chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives all over their body that would appear for 1 hour and then go away; felt like burning from the inside; super itchy/ hands and feet would itch like crazy with nothing on them; really bad rash with hives all over their body/rash would appear always on their arm and legs and sometimes on their chest and belly and pubic area and back.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over their body that would appear for 1 hour and then go away), BURNING SENSATION (felt like burning from the inside), PRURITUS (super itchy/ hands and feet would itch like crazy with nothing on them) and RASH (really bad rash with hives all over their body/rash would appear always on their arm and legs and sometimes on their chest and belly and pubic area and back.) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 003B21A and 077C21B) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (hives all over their body that would appear for 1 hour and then go away), BURNING SENSATION (felt like burning from the inside), PRURITUS (super itchy/ hands and feet would itch like crazy with nothing on them) and RASH (really bad rash with hives all over their body/rash would appear always on their arm and legs and sometimes on their chest and belly and pubic area and back.). The patient was treated with BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (hives all over their body that would appear for 1 hour and then go away), BURNING SENSATION (felt like burning from the inside), PRURITUS (super itchy/ hands and feet would itch like crazy with nothing on them) and RASH (really bad rash with hives all over their body/rash would appear always on their arm and legs and sometimes on their chest and belly and pubic area and back.) outcome was unknown.            Really bad rash with hives all over their body that would appear for 1 hour and then go away and this would happen 3-4 times a day. No concomitant medication was provided by the reporter Patient has taken acupuncture herbal and antihistaminic diet as treatment medication
Crying from time of vaccines until next day. Sleeping only 2 hours at a time, low grade fever (1st day). Tylenol given then, met Dr at ER on 9/9/03. Baby calmed down and happy during car ride to ER.
A solicited report has been received from a pharmacist concerning a 28 years old female patient. No relevant history, concomitant disease and concomitant medications were reported. Patient had received FLUMIST QUADRIVALENT, unknown dose for unknown indication, started on unknown date. Pharmacist reported that when administering the FLUMIST QUADRIVALENT, the majority of the second dose went into the right nostril. Pharmacist reported that patient developed a runny nose after receiving FLUMIST QUADRIVALENT. The outcome of the events of runny nose and majority of the second dose went into the right nostril was unknown. Reporter considered the events of runny nose and majority of the second dose went into the right nostril to be non serious.
Information has been received form a registered nurse concerning a 16 year old female. The pt wsa vaccinated with first and second doses of varicella vaccine on 10/05/2000 and 11/02/2000, respectively. In July 2001 the pt's varicella zoster virus antibody test was negative. On 07/24/2001 the pt received an additional dose. Additional info has been requested.
Minutes after receiving the vaccine he developed dizziness, nausea, and migraine. Symptoms did not subside patient sent to Emergency Room
Localized redness, irritation/ induration to left deltoid - quarter size some bruising.
Pfizer Bivalent Booster given to patient instead of Pfizer Monovalent.  This should have been dose 2 in primary series.
The vial was initially stored in the refrigerator on 07-Sep-2022 and administered on 11-Oct-2022; No adverse event; Received the Moderna COVID 19 vaccine after the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Sep-2022 and administered on 11-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 12-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Avocado).    On 11-Oct-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Sep-2022 and administered on 11-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Sep-2022 and administered on 11-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after the 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Sep-2022 and administered on 11-Oct-2022).    No concomitant medications were reported.  The monovalent vaccine was initially stored on 07-Sep-2022. The vial size was 2.5 ml. The vial did not underwent any temperature excursions.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657633 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657633:Same Reporter
This case was reported by a pharmacist and described the occurrence of injection site pain in a adult female patient who received FLULAVAL QUADRIVALENT (batch number 579G3, expiry date 30th April 2015). On 1st October 2014, the patient received FLULAVAL QUADRIVALENT .5 ml. On an unknown date, less than a month after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be probably related to FLULAVAL QUADRIVALENT. Additional information: Pharmacy intern reporting adult female patient received vaccination 3 weeks ago. Patient contacted the pharmacy today reporting she is still having pain at the injection site.
Administration error - wrong vaccines given. Patient was supposed to receive Hepatitis B dose #3 and instead nurse mistakenly repeated 6 month shots (listed on next page).
On the left arm had hives / after receiving the vaccine; This case was reported by a nurse via call center representative and described the occurrence of hives in a 11-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 7N43B, expiry date 30th June 2021) for prophylaxis.   On 29th September 2020, the patient received the 1st dose of FluLaval Tetra 2020-2021 season. On 29th September 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to FluLaval Tetra 2020-2021 season.  Additional details were received as follows: The age at vaccination was not reported but could be 10 or 11 years. The reported stated that the patient had hives after receiving the vaccine. The reporter consented to follow up. This case has been linked with cases US2020211156 and US2020211161, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211156:same reporter US-GLAXOSMITHKLINE-US2020211161:same reporter
Complication from procedure; Could not get second dose as scheduled; A spontaneous report was received from a consumer concerning a 79-year-old male patient who experienced complication from  surgery/ post procedural complication and could not get second dose as scheduled/ Inappropriate schedule of vaccine administered.   The patient's medical history or concomitant medications were not provided.     The patient received his first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly in the left dominant arm  for prophylaxis of COVID-19 infection on 08 Jan 2021.  On 08 Feb 2021 the patient underwent an outpatient surgical procedure. He could not get second dose as scheduled on 12 Feb 2021. On 18 Feb 2021, he was admitted to the hospital due to complication from procedure.    Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event could not get second dose as scheduled at the time of this report was resolved. The outcome of the event complication from procedure was unknown.; Reporter's Comments: This report refers to a case of a 79-year-old male patient who experienced  a post surgical procedure complication after the first dose  mRNA-1273 (lot #-unknown)  and could not get second dose as scheduled (Inappropriate schedule of vaccine administered). There is limited information to assess the exact post surgical complication as the surgical and description of the complication was not provided.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 4/17/2021 and 5/15/2021. Presented to ED on 1/9/2022 with two week history of cough, shortness of breath, and diarrhea. COVID positive with PNA. 1/13 respiratory distress requiring intubation. On 1/15 septic shock requiring pressure support. 1/16  remained hypoxic despite maximum vent support. Developed atrial fibrillation with rapid ventricular response that did not respond to amiodarone, but improved with synchronized cardioversion. Patient subsequently expired on 1/18.
DRIPPED DOWN TO ELBOW; POSSIBLE UNDERDOSE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 043A21A expiry: not reported) dose was not reported, administered to left arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced possible underdose. On 06-APR-2021, the subject experienced dripped down to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible underdose and dripped down to elbow was not reported. This report was non-serious.
general feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (general feeling sick) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced MALAISE (general feeling sick). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, MALAISE (general feeling sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: increased (High) Increased. On 09-Mar-2021, Heart rate: increased (High) Increased. On 09-Mar-2021, Oxygen saturation: decreased (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant product was reported.
soreness at the injection site; tiredness; occasional nauseous; gassiness; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Aug2021 as dose 1, single for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported as a Pfizer Employee, patient received the first dose of the Pfizer Vaccination on Tuesday 10Aug2021. Patient instructed to expect symptoms very similar to an Influenza vaccination that would last a 1-2 days. Patient would like to report on 10Aug2021 extended tiredness and gassiness (flatulence) more than 48 hours after receiving the first Covid-19 dose. also experienced soreness at the injection site, which radiated through the front and back of shoulder as well as occasional nauseous. The soreness and nausea have subsided, but the tiredness and gassiness has not. symptoms are worse in the evening/night than they are in the morning and afternoon. did not experience these symptoms until approximately 7 hours after the first injection was administered. Outcome for the event soreness at the injection site and occasional nauseous was resolved on unspecified date in 2021 and for remaining events outcome was reported as not resolved at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (29Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
1st dose on 2016, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo with an associated reaction of no adverse event (received 1st dose in 2016).   On an unknown date, the patient did not receive the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: The pharmacist reported that the patient was late for the second dose of Menveo. The reporter reported that only the first dose of Menveo was administered. No LOT number and expiration date and no vaccination date provided. The reporter stated that the vaccine was administrated on another facility. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Menveo, which led to incomplete course of vaccination.
red itchy patch on left arm. also warm to the touch. not really painful. itchiness started monday evening (4/12/21), woke up the next day (tuesday, 4/13/21) with redness and itchiness
sharp chest pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and CHEST PAIN (sharp chest pain) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (fatigue). On 11-Feb-2021, the patient experienced CHEST PAIN (sharp chest pain). At the time of the report, FATIGUE (fatigue) and CHEST PAIN (sharp chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details were not provided.
Patient reported feeling tingling on the lip, nose,  cheeks and both arms especially when she went outdoor, about 1 to 2 hours after receiving the flu shot. No redness or swelling on the injected site. I advice patient to go see doctor as soon as possible and to report back to me if the symptoms become worse.
Seizure requiring rescue medications which occurred 30 minutes after vaccine administration. Patient normally has a seizure every other day, so there was some suspicion that the vaccine could have exacerbated an underlying seizure condition.
lt arm became stiff & painful during noc p/vax;site of pneumococcal vax devel area of erythema 6-8" diameter;12MAY98 lt axilla was also stiff & tender;12MAY98 PM devel fever of 101;later same noc devel joint pain & malaise;fever 103;saw MD;
pt recv vax 29NOV95 & 15FEB96 pt exp fussiness & a diffuse rash described as 20-30 varicella-like lesions;no fever;no prior exposure to varicella but had contact w/other children
About 5 hours after receiving the vaccine, I was overcome with uncontrollable muscle spasms / body shakes. After about 5 minutes they subsided, but the same thing happened a few hours later and were so overwhelming I had to crawl on the floor to move. I felt achey and exhausted, with heavy night sweating. The next day, symptoms included  light sensitivity, headache, chills, sweats, body aches, fatigue and a 101 degree fever. My symptoms subsided by the next day, about 36 hours after the initial injection.
Pt developed discreet diffuse papular rash today after receiving vaccines this morning. Afebrile.
polyarthritis without synovitis 1 month after 2nd dose, resolved for several weeks, then recurred. ongoing for 3 months now.
Gave patient 0.05ml MMR Sub Q in Rt arm at 09:30am. At 09:47am patient started to have a sl runny nose and cough x 2-3times. Dr. listened to pt and chest was clear. Watched patient for next 18 minutes symptoms went away. At 10:05am gave patient 0.10ml MMR Sub Q in left arm. At 10:32 patient developed cough again, redness on left upper arm and left shoulder. C/O itching. Dr. listened to patient and ordered 25mg of BENADRYL PO. After BENADRYL given coughing, redness resolved and patient discharged to home at 12:05pm. Grandmother instructed to watch for any further complications from vaccine and report to us immediately should any occur or call 911 in case of emergency.
Patient received her second dose of Moderna Vaccine at 17:00 and at 17:09 reported developing lightheadedness, itchy throat and subsequently became SOB and diaphoretic.  Tachycardia noted at 120 bpm, and BP 148/80, RR 26.  Medical First Response called and Dr. present administering Epi 0.3 ml sq to left lateral thigh at 17:12.  Benadryl 50 mg given in R. Deltoid at 15:14. Pt. vital improved- 17:28: BP 130/82 and HR 90 RR 18.  Transferred to ED. Noted to be diaphoretic, SOB, ashen skin and wheezing in the ED.  Given Epi, Pepcid, Deacadron, Benadryl in ED and pt. responded well and discharged when hemodynamically stable.  Discharge with Predisone and Benadryl.  PCP f/u 2/4/2021
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL K007264, expiry date 02-MAR-2017. No adverse effects were reported. This is one of the 4 reports received from the same reporter. Additional information has been requested.
T101-temp to 105; taken to ER;place in ice;sz activity, eyes rolled back in head-hearing loss;
Headache and diplopia accompanying a cerebellar hemorrhage occurring within about 24 hrs of an influenza vaccination.  7/31/09 Hospital records received DOS 11/15/08 to 11/18/08. Assessment: Cerebellar/extracerebellar hemorrhage, horizontal diplopia, possible Marfan's or other connective tissue disease. Patient presents as alert but somewhat slow. Somewhat dry mucous membranes. Slightly tachycardic. Bilateral hemispheric cerebellar hemorrhage. Left against medical advice. 9/29/09 ICD9 codes received for date of service 11/14/08 to 11/18/08.  ICD9 codes: V64.81, 228.02, 358.2, 378.85, V79.8, 692.9
13 hours after administration of vaccine,  episode of syncope walking towards bathroom Fall resulted in fractured left humerus
Dropping of face Trouble talking Heart racing Fears blood clots Bad headache  Ending result after 2 times in ER is I now have Bells Palsy
covid vaccine breakthrough case   dose 1 3/22/21 Pfizer EN6207 dose 2 4/12/21 Pfizer EW0158
Pemphigus foliaceus; This literature-non-study case was reported in a literature article and describes the occurrence of PEMPHIGUS (Pemphigus foliaceus) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PEMPHIGUS (Pemphigus foliaceus) (seriousness criterion medically significant). At the time of the report, PEMPHIGUS (Pemphigus foliaceus) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered PEMPHIGUS (Pemphigus foliaceus) to be related.    Relevant concomitant and treatment medications were not reported.  Patient had Pemphigus Foliaceus after mRNA-1273 vaccine. Company comment- This literature-non-study case, concerns a 67-year-old female patient, with no medical history reported, who experienced the unexpected serious (medically significant) event of Pemphigus (reported as Pemphigus foliaceus) that occurred in the context of mRNA-1273 vaccination (dose number not specified). Latency cannot be assessed since vaccination date nor event onset date was disclosed. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. Elderly age could be a risk factor to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature-non-study case, concerns a 67-year-old female patient, with no medical history reported, who experienced the unexpected serious (medically significant) event of Pemphigus (reported as Pemphigus foliaceus) that occurred in the context of mRNA-1273 vaccination (dose number not specified). Latency cannot be assessed since vaccination date nor event onset date was disclosed. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. Elderly age could be a risk factor to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Ruptured appendicitis, surgical removal. 5 day hospitalization, with IV antibiotic therapy. Stable recovery post hospital therapy.