chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 17 month old female with no medical history who on 11/06/03 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. The physician indicated that on 12/2/03 the patient came into the office with a rash all over her body and a fever of 14.5. It was noted that the patient did not have any symptoms the day before she came to the office. The patient was immediately sent to the hospital where cultures of the sores were taken (results pending). She was treated with ceftriaxone sodium (ROCEPHIN) on 12/2/03 and on 12/3/03 her fever was gone and the rash had almost completely cleared up. The physician indicated that he does not know yet if the rash was actually chicken pox. At the time of the report, the patient remained hospitalized and was noted to be recovering with sequelae. A product quality complaint was not involved. Additional information has been requested. Follow up on 12/19/03: "Additional information was received from a nurse which indicated that on 12/05/03 the pt was seen in the physician's office and the fever had resolved and the rash was resolving and fading.  The nurse indicated that she thought that the culture results came back as a bacterial infection but she was not sure if they were conclusive.  Additional information has been requested." Follow up information was received from the physician who reported that the patient present with a rapidly spreading chickenpox-looking rash and a fever of 104.9 degrees. Subsequently, the pt was admitted to the hospital for three days to rule out sepsis. All cultures, including chickenpox nasopharyngeal cultures, blood cultures, and cerebrospinal fluid cultures were negative. The patient was treated for potential sepsis with IV ceftriaxone sodium. It ws noted that the patient recovered. The physician also indicated that the pt had no adverse events followng prior vaccination. No further information is expected.
BlurredVision, Dizziness, Headache, Myalgia, Arthralgia & Fever Narrative:  Fever 102, migraine, dizzy, blurry vision, arthralgia, myalgia; Day 3 no fever; other s/s continuing. PCP aware  Other Relevant History:
her arm was sore; her arm started to itch and get red and swollen; her arm started to itch and get red and swollen; her arm started to itch and get red and swollen; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 25Jan2021 as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her arm was sore and her arm started to itch and get red and swollen on 26Jan2021. Clinical course of the events was as follow: the patient said she got her COVID vaccine on Monday 25Jan2021 at the institute. She said what happened was at first, she had nothing then on Tuesday she woke up and her arm was sore and later in the day it started to itch and get red and swollen and today, Thursday it was a tiny bit less swollen she thought but still red probably about 4-5 inches toward going under her arm and it had itched a little less than it did. She called to see if this was anything to be concerned about. She said she could really quickly answer questions but she just got home from the hospital visiting and the nurse was going to be stopping by her house soon. She would rather bet transferred to where she needed to go now because the nurse was going to be walking through the door any minute. The outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected.
positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for COVID-19) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure (High). Concomitant products included LOSARTAN and CHLORTHALIDONE for Blood pressure increased, CARVEDILOL, DICYCLOMINE HCL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 (positive for COVID-19). At the time of the report, COVID-19 (positive for COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Acute urticaria (hives), dermatographism, and severe itching chest, stomach, arms and legs.  Severe scalp itch/burning sensation.  Not specific to vaccine site.  Vaccine dose 1 of 2 administered April 23, and symptoms began in the following weeks (significant enough to take note May 20).  Dose 2 of 2 given May 21.  Symptoms persisted until dermatologist prescribed 180 mg daily of fexofenadine HCl (Allegra) on June 10, and gradually improved from there.  Filling this form out on Sept 23 and still experiencing scalp itch when I don't take the Allegra (have been gradually going off the Allegra).
10 days after MMR, pt had fever to 102 with facial and truncal rash x 7 days. The desquamation on 8th day. Liver enzymes elevated. Hospitalized for dehydration. 1/7/08-ED notes received for DOS 12/3/07-no hospital admission. C/O rash and temperature starting night before. Rash has gone from neck to trunk, arms, legs, macular becoming confluent. Nausea and vomiting. Body aches. PE: rash appears to be clearing. Confluent erythmatous viral exanthem across trunk and extremities.
This spontaneous report was received from a nurse practitioner regarding a 18 month old patient of unknown gender. There was no information on pertinent medical history and drug reactions or allergies. The patient was vaccinated with a dose of RECOMBIVAX HB strength 5/0.5 MCRG/ML (microgram/millilitre)(route, product lot#, Expiry date not reported) on 29-JAN-2013 and on 01-APR-2013. On 05-AUG-2014, the patient received 2 doses of pediatric RECOMBIVAX HB. No adverse symptoms were reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 02-FEB-2017 at 15:50, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441:  US-009507513-1704USA000389:  US-009507513-1704USA000390:  US-009507513-1704USA000391:  US-009507513-1704USA000392:  US-009507513-1704USA000393:  US-009507513-1704USA000394:  US-009507513-1704USA000395:  US-009507513-1704USA000396:  US-009507513-1704USA000397:  US-009507513-1704USA000398:  US-009507513-1704USA000399:  US-009507513-1704USA000400:  US-009507513-1704USA000401:  US-009507513-1704USA000402:  US-009507513-1704USA000403:  US-009507513-1704USA000404:  US-009507513-1704USA000405:  US-009507513-1704USA000406:  US-009507513-1704USA000407:  US-009507513-1704USA000408:  US-009507513-1704USA000409:  US-009507513-1704USA000410:  US-009507513-1704USA000412:  US-009507513-1704USA000413:  US-009507513-1704USA000414:  US-009507513-1704USA000415:  US-009507513-1704USA000416:  US-009507513-1704USA000417:  US-009507513-1704USA000418:  US-009507513-1704USA000419:  US-009507513-1704USA000420:  US-009507513-1704USA000421:  US-009507513-1704USA000422:  US-009507513-1704USA000423:  US-009507513-1704USA000424:  US-009507513-1704USA000425:  US-009507513-1704USA000426:  US-009507513-1704USA000427:  US-009507513-1704USA000428:  US-009507513-1704USA000429:  US-009507513-1704USA000430:  US-009507513-1704USA000431:  US-009507513-1704USA000432:  US-009507513-1704USA000433:  US-009507513-1704USA000434:  US-009507513-1704USA000435:  US-009507513-1704USA000436:  US-009507513-1704USA000437:  US-009507513-1704USA000438:  US-009507513-1704USA000439:  US-009507513-1704USA000440:  US-009507513-1704USA000441:  US-009507513-1704USA000442:  US-009507513-1704USA000443:  US-009507513-1704USA000444:  US-009507513-1704USA000445:  US-009507513-1704USA000446:  US-009507513-1704USA000447:  US-009507513-1704USA000448:  US-009507513-1704USA000449:  US-009507513-1704USA000450:  US-009507513-1704USA000451:  US-009507513-1704USA000452:  US-009507513-1704USA000453:  US-009507513-1704USA000454:  US-009507513-1704U
Resting heart rate was 65 BPM, jumped to 133 BPM until 9 pm that night. Body aches for several days.
The reporter did not know what the patient died from; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII) (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DEATH (death) with onset 28Oct2021, outcome "fatal", described as "The reporter did not know what the patient died from". The patient date of death was 28Oct2021. The reported cause of death was "Unknown cause of death". The reporter reported that her sister had 2 of her COVID-19 vaccines and the flu shot. Her sister died on 28Oct2021. The reporter reported that she did not know what kind of condition she had and she could not talk about her sister's stuff because she did not know. The reporter reported she hadn't seen her sister in 5 years and she did not know what she died from. The report was not related to a study or programme.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Unknown cause of death
Congested; Her right arm from Shoulder to Elbow was shaking, Legs were also shaking; Rash on the right Arm Injection Site; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congested), TREMOR (Her right arm from Shoulder to Elbow was shaking, Legs were also shaking), VACCINATION SITE RASH (Rash on the right Arm Injection Site), CHILLS (Chills) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced NASAL CONGESTION (Congested), TREMOR (Her right arm from Shoulder to Elbow was shaking, Legs were also shaking), VACCINATION SITE RASH (Rash on the right Arm Injection Site), CHILLS (Chills) and HEADACHE (Headache). On 29-Mar-2021, NASAL CONGESTION (Congested), TREMOR (Her right arm from Shoulder to Elbow was shaking, Legs were also shaking), VACCINATION SITE RASH (Rash on the right Arm Injection Site), CHILLS (Chills) and HEADACHE (Headache) had resolved.            There was no concomitant medication reported. Treatment for the events included bromelain natural supplement (Pineapple driven).
Beginning in July 2021, I had irregular spotting. Beginning in August 2021, I started heavy, menstrual bleeding despite being on a hormonal pill. I have been on the same pill for years without side effects.
1 week after 1st dose had a severe rash in same arm. Red, hot, itchy and extremely hard and swollen. It want down my whole arm. Fever of 99.9 when I?m normally 97.1 low normal. Nausea
The patient received the HBV (adult) 3rd dose on 4/24/16 and developed severe cervicothoracic transverse myelitis on 5/8/16 and was subsequently diagnosed with neuromyelitis optica.
Pt has mast cell activation disorder where she experiences allergic reactions from a wide variety of substances. Experienced extreme bone pain that lasted for about 4 days, possibly resulting from egg component of flu vaccine.
Pfizer booster on 11/21/2021.  On 11/23/2021, developed fever up to 102, vomiting, body aches, nausea, chills.  By 11/25/2021, had chest pain and a heart rate in the 180s.  Went to ER on 11/25/2021.  Covid test negative.  Diagnosed with massive inflammatory likely r/t Pfizer booster response by Patient.
Pt recvd vax & exp serum sickness type react consisting of joint pain, weakness &/or diarrhea; workup has included numerous tests for collagen vascular disease, & has been non-diagnostic;
redness; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown. No concomitant medications were reported. The patient received the second booster dose of Moderna vaccine on 13-Apr-2022.  The patient reported that the patient could feel the area when the patient touches it.  No treatment information was provided.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 06Jul2021 (Lot number: EY0584) at the age of 16 years as dose 2, single and intramuscular, administration date 15Jun2021 (Lot number: EW0177) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Tree nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxiclin, reaction(s): "Known allergies: Amoxiclin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jan2022, outcome "recovering" and all described as "Tested positive for COVID". The event "tested positive for covid" and "tested positive for covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical source: No any other Vaccine in four weeks. Tested positive for COVID on 20Jan2022. Congestion and sore throat are only symptoms, which began on 18Jan2022. The patient experienced covid prior vaccination and also tested post vaccination.
COUGH, FEVER, HEADACH, SORE THROAT, BODY ACHES, DIARRHEA, SHORTNESS OF BREATH
mom said pt had high pitch shrieking cry that was not persistant & was not assoc w/fever mom said pt had no limp rxn & no sz but was excessively sleepy p/but could not quantite this info;
Redness and swelling to both arms involving full upper arm area. HR 104, temp 100.4, nausea and fatigue. Started evening after getting shots, continued through 10/22/17 PM. When she woke up on 10/23/17 redness was gone and was feeling better.
Assessment & Plan: Pt is here to discuss post covid vaccination symptoms after vaccine was given 5/7/21. Reviewed information. Additional research done prior to seeing patient.  While ivermectin may be used in the clinical trial setting it is not currently recommended for outpatient treatment howevver, it has been shown to decrease time of symptoms by about 2 days. Given taht we are so far from the vaccine I am more thinking that this might be continued elevated body inflammation. She also has joint pains and arthritis, thus we discussed using mobic which given its NSAIDs category is generally not recommended immediately after vaccines due to decreased antibody response. Given she is still having these global inflammation symptoms, with joint pains/body aches, will start mobic 7.5mg bid for around a month. If no benefit, could consider low dose prednisone burst to help diminish any further inflammation. However if the mobic does not help the symptoms, I do not suspect continued improvement in symptoms with prednisone but could try 5-10mg QD x 5 days. Other options which may be helpful if it is suspected to be mast cell activation would lbe antihistamines +/- montelukast. She will f/u in 1 month or sooner should condition worsen
no adverse event; Bivalent vaccine was given past the 12 hrs; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given past the 12 hrs) and NO ADVERSE EVENT (no adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given past the 12 hrs). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given past the 12 hrs) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given past the 12 hrs).    Concomitant medication was not reported.  It was noticed that, patient received Bivalent vaccine was given past the 12 hrs. Treatment medication was not reported.
From initial information received on 1/19/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a cluster of five patients received a dose of DECAVAC, lot number U1206BA, administered IM on 1/13/05. The site of administration was not reported. The following day, on 1/14/05, all five patients experienced pain at the injection site, as well as extreme muscle pain and flu-like symptoms. The patient's recovery status was reported as unknown.
7.5 CM form induration of (R) deltoid 24 hours after vaccine administered.
Approximately 6 hrs post shot, mom picked her up, she threw her head back, eyes rolled back and body jerking. Lasted few seconds but was "out of it" for approximately 15min. Called ambulance, taken to ER. Dx - febrile seizure.
30 minutes after vaccine I developed left facial numbness and excessive eye watering left eye. Reported to pharmacist.  I also developed an earache and shooting pains behind the left eye the same day. The day after I developed left inner arm pain and numbness and tingling left hand that is still unresolved. Extreme neck and shoulder pain both sides. Tingling in toes left foot. Hands and feet swell at end of day. I called my family doctor who was not impressed. Since then, I have had severe pain in both breasts(implants). Had a mammogram and the radiologist is sending me for an MRI. Something is wrong.
2/6/2009  7:00 p.m.  To E.R. by ambulance for sudden onset altered loss of consciousness.  Obtained labs, CT, lumbar puncture.  Had been c/o insomnia over 3 weeks prior to event, but also documented in pt. record as having 'troubles getting to sleep at night' in 4/2008.  3/23/08 MR received for ER visit 2/6/08 with DX:  Vomiting, unclear etiology.  Altered LOC, unclear etiology. Pt presented with acute onset of vomiting with altered LOC.  Pt recently reporting H/As and near syncopal episode.  PE WNL. Given KCl for mild hypokalemia and d/c home for outpt f/u.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 22-SEP-2015, the patient was vaccinated with an improperly stored doses of ROTATEQ lot # L008053 with expiration date on 30-NOV-2016, oral, (dose was not provided) and RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The vaccines were exposed to temperature excursion of 34 degrees F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Macular rash on injection arm (3) - 2 upper arm. 1 at elbow - rash appeared 24 -48 hrs after injection.
For about 2 days after shot, soreness.  Beginning a week after the shot, swelling and itching. Rash. Swelling and intense itching lasted about 4-5 days.   Mild itching continues even now ( 14 days after shot, 7 days after symptoms began.)
3 weeks later started feeling pain left upper and lower teeth hurting went to dentist a week later no abscess or infection found but did see upper apthous type ulcer under LEFT upper lip given topical without relief .after 3 weeks still in severe l upper and lower jaw with more ulcerations and pai and diagnosed with shingles. Pain even more severe and ulcers and pain limited to left side jaw mouth . No external rash or lesions
Minutes after receiving my vaccine my left arm began to go numb with a full head headache following soon after. I was then moved to the observation area where my chest got tight, I had difficulty breathing and my temperature fluctuated which made me shake. When hives began to show on my face, neck and ears the on-site medical staff gave me a shot of epinephrine and Benadryl and put me on oxygen, during this time an ambulance was called by the staff. When I got to the hospital my heart rate and blood pressure was high, I was given oral steroids to help my anaphylaxis. For days after being released from the hospital I continued to have deep muscle pain and weakness in my left arm as well as a very strong headache
Pain, bruise and swelling in the injection site, red tender hive adjacent to the injection site (7 cm in  size) in first 24 hours , pain and swelling of the left axillary lymph node starting the second day and persists; body ache, fatigue and increased body temperature (~100F) the second and third day. Ibuprofen was taken every 6 hours since the second day, and rest I think it is getting better.
Fever 105 x 3d with vesicular/papular rash on face, extremities and trunk.
Patient developed severe systemic rash, elevated temperature, continuous crying, inability to sleep. A month later patient stopped smiling, and developed severe diarrhea enlarged abdomen, shortly after, patient stopped babbling, or engaging and has been diagnosed with PDD.  6/25/09 Vaccine and medical records received DOS 11/13/06. Well child visit. Hemangioma noted on labia major and scalp.