
Hospitalization with COVID-19 following COVID-19 immunization. Immunized with Moderna COVID-19 vaccination on 1/26/2021 and 2/23/2021.
pt recvd Tetanus Toxoid vax on 1OCT92 & 11NOV92 was hospitalized w/sx of meningitis or encephalitis; pt devel some paralysis & was thought to have GBS; pt still exp numbness in hands & legs, & bladder control problems;
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (Lot # 03880) SQ in July 1995 and second 0.5 ml dose of VARVIAX (Merck) (Lot # 1253Z) SQ in October 2007. The patient was also vaccinated with the first dose of MMR II (Lot # not reported) on 05-MAR-1991 and the second dose of MMR II (Lot # 0902W) on 28-MAR-1994. No concomitant medications were reported. The nurse reported that on 15-JAN-2013, on recent blood work, the patient was found to have negative antibody titers to varicella and negative titers for all components of the MMR II. The outcome for negative antibody titers to varicella and negative titers for all components of the MMR II was reported as not recovered/not resolved. The relatedness for negative antibody titers to varicella and negative titers for all components of the MMR II was unknown for VARIVAX (Merck) and MMR II. This is one of several reports received from the same source. Additional information is not expected.
Hypersensitivity reaction; Redness; Rash in her trunk and torso upper area/ Rash in her kness; Psoriasis worsened; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriasis since 02-Jan-1975, Hypertension since 03-Jan-1995 and Vitamin D3 deficiency. Concomitant products included ESTRADIOL for Hormone replacement therapy, AMLODIPINE, LOSARTAN and CHLORTHALIDONE for Hypertension, VITAMIN D3 for Vitamin D3 deficiency.   On 11-Feb-2021 at 6:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PSORIASIS (Psoriasis worsened). On 22-Mar-2021, the patient experienced RASH (Rash in her trunk and torso upper area/ Rash in her kness). On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction) (seriousness criterion medically significant) and ERYTHEMA (Redness). The patient was treated with PREDNISONE for Rash, at a dose of 60 mg and CLOBETASOL (topical) for Psoriasis, at an unspecified dose and frequency. On 01-Jul-2021, ERYTHEMA (Redness) had resolved. At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), PSORIASIS (Psoriasis worsened) and RASH (Rash in her trunk and torso upper area/ Rash in her kness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 15-APR-2021, the patient went to a dermatologist and was prescribed a longer term prednisone therapy.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of Psoriasis is a possible confounding factor.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up information received on 15 Apr 2021and new treatment information is reported. On 16-Jul-2021: Follow-up information received and information about Patient demographics, Medical history, Concomitants, and New Event is reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of Psoriasis is a possible confounding factor.
Patient developed fever, chills, headache and sore throat. Patient also developed a cough which lasted longer than the other symptoms.
Dizziness BP: 170/88 Pulse: 74. After 15mins no complain of dizziness BP: 146/78 Pulse: 68 As per patient, patient had fell in october 2021 since then her B.P remains high. Patient stayed extra 15mins for observation. Advised to notify PHP about reactions. Patient left with assistant, no more dizziness.
Initial report received from a healthcare professional on 01 June 2012, who provided information on this case of one unidentified patient out of a cluster of 10 unidentified patients (previously reported as approximately nine unidentified patients), in case number 2012-05660. Information on the remaining nine patients is captured in case numbers: 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06072. The reporter for this case is also the same reporter as case numbers 2012-05658 (six elderly patients) and 2012-05659 (two adolescent patients). The reporter stated, of the cases reported as vaccine failure, one unidentified patient received an injection of FLUZONE, sanofi pasteur Inc., lot number reported as UT443AA in dose form 0.5 milliliter (mL) syringes, single dose syringe (route, site and date of administration were not reported). An unspecified amount of time later, the patient tested PCR positive for influenza A/H3 at the state laboratory, since January. The patient's outcome was not reported. There was no additional individual patient information available. Followup report was received from a healthcare professional on 15 October 2012. The case now met the criteria for an expedited report since receiving patient identity. A 31-year-old male patient received a FLUZONE, lot number UT443AA, on 14 October 2011 (route and site not reported). The patient tested positive with PCR for influenza A/H3N2 on 03 May 2012. The approximate treatment date was 03 May 2012. Pre-existing allergies and medical conditions were not reported. The patient's outcome was reported as recovered. Documents held by sender: None.
12/16 received covid vaccine 12/22 headache and loss of taste 12/23 tightness of chest 12/24 cough, body aches and fatigue 12/25 chills  12/26 fever of 100.1
Started having very painful, swollen, inflammed joints in fingers that rapidly spread to feet, knees, wrists and other joint. Seen had primary care doctor, lab work done, elevated RA factor, referred to Rheumatologist, seen there in August 2010, diagnosed with Rheumatoid Arthritis in September 2010, started on meds immediately.
Fever around 101. Ibuprofen seemed todo very little. Fever lasted for 25 hours. Body aches, sore throat, mild cough, lasted about 36 hours.
Second vaccination received 4/17/21.  Leg and knee pain/discomfort and some difficulty walking noted six days after vaccination on 4/23/21.  Discomfort  continued intermittently for several days.  Developed rib/side pain and difficulty taking a deep breath on 5/9/21.  Went to ER on 5/10/21.  Following extensive blood work, x-Ray and CT scan, was diagnosed with multiple bilateral pulmonary emboli.  Started treatment on blood thinner (Eliquis) same day and  symptoms have improved.  Currently under care of a Hospital.
8 days after vaccine.  Arm became swollen, hard and hot at injection site   and extreme itchy and painful
Pt reports rash at injection site 4"x 2" on 12/29/00, increased to 10" x 5" by 12/31/00, fever 102F, chills on 12/29 through 12/31. Affected area on arm was red swollen, hot to touch, sensitive, hard. gradually turned purple last 3 = wk's.
Client sat on exam table for vaccination then sat on MOC lap after vaccines administered. This provider vaccinated sibling while patient sat in mother's lap. Minutes later, client stated felt nauseous but declined drink of water/H2O. Client stood and splashed water on face and walked around room. Client developed pallor and became diaphoretic when leaned back into FOC lap and eased to ground. When asked if okay - client nodded head up and down then had legs extended out and right hand with clenched fist and bent elbow. Safety of child ensured - was eased to ground without difficulty or injury. Cool compress to forehead and air fanned toward client. Parents reassured. Juice provided to client. Instruction to F/U with provider. Business card given to MOC in case PCP has any questions or concerns. Supervisor notified.
A few hours after receiving the shot, my left arm got a little sore. The next day, and for about 2 weeks after getting the shot, my arm remained sore at and around the injection site. Then 3 days later my arms and legs and around my waistline broke out in small, hard bumps and rashes. The rashes worsened to the point of oozing a clear liquid and became very painful. It felt like I had broken glass circulating in my bloodstream. It got so bad I drove myself down to the Montage Health urgent care facility.
THROMBOSIS; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested (Dose number in series 1). No concomitant medications were reported.  On an unspecified date, the patient diagnosed with thrombosis thing adverse effect and it is because of the J&J vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211163766-COVID-19 VACCINE AD26.COV2.S-Thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
During MMR administration: c/o dizziness after (immediate): patient stiffened, head back, eyes rolled back, pale, sweaty, stopped breathing, urination in clothing. Recovered on own after 15 second. Decrease BP decrease HR given O2 via nasal canula.
The patient is a 36 y.o. female w/ hx of migraines, renal artery stenosis s/p right renal artery stent placement, and HTN who presents to the Emergency Department with left leg swelling and rash. Patient reports that while shaving her legs this morning she noticed that there was a rash to her left lower leg anteriorly. It has persisted throughout the day, and tonight she also noticed that her LLE appeared to be more swollen than her RLE. Patient denies any pain of her LLE, but reports that she has some paresthesia in it. She denies any associated fevers, chills, SOB, or chest pain. Patient has not been diagnosed with any autoimmune disorders, and has never had a DVT. She also denies any recent long periods of immobility, recent surgeries, and any oral contraceptive use. Patient presents significantly hypertensive with SBP in the 220s, but she notes that this is in the setting that she has not taken her nightly dose of Labetalol.
Information has been received from a physician concerning a 24 year old female with obesity, hypersensitivity and asthma and a history of headaches who on 29-MAY-2007 was vaccinated in the left arm with a 65 ml confirmed dose of Gardasil. Concomitant therapy included albuterol, phentermine HCL, antimicrobial (unspecified) and Yasmin. On 29-MAY-2007 the needle accidentally hit a "vursar sac" in the patient's left arm. Subsequently, the patient developed arm pain. The patient was going to physical therapy and is seeing an orthopedic doctor. At the time of the report the patient had not recovered. The reporting physician considered arm pain to be disabling. Additional information has been requested.
Had a horrific headache for 5 days after my second dose and then my right eye was filled with blood.  I never get headaches and I?ve never had this eye issue before.
Idiopathic small fiber neuropathy diagnosed via skin biopsies. No known cause was found. Symptoms started three days after second dose, then they went away. They returned about a month after my third dose (first booster).   Symptoms include tingling, numbness and some pain, especially in my left foot, but also in hands, arm, face, and tongue.
Scratchy throat during the 15 minute observation period. Placed under enhanced observation with EMT's including medical director and half dose of benadryl.  Symptoms resided and patient was cleared with medical director and released. Total time on site 45 mins.
Dizziness, fever, severe body ache *symptoms occurred within 3-4 hours post vaccination.
11 days after MMR, developed itch rash on face and trunk. 1 day of headache 8 days after (gone now).
The patient had no adverse event, the grandmother had a case of shingles 3 days after the ProQuad was given. Parent of child, gave permission for CDC to call