chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In or about 2009, a healthcare provider at a county public health department administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 20-OCT-2016, the patient was treated by a healthcare provider for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Vaccine received 8 Jan 2021. No symptoms until 30 Jan 2021, then had pain in left triceps that has been constant, achy since. Has intermittent tingling down left arm that goes into pointer finger. No loss of range of motion. No swelling or redness.
Within 2 minutes or patient receiving the vaccine he passed out and fell out of the post vaccine waiting chair onto the floor. He was unresponsive for approximately 10 seconds. Upon becoming responsive he was alert and oriented x3. Blood pressure was monitored while waiting for EMS to arrive. Blood pressure was 150/94 heart, heart rate of 98, he was diaphoretic.
sz later that day w/fever, taken to ER for work/up Ct, EEG, f/u neurology consult done;
PATIENT WAS INSTRUCTED TO TAKE BENADRYL 50 MG AND TYLENOL 500 MG PRIOR TO COMING FOR VACCINATION.  SHE SAID SHE DID.  SHE RECEIVED THE VACCINE AND WAITED APPROXIMATLY 30 MINS BEFORE BEING ALLOWED TO LEAVE.  NO PROBLEMS  WERE VOICED NOR NOTED AT DC. PATEINT SAID ABOUT 45 MINS OT 1 HR STARTED ITCHING, NAUSEA, SKIN FLUSHED, NO FEVER, SWELLING IN LIPS, MOUTH EXCORIATION. SAID SHE TOKE BENADRYL EVERY 6 HOURS 25 MG. 2ND DAY HAD LYMPH NOTE SWELLING IN AXILLA AND NECK. CONT BENADRYL AT 50 MG EVERY 6 HRS DUE TO SYMPTOMS LASTED 3-5 DAYS. WENT TO HER LOCAL ER  ON DAY 5 AND RECEIVED PO ASA,  IM DECADRON. AND PO ZOFRAN. DAY 6 WENT TO HER PRIMARY PHYSICIAN AND RECEIVED RX FOR PREDISONE 10 MG DAILY, MELOXICAN FOR MUSCLE PAIN.
Information has been received from a nurse concerning an 11 year old male with no pertinent medical history, drug reactions or allergies who on 07-AUG-2007, at 14:00, was vaccinated subcutaneously with a second dose of varicella virus vaccine live (Oka/Merck) in the right arm (Lot# 652724/0459U). On 08 AUG 2007, the patient developed the following injection site reactions in the right arm: rash (12 cm x 10 cm), swelling, induration (3 cm x 3 cm), and erythema (dark red in the center and pink in the periphery). The area, which was not painful, was reported to resemble a "wasp sting". There was no illness at the time of vaccination. Unspecified medical attention was sought. The patient recovered on an unspecified date. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
told mother he could hear voices that were not there.; wont watch movies or play games; Agitation; Nervous; Anxious; couldnt sleep; This spontaneous case was reported by a physician assistant and describes the occurrence of HALLUCINATION, AUDITORY (told mother he could hear voices that were not there.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Down's syndrome.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced HALLUCINATION, AUDITORY (told mother he could hear voices that were not there.) (seriousness criterion medically significant), DECREASED INTEREST (wont watch movies or play games), AGITATION (Agitation), NERVOUSNESS (Nervous), ANXIETY (Anxious) and INSOMNIA (couldnt sleep). At the time of the report, HALLUCINATION, AUDITORY (told mother he could hear voices that were not there.), DECREASED INTEREST (wont watch movies or play games), AGITATION (Agitation), NERVOUSNESS (Nervous), ANXIETY (Anxious) and INSOMNIA (couldnt sleep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatments were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's medical history of Down Syndrome may be contributory to the development of the psychiatric episode related-events.   This case was linked to US-MODERNATX, INC.-MOD-2021-075678 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's medical history of Down Syndrome may be contributory to the development of the psychiatric episode related-events. US-MODERNATX, INC.-MOD-2021-075678:Case for first dose
high fever (104+), headache, occular migraine,  body aches and pains, chest pain and tightness, burning sensations in chest and on surface of skin, shortness of breath,  racing heartbeat, hallucinations, incontinence.
Left arm swelling, erythema started 24 hrs after shot.  Acetaminophen/Cool compresses.
Throbbing pain within 5 min.  Swelling within 1 1/2 hours, Rash on left arm the next morning. Lots of discomfort on left arm and left side that first night.  Arm was swollen over double.  Lymp nodes swelled and no voice.  DId not move arm.  Rash on upper body that first 2 weeks.  The rash on the left arm continued the first 4 weeks.  Very swollen...HOT to touch...looked like alligator skin and raised.  Now it comes for 2 days and goes down for a few days.  Get mentally foggy unless I take an allergy medication 3-4 times a day.  Advil every 4 hours for joint pain...it has been miserable!  Swelling in joints on upper body.  EXHAUSTED.  Thryoid was normal prior to the vaccination and has double-now on Thryoid Medication.
Patient had atrial fibrillation in the past and he is on propafenone. He said he did not had episodes for a while til he got the shot and experience the next day 20 hours after the shot.And he said he was ok the following days after the shot.
when eating supper, jaw felt swollen et felt swollen inside lt jaw;had discomfort et tenderness still sl sore p/ 11 days;
Since receiving the vaccine I developed a canker sore in my mouth evert menstrual cycle.
Narrative:  1/15/23 at 10:33 - Pt presented to ED c/o SOB worsening since diagnosis of COVID on 1/10/23. Pt states he has been increasing his oxygen use. In ED, Pt with oxygen sats of approx. 80% in room. He normally wears oxygen overnight and has a hx of COPD and CHF. Pt also has hx of atrial fibrillation as well, he does have some increased lower extremity edema. He has been continuing oxygen 24/7 instead of just at night, and still feels SOB. Pt administered Lasix 40mg IV, labs and x-rays obtained. Troponin is 0.02. Pt had no chest pain complaint, just dyspnea. EKG showed a-fib with no new changes. Pt to be admitted with diagnosis = COVID +, CHF, CAD AD, A-fib, dyspnea. (Admission 1/15 - 1/18/2023) PRINCIPAL DIAGNOSIS (Reason for admission after study): #Acute Hypoxic Resp Failure #HFrEF Decompensation: AKI, hypovolemia: Resolved #Hypokalemia: Resolved #COVID Infection ADDITIONAL DIAGNOSES - Chronic Problems: #afib on Xarelto #Chronic Hypoxic Resp Failure (on home nightly O2) #Interstitial lung dz (2/2 textiles factory work, pulm fibrosis, PFTs 2/2022 showing no airway obstruction, lung volumes consistent with restrictive lung dz) #OSA - CPAP #CAD #Aortic Root Dilation (mild to mod) #Previous CVA #HTN #T2DM on insulin HOSPITAL COURSE: #Acute Hypoxic Resp Failure - Pt has been off bumex 4mg BID since 12/2022 hospitalization for hypotension, - O2 sats 85% on RA - Home O2 adjusted to 2L/NC continuously #HFrEF Decompensation: - TTE 11/2022: LVEF 50-55%, RV mild-mod dilated w/mild-mod decresed fxn/ - Lasix 40mg IV bid - return to outpatient Bumex dose. - CXR: bilateral increased interstitial opacities with small right pleural effusion (concerning for pulmonary edema although worsening Covid pneumonia cannot be excluded). - BNP: 273 (was 168 on 12/3/2022) AKI, hypovolemia: Resolved - S/P 1 Liter NS - Cr 1.2 #Hypokalemia - K 2.8 -> 3.8 -> 3.4 - KCL 40meq x 2 ordered - will monitor K closely daily, especially in setting of aggressive diuresis #COVID Infection -Clinically, patient appears to be having heart failure decompensation and suspect less contribution from Covid towards patient's dyspnea and hypoxia -Remdesivir ordered: day #3 -Holding off dexamethasone for now due to concern for possibly worsening heart failure decompensation Discharge date = 1/18/23
pt recvd 1 dose of Engerix-B & exp disseminated intravascular coagulation, hepatosplenomegaly & fever;
Thursday, Sept. 24, 2009 at or about 1:20 p.m. a telephone call was received at clinic from the mother of patient stating the patient was complaining of difficulty breathing since FluMist administration.  Instructed parent to take patient to the nearest emergency room for further evaluation.
I received the first vaccine dose on 9/16/2021. On 9/17/2021 I noticed my right eye was burning. By 9/22/2021 my Right eye was still burning and more painful, eye was swollen, watering, sensitive to light. I went to my eye doctor on 9/23/2021 and she told me my right eye is inflamed. She gave antibiotic eye drops.
Pt rcv PCV13 on 10-21-15, RTC on 10-26-15 with redness and pain to inj site with some itching. Pt treated with KEFLEX 500 mg 1 TID x10 days and prednisone 10 mg 1 QD x 5days, pt RTC on 10-28-15 redness and itching had spread. Pt given 1 gram ROCEPHIN and clindamycin 300 mg TID x 10 days and BACTROBAN. Pt f/u with dr on 10-30-15 and admitted to hospital x 2 days.
chest pain; This is a spontaneous report from a contactable consumer (Caregiver). A 21-year-old male patient (grandson) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on an unspecified date at age of 21-year-old at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at age of 21-year-old for COVID-19 immunisation. Caller stated his grandson (21-year-old) received his second dose of the Pfizer COVID vaccine yesterday and this morning when he woke up he has been having chest pain on and off. caller wanted to know if that has been consistent with the second dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hospitalization with unrelated diagnosis, tested prior to transfer to transitional care unit, patient is asymptomatic.
Patient was noted to have a dermal lesion on the lower arm that measured approximately 1.5 cm in diameter.  This lesion was made up of four or five 2mm in diameter vesicular lesions in close proximity to one another (cluster).  The area around the lesion was erythematous, but did not appear to be pruritic. Vesicles were intact.  A second, perhaps older, lesion was subsequently noted on the thigh. This second lesion was approximately the same size and was also erythematous, non pruritic. Clusters of about 2mm raised lesions made up the lesion, but these clusters were not apparent visually and could only be deciphered by palpation.  Two of the 2mm bumps had evidence of thin dark red scabbing on the surface measuring about 1mm in diameter.  This cluster looked like it was recently vesicular, but had ruptured.  Parent making this report was not present at vaccination, but believes that patient was vaccinated  intramuscularly on the thigh.
Severe local reaction to vaccine - temp 99.7 - headache, unable to lift (R) arm. Joint pain redness & swelling. On antibiotics & steroids.
This spontaneous report was received from a pharmacist refers to a 68 year old male patient. On 09-APR-2015 the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65 ml administered via subcutaneous with lot # J011826 and expiration date: 26-DEC-2014 in the left arm. No adverse effects reported. Additional information is not expected due to the reporter could not be contacted again.
pt received vaccine, 15 min later, pt got chest pain & sob, brought back to assessment tent, vitals taken, bp at 208/103, per MD, rec. 911 for tx to ED, pt taken to ED via EMS.  BP prior to leaving, down to 158/85, pt still with chest pain, but less painful.
The minute I got the shot within 5 minutes my lips were tingling and my throat got tight. They were worried. As the days went on it got progressively worse. 9th, lips were dry and split, 10th sense of smell was off. Smelled burnt plastic. More sensitive to smells. 11- massive migraine and nightmares. 16th skin sensitive to touch, burning, itching. throat got tighter they told me not to get my 2nd shot. Different symptoms were experienced each day. On the 14th- it felt like how it was when I first got the chemical exposure.
I gave the Gardasil in the Lt arm, immediately she was c/o pain and itching, swelling and redness occurred, ice applied and Benadryl given per MD.
Soreness in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness in shoulder) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Soreness in shoulder). At the time of the report, ARTHRALGIA (Soreness in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Patient received booster shot in 4 months instead of at 6 months. Patient got booster shot 2 months early
the patient had bloodwork done and his Varicella titer was negative; unsure if he was previously vaccinated with VARIVAX on 01/23/2020 the same patient was administered a dose of VARN AX; the same patient was administered a dose of VARIVAX  intramuscularly; This spontaneous report has been received from  a nurse, referring to a male patient of unknown age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies was not provided.  On 23-JAN-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX),  by intramuscular administration (incorrect route of product administration) (conflicting information since it was also reported as "subcutaneous"); lot number R009821 and expiration date 03-APR-2020 for immunization from  varicella (strength, frequency, dose and anatomical location were not reported).  It was stated by the reporter, that the patient was unsure if he was previously vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), and underwent on an unspecified date a laboratory diagnostic procedure reported as "bloodwork", that showed his Varicella titer was negative (varicella virus test negative) (inappropriate schedule of product administration).  The patient did not receive any treatment for the event and did not seek medical attention.  At the time of reporting, the outcome of varicella virus test negative was not reported.  The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) and varicella virus test negative was not provided.
EMPLOYEE HAD FEVER OF 102 TEMPERATURE, SORE THROAT, AND CHILLS THE FOLLOWING DAY. MISSING 2 DAYS OF WORK ALSO.
Immune system started attacking liver; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE-MEDIATED HEPATIC DISORDER (Immune system started attacking liver) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Liver cirrhosis since 2010.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE-MEDIATED HEPATIC DISORDER (Immune system started attacking liver) (seriousness criterion medically significant). The patient was treated with BUDESONIDE for Immune-mediated hepatic disorder, at a dose of 3 mg. At the time of the report, IMMUNE-MEDIATED HEPATIC DISORDER (Immune system started attacking liver) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Alanine aminotransferase: 62 (abnormal) 62. On 17-Feb-2021, Aspartate aminotransferase: 63 (abnormal) 63. On 17-Feb-2021, Blood alkaline phosphatase: 273 (abnormal) 273.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided. 01-Nov-2021: AST was 35, Immunoglobulin was at 1800. Dr said: Patient's immune system started attacking his liver.  Company's comment: This case concerns a 66-year-old, male patient with a history of liver cirrhosis, who experienced the unexpected serious AESI event of Immune-mediated hepatic disorder. The event occurred at an unknown time after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events were ongoing. The medical history of cirrhosis remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.   This case was linked to MOD-2021-389025 (Patient Link).; Sender's Comments: This case concerns a 66-year-old, male patient with a history of liver cirrhosis, who experienced the unexpected serious AESI event of Immune-mediated hepatic disorder. The event occurred at an unknown time after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events were ongoing. The medical history of cirrhosis remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.
The pt experienced edema, bruising, redness, swelling, and nausea. Symptoms began 10/27/00. No vomiting was experienced.
No adverse event; Vaccines stored in the refrigerator underwent several temperature excursions; Vaccines stored in the refrigerator underwent several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 11:26 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. In 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions). On 22-Sep-2022 at 11:26 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions).    No concomitant medication was provided. On an unknown date, patient received dose 1, dose 2, dose 3 of Moderna vaccine, intramuscularly at deltoid muscle. Patient received dose 4 at deltoid muscle. It was reported that refrigeration excursions identified, state vaccine was housed in these units. The state department was made aware of the situation. The reporter stated that the clinic she was assisting, underwent several temperature excursions with Monovalent and Bivalent vaccines stored in the refrigerator going back to Aug/2022.  It was reported that no adverse reactions were reported to their knowledge. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654537, US-MODERNATX, INC.-MOD-2022-670050 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654537:same reporter US-MODERNATX, INC.-MOD-2022-670050:same reporter
Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and COVID PNA.  Provider d/c note:  "75 YO female with a PMHx of hypertension, hyperlipidemia, anxiety/depression who presents with fevers, sore throat, shortness of breath, abdominal pain.  Found to have COVID pneumonia and uncomplicated diverticulitis.  CT PE negative for pneumonia or pulmonary embolism.  CT abdomen did show sigmoid diverticulitis without abscess.  She was also hypoxic requiring oxygen with ambulation.  She was treated with dexamethasone and remdesivir.  She was also treated with ciprofloxacin and Flagyl for diverticulitis.  Hypoxia resolved the next day, even with ambulation.  PT recommended home with assist and she stays with her son and his family.  Patient felt well and wanted to return home.  I offered the opportunity to stay in the hospital to complete remdesivir course if she wanted and she declined.  Due to the fact that she received IV contrast twice in 2 days, she was given a 500 mL bolus to protect her kidneys."