chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer (also the subject) and described the occurrence of injection arm pain in a 62-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to hydrocodone and smoker. Historic vaccination included pneumonia vaccine (non-gsk); manufacturer unspecified; unknown; unknown given on an unspecified date. Concurrent medications included ADVAIR and COMBIVENT. On 3 October 2011 at 15:15 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 10 October 2011, 7 days after vaccination with FLUARIX, the subject experienced injection arm pain, injection site movement impairment ("loss of range of motion, could not move him, complete loss of mobility"), not sleeping and inability to perform daily activities ("could not dress, cook"). The subject stated that 1 week after the vaccination she developed significant pain in her left arm and loss of motion. She denied any injection site immediate reaction from the vaccination. According to the subject, she continued to worsen to the point of complete loss of mobility in the injected arm. She stated she could not sleep, dress, cook or move her arm. The subject reported that she was only able to get 2 hours of sleep a night for 3 months. The subject saw her physician on 14 December 2011 and again on 12 January 2012 for "continued problems". An X-ray demonstrated no physical damage or tears in her arm. The subject had a magnetic resonance imaging (MRI) on 20 January 2012 and again no injury to the shoulder or arm was seen. The subject saw an orthopedist on 25 January 2012 who treated her with a cortisone injection, pain medications and range of motion exercises. According to the subject, the cortisone injections stopped the pain and the exercises have made a very small improvement in the range of motion. The subject noted that she is not certain if she will ever be able to have full range again like this on the internet and is angry over the loss of function and money". The subject indicated that she has not pursued legal action at this time, but may proceed for reimbursement. The subject stated she reported her events to the FDA. At the time of reporting, the injection site arm pain was resolved as of 25 January 2012 and the injection site movement impairment and not sleeping were improved. The outcome for inability to perform daily activities was unknown. Follow-up information was received via the consumer on 27 March 2012. It was reported that the subject still had ongoing issues following vaccination with FLUARIX. She noted pain in her arm described as severe pain with certain arm movements and "loss of range of motion". The subject noted still not having full use of her arm. She reported that her condition may require additional cortisone shots and therapy. This subject has received ADVAIR concurrently. For details concerning events associated with ADVAIR use, please see case A0912059A.
Axillary fevers 101.2 to 101.6 since vaccine (after 4 days). Responsive to antipyretics. No other symptoms of URI/Flu. Acting normally despite fever.
pt had a pallor spell, unresponsiveness, feet cold to touch;came to MD office was OK;
severe chills, fever, fatigue, urinary tract infection (no symptoms before 5/02,  more memory problems than previous ( normal aging, not dementia).
Bivalent were administered after multiple temperature excursions; Doses of refrigerated Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions; No Adverse event; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent were administered after multiple temperature excursions), PRODUCT STORAGE ERROR (Doses of refrigerated Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent were administered after multiple temperature excursions), PRODUCT STORAGE ERROR (Doses of refrigerated Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent were administered after multiple temperature excursions), PRODUCT STORAGE ERROR (Doses of refrigerated Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent were administered after multiple temperature excursions) and PRODUCT STORAGE ERROR (Doses of refrigerated Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions).    Concomitant medication was not reported. At the time of the excursion product were refrigerated.  Individual vials or unbroken cartons was 6 vials and vial size were 2.5 mL. Maximum or minimum temperatures reached, was on 18-Oct-2022 (8.4C and 8.9C), 24-Oct-2022 (8.1C, 8.6C, 8.6 C, 8.1C) and at 10.25 (8.5 and 8.5) for 15 min each duration.  On 11-Oct-2022 vials moved from freezer to refrigerator. No visual inspection noting any vaccine state changed.   Treatment drug was not reported.
Patient received the 1st dose of the Moderna bivalent booster (previously received J&J; date unknown).  Per the parents of the patient, the patient fainted within 5 minutes of getting the vaccine while sitting down and seized for several minutes. The mother of the parent notified the pharmacy. The pharmacist on duty immediately tended to the patient. By that time, the patient was alert but looked pale and was sweating. he patient also indicated he was nauseous and felt cold. The patient was given water, and the pharmacist tried getting a blood pressure but the reading was interrupted because the patient was not feeling well and asked to stop the monitoring. The paramedics were notified and verified blood pressure was low (90s/60s) and gave the patient an IV and continued to monitor the patient's BP. The patient's BP returned to normal within 30 minutes of the paramedics arriving and the patient was released and transport to the hospital was not required.
After recieving vaccine, Mariah started having bouts of rectal bleeding and diareah. In additin to this she had a very loud barking "chronic" cough. Months and months of her PMD telling us not to worry, she finally diagnosed with Ulcerative Colitis. She has had to have a total colectomy resulting with an ostomy and several blood transfusions.  4/28/09 Extensive MR received for multiple hospital admissions and ER visits from 5/2008-4/2009 with the following D/C DX:  DOS: 10/3-5/2008- Inflammatory Bowel Disease.  Anemia s/p PRBC transfusions DOS: 10/8-31/2008- Ulcerative Colitis.  Pancreatitis. S/P Lap Colectomy with Ileostomy.  Ex lap, ahesiolysis, wash out.  DOS 1/5-8/2009- Ulcerative Colitis s/p Colectomy.  Acute pancreatitis.  Pancreas divisum.  UTI.   DOS 2/16-22/2009- Lap Cholecystectomy.  Lap-assisted J-pouch ileorectal anastomosis.  Anorectal pull through.  Loop ileostomy.   DOS 4/3-6/2009- Ulcerative Colitis, Pancreatitis.  Bowel Obstruction.   Multiple ER visits with DX:  4/25/08 Cough.  hematochezia 5/4/08  GI bleed.  Abdominal cramping  5/22/08 Crohn's exacerbation  6/8/08 Rectal bleeding.   7/26/08, 7/27/08, 9/8/08 Crohn's Flare.  10/8/08 IBD and drug induced pancreatitis. 11/17/08 Gastroenteritis as well as multiple episodes of abdominal pain. Otolaryngology consult 9/8/08 for 9 month hx of chronic cough.  Seen in Pulmonary Clinic 3/26/09 for f/u of chronic cough 2' to ulcerative colitis.`  Pt initially presented 4/25/08 with c/o 4 wk hx of chronic cough, sore throat and 2 week hx of rectal bleeding. PE WNL. Returned 5/2/08 with c/o rectal bleeding and abdominal pain-frank blood and diarrhea.  Frequent hospitalizations and Er visits as above continue to present with multiple surgeries and procedures (above).
Patient is still having a serious injection site reaction: redness, swelling, bruising, pain. She has also has headaches and GI distress. It has been almost 4 weeks since her immunization.
You can get shingle shots and still get shingles, I did it/Suspected vaccination failure; Still get shingles, I did it; Painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   The reporter considered the vaccination failure, shingles and pain to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 23-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient still contracted shingles despite getting the Shingrix vaccine. The reporter stated that, if you could get the Shingles shots and still got shingles and she know that as she did it and painful. The reporter thought that the event might had been related to the drug. The reporter did not agree to contact her healthcare professional. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
The patient said that the shingrix shot is causing him sleep disturbances. He said it started right after he got the shot and that he wakes in the middle of the night. He said nothing else has changed other then receiving the vaccine
Vaccine given from a vial that had been punctured for more than 24 hours/gave two Moderna vaccines that were expired by 14; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given from a vial that had been punctured for more than 24 hours/gave two Moderna vaccines that were expired by 14) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 039C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given from a vial that had been punctured for more than 24 hours/gave two Moderna vaccines that were expired by 14). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given from a vial that had been punctured for more than 24 hours/gave two Moderna vaccines that were expired by 14) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  Reporter wants to know if there is a need  to revaccinate their patients.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received contains No New Information
Gave bivalent dose (booster) instead of 2nd dose of primary series. She did not having any adverse reaction to vaccine. She is 10w-0d and expected due date is 10/3/2023.
SHINGLES VACCINE: Shot in left arm...cannot move my arm away from ribs...feels like the shot settled in my shoulder socket...today is day 3 and still in severe pain.
Severe abdominal pain/cramp few hours after taking each dose.  It lasts for about 24 hours.  Loose stool frequently for the immediate 24 hours after taking the pill.
Tinnitus, ear hissing sound.  Visited HCP 04/14/2021 to have ears cleaned.  Reported tinnitus symptoms.  Cleaning did not resolve issue.
Received a call from patient above stating that she became very ill 4 days after the 2 vaccines were given.  Pt. reported nausea, extreme fatigue, which she states she "went to sleep and passed out" for a period of time?, Had R shoulder and R neck pain that was so severe that she could not move.  Injection given L deltoid.
pt devel visual loss in both eyes 3wk p/vax;4NOV93 noted blurring of both eyes rt > lt;BP 130/100;pupillary defect;visual field testing revealed upper nasal island of vision;optic disc swollen & peripapillary hem;allerg react;neuropathy;
Received vaccine on may 12,2009 at 4:19pm. Later in evening developed body aches, chills and "fever in side". Left arm became swollen and red.
13:50- Approximately 5 minutes after vaccine administered pt became flushed, nauseated and c/o lightheadedness.  Patient alerted observer and medical assistant called for transfer of the patient to the first aide office.  Patient then evaluated by EMS on duty:  VS: b/p 142/80, SaO2 100% on RA.  PMHx: Migraines Medications: Fiornial, patient had same s/sx after 1st vaccine. 1435: Patients symptoms resolved and patient was cleared by EMS to discharge home.  Ambulated on own without weakness.  Escorted out by Paramedic to car.
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 05-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2106; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; and 10 F for 2 hours on 03-APR-2016. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, frequency were not reported) after being stored improperly. No adverse effects were noted. No product quality complaint (PQC) was involved. Additional information has been requested.
Experiencing dermatagraphism all over my body as a reaction to the Moderna booster (received Moderna for vaccines 1 and 2). This causes extreme discomfort and itchiness. I went to urgent care (outcome: prescribed 50 mg prednisone daily for a week which did not work), primary care (outcome: referred me to an allergist) and allergist regarding this. Currently, on a combination of prednisone (10 mg) and zytec (one pill) twice a day which is keeping the dermatagraphy at bay. However, was informed that I may be on this cocktail until the portion of the vaccine causing the reaction wears off which may be months,.
Soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 17:15 (Lot number: FK5127) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 19Nov2021, outcome "recovering", described as "Soreness at injection site".  Additional information: of soreness at injection site; started yesterday and continuing today but reportedly a lot better today  No follow-up attempts are possible. No further information is expected.
Post vax that evening the patient had a temperature of 105F with no other symptoms. The patient was seen in the ER where he had a convulsion. The patient was treated with medicine to lower the fever and sent home. Dr will be giving the next set in her office.
Rash on lt upper back?-Got shingles on my left torso, painful nerve pin, given steroid and acyclovir, fatigue
Swollen lymph nodes was found under the left armpit. And a tingling sensation in my lower back and fingers, like a shooting nerve feeling.
After receiving the vaccination, he started feeling lightheaded, then started sweating. He asked for water and drank water prior to a brief episode of syncope. He denies any trauma to his head or any part of his body. No mental status changes. He was assisted to the supine position on the floor, then was able to ambulate to a private section of the area and lay recumbent on an EMT gurney.  He has a history of syncope with needlesticks.
pt ran fever 102 & vomited 3-4 time morning p/inject w/DTP/MMR; later same day devel urticaria-poss related to DTP vax;
itchy or burning on different spots of back, neck, arms, upper thighs, face; mild allergic reaction; 19 mRNA VACCINE; Lot number: er2613) as a single dose via unspecified route on 17Mar2021 at 15.30 (at the age of 57-year-old) for COVID-19 immunisation. The patient medical history included spasmodic dysphonia, acid reflux. Concomitant medications included omeprazole (MANUFACTURE UNKNOWN) delay release 20milligram, vitamin c (MANUFACTURE UNKNOWN), calcium d3(MANUFACTURE UNKNOWN), muti. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested positive for COVID-19 since the vaccination. The patient was allergic to pistachio nuts from Spain or the red dye in it. Patient previously took benadryl in the past to relieve allergy symptoms. The patient experienced mild allergic reaction on 17Mar2021 at 15.30., itchy or burning on different spots of back, neck, arms, upper thighs, face, felt burning at 11:30 PM, but better than that first hour. Patient had taken treatment for the reported events. The clinical outcome of mild allergic reaction, and itchy was recovered .   No follow-up attempts are needed. No further information is expected..
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnic origin. 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, expiry: Unknown) dose, 1 total, start therapy date was 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 patient experienced suspected covid-19 infection and suspected clinical vaccination failure. On an unspecified date, the patient died from suspected covid-19 infection. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).  This case, from the same reporter is linked to 20210950539, 20210950479 and 20210950658.; Sender's Comments: V0: 20210950686- COVID-19 VACCINE AD26.COV2.S- suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210950686-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: SUSPECTED COVID-19 INFECTION
Fever. Sweating. Felt like body on fire. Threw up and then dry heaved all night. Bad h/a. Hurt all over. Disoriented. Room spinning. Dizzy. Severe stomach pain. Felt like going to die.
a rash that started at the site of the pentacel injection and then extended to the length of the leg, the other leg, the arms, the trunk, & the face; red/pink papules that are discrete on the arms, legs, and trunk; on cheeks they coalesce; they blanch upon pressure
Patient called to let us know a few weeks later that since the shot she has had nerve pain shooting down her arm randomly.  She said that she will be cooking dinner and lift a pot and suddenly drop it due to the pain.  She went to the doctor's office and they prescribed her gabapentin 100mg tid.
Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with Papilloma viral infection and no known drug reactions or allergies, who on 28-JAN-2010, was vaccinated IM with the first 0.5ml dose of GARDASIL (lot number 663451/0216Y), on 30-MAR-2010 was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number 663451/0216Y) and on 02-MAR-2011 was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot # not reported). Concomitant therapy included vitamins. It was her first pregnancy. The patient's LMP was on 21-APR-2010 and the estimated conception date was on 05-MAY-2010. It was reported that on 22-JUN-2010, the patient had an ultrasound performed at 11 weeks of gestation. On 09-JUL-2010, the patient had staphylococcus aureus infection. On 16-NOV-2010, the patient had an other ultrasound performed for fetus reason growth. The nurse reported that on 11-JAN-2011 the patient delivered a healthy male baby at 32 (also reported as 38 weeks by the physician) weeks LMP without any complications or medical reactions during pregnancy or labor. The baby's weight was 7 lb 4 oz. The patient did not have any complication during pregnancy labor. Additional information is not expected.
Meningococcal MCV4 Lot# U3433AA - Exp. 08/02/11 vaccine administered 08/10/11, 8 days after expiration date. Meningococcal MCV4 Lot# U3778AA Exp. 10/14/12 readministered: 8/24/11.
use aspirin or acetaminophen after the Moderna booster dose; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (use aspirin or acetaminophen after the Moderna booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 NO ADVERSE EVENT (use aspirin or acetaminophen after the Moderna booster dose). At the time of the report, NO ADVERSE EVENT (use aspirin or acetaminophen after the Moderna booster dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.