chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported hives and swelling of the hands to the pharmacy on 9/8/23 that began in the morning the day after receiving the vaccine. She first used benadryl gel but said that did not help so she took 2 benadryl tablets and 1 pepcid tablet which helped. It is mostly resolved now.
Pt said on Tuesday morning she woke up with hives around neck and it has gradually spread to arms and trunk
Second dose not yet given.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th June 2018).   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 details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that the patient did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The pharmacist reported that the second dose of Shingrix greater than 6 months. The reporter consented to follow up.
Extremely sleepy at 10:00pm woke up at 11:30pm with fever, chills, body aches Lasted almost 24 hours Woke up fine Sunday morning then at 8:30pm, Sunday night fever spiked again (102.7) then no more symptoms
Patient was feeling fatigue, unwell the night after getting the vaccine. The next day he stayed home, did not go to work as he was not feeling well.  Two days after getting the vaccine,  he had trouble breathing, an ambulance was called  and he was pronounced deceased hours later. He had a heart attack.
Many rashes in my legs , face, some are big. It bothers all the time and scratches a lot. I am tired, having headaches at times, and accelerated heart beat sometimes.
vials were stored in the refrigerator and thawed on same day of administration; Vaccine was administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the expiration date) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the expiration date) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 169.  Concomitant medications were not reported.  The patient had received booster 1. The patient had no known reactions. The vials were thawed on same day of administration. The vials did not undergo any temperature excursions.  Treatment information was not reported.
Joint pain, focused initially in knees and ankles and now primarily in ankles and feet.  Significant pain and difficulty walking first thing in morning through early April (>4 months).  I have not been able to exercise or walk  or exercise recreationally, and I am paying for expensive on campus parking next to my office, which I used to never do.    I used to walk 3-5 miles a day and also do yoga, etc.  Some days pain was so severe when I got home, I would make sure I did everything I needed on the first floor before going upstairs so that I would not have to do the stairs more than once.   I am now in PT, including icing and NSAIDs, which is helping considerably.   After the first series, I had similar symptoms, plus approx 3 weeks of severe fatigue, and the pain from that event was largely resolving by the time I went in for the booster.
pt brought to the ED on 5/26/22 after a fall; left hip fractured; CT of head and C-spine without acute abnormalities; A fib with RVR; pt found to be positive for COVID; c/o cough and scratchy throat x 2 wks; O2 supplementation; dexamethasone; ORIF; suffered cardiac arrest the following day and never regained ROSC after 2nd arrest
Narrative:  Unknown if death is related to vaccine, reporting as adverse event since it was within 42 days of receiving vaccination
This spontaneous report as received from a nurse refers to a 2 patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of PNEUMOVAX 23 (dose and route of administration were not provided), which were exposed to temperatures outside of the proper storage ranges. No adverse effect reported. This is one of several  reports received from the same reporter. Additional information has been requested.
Complete Amenorrhea after vaccine, had menstrual cycle at the time of first vaccine. Never missed a cycle except for both pregnancies. Was not peri-menopausal and never irregular. No menses since after the second vaccine. It has been almost 4 months
PATIENT REPORTED 2 DAYS LATER REDNESS AND SWELLING ON SHOULDER
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-OCT-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-JUL-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Patient developed blister on left arm around area of the vaccination. It appeared in the morning, raising the bandaid. Patient removed band-aid. States area is itchy. This was the booster vaccine Bivalent Pfizer
pt recvd intradermal inject of Cholera vax & devel a 3 inch wheal @ the inject site;
swelling of the arm; severe pain, could not sleep; metallic taste in mouth and tongue/mouth felt very strange; neck and chin were extremely itchy; pain; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (swelling of the arm), SLEEP DISORDER (severe pain, could not sleep), DYSGEUSIA (metallic taste in mouth and tongue/mouth felt very strange), PRURITUS (neck and chin were extremely itchy) and PAIN (pain) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030MZOA and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PERIPHERAL SWELLING (swelling of the arm), SLEEP DISORDER (severe pain, could not sleep), DYSGEUSIA (metallic taste in mouth and tongue/mouth felt very strange), PRURITUS (neck and chin were extremely itchy), PAIN (pain) and FATIGUE (fatigue). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling of the arm), SLEEP DISORDER (severe pain, could not sleep), DYSGEUSIA (metallic taste in mouth and tongue/mouth felt very strange), PRURITUS (neck and chin were extremely itchy), PAIN (pain) and FATIGUE (fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient is not on any concomitant medication ,she reported that she had experienced symptoms for 3 days, which subsided, and never came back.
12 hours after the second shot I had chills; followed by a low fever of 100.4 and body aches; followed by a low fever of 100.4 and body aches; This is spontaneous report from a contactable consumer (patient). An 40-year-old non pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on left arm on 11Feb2021 12: 00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first single dose of bnt162b2 on 21Jan2021 12:00 via unknown route on left arm single for Covid-19 immunization. The patient had no allergy. The patient not-receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient not received within 2 weeks of vaccination; Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. it was reported 12 hours after the second shot (11Feb2021) patient had chills. This was followed by a low fever of 100.4 and body aches. The chills and body aches continued for 24 hours until they subsided. Event duration was 24 hours. Patient not received treatment. The outcome of the events was recovered on 12Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
got 1 Shingrix shot, then covid hit, never received the 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter said that, the patient got 1 Shingrix shot, then covid hit.  Till the time of reporting, the patient had never received the 2nd shot.  The reporter asked if he should get a 2nd shot or if it was  too late.
Pt reported that he received the 1st Pfizer dose on Feb. 10, on the 13th he reported fever, chills and feeling unwell. On Feb 14th, the pt went to his local doctor and was tested for COVID-19, on the 16th he was notified the COVID-19 test was positive. Pt was instructed to quarantine for the next 14 days, he understands the instructions he was given and will continue to monitor his health.
Very aggressive polyarthritis that has lasted around 6 months, although it is currently much better.  This caused significant mental trauma and hindered my ability to work.
Area of 3cm circumfrential induration, warmth, erythema over injection site.
Pt. received Hep B, HIB, Hep A on 7/27/10. Presented on 07/29/10 with 12 x 18 cm erythematous area warm to touch and firm approx. 48 hrs after vaccine with HIB (R) thigh. Pt. given BENADRYL and f/u in 24 hrs for cellulitis.
Chills.; Nausea; Diarrhea; muscle aches; Booster; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-year-old male patient received bnt162b2 (Comirnaty, Solution for injection) via intramuscular, administered in arm left on 13Oct2021 12:30 (Lot Number: FF8839) (at the age of 35-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included known allergies: Sulfa Drugs from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient had previously received the second dose of bnt162b2 (Comirnaty, Solution for injection) via an unspecified route of administration, on 04Feb2021 (Lot Number: FL3247) (at the age of 35-years-old) as dose 2, single and first dose of bnt162b2 (Comirnaty, Solution for injection) via an unspecified route of administration, on 15Jan2021 (Lot Number: EL3247) (at the age of 35-years-old) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 13Oct2021 12:30, had administered booster. On 13Oct2021 16:30, the patient experienced nausea, diarrhea, muscle aches, chills. The patient did not received treatment for the events. The outcome of the events was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Patient c/o rash with small red bumps over upper body, including the trunk and both arms, starting on 4/8/23.   Reports rash was itchy at the time it started.  Has taken no meds.  States rash has faded and is "almost gone and no longer itches".   Does report she is sometimes sensitive to environmental factors that cause redness and itching on her skin, but that this seemed different to her.
1st dose Oct2018, 2nd not yet, Didn't knowneed 2nd; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in October 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Oct2018, 2nd not yet, Didn't knowneed 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 09-Mar-2023 The reporter was the patient.  The reporter reported the case via interactive digital media. He had not received the second dose yet. He did not realize a second dose was needed.  He planned to receive the second dose. Nothing else was reported. Did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023037532:same reporter
Rigors, chills, teeth chattering to the point I chipped a tooth, body aches, severe headache, nausea, severe diarrhea, GI pains, cramping, anorexia.
This retrospective pregnancy case was reported in a literature article and described the occurrence of Hepatitis B surface antigen positive and Hepatitis B core antigen positive in an adult female subject who was vaccinated with Hepatitis B vaccine recombinant (manufacturer unspecified). The subject's last menstrual period and expected date of delivery were unknown. The authors reported that the subject did not have Hepatitis C or any major medical illness. No further information was provided on the subject's medical history, concurrent medical history or concomitant medications. The subject reported having received an undetermined number of doses of unspecified Hepatitis B vaccine on unspecified dates (doses, routes and injection sites unknown; batch numbers not specified). On an unknown date, at an unspecified time after vaccination with Hepatitis B vaccines, the subject was tested positive for Hepatitis B surface Antigen and total Hepatitis B core Antigen. It was not possible to determine if exposure occurred during pregnancy or within the 3-month period prior to conception with the information provided. This case was assessed as medically serious by GSK due to possible vaccination failure. Treatment was unknown. The outcome of the events and of the pregnancy was unspecified. The authors did not comment on any causal relationship between the event and the unspecified hepatitis B vaccine. The authors' conclusion stated that "although the majority of discrepant HBsAg reactive screening results from this retrospective analysis of pregnant women were false positives, true positives occurred. Total anti-HBc was the most useful single test to resolve HBsAg discrepancies. Validation of a testing algorithm for resolving discrepant results will require prospective studies". This case is 1 of the 2 valid cases reported in the same literature article (see case B1020364A).
BOOSTRIX was given to the infant at 4 mo old. Error was noticed at 6 mo visit 9/12/08 when writing DTaP into that lot # and mfr were wrong. Infant had no adverse events.
Patient started experiencing itching on head, neck arms and back on 01/21/21. She had received the Moderna COVID 19 vaccine on 01/15/21.
1st Vaccine: red circle on arm, radiating heat, itchy, sensitive to touch, entire top of the arm. Lasted 2 weeks, was prescribed antibiotics. Antibiotics did seem to help. 2nd Vaccine: started reacting 10pm same day, uncontrollable shivers, fever, both intense, and Fainting. Weakness/fatigue Lasted throughout the night, the next morning had aches and pains but fainting had stopped. 24 hr period. Took tylenol as needed.
50-year-old male status post heart transplant on 02/08/2017.  He developed antibody mediated rejection in June, 2020. He received multiple sessions of plasmapheresis and IVIG.  Last echocardiogram in March 2021 revealed normal LV systolic function with an EF of 60%.  He presented to the ED on 6/10 with cough and dyspnea.  Labs revealed lymphopenia, neutropenia, and leukopenia and tested positive for COVID. He is s/p Pfizer vaccination on 2/22 and 3/15. He received casirivimab, imdevimab on admission.  Before this admission, he was taking tacrolimus 4/3.5 mg twice daily, Rapamune 1.5 mg daily, MMF 1000 mg twice daily, and prednisone 5 mg daily.
ear infection and closed/clogged ears ongoing cough pressure in chest urgent care visits, doctor's visits, multiple tests and bloodwork done - all tests come back clear, but symptoms continue; was never tested for covid 19
Received Fluzone on 11/1/07.  That night started itching, and was scratching her skin.  On 11/2 she had hives and bumps all over.  On 11/3, her hands were swollen.  She saw here doctor who gave her a steroid injection, and placed her on steroids.
11 days after the vaccine, I woke up at 01:30 AM with SEVERE Vertigo, nausea, and some chills. My tinnitus was the loudest it's ever been. Now, 5 days later, I'm still nauseous and dizzy during the day. My ears are full (especially my left ear) and I can't lay on my left side without experiencing vertigo.
Information has been received from a health professional concerning a 73 year old white female with breast cancer, renal failure acute, renal insufficiency, hypertension, degenerative joint disease, hypercholesterolaemia and cardiac disorder and a history of rib fracture who on 10-OCT-2006 was vaccinated with a dose of ZOSTAVAX (lot number reported: "70089"), subcutaneously in the left arm. On 01-OCT-2007, the patient developed zoster lesions on scalp, face, eye (right). There was no illness at the time of vaccination. Additional information has been requested.  2/26/08 Reviewed pcp medical records which reveal patient experienced fall from ladder & seen in hospital.  Seen in office 10/2/07 in f/u & had rash suddenly 4 days prior to office visit starting as hypersensitivity on scalp.  Now had extensive raised red crops of painful skin lesions & fatigue.  Right eyelid was puffy w/non-purulent drainage.  Tx w/antiviral meds, pain med & referred to ophthalmologist.  Returned to office 10/8/07.  Rash improved.  Returned to office 11/8/07 for continued right eye & rib pain. FINAL DX: Rib fractures; herpes zoster w/ophthalmic complications.  Follow-up received 04/16/2008 from a healthcare professional. It was reported that the patient with hypertension, coronary artery disease, breast cancer, degenerative joint disease, allergic rhinitis and allergy to hydrochlorothiazide (manufacturer unknown) (WAES# 0801USA00056) and lisinopril (manufacturer unknown) (WAES# 0801USA00055), and hypercholesterolemia and a history of rib fractures developed hypersentivity in the right scalp and around the right eye and then broke out in a papular/vesicular rash in the same area. Very painful zoster lesions (onset date reported as 29-SEP-2007, previously reported as 01-OCT-2007). The patient was prescribed VALTREX and NEURONTIN and the patient was referred to ophthalmology due to eye involvement. The patient required a doctor's office visit. The patient was recovering. It was reported that the rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. Pain was reported as "10". It was reported that the patient had a history of chickenpox in childhood and had not had recent exposure to chickenpox or herpes zoster. A direct fluorescent antibody was not done and a specimen was not collected for PCR. No further information is available.
I woke up at 1:00 am, the morning after my second shot. April 3, 202-. I was dizzy and tried to stand up to use the bathroom. I almost fell, grabbing onto a piece of furniture and the wall for support. I had a splitting headache and was nauseous. I made it back to bed. Lying very still in one position made the room stop spinning. I spent the next day in bed, sleeping most of the day, only able to drink water, with the same symptoms. That night, I was still dizzy and still had a splitting headache! Added to these symptoms of dizziness, nausea, headache, every joint in my body hurt! The next day, April 4,2021, I was able to walk, assisted, and finally ate applesauce.  I was still dizzy, but it was better. Today, April 5, 2021. I am feeling better, but really spacey and my vision is a little blurry. I do wear glasses and use reading glasses. I do not feel 100% yet.  If I had this reaction to the first shot, I would have never gone or this one! She I was injected, it but down my arm, into my fingers immediately! My arm is still hurting!
Angioedema developed 5 days after influenza vaccine was administered. Having a full allergy work up at current time with Allergist. Seen at local ER 11.6.2020
PATIENT WAS GIVEN THE MONOVALENT PFIZER COVID-19 BOOSTER INSTEAD OF THE BIVALENT BOOSTER. PATIENT DID NOT EXPERIENCE ANY IMMEDIATE SIDE EFFECTS OR ADVERSE EFFECTS, DISPLAYED NO SIGNS OR SYMPTOMS OF A REACTION. CALLED AND THEY SAID THAT PATIENT WILL JUST NEED TO COME IN TWO MONTHS FOR BIVALENT BOOSTER SHOT.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   Contacted patient x 2 to informed of adverse event, but unable to speak with patient.