chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt in Rex ED 9/19 with worsening hives not responsive to home use of benadryl. Pt states he got the flu vaccine 9/17 and later that day developed scattered hives, then reports worsening scattered hives and itching. 9/19 he was awakened from his sleep by the itching and hives on arms and back, and presented to ED 05:20 AM. He reports no previous reaction to any flu shot in the past and denies new meds or insect bites. Rx'd prednisone 60mg po (and given oral steroid taper rx for home x 6 days), pepcid 20mg po, benadryl 25mg po q6h prn. Monitored to see that symptoms were no longer progressing and was discharged to home and referred to allergist. Per discharge summary: acute urticarial hive reaction 2 flu vaccine or preservative in the flu vaccine. There is no information regarding what type of flu vaccine was given, where given, lot #'s, pt has no PCP listed.  Pt was discharged in improved condition. Rex Healthcare ED is in Wake County, NC but there was no information about where the pt got his flu shot.
Possible administration error. Injection likely did not go into muscle and was given in subcutaneous tissue. On day 8 after injection patient developed hives, redness, swelling, induration, and warmth to anterior deltoid where vaccine was given. Day 9 local reaction worsened and swelling, redness, induration became bigger. Day 10 (today) continues with erythema, swelling, and warmth. No systemic signs of illness. No fevers. Skin intact and without blistering or necrosis.
I got called to freezer aisle, patient was complaining of lower back pain. No rash, no sweeting, no problem breathing. The only issue was lower back pain.  I got patient a chair and took his blood pressure. It was 128/79. Patient was coherent, no other issues then lower back pain.  The EMT came and asked patient questions.  Patient was reaching up to grab an ice cream carton when he felt the lower back pain later. The EMT stated that he could have pulled a lower muscle.
patient who was under 65 and received a dose of p23 and needed another dose 5 years later, but they never received it; No additional information; This spontaneous report was received from a pharmacist, via a company representative, and refers to an Adult male patient (Age reported as "under 65").  No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On an unknown date, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  It was stated that, the patient needed another dose 5 years later, but never received it. There was no adverse event reported and no product quality complaint was involved.
Rigth arm swollen, red, warm, and painful. Treatment: Prednisone one tablet by mouth as directed MG UD.
High temperature. Day 1, 100.6; day 2, 99.5, day 3, 99.7 day 4, 98.5. A general feeling of aches and pains. The first day, I actually went to bed. A heating pad was placed on arm, neck and shoulder for the subsequent four days.
Fever, headache, fatigue, body aches, lasted about 5 hours starting at 3:30pm
About 10 hours after vaccine started running fever with headache and body aches.  Temp 101
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 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm 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); "former smoker" (unspecified if ongoing); "autism" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: B12 [CYANOCOBALAMIN]; D3; TYLENOL. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RASHES ALL OVER THE ARMS, NECK, FACE, CHEST AND HEAD/ IT ITCHES EVERYWHERE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: diphenhydramine hydrochloride. On 24-MAY-2021, the subject experienced rashes all over the arms, neck, face, chest and head/ it itches everywhere. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rashes all over the arms, neck, face, chest and head/ it itches everywhere. This report was non-serious.
Acute hypoxemic respiratory failure d/t COVID19/sepsis d/t pneumonia requiring ICU admission
Redness to arm, redness and hives, spread through whole body.  Onset since 06/24/2005 til present.  Benadryl given with no affect on child.  Parents took child to doctor's office.
? Soreness in upper arm at injection site (for only about 24 hours after the injection. I expected this. ? Pink, splotchy skin, upper arm below injection site (Morning after injection and the day after that). ? Swollen upper arm (morning following injection (given Tues.; also: Wed., Thurs., Friday).  ? Minor pain upon pushing on swollen areas on arm, heat in pink areas) first and second days after injection; though no longer sore at injection site. ? Minor pain when raising or extending arm (Night of the day of injection, first and second days after injection only). ? Swollen, pink, puffy middle arm, especially above and at below elbow (Pink areas warm to the touch) late afternoon, day after injection plus two more days. ? Swollen, pink, puffy elbow area and about half way down lower arm (Two days after injection, late afternoon) ...swelling and pink moved down arm during the second, third forth days after the injection. ? Slightly impeded elbow bending due to swelling. Pain very minor and didn't restrict movement (Lasted first and second days after injection only). Note 1: Pink skin abated 4th day after shot; swelling gradually abated and was mostly gone by Sunday (5 days after injection). It gradually moved down arm just past the middle of my forearm over the course of four days. Note 2: During the entire time of the reaction, I felt generally normal: no fever or fatigue noted. The reaction did not impede my workout at the gym on the day after the shot nor any other activity. Note 3: The reaction was virtually completely resolved by Sunday afternoon, (fifth day after injection). Note 4: I have photos upon request. Note 5:  I received PVC 13 shot one year before the PNEUMOVAX 23 shot.
Constant pain from the left side of her neck, crook of neck,  to her elbow on the side she got the vaccine, feels paralyzing; Constant pain from the left side of her neck, crook of neck,  to her elbow on the side she got the vaccine, feels paralyzing; Constant pain from the left side of her neck, crook of neck,  to her elbow on the side she got the vaccine, feels paralyzing; Can feel where the needle went into her arm; She can't sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Anatomical location: Right arm), for COVID-19 Immunization. The following information was reported: NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Constant pain from the left side of her neck, crook of neck, to her elbow on the side she got the vaccine, feels paralyzing"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "Constant pain from the left side of her neck, crook of neck, to her elbow on the side she got the vaccine, feels paralyzing"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Can feel where the needle went into her arm"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "She can't sleep". Therapeutic measures were taken as a result of neck pain, arthralgia.  Additional information: She got her last vaccination on 11Sep2021 and she has had constant pain from the left side of her neck, crook of neck, to her elbow on the same side she got the vaccination. She has tried heat, Tylenol and cold and nothing helps. Tylenol was not effective and she took 500mg pills, sometimes up to 4 pills a day. She got the Tylenol packets from the gas station.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu shot on 9/14/2010 HepB and TDAP 9/17 w/PPD. 9/17/2010 First became ill with chills, rash, body pain in bones. Then wheezing, coughing, congestion, swollen glands, coughing, throat felt tight. This was within about 48 hours. Developed peripheral nerve problems, high blood pressure events, sores on scalp, memory and personality change, Raynauds, loss of strength over 12 month period.
Blood in stool (small amount) the day after first dose of Rotateq. This was reported by parents, and was associated with an increase in volume and frequency of stools that day. We have since given child a second dose of the vaccine 2/21/07.
Ear drum ruptured placed on antibiotic developed thrush placed on med vomiting developed high fevers
This is a spontaneous report from a contactable consumer. A 67-year-old female patient received PREVNAR 13, (lot number and expiration date unknown), via an unspecified route of administration on 15Jun2018 at a single dose for immunisation. Medical history included heart racing. Concomitant medication included TENORMIN (50 mg tablet) for heart racing. On 15Jun2018, the patient experienced extreme nausea, weakness, terrible irritability and chills. The patient just didn't feel good and it just made her lay down for about three days. No treatment was received for the events. The outcome of the events was recovered on 17Jun2018. Information on the lot/batch number has been requested.
Sunday evening I wasn't feeling well, woke up Monday morning with a terrible stuffy nose, cold chills and a painful sore throat. I decided to drink some green tea in the morning before work and thought I would feel better. Today, Tuesday, I'm feeling worse than I did yesterday; and my eyes are watering and my throat is still in severe pain. Prior to having my flu shot I was never once since, with the exception of catching a mild cold in 7th grade I never had once had my flu shot. Now, this year I decide to get my flu shot and I am terrible sick and I wash my hands consistently and eating proper and adequate nutrition.
1st dose 2 years ago, 2nd dose not received; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 2 years ago, 2nd dose not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-APR-2023 The reporter asked that do he/she need to restart the series or could just give the second dose? The reporter was advised to follow up with the sales representative for additional information.  It was unknown whether or not this had already been reported.  No additional information could be provided. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient reports feeling hot/sweaty, nausea, and 'jittery' starting the morning after vaccine administration, and continuing until today (still present). Denies fever, abdominal pain, vomiting.
Patient developed rash 10 days after vaccine given. Rash on back,front, torso, legs free head and scalp 750 lesions. "Cranky".
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age. The patient was vaccinated with an expired dose of RATATEQ (lot # (668359/0982Z), expiration date 06-MAY-2012, reported as 12-MAY-2012, orally, dose not reported) on 31-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
5 weeks pregnant, due date December 29, 2021. Next day after the vaccine fever 102.2 for 24 hrs, chills, dizziness, heavy bleeding the day after. Confirmed miscarriage on May 1st.
SMV thrombosis; CT scan of the head WO IV contrast shows no e/o CSVT
sx began w/ severe h/a & sore, stiff neck, states lymph glands were very sore but not swollen, no rash-began late evening on the day p/vax worsening s/s the next day;21MAR97 sx had greatly subsided but still c/o joint stiffness;
4/27/21 @ 0825  She had small bumps on her injection arm and subsequently had more appear on her left arm. RN administered 25mg of Benedryl @ 830. Employee complained that she was beginning to feel sweaty. Accompanied her to a private room where she could remove her mask. Employee noted that her legs were slight swollen and red. Her lower extremities were blanchable. She c/o that her legs were beginning to "burn"  4/27/21 1109 Taken to ED. RLE edema> LLE Edema.  was given 25mg IV benedryl, Solu-medrol 125mg IV, Pepcid 20 mg IV. D/C'd with prednisone & Epi pen 5/7/21 She reports- Sore throat (I never had it except when I was extremely sick) - Pain in left ear while swallow - Sometimes I feel I don?t have enough oxygen and it provokes cough. I never had it in my life even if I had allergy. It might happened several times in week but not daily. 5/13/21 Seen by MD - HENT: Positive for sore throat - Respiratory: Positive for cough - Cardiovascular: Positive for leg swelling (right leg, the same one which got more swollen during the first 15-20 min of vaccine.) - Comments: Cobblestoning present. Trace nonpitting edema on the top of the right foot, just below the ankle. - High dose steroids can also cause some swelling and theses should be near done washing out of system. Associated tingling and feeling of coolness may be coming from deep peroneal nerve irritation in setting of swelling.  Blood tests were collected for LAB. prescribe a nasal spray for treatment of allergy.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/06/21,pfizer,Lot#EL3246 2nd dose: 01/27/21,Pfizer,Lot# EL9262 Diagnosed covid positive:07/12/21 Exposure:unknown Symptoms:fever, fatigue,muscle ache,loss of smell,chills,runny nose,headache.
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned an adult female. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-NOV-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Patient stated that a has a bumpy  rash  that is red. He also stated that he feels really cold and has a headache. He said he took some Motrin and is feeling a little better
Information has been received from a physician concerning a 17 year old female patient with no medical history and a amoxicillin allergy who on 28-FEB-2007, was vaccinated IM with a first dose of GARDASIL (Lot# 653735/0688F). Concomitant therapy included hormonal contraceptives (unspecified). On 28-FEB-2007 later in the evening, the patient developed hives on her body. The patient took BENADRYL for the hives and the following morning the hives subsided. No laboratory diagnostic studies were performed. On an unknown date, the patient recovered. It was also reported that the patient is late for the second dose as of 24-JUL-2007 and has still not received the second dose. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician concerning a 18 year old female student with mild/intermittent reactive airway disese and a amoxicillin allergy, and a history of a viral illness in early February (2/3 x 1 week), who on 28-FEB-2007 at approximately 15:10, ws vaccinated IM with a first dose of GARADSIL (Lot# 653735/0688F). Concomitant therapy included hormonal contraceptives (unspecified). On 28-FEB-2007 at approximately 17:00, one to two hours after the vaccination (previously reported at later in the evening), the patient developed hives on her body. The patient took a dose of BENADRYL for the hives. On 28-FEB-2007 the patient recovered (previously reported as "the following morning the hives subsided"). No laboratory diagnostic studies were performed. It was also reported that the patient is late for the second dose as of 24-JUL-2007 and has still not received the second dose. No product quality complaint was involved. Additional information is not expected.
injection site is hard; He had chills; injection site is red; injection site is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site is hard), CHILLS (He had chills), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE PAIN (injection site is sore) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (injection site is hard), CHILLS (He had chills), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE PAIN (injection site is sore). At the time of the report, VACCINATION SITE INDURATION (injection site is hard), CHILLS (He had chills), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE PAIN (injection site is sore) had not resolved.            Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
STAGE 3 LYMPHOMA; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age. 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, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced stage 3 lymphoma. It was reported that, "my friend now has stage 3 Lymphoma".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stage 3 lymphoma was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220245831-covid-19 vaccine ad26.cov2.s-stage 3 lymphoma. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Uncontrolled shaking, body pain, headache, nausea, mild fever, diarrhea, weakness, extreme fatigue, profusely sweating
CRP has been going up back in Jun 2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing), notes: She continues to experience arthritis.; "Diabetic" (unspecified if ongoing); "Multiple bleeding stomach polyps" (unspecified if ongoing), notes: multiple bleeding stomach polyps,; "Erythema Nodosum" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing), notes: She has Osteoporosis now and it was Osteopenia.; "Osteopenia" (unspecified if ongoing), notes: She has Osteoporosis now and it was Osteopenia. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Jan2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: C-REACTIVE PROTEIN INCREASED (non-serious) with onset 2021, outcome "unknown", described as "CRP has been going up back in Jun 2021". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to a 2 month old patient. On 18-OCT-2013 the patient was vaccinated with an expires dose of RECOMBIVAX HB (lot # 669599/0231AA, expiration date 14-OCT-2013) 0.5 ml intramuscular (it was unspecified if this was the patient's first or second dose). Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1310USA009308 via same reporter link. Additional information has been requested.
Booster Shot. Very soon after getting the shot I started having tinnitis and to this date of reporting it has not stopped.
For 1-2 days after vaccination, had mild soreness at injection site and fatigue. One week after vaccination, developed large, raised, red, itchy rash around injection site. Deltoid was tender and hot to the touch. Also experience fatigue. Lasted 5 days, eventually resolved with use of hydrocortisone to site BID, Aleve, and cetirizine.