chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. No Medical History information was reported.On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported.No treatment medications were reported.It was reported that the vials were administered to at least 12 patients but believes it could be more cause they immunized 80 patients.This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the unexpected non serious event of expired product administered. The event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration. The expired product administered (mRNA-1273 vaccine with batch/lot number 033c21a0) was administered 19 days past the expiration date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the unexpected non serious event of expired product administered. The event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration. The expired product administered (mRNA-1273 vaccine with batch/lot number 033c21a0) was administered 19 days past the expiration date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Client developed hives (reported by client's mom via phone) approximately 24 hours after administration.
I have a big bump, or knot, a big LUMP on my arm and it hurts, itches and I can't lift my arm
The pt developed vomiting, dehydration, and abdominal pain; diagnosis of intussuseption was made. Treatment with air enema for reduction. per doc 213832, T.C. to grand-mother, clarifications that child had G.I. SXS prior to receiving the vaccine. He was on 4/29/02 evaluated for the purpose of the SXS and was coincidentally given prevnar at that time due to chronic O.M.'s
Shingles-like rash near injection site; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th August 2020, immediately after receiving Shingrix, the patient experienced pain in arm. On 12th November 2020, the patient experienced vesicular rash. On 2nd September 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced sore arm right afterwards for a couple of days and then resolved.  The patient also reported that about a week ago (74 days after receiving vaccine), he developed a shingles-like rash about the size of a half dollar near where he received the injection.  The patient was still experiencing this rash. He asked if he should get the 2nd dose.provided medical disclaimer and suggested he follow up with his health care professional. The reporter did not consent to follow up.
I received my covid -19 vaccine on 10/22/2022. On 12/20/2022 I woke up with heavy sinus congestion and frequent sneezing. I tested positive that day. After contacting my provider, I was prescribed Paxlovid. Symptoms were gone within 36 hours.
Hospitalization for a fall (tested positive for COVID 7 days prior) on dates  6/27/2022- 7/5/2022.  Treated with vitamin C 1,000 mg PO daily, zinc 50 mg PO daily.
PER PATIENT NEUROLOGICAL ADVERSE SYMPTOMS STARTED DAY AFTER SHOT. LEG NUMB/SORE, GENERAL TIGHTNESS/DISCOMFORT SINCE THE  SECOND SHOT.
Three weeks after receiving my second booster I started having chest pain. I called my doctor because I thought it was acid reflux, I was advised to take my famotidine twice a day. I went in to see my doctor after a couple weeks as the famotidine and ablation did not help to alleviate the chest pain. My doctor ordered a PET scan of my heart, they have found abnormality on the diagnostic image.
EDD 11/8/21, onset of vaginal bleeding, within 3 days of 2nd dose of vaccine, pregnancy continues to be viable.
Approximately 2-4 hours after receiving the vaccine, I began to notice a pain in my lower back that was settling into my hips while relaxing in my recliner with my son. The pain became intense to the point where I had to get up and begin walking as I could no longer stand sitting in my chair.  Continued pain on Sunday-Tuesday (November 5, 6, 7, 8). I was taking Tylenol and Motrin with no resolve to the pain Yesterday (November 8) I felt that I was at my worst with symptoms. I began to notice that if I sat too long I would become very stiff and when I would go to stand, I had to receive support to stand and move. Climbing the stairs became unbearable and even walking was difficult.   Today, I am still stiff, but not to the degree where I am as immobile as I was days prior.
he started with Eczema and dermatitis/ confirmed diagnosis of Spongiotic Dermatitis; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (he started with Eczema and dermatitis/ confirmed diagnosis of Spongiotic Dermatitis), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011B224 and 068H21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: J&J COVID-19 (First Primary dose) on 09-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J COVID-19.   On 20-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 21-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ECZEMA (he started with Eczema and dermatitis/ confirmed diagnosis of Spongiotic Dermatitis). The patient was treated with CLOBETASOL for Spongiotic dermatitis, at an unspecified dose and frequency and DUPILUMAB (DUPIXENT) for Spongiotic dermatitis, at a dose of UNK UNK, q2wk. At the time of the report, ECZEMA (he started with Eczema and dermatitis/ confirmed diagnosis of Spongiotic Dermatitis) had not resolved and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, Biopsy: the doctor confirmed diagnosis of Spongiotic Dermatitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. It was reported that within 2-3 weeks after shot 3 in AUG2022, patient started with Eczema and dermatitis.  The dermatologist tried different topical steroids; last one was Clobetasol topical which did not help.
Mild nausea at about 20 minutes  post injection. Not unusual for me. Was on a 30 minute hold. Felt good. Left the station. Started to feel a little difficult to swallow. Tongue obviously swollen. No difficulty breathing.  No hives. Called PCP. Notified Deputy Chief. Drove to clinic as precaution. Dr. advised of reaction. Dr. advised me to take Benadryl, 50mg, Every 6 hours for that day and the folllowing.  Swelling improved within 1-2 hours of first Benadryl dose.
Approximately 20 minutes post injection patient felt tingling/numbness in the left pinkie finger, migrated to right pinkie finger with one hours.  Acetaminophen
13Nov95 pt recv vax 1 dose of varicella virus vax live. 7Jan98 pt devel "quite a few" lesions abdomen & back dx by MD as chickenpox.
Information has been received from a physician concerning a 66 year old male with a history of gall bladder disease, cholelithiasis and stent insertions for known cardiovascular disease who in 2002, prior to traveling, was vaccinated with a dose of hepatitis B virus vaccine. On 10/4/03, the patient was found to have a positive IgM core antibody for hepatitis B which implied acute hepatitis B. A hepatologist was consulted who said that this finding can rarely be seen with a drug reaction. The reporting physician was leaning towards a diagnosis of failed hepatitis B vaccine with subsequent hepatitis B infection, although drug induced hepatitis was still in the differential. The patient was doing fair with weakness, lethargy, anorexia and jaundice. As of 10/14/03, his bilirubin was between 12-15 and his prothrombin time was slightly elevated. Clopidogrel bisulfate and aspirin were recently discontinued, and the patient continued on a beta blocker and metoprolol succinate. The patient was noted to be taking the following medications: ezetimibe, pravastatin Na, clopidogrel bisulfate, aspirin, a beta blocker and metoprolol succinate. The patient began taking ezetimibe around 7/23/03. Subsequently, the patient experienced acute hepatitis B. On 8/11/03 the patient presented to the physician's office with a severe right upper quadrant pain. On 8/19/03 the patient's liver function tests were found in the 400 ranges. On 8/11/03 therapy with ezetimibe was discontinued. The physician described the reaction as a severe liver reaction. The patient had been taken off pravastatin Na and ezetimibe. The patient outcome was not reported. Follow up information was received from the nurse who reported that on 8/3/03, the patient was seen by the physician, a GI specialist, for complaints of abdominal pain, jaundice and abnormal LFT's. The nurse had no information pertaining to treatment for the events. On 8/11/03 therapy with ezetimibe was discontinued. On 10/2/03, the patient had repeat lab findings. As of 10/8/03 the patient's right upper quadrant pain was reported as intermittent. The nurse reported that the physician was questioning if ezetimibe may have caused the increase in the liver function tests. As of 10/8/03, the patient remained off ezetimibe. Additional follow up was received from the physician who reported that the patient was placed on therapy with ezetimibe and in July 2003, after 3 weeks of therapy with ezetimibe, the patient complained of abdominal pain. Pravastatin Na and ezetimibe were discontinued at that time. The patient had a known history of gall stones disease. The patient also received the hepatitis B vaccine 1 year ago, prior to traveling, after it was determined that he had negative serology for hepatitis B. Since 7/03, he has had cholestasis and slowly rising liver function tests with transaminases currently in the 600-700. He was felt to have obstructive jaundice but ERCP, MRCP and CT scan showed a normal liver, stones in bladder and no common duct disease. Upon internal review, acute hepatitis B was considered to be an other important medical event (OMIC). Additional information is not expected.
This is a prospective pregnancy case. This 25-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX QUADRIVALENT, FLULAVAL QUADRIVALENT Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX OR FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. On 26th September 2014, the subject received Flu Seasonal QIV Dresden .5 ml. The subject received Flu Seasonal QIV Dresden during the second trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to Flu Seasonal QIV Dresden. Pharmacist provided limited information. More specific gestational timing was not available. Minimum information collected for asymptomatic adverse event.
my bowel movement has almost no smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (my bowel movement has almost no smell) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (my bowel movement has almost no smell). At the time of the report, ANOSMIA (my bowel movement has almost no smell) outcome was unknown.            Concomitant roduct use was not provided.  Treatment information was not provided.
Around 4:00AM my head was pounding and my left side was numb. I thought I was having a stroke and went to ER.
itchy mess; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included cancer.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pruritus (Verbatim: itchy mess). The patient was treated with soap (nos) (Soap), benadryl (nos) (Benadryl), medication unknown (Cream (Medication Unknown)) and dermatologicals nos (Lotion). The outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     It was unknown if the company considered the pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2023 This case was reported by the patient via interactive digital media. The patient had one Shingles shot and doctor did not stated anything about the second one. The patient reported that right now after having chemotherapy and radiation the patient was in itchy mess. The patient reported that cancer doctor did not seem to care. The patient reported that he/she had used every cream, lotion, soap, and nothing works. The patient take Benadryl at night. The patient stated nothing work and asked any suggestions out there. Follow-up would not possible as no contact details were available.
The patient was an unfortunate 74-year-old female, nonsmoker with recently diagnosed hepatocellular carcinoma/cholangiocarcinoma.  She was started on chemotherapy at the HCF on December 21.  She was then admitted on September 25 for shortness of breath, acute renal failure.  She required dialysis.  She was diagnosed with thrombosis of the portal and superior mesenteric veins.  She was placed on a heparin drip and transitioned to Coumadin.  Course was also significant for hypoxic respiratory failure and rash.    On October 21, she was transferred to another facility for further evaluation and management.  Renal was consulted for ongoing dialysis.  Insulin coverage was provided.  She was maintained on Coumadin, which was somewhat hard to titrate.  She then developed septic shock, which may have been from urinary or peritoneal source.  She was placed on broad-spectrum antibiotics.  She was seen by Infectious Disease.  She continued to deteriorate.  She required pressor support.  Given her poor prognosis, clinical decline, untreated malignancy, and overall situation, she was made DNR and transitioned to comfort care after discussion with the family.
Patient was only given the Diluent part of vaccine.  This was noticed 6 days later while doing inventory.  Pt was notified.
Lost the range of motion in the arm where I received the vaccination. This lasted for approximately 4-6 months. It's now been almost one year since my first dose and I can still feel tenderness in the area surrounding the shoulder socket. Arm also feels weak and after a long day of use it's sore and achy
Patient started having cluster seizures the Saturday after his vaccination.  He has been seizure free for over a year following a low-carb diet and has not deviated from his diet in over a year.  The first seizure was Saturday morning, followed by vomiting and sleeping for 7 hours during the day on Monday.  Monday evening around 9:30pm he had a seizure that lasted over 5 minutes, diazepam was administered at 7 minutes and the seizure did not stop until about 10 minutes after the diazepam.
Up and down red sports and the spots are raised; Raised rash; This case was reported by a consumer via call center representative and described the occurrence of erythromacular rash in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, 3 days after receiving Shingrix, the patient experienced erythromacular rash and raised rash. On an unknown date, the outcome of the erythromacular rash and raised rash were recovering/resolving.   It was unknown if the reporter considered the erythromacular rash and raised rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. The patent developed a rash on both of his legs. The rash was on the entire legs and the patient described it as up and down red sports and the spots are raised. The patient consented to follow up.
W/in 12 hrs p/immun, child experienced fever of 104, headache, & tenderness @ inject site. Treated w/Tylenol & cold packs. On 25JUL90, 2 days later, child was asymptomatic.
Adverse Event 1 - Heart Palpitations/abnormal heartbeat (two days after vaccine, on 12/18, lasting for 1 hour from 11PM-12AM) Adverse Event 2 - Heart Palpitations/abnormal heartbeat (three days after vaccine, on 12/19, lasting for 4 hours from 12PM-4PM, light chest pain before, light headache afterwards)
Pt recvd Hep B vax in JUL91 & exp burning & pain @ inject site; The lot# of Hep B vax was changed & the sx did not recur;
09/06/22 presents to ED for "A. fib". PMHx of "A. fib."
Local erythema, swelling and tenderness of the entire left deltoid. Worse 24 hours after vaccine. Saw pt 48 hours after vaccine and the inflamed area was warm, slightly tender, poorly demarcated but was over 9 x 7cm area suspect rnx was due to DTaP
I have been having pain my chest; Nausea; Sore throat; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection), unknown single dose (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as a single dose, for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient got vaccinated with the Pfizer vaccine on Saturday and had to do a questionnaire that would he/she take any antibody and he/she said he doesn't know because he was not concerned a couple of weeks ago and got some blood work taken and they asked him if he wants to get some antibody infusion and he/she said yeah but wasn't like too sure what it. They told him/her that it would guarantee like if he/she got cold that he wouldn't die. So he/she got that infusion then. The patient reported that he/she experiencing some side effects from Saturday. Had pain in chest, nausea and sore throat. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for vaccine/BNT162B2.
Felt cold; weak; sleepy; muscle pain; fever. Lasted for a day and a half.
child experienced a febrile seizure on 6/11/2008 was seen and treated in the emergency room
DOSE #3 OF PFIZER (COMIRNATY) COVID VACCINE GIVEN 2/19/22, LOT #FK9896; pt had a positive  COVID test on 6/29/22 at Hospital; another positive COVID test on 7/6/22 from Hospital; the only medical records sent was the discharge disposition and a statement that the pt was in hospice and not in the hospital; name of hospice not given
09/20/2006 fever, seizure, seen in ER discharged home. Had second seizure on 09/21/2006 and was admitted to hospital for further treatment.  10/24/06 Received medical records from hospital which revealed patient admitted on 9/21/06 with dx: seizures & fever.  AM of admit patient initial in usual state of health (with known medical anomalies ie agenesis of corpus callosum) & later that day developed head rolled back, eyes deviated & left arm & leg jerking for approx 3-4 min.  Mom & EMTs noted fluid from ears & circumoral cyanosis along with fever 103.  Returned to baseline in ER & was d/c to home w/Dx: febrile seizure.  Sleepy at home rest of day & then during the night had another seizure lasing approx 2 min.  Returned to ER where had another seizure while awaiting CT scan. Placed initially on IV antibiotics & antivirals as well as antiseizure meds.  Antibiotics & antivirals were d/c when all cultures were neg but continued on seizure meds at d/c. Birth hx: 35 wk gestation & was in NICU for about 1 month. PMH: micro deletion chromosomal anomaly with some congenital abnormalities & vertebral anomalies; VSD; GERD; developmental delay (receiveing PT/OT); & hx of recurrent OM (subsequently had PE tubes placed in 10/06). Exam noted a very tired appearing infant w/perforated right TM, obscured left TM, + systolic murmur, hypertonic extremities, long standing papular rash on cheeks & arms. LABS: all essentially WNL DX: multiple seizures in 24 hr period w/o return to baseline & associated fever; Right OM w/perforation; & mild dehydration.