chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient came in for vaccine- administered first covid shot. patient waited 15 minute waiting period. felt OK. left to go to car, then started to feel funny. lips and face itchy and warm. came back to pharmacy to get advice. gave her Benadryl, thinking maybe just a localized reaction. after 10 minutes, no improvement. at that point patient started to get hives. then progressed to trouble breathing and tongue swelling. called 911 and administered epipen. patient was then able to breath more easily. rescue squad came and evaluated her and transported her to hospital.
Headache, fatigue, sore throat, body ache, edema at injection site. Denies fever or redness at site. Treated with TYLENOL 500mg 2 tabs & Health Sense Mucus Relief DM expectorant & cough suppressant.
pain; few aches; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY, PAIN, and PAIN in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY. On an unknown date, the patient experienced PAIN and PAIN. At the time of the report, PAIN IN EXTREMITY, PAIN, and PAIN outcome was unknown. Not Provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs are not provided. Treatment drug information does not provided. The action taken with the drug was not applicable.   Reporter did not allow further contact.
After getting it I went home and slept about 3 hours and woke up with fever of 99.3. Had a pounding headache that Tylenol nor ibuprofen could relieve. Body began to ache to the point I was in tears. Checked fever again and was at 99.9. Took more Tylenol and Ibuprophen and went to bed as much as I could. Woke up and took Tylenol the next morning. Checked temperature because I still had a pounding headache and was at 100.2, started sweating and shaking as in cold sweats. No appetite. Spent most of the day resting with most symptoms still accruing. On 3rd day I have no fever. I?m not as weak and I?m able to get around a lot better. Still a little nauseous but definitely feeling better then the previous days.
Vagal presyncope. Tachycardia. Cold sweat, lightheadedness about 15min post injection. Having had multiple vagal episodes before, including with other vaccines, I oncreased my SVR by kneeling down. Symptoms resolved after 15min of continuous kneeling.
Second dose of MMR and Varicella but first dose given combined - vaccine was given on 03/28/18 with a small reaction (rash) at time of vaccine and larger rash on both legs in days after vaccination as reported by mother.
Headache, Myalgia & Arthralgia Narrative:  Employee reports headaches, body aches, and joint pain following the second dose of the vaccine. Also notes "head feels heavy."  Reports used Tylenol and Motrin for symptom relief.
no adverse event; A temperature excursion for ROTATEQ was reported. The product has been administered to one patient on 15AUG2021; This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 15-AUG-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent with one improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot number 1741235, which was verified to be a valid lot number, expiration date reported, and upon internal validation established as 09-MAR-2022), as prophylaxis (frequency, route of administration, anatomical location, and vaccination scheme were not reported) (product storage error). The administered vaccine underwent a temperature excursion of 10 degree Celsius (C), 9.4C, and 9.5C during a time frame of 27 minutes, 43 minutes and 17 minutes respectively. There was no previous temperature excursion. No additional adverse events were reported.
Erythema, warmth, pruritus below injection site. Area about 3x4 inches. Lasted about a week
The next morning after her vaccination date on 11-18-21 she woke up around 6:45 am with a heart rate exceeding  normal levels. After taking  our kids to the schools she returned home almost collapsing. I took twice her blood pressure and oxygenation level and the results were as follows: 1.- Oxygenation level : 87 2.- Heart beating rate : 116 3.- Blood pressure : less than 60 if I remember correctly(found this condition very weird). Right after taking those vitals i took her to the Hospital Emergency room  where she arrived in someway already stable but in shock.  After this incident , she began deteriorating mentally or cognitively to the point where she lost her life history short and long term memory. including the capacity to walk and conduct her normal occupational activities. She also lost her bearings on time and location including forgetting about essential things like eating or recognizing our two children's as her own. Her condition remains the same as of today withy a slightly improve in her mobility. During her rapid decay I took her one more time to the emergency hospital in 2021 when she failed to recognize me times in a day.
PATIENT EXPERIENCED RASH, REDNESS, SWELLING, FLUID (WATER POCKETS) AND ITCHING ALONG ENTIRE LEFT SIDE OF BODY INCLUDING ARM, LEG, TRUNK, NECK AND HEAD (LEFT SIDE ONLY)
Subsequent to receiving one dose of varicella virus vaccine live, testing results were negative for VZV antibodies. It was also noted that the pt did not respond to hepatitis B vaccine. Additional information has been requested.
Overnight after shot felt mild chills and nausea. At 7:15 the following morning was suddenly overcome by light- headedness, which rapidly intensified. Felt as though I would pass out. Vision became blurred, sharp tingling all over body, especially in hands and feet, cold sweat and nausea. Nearly vomited. Could not stand up while this was happening. Overall lasted approximately 20-30 minutes, after which I felt better, but weak, with headache and chills remainder of the day.
high blood pressure; tachycardia; This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 31-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number M5325, expiry date 30th June 2020) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe (batch number Unknown, expiry date 30th June 2020) for prophylaxis.   In October 2019, the patient received Fluarix Tetra 2019-2020 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. In October 2019, less than an hour after receiving Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced blood pressure high and tachycardia. On an unknown date, the outcome of the blood pressure high and tachycardia were recovered/resolved.   It was unknown if the reporter considered the blood pressure high and tachycardia to be related to Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported it could be 31 years. In October 2019, the patient received a dose of Fluarix Tetra and within 15 minutes, she experienced high blood pressure and tachycardia. Both the events were resolved. The reporter consented to follow up with her HCP (health care provider).
Within 5 minutes of administration, patient began to experience some nausea and alerted pharmacy staff. The pharmacist gave patient trash can and began monitoring patient condition. Patient stated has anxiety and has experienced this before. Patient was pale at this time. After 10 minutes  from vaccination, patient began to get sweaty. pharmacist gave patient an ice pack for forehead and helped patient to the floor. Patient sat on floor and remained conscious. After several minutes on the floor. patient's color returned and he stated was feeling much better. Patient returned to his chair at this time (about 15 mins post vaccination). Patients condition continued to improve from there on. Patient waited at the pharamcy for 30 more minutes to ensure syncope event had past and no other issues arose. Patient left after 45 minutes stating they feel normal.
Diagnosis of hyperparathyroidism via blood and urine test. Probable parathyroid adenoma awaiting  CT to confirm.
PATIENT CALLED PHARMACY AND STATED THAT HER ARM HAS FORMED A RASH UNDER THE INJECTION SITE. SHE SAID IT IS ABOUT 3 INCHES WIDE AND 6 INCHES LONG. SHE ALSO SAID THAT IT IS WARM TO THE TOUCH. I ADVISED THE PATIENT TO TAKE SOME BENADRYL AND MONITOR THE RASH. IF IT GETS WORSE OR SHE BEGINS TO EXPERIENCE OTHER SYMPTOMS, TO GO SEE A DOCTOR.
Initial report was received on 17 September 2012 from a health care professional. A 91 year-old male patient with an unknown past medical history had received and Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later on 14 September, presented in the ER (emergency room) with necrotizing fasciitis in the left arm and was hospitalized. According to the reporter, the patient was unsure which arm he had been vaccinated in or on what date. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Left leg swollen; child irritable; Rx Tylenol q 4 hours with relief. Crying inconsolably for 3 hours.
Started with chills, then severe headache, body aches, and ETOH like withdrawals (mind racing, delusional thoughts), nausea, tossing and turning unable to get comfortable (Though I spent 18 hours in bed, Fitbit recorded only 3.5 hours of sleep). Please note this writer has never experienced etoh withdrawal personally, however he has taken care of many patients requiring hospitalization for the same. The bulk of all simultaneous symptoms occurred from 0200 on 1/14 to 1030 hours of same day. Headache unrelieved by Tylenol (500mg at 2230 on 1/13, 1000mg  at 0245 on 1/14, then Advil 400mg at 0945 on 1/14).
Patient received 3rd dose of Rotarix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number K2FM7, expiry date 4th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Previously administered products included Rotarix (received 1st and 2nd dose on an unspecified date).   In December 2021, the patient received the 3rd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. In December 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: Registered Nurse reported that, the patient received 3rd dose of Rotarix, which led to extra dose administered. They noticed this situation at the facilitie on 7th March 2021 and got in contact with baby's mother who stated that the baby did not present any adverse events and was ok. The health care professional (HCP) got in contact with the CDC (Center for Disease Control) who provided information and explained that importance was in the interval between doses than the number of doses. The reporter consented to follow up.
Light-headed (foggy, not dizzy). Difficulty taking deep breaths/ getting a full breath.
Pt presented with 25x30mm red, hot, raised area on lateral (L) thigh, noted yesterday morning, worsened today; no fever per mother. States pt has had a red "bump" at this site since receiving Varicella injection on 30 Apr 08; pt's sister has had a similar delayed reaction to Varicella vaccine in the past. Mom states she was advised by a phone-advice nurse to place cold packs at the site, which may have contributed to the persistence of vaccine serum / irritation in the local tissue; pt was scratching the site throughout triage and screening today as well. Pt was diagnosed with cellulitis and placed on Cephalexin 250mg x 10 days.
This case was reported by an attorney and described the occurrence of autism spectrum disorder in a male patient who received hepatitis B vaccine recombinant and diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. This report was received via the litigation process and a physician or other health care professional has not verified the report. The attorney stated that on 5/3/98, the patient received Engerix B (lot # ENG4248A2). On 7/10/98, the patient received Infanrix (lot # DTPA852A2), on 9/3/98, the patient received Infanrix (lot # DTPA860A2). On 11/6/98, the patient received Infanrix (lot DTPA916A2). At an unknown time after receiving Engerix B and Infanrix vaccines, the patient developed autism spectrum disorder. The event was attributed to exposure to thimerosal from the vaccine. This case was assessed as medically serious (OMIC).
Arm near injection site is red, itchy, tender, and warm to the touch.  Began 2 days after vaccine. Has not resolved yet.
This spontaneous report was received from a other health professional (healthcare worker) refers to unspecified patients of unknown demographics. Since an unknown date these patients were administered with improperly stored VARIVAX (Merck) (dose, frequency, therapy route, lot #, expiry date not specified). No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event was unknown. Reporting healthcare worker considered the event to be not related to VARIVAX (Merck). Additional information has been requested.
Mom took pt to ER due to 4x5cm redness on rt leg; Was told pt had cellulitis & to get tx w/ATB & hot packs; Leg has improved & now has large area that is bruised; Keflex x 7-10 days;
Patient reports having pain around right rib cage, emanating from spine, vertigo, nausea, headache, joint pain and muscle soreness beginning a few hours after vaccine and continuing for about 36 hours.
Patient received moderna vaccine on 2/12/21. Unsure of LOT and vaccine route and site. On 2/1/22, found to be COVID positive. Presented to ER on 2/15/22.  Admitted through the emergency room after he presented with increasing abdominal pain and  discomfort, and subsequent radiographic evidence of what appears to be metastatic lung cancer to the liver. He was admitted at this time for further care. Did not receive therapy for COVID during hospital stay. Discharged on 2/16/22
like the flu; in bed for a day and a half; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like the flu), IMPAIRED WORK ABILITY (in bed for a day and a half) and CHILLS (chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A, 080M20A and 037F21A) for COVID-19 vaccination.     Concurrent medical conditions included Emphysema, COPD, Blood pressure, Aneurysm and Oxygen consumption.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like the flu), IMPAIRED WORK ABILITY (in bed for a day and a half) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (like the flu), IMPAIRED WORK ABILITY (in bed for a day and a half) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  Patient reported that his doctor did not recommend to take the third dose, but he decided to do so all the same because of his several underlying conditions.
Fever & rash & pain at injection site 10 cm firm, red, warm reaction at site.
Patient's reports warmth all around neck, and pain in arm where she was vaccinated lasting from 9/19/2019 until present (10/1/2019). Patient's arm pain extends to neck and can not fully lift arm.
Comes in complaining of gradual leg swelling over a 3 day period. No fever on exam, left anterior thigh 2.0cmx4.0cm tender and red area with hard nodule underneath approximately 1x2cm.  Right anterior thigh 0.5x1. Red and tender. Diagnosis: Cellulitis treated with Augmentin ES 600 1.5 tsp twice daily for 10 days. Was rechecked 06/14/04 and pain and swelling is resolved. Redness decreased, child actually refused to take Augmentin.
Information has been received from a registered pharmacist concerning a 74 year old female patient with allergy to penicillin and salicylates and no pertinent medical history who in 2002 was vaccinated with a dose of PNEUMOVAX 23 and had no reaction. On 29-SEP-2010 the patient received a second 0.5ml SQ dose of PNEUMOVAX 23 (Lot #665708/0651Z). Concomitant therapy included "thyroid pills and an inhaler". On 29-SEP-2010 the patient developed local injection site reaction after receiving second dose of PNEUMOVAX 23. The site of injection became painful and swollen. At the time of the report the patient had not recovered. The patient sought unspecified medical attention. No laboratories or diagnostics studies were performed. Follow up information has been received from a registered pharmacist who indicated that on 29-SEP-2009 the patient received an injection of PNEUMOVAX 23. It was reported that the patient had had PNEUMOVAX 23 at least 3-4 times in his life; she had had PNEUMOVAX 23 before with no problem. Concomitant therapy included levothyroxine Na. Called the next day and was swollen and sore. The pharmacist called the next day and the patient was better. Swelling of the injected arm lasted 2 days. The pharmacist stated that the patient had since made a full recovery (also reported as not recovered). Additional information is not expected.
Rash spots on left shoulder/back. Diagnosed as shingles per Dr. on 2/10/15.
I was sore after the shot. I waited to exercise for a few days. On Monday I felt a burning sensation in my shoulder muscles. I discovered a lump under my left arm in my armpit area. It is painful. I also had euphoria upon receiving the vaccine.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age with allergy to penicillin. No concomitant medications were reported. On 04-DEC-2014 the patient was vaccinated with ZOSTAVAX lot # K012924, subcutaneous in the right arm. In DEC-2014 the patient experienced headaches, large painful area of redness, warmth, and swelling at injection site after administration of ZOSTAVAX on 04-DEC-2014. The outcome of headaches and large painful area of redness, warmth, and swelling at injection site was reported as not recovered/not resolved. The patient sought medical attention by going to the pharmacy. No further information was provided. Additional information has been requested.
MA stated they inadvertently administered an expired dose to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Medical assistant stated that, they inadvertently administered an expired dose of Bexsero to the patient, which led to expired vaccine used. The reporter inquired if the dose was okay. The reporter consented to follow up.
PT PRESENTED WITH THE REQEUST FOR 2ND DOSE OF MODERNA VACCINE. PHARMACIST /IMMUNIZER ENQUIRED ABOUT THE FIRST DOSE, IF THERE WERE ANY REACTION ? SHE REPLIED SHE JUST HAD FLU AFTER THE VACCINE, BUT NO ALLERGIC REACTION. VACCINE WAS ADMINISTERED. 10 MINUTES AFTER THE VACCINE, SHE COMPLAINED ABOUT BREAKING OUT IN HIVES. WITH HER VOICE CHANGING AND HAD TROUBLE SPEAKING. USE OF EPI PEN WAS RECOMMENDED , SHE ADMINISTERED AN EPIPEN TO HER THIGH.  PHARMACIST WAS ABOUT TO CALL 911, WHEN SHE AND HER CAREGIVER SAID SHE DOESNT WANT ME TO CALL 911. THEY WILL GO TO THE ER THEMSELVES. CAREGIVER RUSHED HER OUT OF THE STORE TO HOSPITAL. 10 MINUTES LATER THEY SHOW UP AGAIN AT THE DRIVE THRU WINDOW TO PICK UP THEIR VACCINE CARDS. PATIENT LOOKED VISIBLY  IN MUCH BETTER CONDITION THAN SHE LEFT. AN ER VISIT WAS RECOMMENDED ONCE AGAIN BY PHARMACIST AT DRIVE THRU. AS OF YET NOT SURE WHETHER SHE IS GOING TO EMERGENCY OR NOT.
Tinnitus; First dose on 17 Jan 2021 and second dose on 09 Feb 2021; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (Tinnitus) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 17 Jan 2021 and second dose on 09 Feb 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Hypertension.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 17 Jan 2021 and second dose on 09 Feb 2021). In May 2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 17 Jan 2021 and second dose on 09 Feb 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After receiving the second dose of the Moderna Covid 19 vaccine and before receiving the first booster dose patient developed tinnitus.  The patient did not took any treatment medication for this symptom.