chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTERED VACCINE OUT OF TEMPERATURE RANGE; This spontaneous report received from a pharmacist concerned an 18 year old female. 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: Unk) 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 an unspecified date, the subject experienced administered vaccine out of temperature range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine out of temperature range was not reported. This report was non-serious. This case, from the same reporter is linked to 20210343668.
Presented to ED with dyspnea and lab showed elevated troponin and COVID PNA as well as CHF exacerbation. Steroids initiated, but no abx noted as needed ber ID physician. Bumex increased for CHF exacerbation. Discharged 4 days after admission oncce stable and recommended outpt follow up due to multiple comorbidities and poor overall prognosis. Patient had first dose of COVID vaccine followed by a positive COVID test at the hospital 21 days later.
Pt states he has chills, fever, severe body aches, severe pain at injection site with redness and edema the size of "half of a tennis ball" and trouble sleeping.
Patient falsified DOB when registering for vaccination, stating the minor's DOB. Guardian did not consent to the vaccination. Department of Health verified with statistical records that the patients actual DOB which made the vaccine a contraindication.  1st Moderna vaccination given: 01/19/2021 2nd Moderna Vaccination given: 02/16/2021  No known adverse reactions noted.
Pneumovax and Menactra given in left deltoid on 7/29/2008 about 1:30pm.  That evening he began to have pain in shoulder, fever to 102, and chills.  He was seen in the office and found to have marked tenderness, swelling and warmth of the left deltoid.  WBC was 13.7K.  The following day he was seen with 104-105 fever, red eyes, vomiting and marked tenderness and swelling of the left upper arm.  He was admitted to the hospital.  WBC 21K.  His fever continued for three more days and he developed cellulitis from shoulder to elbow.  He was discharged on 8/2.  He was seen on 8/4 with resolution of fever and redness but was still very tender and some swelling around original injection site.  8/26/2008 Reviewed hospital medical records of 7/31-8/2/2008. FINAL DX: fever, vomiting & cellulitis left deltoid. Records reveal patient experienced good health on day of vaccinaiton.  Next day returned to PCP w/ chills, fever, stiffness, generalized aching & injection site pain, redness & warmth.  Developed red watery eyes, chest tightness, vomiting & increased chills/fever of 104. Tx w/IVF & anti inflammatory meds.
flu; pneumonia; sepsis; Initial information received on 24-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media.  This case is linked to cases 2020SA302174 (same reporter).  This case involves a patient (unknown demographics) who experienced flu (influenza), pneumonia and sepsis, after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE (reported as It was 90 days of misery).  On an unknown date, the patient developed a serious pneumonia and sepsis unknown latency following the administration of INFLUENZA VACCINE (reported as It was 90 days of misery). Both the event was assessed as medically significant   All the events were leading to death.  Case details: Patient got the shot and the downhill trend.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  It is unknown if an autopsy was done.   The causes of death were reported as influenza, pneumonia and sepsis.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a patient (unknown demographics) who died due to influenza, pneumonia and sepsis after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. However, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: flu; pneumonia; sepsis
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. Concomitant products included Aspirin. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on right arm. The patient experienced local injection site pain. The injection site pain resolved within 3 days.
shot done in the left arm and between my shoulder and my heart, I was getting shooting pain every once in a while; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Oct2022, outcome "recovered" (Oct2022), described as "shot done in the left arm and between my shoulder and my heart, I was getting shooting pain every once in a while". The events "shot done in the left arm and between my shoulder and my heart, I was getting shooting pain every once in a while" required emergency room visit.  Additional information: The patient stated, "In Oct2022 (Monday) the patient got the Booster shot (Clarified as Pfizer COVID-19 Vaccine) and 21Oct2022 (yesterday) morning the patient had a shot done in the left arm and between shoulder and heart the patient was getting shooting pain every once in a while. So, the patient went to the emergency room, the patient figured may be something was with the heart, but they checked out everything, heart was fine, there was no problem. The patient asked them if this could have been because of the shot, again the patient got it into the left arm and Oct2022 (Friday) the patient started to get that shooting pain that only left for couple of second then go away, so the patient don't know if certainly to do with shot or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, itching, redness. Went to Dr. got injection put on antibiotics.
Erythema edema 6x7 cm with some induration, at injection site. left thigh, mild pruritus.
I've been fatigued, lightheaded, have had heaviness, joint pain, tingling on right side of body, shaky, stuttering. I went to the ER. Diagnosis possible reaction to booster dose.  I started having seizures and have been to ER 3-4 times. Due to the seizures I'm not allowed to drive or be left alone. I am currently not allowed to work with no return date.
Patient didn't receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose was received about 2 years ago, 0.5 mg/ml in left arm).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 26-Aug-2022:  Reporter's comments: This case was self reported by the patient. The patient received the first dose of Shingrix. The patient did not received second dose yet. The patient did not have any further information regarding the vaccine. The reporter did not consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
The patient was seen for a well child evaluation on 5/21/10. He received the vaccinations stated at that time. His mother describes that within 1 hour of vaccination, he was fussy and had a fever. He continued not to feel well. He did not want to eat. Around 11pm, he was being held by his father and started shaking. Mother states eyes rolled back also foaming at mouth and this lasted 30 minutes. They then took him to the ER. Received TYLENOL or MOTRIN. Since, has still not eaten well, is fussier than usual. Had continued to feel warm to mom. Afebrile at follow up visit.
Patient started having chest pain on Friday night.  The pain increased throughout the night.  The next morning we took him to the emergency room.  He was admitted to the hospital and remained there until Monday afternoon.
This is the patient's words and timeline.  Developed mild headache by 1230  Left arm became sore and tender to touch by 1300 Developed mild headache and mild sore throat  by 1330  Started feeling fatigue and general malaise by 1400 BP elevated from 127/74 @ 1200 to 144/91 and stayed elevated for rest of the day.  ( I take 10mg Bistolic ?beta-blocker? 2x daily for HTZ.) over the past 5 weeks my BP stays 110-125 area all day due to the split dose. Temp 98.0 @1400 Headache increased from mild to moderate, took 500mg Tylenol  and 800mg ibuprofen w/ famotidine ( Duexis) Left arm became very painful ( maybe 6 of 10) by 1800 followed by body aches mostly in the flanks but also in the hips.    Body chills and shivering set in around 0200 , no fever.   I woke up several times to find myself scratching at the injection site. Noticed a 5-10cm whelp developed at injection site.  Site became warm to the touch and pain radiated into the AC of left arm.  0500 I woke up with abdominal pain and nausea. (no vomiting or diarrhea.) Took another round of ibuprofen w/ famotidine ( Duexis)  and Tylenol by 0700  Still currently have moderate body aches, fatigue, and arm is still painful to touch and movement. Headache is 2 of 10, abdominal pain is mild and comes and goes. BP was decreased to 122/73 @ 0700
This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age who on 23-AUG-2012, was vaccinated with a dose of MMR II (dose, route and lot number not reported) that was exposed to 10 degrees C for nine hours. The patient was not experiencing any known symptoms. Additional information has been requested.
within 48 hours of 1st dose, mental status changes, slurred speech, weakness within 24 hours of 2nd dose, sudden onset of arm and leg weakness, "in and out of it,"  layed on the floor for 7 hours until she was able to get up and call for help
Got shot: face swelled up, joint pain moderate, muscle tight, could hardly move. MOTRIN helped. Lasted 27 hours and went back to normal.
Patient said around 8 or 9 at night that his arm was starting to ache then sometime after midnight he started having severe diarrhea and vomiting. Patient had a similiar reaction last year and it lasted for 3 days.
Rash on temples.  In 24 hours the rash had spread from head to foot.  Rash acted like a burn, hot to the touch, no fever, 1 wk and 1 day after shot skin peeling.
Bad diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 01Apr2021 at 01:45 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have a history of allergies to any food or medications or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 23:00, the patient experienced bad diarrhea for 4 days. No therapeutic measures were taken for the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event bad diarrhea was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Severe pain in every joint. Pain so intense i could not stand or even pull myself off the couch. Took ambulance to Medical Center. Admitted. Severe swelling left knee and left thumb joints to wrist. Excruciating pain. Non-ambulatory, HBP
Doses administered to patients 18 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Vial had been punctured for 18 hours. The vial was stored in the refrigerator after the first puncture. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 23-OCT-2018 the patient was inadvertently administered with VARIVAX (lot # N008077, expiration date: 09-MAR-2019, route: intramuscular, dose detail were unknown) and M-M-R II (lot #, expiration date and dose detail were unknown, route: intramuscular) for prophylaxis(subcutaneous injection formulation administered by other route). No adverse effects were reported.
Patient became ill the day after the vaccine with severe cough, chills and fever and was diagnosed with pneumonia today, one week after the vaccine administration and treated with an antibiotic.
Allergy to red meat became prevalent again. Since becoming allergic to red meat in the summer of 2020, I had gained a tolerance to red meat to the point where I could consume as much as I wanted. This lasted between August 2020 and the date listed in this report. On that date I consumed red meat and had an allergic reaction to it. The reaction was a swelling of the fingers, hives on the arms and knees and wrist. As I didn?t have any reactions to red meat in the previous 10 months I didn?t make the connection that I was allergic to red meat again. The following Monday I consumed more red meat. That night I was very drowsy and went to bed at 1900. At around 0100 Tuesday morning I woke up with a terrible stomach ache and could feel my hands itching. I tried to go back to sleep. At around 0430 I woke up again with completely swollen hands to the point where I couldn?t bend any joint in them, hives on my wrists, knees, elbows, neck, forehead, back, and back of thighs. I went to the hospital for a severe allergic reaction. This is the exact same allergic reaction that I would have when I consumed red meat in June 2020 at the height of my allergy, but I had never had a reaction like it since then. Now I am sensitive to red meat again and I can?t think of any reason except that I received the vaccine. I have not consumed red meat since.
Information has been received from a physician concerning an 11 yr old pt who on 01Jun05 was vaccinated with a dose of varicella virus vaccine live (lot 647960/0070R). It was reported that on 10Jun05 the pt experienced breakthrough varicella with a rash, with less than 20 lesions, mostly facial and a fever. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Patient received 3rd dose and final dose of pre-exposure rabies vaccine, 3rd dose of HPV4 vaccine about 25 minutes apart. Immediately of HPV administration patient had generalized muscle twitching, no rigidity, eyes rolled back, he was cold and clammy, no loss of consciousness.
COVID-19; COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 23Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir from 22Feb2023 to 26Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Malaise, weepy, achy, immobile right arm, and mild immobile left arm. Next day 5 X 3 inch red mark below shot. Next three day hot to touch. 9/7/2012 Rubbery legs from below knee to about 5 inches toward ankle, for 3 steps.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Information regarding concurrent condition, historical condition and concomitant therapy was not reported. During the entire time from 26-AUG-2015 to 13-OCT-2015, doses of M-M-R II (lot # K007108, expired date 16-MAY-2016, rHA) was improperly stored to 9 centigrade. On 12-OCT-2015, the patient received a dose of this improperly stored vaccine, subcutaneously. No known adverse effect was reported This is one of the several reports with the same reporter. Additional information has been requested.
Pt admitted on 08/16/06 (through ER visit); discharged 8/18/06. Child with diarrhea. 9/15/06 Received medical records from hospital which reveal patient experienced excessive sleepiness, poor feeding, slight stuffy nose & diarrhea prior to admission on 8/16/06 for overnight observation.  Diagnosis: acute fever in neonate.  Septic w/u was done & all neg.  Final diagnosis: neonatal fever, probable viral illness.  Had continued diarrhea on d/c to home folloiwng day.  All labs, including rotavirus, were neg./ss
From 7/30/12 to approximately 8/7/12 developed cyclical (every 50 minutes) episodes of diaphoresis, hot flush and slight weakness. Each episode lasting approximately 5 minutes. Seen in our office on 8/4/12. Vitals were monitored for approximately 2-3 hours. Labs done.
Swelling on left arm starting at the site of injection and going down toward elbow with pain.
Lightheadness lasting 10 seconds, stated "feel confused, like a high (1 sec) feel tired-Sx for 30 minutes.
This case was reported by a nurse via call center representative and described the occurrence of pruritus in a adult female patient who received MENVEO. Concurrent medical conditions included latex allergy (experienced allergic reaction in the form of rash). On an unknown date, the patient received MENVEO at an unknown dose. On an unknown date, immediately after receiving MENVEO, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovered/resolved. It was unknown if the reporter considered the pruritus to be related to MENVEO. Additional details were provided as follows: In the morning of the reporting date, the nurse passed out the purple MENVEO binder tags and received a Skype message from one of her pediatric staffs. The patient inquired the nurse whether the holder things of the MENVEO vaccine contain latex. It was reported that the patient started itching right away when she opened the MENVEO vaccine pack and touched them with her fingers. The itching lasted for 10 to 15 minutes only. The patient did not have further complaints and it was confirmed with the manufacturer for these vaccine that it does not contain latex.
Glands under tongue swollen; chills; muscular aches; eyes very red. Symptoms lasted less than 24 hours.
The injection was administered on 03May2021 around 1:45pm and soreness at the injection site started within 4 hours. The site was sore and warm to the touch. Patient experienced headache, fever, chills, achy joints, sweating, and fatigue. On 05May2021, all of the events resolved. On 05May2021 the patient began to feel pain in the groin lymph node area and the underarm area of the left arm.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: cellulitis-Medium
(Pt has never smoked). Vision changes. Sore arm. Achy muscles, fatigue, poor sleep - developed coating in tongue, mouth. Started coughing, increased HR noted. Started having trouble breathing, increased BP, poor concentration. Stumbling, unsteady gait. S/s "asthma" type attack - sought med help on 8-27-10 - have to been ER x 2. Dr's offices x 4, off work since 8-23-10. Continue to have resp. problems, numbness of toes, balls of feet also. Continue to have cough, change in voice, resp. problems.
Developed Shingles, approx 7 days after 2nd dose after 2nd dose
Pt developed a blotchy rash on stomach, bra line, under armpit and up neck. Nothing on arm except soreness. This occurred 2 days after receiving vaccine.
Chills, body aches, and headache approximately 12 hours after injection. Chills and body aches lasted a few hours. Headache lasted about a day. Red, warm rash (not itchy) near injection site approximately 3 days after injection.