chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cramping / related to her menstrual cycle; This is a spontaneous report from a contactable consumer (patient's mother). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration in arm on 22Dec2020 (time between 10 and 11), single dose for COVID-19 immunization. There were no medical history and concomitant medications. The mother has a question or concern she was not sure. Her daughter was a nurse and got the vaccine this morning. An hour later she took naproxen sodium (ALEVE). Her daughter was now concerned and anxious, that she has messed up the efficacy of the vaccine. She took the naproxen sodium because she was having cramping pain unrelated to the vaccine. The patient does not know when the cramping started, she states that it was related to her menstrual cycle. She came home from work, she had the vaccine at her work which was the hospital, she was a night nurse, she was having twinging, so she took the naproxen sodium so she could sleep. She took 2 tablets an hour after receiving the vaccine. She has not been positive for COVID. Clarifying she has not tested positive in a COVID test. She was not tested for antibodies. Therapeutic measures were taken as a result of cramping. The outcome of the event was unknown.  Information for Lot/Batch number has been requested.; Sender's Comments: The event cramps menstrual is considered an intercurrent medical condition and is assessed as unrelated to BNT162B2.
Headache for 5 days starting 12 hours after vaccine; Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine; Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine; Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine; Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient (non-pregnant) received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number: EW0196) via an unspecified route of administration, in the left arm on 25Jun2021 (at the age of 36-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was non-pregnant at the time of vaccination. The vaccination facility type was pharmacy or drug store. The patient medical history includes food allergy, (allergy: shrimp), drug hypersensitivity (Allergy: Sulfa). Concomitant medications included (received within 2 weeks of vaccination) Prenatal vitamin, Sertraline Hydrochloride (ZOLOFT) and Iron. Past drugs included PCN, Diflucan and there allergy. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since the vaccination. The patient previously received BNT162B2 (BNT162B2, Solution for injection, Batch number: EW0180) via an unspecified route of administration, in the left arm on 04Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. On 25Jun2021 23:00, 12 hours after vaccine, the patient experienced headache for 5 days. She also experienced hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine. She was currently breastfeeding and 5/8 weeks postpartum at times of vaccine. The patient did not receive treatment for events. Outcome of the event was recovered on an unspecified date in Jun2021 while rest events recovered on 28Jun2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021822395 same reporter/drug, different patient and event
Patient returned for 2nd COVID shot after softball practice. She was slightly apprehensive and scared to receive her dosage.  Moments after receiving her vaccine she seemed to gaze off and her head fell forward and then back.  Her eyes remained opened with her head tilted back but she was unresponsive for 15 seconds. She was attentive and responsive after this time.  She started to sweat on her arms and forehead and above her mouth.  We gave her water to drink immediately and a cold compress.  It was difficult to discern if the patient experienced a seizure or was merely semi conscience. Her head shivered very slightly.  She has dark eyes so it was difficult to see if her pupils were pinpoint as this occurred, but when alertness was restored her pupils were dilated.  Patient was taken to hospital/urgent care
expired Ipol was given to a patient/ no AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who received expired 0.5 ml fourth dose of suspect IPV (VERO) lot N1K921M (Expiry date 14-Nov-2019) via unknown route in the left thigh for prophylactic vaccination, on 03-Feb-2020.  medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  It was an actual medication error case due to expired vaccine used.  At the time of reporting no adverse was 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 and Module VI of the 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.
Chills, rigors,fever with TMax 104.2 Headache Dizziness, near syncope Nose bleed Menstrual period for first time in approx 5 yes
Lost all sounds unable to move around laid on the floor for almost two weeks high fever no sign of improvement even after seeing our doctor a few times after shot.  Stopped eating foods of almost every kind.
Severe lethargy, mild chills, low fever, bad headache, so very tired for 5 days. Not sure if symptoms are over yet. Still tired, but other symptoms are better
booster dose given past 30 day use by expiration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster dose given past 30 day use by expiration) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE NRVV AD26 (Patient received J&J vaccine dose) on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster dose given past 30 day use by expiration). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (booster dose given past 30 day use by expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  Date the vial was initially stored in the refrigerator: 11 Nov 2021   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Non Significant follow up appended. Contact information was updated.
patient got her flu shot on 11/09/2021, on 11/10/2021 the day after her shot, patient got  pain in her right eye. patient believes that it's because of the shot. patient has Glaucoma in her right eye.
On day 2 (48-72 hours later), developed urticaria and itchiness. Resolved spontaneously over the next few days. Then on day 8 (1/27/2021), developed redness, itchiness, swelling, and mild pain at the injection site. Seemed to be a delayed injection site reaction. Resolved spontaneously over the next few days.
Tempature of 103 for 24 hours, severe diarrhea, vomiting and severe headache that lasted over 24hours.  Medication would not relieve the headache.
This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR INFECTION (Ear infection). At the time of the report, EAR INFECTION (Ear infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included amoxicillin.
This spontaneous report as received from a nurse via a company representative refers to 56 patients of unknown age and gender. The company representative reported that these 56 patients who were assumed to received the M-M-R II (lot#, dose, route not reported) had mumps. Outcome of the event was unknown. This is one of several reports from the same reporter. Additional information is not expected.
Redness & swelling on (L) arm at injection site. Cool compress applied. TYLENOL as needed recheck in 2-3 days.
Patient received 4th dose of 0.25 ml..  Patient had received a 0.25 ml dose in Nov 2021
Received flu shot in right deltoid. Very painful. Arm got very stiff as time progressed - could not straighten. Seen by Employee health 11/4/13. Seen by dr several months later.
This literature marketed report as received from authors of literature article refers to 2 patients of unknown age and gender with multiple sclerosis (MS). On unknown dates, the patients demonstrated insufficient immunity and were vaccinated with VARIVAX (dose, route of administration, lot #, and expiration date were not provided) prior to ocrelizumab dosing.
having fever symptoms on 02Jan2022 who has also tested positive; having fever symptoms on 02Jan2022 who has also tested positive/ Both experienced fever at about 101 and fatigue from covid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single and administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 02Jan2022, outcome "unknown", described as "having fever symptoms on 02Jan2022 who has also tested positive"; COVID-19 (medically significant) with onset 02Jan2022, outcome "unknown", described as "having fever symptoms on 02Jan2022 who has also tested positive/ Both experienced fever at about 101 and fatigue from covid.". The patient underwent the following laboratory tests and procedures: body temperature: (2022) 101; sars-cov-2 test: (unspecified date) positive. It was reported that, patient did not received booster yet. Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 09-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Infant patient who received a dose of ADACEL lot C55418AA via intramuscular route in unknown administration site of HEPATITIS B VACCINE not produced by Sanofi Pasteur lot number not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapies were not reported. This was the case of medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that Infant received ADACEL. Order was written to give hep B but ADACEL was administered. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: none.
Rash, wheals maculopapular raah all over my body. Fever chills sinus tachycardia
FOLLOWING MMR VACCINE ADMINISTRATION, MOM REPORTS CHILD DEVELOPED A RASH, EVENTUALLY OVER WHOLE BODY, SIMILAR TO MEASLES.  THIS WAS CONFIRMED BY HER PHYSICIAN.
Information has been received from a licensed practical nurse concerning a 9 year old white female with allergies to penicillin and pertussis, intermittant reflux and asthma and a history of a heart murmur, bleeding ulcers, esophagitis and hives from pertussis who on 27-Jun-2001 was vaccinated in the left arm with a first dose of varicella virus vaccine lvie (lot #535461/1246K). It was reported that the patient had vomiting and diarrhea at the time of vaccination. On 14-Oct-2003 the patient presented with about 25 vesicular lesions, generally disseminated and a low grade fever. No treatment was required for the AE. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available. Follow-up information indicated that the mother brought the patient to the office for a rash. She indicated that the patient was exposed to chicken pox three weeks ago and the patient's brother (WAES 0310USA01481) broke out with them on 09-Oct-2003. The onset was reported as 12-Oct-2003 and the patient had 25 lesions. It was also reported that the mother stated that the patient only had 10-12 lesions. The diagnosis was "atypical chickenpox presentation. The patient recovered on 17-Oct-2003. Additional information has been requested.
he stopped growing; This spontaneous report was received from a consumer refers to a currently 22-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in July 2012 (reported as 7 years ago), when the patient was approximately 15-year-old, he was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, frequency, route of administration, lot# and expiration date were not reported) for HPV prevention.  On an unknown date (reported as receiving around the same time), the patient started therapy with isotretinoin (ACCUTANE) (frequency, route of administration, strength, dose, lot# and expiration date were not reported) for acne. The reported stated that the therapy with isotretinoin (ACCUTANE) was closely monitored. On an unspecified date, the patient stopped growing. He was predicted to grow to 6 feet 2 inches but reached 5 feet 10 inches. The patient did not received any treatment. Therapy with isotretinoin (ACCUTANE) was discontinued. The reporter considered that the isotretinoin (ACCUTANE) stopped his growth plates and that it has been added to the pamphlet. The reporter also considered that it was not the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as the patient tolerated that with no issues and no rashes. The outcome of the event was not reported.
Really bad headache, arm painful to the touch, whole body pain and achiness, general malaise, tiredness. Lasted about 24 hours. Ibuprofen and a hot shower helped alleviate symptoms. After approx 24 hours only a soreness at injection site remains.
Patient received influenza vaccine in left deltoid on 9/25/2014. Patient still experiencing arm soreness in March 2015.
Headache, Myalgia, CHIILS, WEAKNESS Narrative: HAD TO STAY HOME FROM WORK
Shot#1: large bump at injection site and soreness for several days. One week later awoke very dizzy which wore off about five hours later. Shot#2: 4 weeks later (shot in opposite arm)  -no immediate effects. One week later awoke with severe dizziness and nausea which persisted several hours. Call to physician advised going to ER. Had EKG, CAT scan, and two blood draws. All showed normal values.Symptoms reduced in the afternoon. For several mornings following awoke slightly light-headed. Several weeks into 2022 have had slight light-headedness upon awakening.
pt recvd vax & devel fever of 101 & up; bulging fontanel;
Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Dry cough). At the time of the report, COUGH (Dry cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter called reporting that patient who received his 1st dose of the Moderna COVID19 vaccine 2 weeks ago had a dry cough during the whole time of the call
Breakthrough case after three admissions Moderna 1/27/21 Lot# 302H20A;  Moderna 2/27/21 Lot# 011M20A;  Moderna 11/17/21 Lot# 051F21A
My lower right arm, the same arm I received the vaccination, has been slowly going numb since this morning and is increasingly losing feeling.
I?m reporting this event  just in case but fully support the vaccine and would get it again. I got my booster around 12pm on  11/5. By 2am on 11/6 I tad a fever, extreme fatigue, headache and mild fever. By 7am I only had a  headache along with body aches. By the afternoon my headache and aches subsided but the left side of my vagina (inner and outer labia) were swollen, dry and extremely tender. I couldn?t walk or sleep. It burned slightly to pee. Overall the swelling and dryness was extremely painful. I spent the next few days icing the labia and showering 4-5 times a day to keep the area clean. The swelling subsided over time and the ulcer like wound healed. While recovering  I  avoided the burning feeling by pulling my left labia to the side and aiming my urine towards the right so it could heal.  By 11/7 I started feeling  fatigued and getting loss of appetite along with slight nausea.  I felt weak and knew I had something wrong.  I went to the intermediate care and ended up with a UTI. While I think the UTI is most likely from my cleaning practices, there may be a correlation with my swollen labia after the shot. I am now on dose 4 of Cephalexin 500mg (2x daily) and I?m beginning to feel much better.
Chills, fever of 101.4, vomiting, body aches, headache, diarrhea
during the following 3 weeks, I'd experienced weird things like anxiety( excessive worries about anything, feeling of my heart beating fast, sometimes feeling my breathing is very fast, chest tightness or heaviness, and feeling that I'm losing control for few seconds, feeling cold that I put on the heavy jacket that I never used except in cold winter! feelings of boneaches especially in my fingers joints, some days I'd nausea and feeling that my stomach torture me! All the previous symptoms were on and off many times per day, I was using Tylenol and Ibuprofin almost every day. lately, I'd 4 days of continuous symptoms, that I feel like panic and cold with all the above symptoms.(from 29th April to May 3rd).
arm was sore; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The pateint stated that getting shingles shot was no big deal. The patient's arm was sore for one night. The follow-up would not possible as no contact details were available. For 2nd dose tolerance, refer linked case US2021AMR256465, reported by the same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR256465:same reporter - 2nd dose
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. In December 2015 (reported as on an unspecified date one year ago), the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot # and expiration date were unknown) for prophylaxis. On 07-DEC-2016, the patient was vaccinated with another dose of PNEUMOVAX23 (dose, route, lot # and expiration date were unknown) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Mother communicated on 05/21/2020 at 12:15 pm and reported that the minor had symptoms to vaccination administered on 05/19/2020. Mother communicates with the office again at 12:29 pm and reports that the minor had symptoms. The symptoms were redness in the area and warmth, fever, sore throat and stomach pain, vomiting and weakness. She also specified that the minor was "very thirsty". The mother was advised about the symptoms that patient may present after vaccination. Mother was called on 05/22/2020 to follow up on the minor and indicated that she had to take the minor to the emergency room because the symptoms continued.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 24-SEP-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M032157 with expiration date: 01-JUL-2018 (strength, dose, route and anatomical location were not provided) for prophylaxis. No adverse symptoms reported. The dose of M-M-R II did not have any temperature excursions prior to administration.