chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 102 and trouble waking him after Rabavert vaccine #3. Took to ER. Gave Motrin and Tylenol. They said abnormal reaction to vaccine ("post-vaccination fever"). Seemed to recover, then a couple weeks later began to regress, stopped talking, feeding, pottying, started falling, playing with only a few toys, staring, eyes turning, floppy, meltdowns over small changes or even getting dressed, flapping arms, walking on toes; diagnosed with autism 9/7/06 by Dr. Patient received shots #4 and #5 (#4 on 6/22/2006, lot # 382011C; #5 on 7/6/2006, lot # 385011E).  9/5/08 Reviewed ER medical records of 6/9-9/27/2006. FINAL DX: rabies exposure Records reveal patient experienced possible rabies exposure when a bat was found in his bedroom although no actual bite found.  Parent contacted health department who recommended rabies prophylaxis in ER.  Rabies immune globulin & rabies vaccination initiated.  Bat found to be (+) for rabies.  Developed fever after 3rd vaccine otherwise tolerated all does well.  Reported irritability w/last dose.   1/21/09 Reviewed developmental pediatrician records of 2/5-10/7/2008. FINAL DX: static encephalopathy; autism spectrum disorder, high functioning Aspergers; anxiety; uneven cognitive skills; sensory integration disorder associated w/high functioning ASD; appropriate growth; history of significant loss of skills s/p rabies vaccine w/subsequent return of skills. Records reveal patient tx w/meds, OT & behavioral structural techniques.
SEVERE PAIN , WEEKNESS,  INCOHERENCE , UNABLE TO WALK ,
patient received 1 dose of Prevnar 13 in 2015. Patient also had pneumonia; patient received 1 dose of Prevnar 13 in 2015. Patient also had pneumonia; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), in 2015 as dose number unknown, single (Batch/Lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "patient received 1 dose of Prevnar 13 in 2015. Patient also had pneumonia". Pharmacist said a patient received 1 dose of Prevnar 13 in 2015. Patient also had pneumonia and was recommended by the doctor to get Prevnar 20.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with PREVNAR 113 vaccine in this patient cannot be completely excluded.
Nearly one hour after administration of the vaccine, my hands became slightly tingly and itchy. When I woke the next morning, my hands were red, swollen and extremely itchy and had whelps around some of the joints. This progressed up into my wrists and elbows as the day went on. This is similar to the symptoms that I experience when I had fifths disease.
3x2cm round, red, indurated area with white halo to right upper outer thigh.
Narrative: He notes having developed fever to 100.4F after the vaccination. The fever started on the evening of the vaccination and persisted for about 2x days prior to resolving. He started to treat it with acetaminophen on the day following development. He did not seek medical care and did not experience other common  adverse effects of the vaccination.
Pain, tenderness and swelling at injection site beginning within 3 hours of injection and extending into day 3. Mild fatigue beginning 12 hours after injection lasting 48 hours; did not prevent normal activities. 48 hours following injection episode of diarrhea lasting 3 hours.
sore arm at injection site; Fever; fatigue; chills; body aches; dizziness; poor appetite; Sore arm; Headaches; This is a spontaneous report from a contactable consumer (Patient). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 13Jun2021 11:00 (Batch/Lot Number: EW0185) (at the age of 13-Years-old) as dose 2, single for covid-19 immunisation. The medical history included Casein (milk protein) from an unknown date and unknown if ongoing. The concomitant medications included guanfacine (GUANFACINE); levocarnitine (LEVOCARNITINE) and guanfacine hydrochloride (TENEX). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 09:00 (Batch/Lot Number: EW0185) (at the age of 13-Years-old) as dose 1, single for covid-19 immunisation. The patient had not been tested for Covid-19 prior vaccination and post vaccination. No other vaccine was administered in four weeks of Covid-19 vaccination. On 13Jun2021 11:00, the patient experienced sore arm at injection site, fever, fatigue, chills, body aches, dizziness, poor appetite, sore arm and headaches. Therapeutic measures were taken for reported events with Tylenol. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Client developed red itchy rash 12 hours after first dose of oral typhoid. Rash spread, no respiratory issues, client went to ER. Was given BENADRYL and steroid injections plus prescription for oral steroids.
Tested positive for COVID19 a week after first dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SARS-COV-1 TEST POSITIVE (Tested positive for COVID19 a week after first dose) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-1 TEST POSITIVE (Tested positive for COVID19 a week after first dose). At the time of the report, SARS-COV-1 TEST POSITIVE (Tested positive for COVID19 a week after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO treatment information Provided No concomitant medications provided
Burning, redness, swelling, pain at the injection site. Chest pains (left), jaw pain (left)
I went the hospital and had my first vaccine waited my 30 minutes. After that I went on my daily business. I was several days feeling the normal symptoms of feeling not well, After a couple of weeks I started noticing a huge ring on my arm. The itchiness was not stop and the pain is horrible. I went to the hospital and was seen my the ER and they recommended some medicine over the counter. Till today the ring has left but the pain in my arm is constant.
Muscle aches 6 hours after vaccine and shivering without temperature 10  hours after vaccine
Starting at approximately 8:30 PM on 2/5/2021 and lasting until approximately noon on 2/7/2021, I experienced redness, urticaria, itching, and skin hot to the touch in an area approximately 2" x 3" around the injection site in my left arm. (This was a larger area than on the day of the injection, when I had similar symptoms for approximately 24 hours before they resolved completely.) The symptoms worsened for about 12 hours (approximately 8:30 AM 2/6/2021), at which point, I also developed low grade fever (highest 99.8F orally), chills, muscle aches, fatigue, sore throat, and general malaise lasting approximately 24 hours (until approximately 2/7/21 at 8:30 AM). The cutaneous symptoms decreased throughout the morning of 2/7/2021, resolving by about noon. I did not contact my PCP or seek any other treatment, nor did I use any OTC medicines to treat symptoms.
Herpes Zoster Opthalmicus/Zoster Keratits; Zoster Uveitis; Post Herpetic Neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 29-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered Herpes Zoster Opthalmicus of the right eye, Zoster Keratitis, Zoster Uveitis and Post Herpetic Neuralgia. As a result of Plaintiffs injuries to the right eye, Plaintiff ultimately was required to have Descemet Membrane Endothelial Keratoplasty of the right eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered/not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  The reporter considered all events to be disabling. Upon internal review, the events of viral uveitis and ophthalmic herpes zoster were considered to be medically significant.
29MAR92 felt hot, bruise @ inject site, golf ball size; face very red & had raised patches;
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 51-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 27-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Was awake at 2200 in father's arms when father noted he was turning his head to the right and R arm and R leg became stiff, eyes rolled back. Entire episode lasted almost one minute. While on the phone with 911, episode stopped. Brought to ED, where temp was 38.5.
PARTIAL DOSE ADMINISTRATION; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The Batch number was reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced partial dose administration, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial dose administration and medication error was not reported. This report was non-serious.
little bit of headache and colds; little bit of headache and colds; feels more like a sinus; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient).  A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at single dose for COVID-19 immunisation.  Medical history included the patient only had one lung (ongoing).  The patient's concomitant medications were not reported. The patient got the vaccine on 11Jan2021, and would be back in Feb for the 2nd dose. The patient wanted to know if she would still need to take the 2nd dose even though she had symptoms and a little bit of headache and colds, it feels more like a sinus. The outcome was unknown.    Information about batch/lot number has been requested.
Redness about the size of a softball around injection site on day 2 after injection. No treatment.
Dizziness if moving too quickly, began 4 days after second dose and still persisting Arm pain, lasted for two days Aches, lasted since second dose Chills, lasted since second dose Trouble breathing, began 4 days after second dose and still persisting
Pt recvd 3 doses of Engerix-B 1OCT90, 27DEC90, 16MAY91 & 13AUG91 lab tests indicated did not convert; recvd a booster dose of Engerix-B on 14AUG91;
experienced soreness for at least 24 hours in her left shoulder; COVID Vaccine 3rd Dose Booster; COVID Vaccine 3rd Dose Booster; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received T162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: unknown), via an unknown route of administration in left arm on an unknown date as dose 3, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: unknown) on an unknown date as historical vaccine as dose 1 and 2, single for COVID-19 Immunization. On an unknown date, the patient experienced soreness for at least 24 hours in her left shoulder. This soreness was more than the 1st and 2nd shots. There were no other unusual symptoms. Event took place after use of product. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Accidently gave Pfizer still of Moderna.  Have spoken with patient no adverse reactions noted at this time.
3 hours after receiving flu shot, patient experienced: sore throat, dry eyes with swelling and yellow discharge. Low grade fever - 99.6, feeling achy.
Extreme headache and photosensitivity on 4/16/21. Spot in central vision, blurry vision in periphery, eye pressure and headache on 4/21/21. Following up vision issues with an opthalmologist.
Slight Nausea, body aches in multiple areas that was bad enough it required me to take a few breaths to encourage my body to move. Discomfort brought me to tears. Eventually took Motrin which helped a little. Next day symptoms began to diminish.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a rash. Follow-up information from the physician indicated that the pt had an active case of varicella.
Severely swollen, tender lymph nodes (approx 2 inches in diameter) in neck/clavical area and axillary area both on same side as injection was given. Injection site warm, swollen; Temperature around 100 degrees Fahrenheit.
ENTIRE BODY ITCHING; RED KNEES; RASH ALL OVER THE BODY; FATIGUE; LETHARGIC; 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced lethargic. On 09-APR-2021, the subject experienced fatigue. On 14-APR-2021, the subject experienced entire body itching. On 14-APR-2021, the subject experienced red knees. On 14-APR-2021, the subject experienced rash all over the body. Treatment medications (dates unspecified) included: prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, and fatigue on 11-APR-2021, and had not recovered from entire body itching, red knees, and rash all over the body. This report was non-serious.
Information has been received from a physician concerning a male pediatric patient who has been vaccinated subcutaneously with 0.5 ml of varicella virus vaccine (Oka/Merck), and subsequently developed a rash. Unspecified medical attention was sought. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Post vax, on 12/16/2000 the patient broke out in a maculopapular vesicular rash with an erythemous base on his abdomen, back, face and extremities. The reported stated that the impression was chicken pox. The patient was treated with Zovirax for 5 days but the patient's symptoms persisted. Unspecified medical attention was sought. Additional information has been requested.
Initial report received from healthcare professional on 12 December 2013. A female patient, who age, medical history and concomitant medications were not reported, received TYPHIM VI (lot number, expiration date, route and site of administration were unknown) on an unknown date. Patient also received Hepatitis B on an unknown date. On an unknown date, patient experienced malaise and fatigue. Laboratory investigation and corrective treatment were not reported. As of this report, the patient was not recovered from the events. Documents held by sender: none.
6 DAYS AFTER THE SHOT I GOT JOINT PAIN AND MUSCLE PAIN TO THE POINT OF NOT BEING ABLE TO WALK. HAD SEVERE STOMACH PAIN, CHEST HURT WAS NOT ABLE TO DRAW A DEEP BREATH. RAN A FEVER OF 102.5 OFF AND ON.
heart attacks; strokes; cancers; COVID-19; nerve damage; Tumour; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attacks), CEREBROVASCULAR ACCIDENT (strokes) and NEOPLASM MALIGNANT (cancers) in an adult 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. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attacks) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant), NEOPLASM MALIGNANT (cancers) (seriousness criterion medically significant), COVID-19 (COVID-19), NERVE INJURY (nerve damage) and NEOPLASM (Tumour). At the time of the report, MYOCARDIAL INFARCTION (heart attacks), CEREBROVASCULAR ACCIDENT (strokes), NEOPLASM MALIGNANT (cancers), COVID-19 (COVID-19), NERVE INJURY (nerve damage) and NEOPLASM (Tumour) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.  Company comment: This is a spontaneous concerning a unspecified age and gender of the patient, with no medical history, who experienced the unexpected serious (medically significant) AESI events of myocardial infraction, cerebrovascular accident and unexpected serious (medically significant)  event of neoplasm malignant, which occurred unspecified days after a dose of (dose number not specified) mRNA-1273 bivalent BA.4/ BA.5 vaccine. At the time of reporting outcome of the event is unknown. No further information for medical review. The benefit-risk relationship of mRNA-1273 bivalent BA.4/ BA.5 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2023: Follow up contains non significant information.
This spontaneous report was received from a licensed practical nurse and refers to a 2 patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX injection (dose, route of administration, frequency were not reported) lot # M007287, expiration date 12-FEB-2018. No adverse effects were reported. Additional information has been requested.
Pt arrived at 3:05pm for Moderna vaccine. IMZ tech administered vaccine at 3:15pm. Pt was starting to feel nauseous at 3:20pm so brought hin back into the IMZ room. He vomited at 3:23pm. Pt describing dizziness, headache, and light headedness. Got pt cold compress, water, and continued asking him to take deep breaths. He vomited at 3:33pm. Pt began feeling shaky at but not as nauseous. Gave new cold towels. Pt remained in IMZ room until 3:49pm when he felt like walking. Pt walked around the store and came back at 4:00pm when he was calling his Mom to come pick him up.  He thanked us and left feeling pretty good.
significant pain; redness in arm; swelling in arm; felt burning; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm, erythema of extremities, swelling arm and burning sensation. On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm and burning sensation were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm and burning sensation to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in her late 60s or early 70s. The medical assistant reported to a field representative that she received Shingrix and felt burning right after the injection. The patient experienced burning right after the injection, significant pain, redness and swelling in her arm. This case has been linked with US2019139615, reported by the same reporter.
Felt woozy after the shot, that passed. Felt mostly okay except for heart palpitations several times a day. And on 1/28, my body "crashed". I suddenly became very fatigued. And following morning I had body aches. This delayed fatigue reaction also occurred after my first PFIZER shot last spring. I can't remember if I had palpitations though.