chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received immunizations of the day his 5 year well check on 9/18/2023. Later in the evening, hours after receiving he developed hives: generalized hives - face, upper and lower extremities and abdomen. He did not have any respiratory difficulty, facial swelling, joint pains, fever, vomiting/ abdominal upset.
4/29/2022 I Had trouble right after my vaccination, I was coughing up mucous. It was no big deal. All of a sudden when I got home I started wheezing and not feeling well. I took Xyzal and it did not help. I went to the ER. They did an ECG to test for cardiac arrest, which I did not have. I was wheezing really bad when the doctor came in. He gave me 2 epi pens then gave me 02. He also gave me Pepcid for nausea. I started itching. The doctor gave me 1 shot. He gave me Benadryl for the itching. I started breathing better and he let me go home. The doctor wanted me to get Allegra in case I had more trouble breathing. He also gave me another epi pen. It took about 5 hours to get through this.
RN, attempted intradermal placement of Jynneos Monkeypox vaccine with leakage from site on L forearm.  A second attempt was made 2 inches higher from original site on L forearm and was successfully done intradermally.  Pt. tolerated well and had no ill effects.
Patient was inadvertently given saline instead of vaccine.  No  untoward event.  Patient was called the next day, 2/12/2021, to have the vaccine administered.
liquid Pentacel and Acthib was administered incorrectly/no AE`; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient who was administered liquid DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] incorrectly/no AE(incorrect route of product administration) on an unknown date for prophylactic vaccination [batch number; dosing details; expiry date; route and site of administration not reported].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate route of vaccination.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Act-HIB for which cold chain break is reported with no reported adverse event; excursion vaccine was administered with no reported adverse; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] for which cold chain break and and excursion is reported with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (expiry date and batch number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) for which cold chain break and and excursion is reported with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered with no reported adverse and was Unknown for the event act-hib for which cold chain break is reported with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA124713:Master Case
Tinnitus starting 2 weeks post vaccination with J&J and increasing in intensity for 2 months.
Information has been received from a physician concerning an 83 year old female who on 17-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included LIPITOR, DIOVAN, calcium (unspecified), aspirin, SYNTHROID, PRILOSEC and iron (unspecified). The physician reported that after receiving ZOSTAVAX (Oka/Merck), on 10-MAR-2009, the patient was confused and was unable to communicate. The patient was admitted to the hospital on 10-MAR-2009 and was currently still hospitalized. The labs were performed (results not provided). At the time of the report, the patient was recovering. Additional information has been requested.
Moderate to severe headache. Chills, lymph node swelling and facial redness lasting about 24 hours.
experienced the allergic reactions; This case was reported by a consumer and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On 19th April 2021, between 5 and 7 months after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself or herself. The age at vaccination was not reported. The patient had received the first shot of Shingrix and experienced the allergic reactions. This case has been linked to US2021AMR137685, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137685:Same reporter
cold sweats profusely on hands and feet; cold sweats profusely on hands and feet; Arm was burning; Arm was itching; headache; soreness; A spontaneous case was received from the consumer concerning female patient of 53 years who received Moderna's COVID-19 vaccine and experienced soreness, arm was burning, arm was itching, headache, cold sweats profusely on hands and cold sweats profusely on feet.  The patient's medical history reported that she was allergic seasonally and allergic to sea foods.  No relevant concomitant medications were reported.  On 22-Jan-2021 prior to the onset of the events, the patient received first of the two planned doses of mRNA-1273 (Lot Number: 030L20A) on the left upper arm for the prophylaxis of COVID-19 infection.  On 22-Jan-2021 the patient experienced soreness. On 24-Jan-2021 the patient experienced arm was burning and itching. On 27-Jan-2021 she had cold sweats profusely on hands and feet. Treatment of the event was not reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, soreness, arm was burning, arm was itching, headache, cold sweats profusely on hands and cold sweats profusely on feet was not provided.
10 days p/flu vax devel occular myasthenia gravis documented by pos edrophonium & pos anti acetylcholine antibiotic test; also began treatment for parkinson disease;
Heart palpitations (fluttering) occurring once every 10-15 minutes, each event lasting less than 1 second in length. Prior to taking the vaccine, the palpitations were only occurring once every month or so. After the vaccine, palpitations became much more frequent.
Chills, fatigue, malaise, headache, muscle aches 1 day after vaccine on 9/1- took ibuprofen  Difficulty sleeping same night as vaccine on 8/31  Day 4 I experienced a numb tongue like one would experience after getting Novocain lasted about an hour, took Benadryl (No difficulty breathing or throat closing off or anything)  Sore arm that lasted a week
Daily headaches in the top right portion of head, above sinus membranes.  Never had headaches before and these continue.  Seeking medical advice but counsel was to report and see if there are any like adverse reactions taking place from this vaccine.  Daily muscle cramps in legs which have subsided 3 months after last injection
6 wk old with fever to 101.4 degrees. Child received a septic work-up, IM antibiotics. Evaluation was negative.
Sore arm; Tired than usual; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced sore arm on day 1 and was a little more tired than usual on day 2, both on unspecified dates. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This solicited report has been received from a 45 years old male patient, who was enrolled in a marketed research, concerning himself. The patient's medical history, concurrent conditions and concomitant therapies were unknown. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route, frequency, site administration, lot# and expiration date were not reported.) for prophylaxis. On an unknown date the patient had heart problems. The patient was also informed that if a person never had the vaccine before, that they were likely to contract the disease. The outcome of the event was unknown. Causality between to PNEUMOVAX23 and the event was not provided. Additional information has been requested.
cellulitis; arm was itching really badly during the night; Swollen; red circle around injection site; Small bluish bruise; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 11-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Small bluish bruise). On 21-Jan-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant), PRURITUS (arm was itching really badly during the night), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red circle around injection site). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Cellulitis, at a dose of 500 mg four times per day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK UNK, qd and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form once a day. On 25-Jan-2021, CELLULITIS (cellulitis), PRURITUS (arm was itching really badly during the night), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red circle around injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore) and VACCINATION SITE BRUISING (Small bluish bruise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  Concomitant medication information was not provided.  The reporter's physician was not sure whether it was a bacterial infection or an allergic reaction as it was delayed.  Treatment information included Antibiotic as well.  Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Vaccination site swelling and vaccination site erythema are consistent with the known safety profile of the vaccine.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Vaccination site swelling and vaccination site erythema are consistent with the known safety profile of the vaccine.
had a fever of 100.6; he lost his appetite and wouldn't drink; he didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had a fever of 100.6), DECREASED APPETITE (he lost his appetite and wouldn't drink) and MALAISE (he didn't feel well) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     No Medical History information was reported.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PYREXIA (had a fever of 100.6), DECREASED APPETITE (he lost his appetite and wouldn't drink) and MALAISE (he didn't feel well). At the time of the report, PYREXIA (had a fever of 100.6), DECREASED APPETITE (he lost his appetite and wouldn't drink) and MALAISE (he didn't feel well) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant concomitant medications were reported.  Treatment details included Tylenol.
pt recv vax 13APR99 & that evening pt appeared blue & exp what was thought to be sz, apnea & unconsciousness;pt was transported to hosp by EMT & hosp;
Even more confused; Very drowzy,patient is falling asleep while driving; Patient is having trouble with driving; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Even more confused), SOMNOLENCE (Very drowzy,patient is falling asleep while driving) and IMPAIRED DRIVING ABILITY (Patient is having trouble with driving) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Even more confused), SOMNOLENCE (Very drowzy,patient is falling asleep while driving) and IMPAIRED DRIVING ABILITY (Patient is having trouble with driving). At the time of the report, CONFUSIONAL STATE (Even more confused), SOMNOLENCE (Very drowsy, patient is falling asleep while driving) and IMPAIRED DRIVING ABILITY (Patient is having trouble with driving) outcome was unknown.            No treatment medication was reported.   This case was linked to MOD-2021-340945 (Patient Link).
+ for covid 7-2020 , was resident of long term unit for dementia at and tested as part of contact tracing.  was asymptomatic at the time of testing.    had covid vaccines later 1-6-21 and 1-27-21 and deceased 12-28-21.  I have no other information.
This spontaneous report as received from a registered nurse care professional refers to a 6 year old male patient with no known allergies. On 17-MAY-2007 the patient was vaccinated with his first dose of MMR II lot # reported as subcutaneous in the left arm. The same day the patient also received his first dose of VARIVAX (Merck), lot # reported as 0301U, subcutaneous in the left arm, and also his first dose of HAVRIX (lot number AHAVB130AA) IM in the right thigh. On 13-MAY-2010 the patient was vaccinated with his second dose of MMR II lot # 665098/0855Y, subcutaneous in the left arm. The same day the patient also received his second dose of VARIVAX (Merck), lot # 662575/0045Y, subcutaneous in the right arm. on 11-FEB-2013, at 9:30 am, the patient experienced small, itchy lesions for 2 days with sore throat, afebrile and was diagnosed with varicella (750 positive lesions). The outcome of patient's varicella was unknown. The patient did not seek medical attention. Additional information has been requested.
Arm redness/swelling at injection site immediately after administration of the MMRV. Iced area for 10-15 min. then sent home. Phoned mother of child then on 7/17/15 at 1:15 pm and was told swelling/redness was gone after about one hour.
31MAR95 sz began while eating & had obstructed airway; mom states pt had a blank stare on face; mom states pt arms were shaking & lip bluish in color, eyes rolled back; mom tried to ventilate pt; mom noted body jerking (like sz);sx cont
Patient felt dizzy, warm, funny feeling in the stomach and turned pale. This happened 5 minutes after the administration of vaccine.
Patient received first dose of Moderna Vaccine, experienced localized redness and swelling at injection site.  One week post first vaccine, patient developed lower extremity petechia and rash consistent with cutaneous small vessel vasculitis. Describes itching associated with rash. Did not develop throat swell, shortness of breath, or other signs of anaphylaxis.
Initial unsolicited report received from a nurseon 24 August 2016. This case involves a 32 year female patient who was vaccinated with a first dose of MENACTRA (batch number U5513BA, expiration date was not reported) intramuscularly in left deltoid and sixth dose of  ADACEL (batch number U5472AA, expiration date was not reported) intramuscularly in right deltoid both on an unspecified date. patient also received YELLOW FEVER VACCINE (batch number, expiration date, site of administration was not reported) subcutaneously on 18 August 2016 at 09:30 A.M. Illness at vaccination was denied. Pre-existing physician diagnosed allergies, birth defects, medical conditions included Attention Deficit Disorder, Raynaud's, anxiety, depression, hypothyroid, asthma sports induced. Patient had not experienced any adverse event prior to vaccination. Concomitant medications included Synthroid, Prozac 10 mg, Xanax 1 mg, Protonix 40 mg, Norvasc 5 mg, Adderall 20 mg, Gabapentin 400 mg, "Spriniee 26". On 22 August 2016, at 08 P.M, four days following vaccination, patient had red elevated itchy area where shot was given, 40 x 30 mm indurated pink red area. On 23 August 2016, events were reported to health care professional. It was reported that patient received five doses of ADACEL in 1983, 1984, 1984, 1988, 1988 and did not experience any adverse event. Lab data was reported as none. Corrective treatment was not reported. The patient was not recovered from events. List of documents held by sender: none.
Information has been received from a physician through a pregnancy registry concerning a 28 year old female with a history of one previous full term pregnancy with no birth defects and no stillbirths or miscarriages in any previous pregnancy who on 2/12/04 was vaccinated with a first 0.5mL dose of varicella virus vaccine live (lot # 931150P). There was no local reaction at the vaccination site. There were no varicella or herpes zoster symptoms post vaccination. The physician reported that he gave the vaccination during the patient's menstrual period (LMP 2/11/04; EDD 11/17/04). Although the patient did not intend to become pregnant, the physician gave a urine pregnancy test prior to her second dose. The test was positive. The physician thought that the patient became pregnant within two weeks of her vaccination. The patient did not receive the second dose. Unspecified medical attention was sought and no treatment was required. A product quality complaint was not involved. Follow up information was received from the physician who indicated that the patient voluntarily terminated her pregnancy on approximately 3/19/04 after discussing it with her gynecologist. It was also noted that the patient terminated her pregnancy within a month. An ultrasound on 3/19/04 was negative and was a normal test. No further information is available.
received a cardiac catheterization; has not had his second dose; was diagnosed with / pericarditis; was diagnosed with minimal coronary disease; trouble breathing; sever chest pain; This case was reported by a nurse and described the occurrence of pericarditis in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pericarditis, coronary disease, chronic lymphocytic leukemia and shingles.   On 10th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 13th January 2020, 3 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pericarditis (serious criteria GSK medically significant), coronary disease, difficulty breathing and chest pain. On an unknown date, the patient experienced cardiac catheterization and incomplete course of vaccination. On an unknown date, the outcome of the pericarditis, chest pain and incomplete course of vaccination were not recovered/not resolved and the outcome of the coronary disease, difficulty breathing and cardiac catheterization were unknown.   It was unknown if the reporter considered the pericarditis, coronary disease, difficulty breathing, chest pain and cardiac catheterization to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not applicable for 2nd dose reported. The patient received the 1st dose of Shingrix and 3 days later he had severe chest pain and trouble breathing. The patient went to the emergency department at that time, received a cardiac catheterization, was diagnosed with minimal coronary disease and pericarditis.  The patient had not received his 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.
not feeling well; approx 10 hrs later, began vomiting, febrile approx 22 hrs later, 1min episode of syncope while vomiting;
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 04-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012482, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.