chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a 53-year-old female patient received a TD Adult vaccination of 3/30/01 at 9:00am. Reportedly at 6:00pm that evening the patient developed a very large, hot, red, "angry", hard area at the injection site. Approximately 5-6 inches in circumference. From additional correspondence received on 5/15/01, it was reported that no other vaccine were given on 3/30/01. From additional mailed correspondence received on 7/10/01, it was reported that the patient's current medical condition is unknown. This case is closed.
Pt. developed redness, swelling and pain after MCV-4 immunization yesterday. Pt. states arm was painful yesterday constantly. Today arm is mostly itchy, painful with movement. H/O immunization reaction to DTaP. Mother gave ADVIL, effective. Denies wheezing or SOB. Pain has been stable. No fever noted. No other symptoms. Symptoms: Skin Rash, Urticaria Pruritus and swelling, pain. Treatment: Cetirizine 5 mg every day.
early jan99 pt noted tinnitus in lt ear subsequent to vax; pt also had left facial paresthesia & lt sided HA (behind eye), never completely resolved, though improved; treated w/medrol dose pack; zithromax, entex
Tested positive for Covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid) in a 65-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.       Concomitant product use was not reported.   Treatment information was not reported .   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received and included updated contact information.
At the beginning of the year my mother, patient, a 57-year-old lung transplant recipient came down with Covid. She received monoclonal antibodies and was better within 4 to 5 days. On May 12 she received her first Covid vaccine. Within a few days, she was feeling sick, my sister had to bring her food and help take care of her cat. By May 19 my sister noticed my mom was experiencing leg pain, walking slower, disengaged with people around her, and not responding in her normal ways. On May 22, around 12 pm, my mom left her apartment under unusual circumstances. She wears false teeth but didn?t put them in, left her cell phone behind, and left her unlocked. She got into her car, ran a red light, and caused a three-car collision. The officer that responded to the scene did not call an ambulance. He issued her a citation and let her go. At this point, we didn?t even know she had been in a wreck. She was later found almost 14 hours after the car wreck at 2:43 AM, 5 miles away at a closed gas station. The officer that found her stated that she was confused, she thought the date was January 1962. She said she was getting gas to put in her truck because she had been in a wreck. She had no vehicle or gas can. The officer placed her under the emergency Act and took her to hospital. She was at the hospital for approximately a week where she was diagnosed with encephalopathy and altered mental status. Because she is a lung transplant patient, she was then transferred to the different hospital. She was at that hospital for another week. They diagnosed her with toxic brain damage consistent with carbon monoxide poisoning. We had her apartment checked, no detectable levels of carbon monoxide. She also does not have a garage or other source of carbon monoxide. She did not have any carbon monoxide in her system either. The doctors hypothesized that she may have been showing signs of dementia when she got into her car and then was exposed to five minutes or less of carbon monoxide during the car wreck which would have wreaked havoc on her faster than a typical person due to her lung transplant underlying health. My sister and I told the doctors about the vaccine and how she had developed the symptoms shortly after. We asked about the possibility of the vaccine causing toxic brain damage. They agreed that it wasn?t impossible but didn?t have research to back it as the cause. On Tuesday, June 7, she was transferred back to hospital with the recommendation to enter hospice care and given a 7 to 10 days life expectancy due to irreversible, extensive brain damage. The damage is attributed directly to toxicity in her brain, not the car wreck.
Couldn't get out the bed for 2 days. On the 9th he had a racing heart that lasted for 30 seconds.
lip swelling, fever, transient shortness of breath day after 2nd gardasil vaccination was given
returned to clinic at 10:40a after MMR vaccine administered. Below is documentation from date vaccine received from provider/MA who saw patient for vaccine and reaction: Emesis in clinic x 1 no diarrhea HR 160-to 130's improving Benadryl provided. Emesis x 1. Urticaria on trunk. Mild flushing of extremities and face. No angioedema. Discuss epi consideration. Pt was observed for an hour. Urticaria improved. HR came down nicely Alert, happy . Add in Pepcid. Epi pen Jr provided. Discussed s/s anaphylaxis that would warrant trip to ED/clinic and Epi usage Benadryl 6 hrs routine for 2-3 days.  Consider pretx before next round of vaccines
Left neck painful nodes-lymphnodes persists after 5 weeks of Moderna#2. Lt neck/shoulder muscle stiffness, chest wall pains, "feeling painful lump mid upper back while swallowing"
About 3 weeks after dose 1, I woke up and had trouble with balance that lasted a month at it's worse. I still have bouts of it. Also, my legs from the shin down to my toes became painful and a little swollen. That has not gone away.  Also, my veins in my right arm and chest are puffy.
This spontaneous report as received from a 75 year old female consumer reporting on herself who two years ago in approximately August 2011, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer reported that she was 6 weeks on 02-JUL-2013 into shingles. At the time of the report, the consumer's outcome was unknown. The relatedness for shingles and ZOSTAVAX was unknown. Additional information has been requested.
heaviness in chest, sweating, increased heart rate. Administered 2 doses of benadryl and called 911. EMTs monitored and took to ER for further evaluation
Day after flu shot, patient got sore throat, muscle aches and chills.  Arm where injection given was sore.  Had headache.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "drug allergy", notes: Known allergies: penicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment from 14Mar2023 to 18Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19  are related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded. This case will be reassessed should additional information become available.
Numb hand; Muscle spasm; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (Numb hand) and MUSCLE SPASMS (Muscle spasm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced HYPOAESTHESIA (Numb hand) and MUSCLE SPASMS (Muscle spasm). At the time of the report, HYPOAESTHESIA (Numb hand) and MUSCLE SPASMS (Muscle spasm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
This report was received from a nurse referring to a 61 year old male patient. Patient's pertinent medical history, drugs reactions/allergies and concomitant medication were not reported. The reporter stated that on an unspecified date, a dose of ZOSTAVAX lot #: M035147 and expiration date: 25-OCT-2017, was exposed to a temperature excursion of 6F for 40 minutes. The reporter also stated that the patient was vaccinated with this improperly stored ZOSTAVAX (route, strength and dosage schedule were not reported. No adverse event was reported. No Product Quality Complaint (PQC) was involved. Additional information is not expected since the reporter denied authorization to contact.
On 11/17/16 the patient reported persistent left deltoid pain with abduction/extension greater than 90 degree post influenza vaccine which required a follow-up visit on 11/18/16. No further treatment since 11/18/2016.
Note: First time in this clinic but 2nd immunizations. Had same immunizations, 2 months before at another clinic. Autopsy results state cause of death to be SIDS.
After 15 hours, left forearm at sight of immunization was tender, red, warm size 2x2 inches round area. Received Tylenol x1 dose in the evening. Symptoms resolved the next day.
Breakout of a rash on the arm where she was given the injection; Rash started with itching; This is a spontaneous report from two contactable consumers one of (patient) via Medical information team. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: PFR, EN5318, Expiration date was not reported), via an unspecified route of administration in right arm on 28Jan2021 as single dose for covid-19 immunisation. Medical history included she had a severe allergic reaction to sulfa. The patient concomitant medication was not reported. Prior Vaccinations (within 4 weeks) patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient reports on the first dose, she had a breakout of a rash on the arm where she was given the injection. Patient answers as the rash started with itching on 28Jan2021 and then she started getting scabs and lesions, within 24 to 48 hours, after the first vaccine. Patient states she still has a little bit of the rash left on her forearm, but it is very minimal. The outcome of the events was recovering.
Itchy lump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy lump at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 003A21A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication.   On 15-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 12-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy lump at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchy lump at injection site) outcome was unknown.            Treatment information included ice pack.
Weakness, hoarseness, painful to take a deep breath, burning and tingling at injection site, muscle aches, burning in toes, fever of unknown orgin.
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a female patient of unknown age who was exposed to 0.5ml vaccine FLUBLOK QIV (batch number: QSAA1828, expiry date: 30-Jun-2019) via intramuscular route on 12-Oct-2018 while she was pregnant as patient did not inform about the menstrual delay at the time of vaccination. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient received the FLUBLOK QIV while pregnant occurred at 28th week of pregnancy. The gestation period at onset and gestation period at exposure data needs to be populated. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. It was a case of Vaccine exposure during pregnancy. No adverse event was experienced. Additionally, at time of reporting, the outcome of the pregnancy is unknown. List of documents held by sender- none.
From phone contact received on 2/20/02 at manufacturer, it was reported that a 4 y.o. female received Ipol on 1/8/02. Discoloration and hard lump at inject site noted by her mother on 2/18/02. Seen by pediatrician 2/20/02. Unresolved.
Sore arm; body aches; fatigue; headache; upper stomach cramp; chills; sensitive skin; symptoms got worse; This is a spontaneous report received from contactable consumer, the patient. A 69-year-old elderly female received the first dose of BNT162b2 (solution for injection; Lot EN6201 expiry not provided) as a single dose via unspecified route in the right arm on 14Feb2021 at 11:30 AM (at 69-years-old) for COVID-19 immunisation. Relevant medical history included asthma, hypothyroidism, and high blood pressure (BP). The patient has an allergy to penicillin, sulfonamide (sulfa), eggs, shellfish and peanuts and all tree nuts. Concomitant medications sans posology/indications included levothyroxine sodium (SYNTHROID), valsartan (DIOVAN), atenolol (TENORMIN), amlodipine, and diazepam (VALIUM NOVUM). The patient did not receive any other vaccines on the same date. The patient denied being diagnosed with COVID-19 prior to the vaccination. The patient reported that on 16Feb2021 at 05:00pm she experienced a sore arm, body aches, fatigue, headache, upper stomach cramps, chills , sensitive skin (no hives) and these symptoms got worse on the second day and continue (fifth day not including day of vaccine), The patient was tested for COVID via nasal swab PCR on 19Feb2021 and was negative. There was no treatment received. The outcome of the events, sore arm, body aches, fatigue, headache, upper stomach cramps, chills, and sensitive skin (no hives), was not recovered.
Mother stated at 7 pm patient got a rash on upper body which progressed to the lower extremities. Then patient had chest heaviness and throat irritation . Mother said began giving benadryl and using albuterol inhaler. Called to have him seen at Urgent Care/ER but was told it could take until morning to be seen if he wasn't severe because of heavy case loads.  Mother continued at home monitoring and treatment and symptoms resolved.
Joint symptom NEC-pelvis on 2013-10-15, clinician comment: possible reaction.
ON 9/4/19 PT RECEIVED HEP A #1. ON 9/17/19 PT WAS BROUGHT TO OFFICE FOR AN ITCHY RED RAISED RASH ON BOTH LEGS NOTED FOR ONE WEEK. MOM ALSO STATED AT THAT TIME THAT ON THE EVENING OF THE DAY SHE RECEIVED THE HEP A VACCINE, PT'S UPPER  AND LOWER LIPS SWELLED W/ REDNESS AND ITCHING AND LATER PEELED.  NO WHEEZING/COUGHING/TONGUE SWELLING/HIVES NOTED. SYMPTOMS RESOLVED ON THEIR OWN OVER THE NEXT TWO WEEKS. THE SWELLING WAS AT FIRST CONTINUAL FOR ONE WEEK, THEN OFF AND ON FOR THE SECOND WEEK.  MOM STATED THIS HAPPENED AFTER BOTH FIRST AND SECOND DOSES OF HPV ALSO, ON 9/12/17 AND 8/28/18.  PT WAS SEEN AFTER 9/12/17 DOSE IN THE OFFICE ON 10/10/17 FOR WHAT WAS DETERMINED TO BE A STERILE ABSCESS AT SITE OF INJECTION. MOM SHOWED A PHOTO OF LIP SWELLING TO DR. AT THAT VISIT, BUT SHE WROTE THAT THE SWELLING WAS DIFFICULT TO APPRECIATE IN PHOTO.
No adverse event; Received half dose instead of a full dose for 2nd primary shot; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Received half dose instead of a full dose for 2nd primary shot) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 037A22B and 037A22B) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received half dose instead of a full dose for 2nd primary shot). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received half dose instead of a full dose for 2nd primary shot) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received half dose instead of a full dose for 2nd primary shot).    No concomitant medications were reported.  31-year-old patient received 2 doses of Moderna COVID-19 vaccine. The 2nd shot was given as a half dose instead of a full dose from a red cap vial of Moderna COVID-19 vaccine.  No treatment medications were reported.
Patient developed rash on the right side of the body after one hour of ZOSTAVAX injection. Injection was given on 10/11/12 patient notified us on 10/15/12. Patient is on HEPCEPTIN. She was cleared to get ZOSTAVAX by her oncologist.
Extreme fatigue; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No COVID prior to vaccination. Not been tested post vaccination. The patient experienced extreme fatigue and weakness on an unspecified date. Patient had bed rest. No treatment was given for the events. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bronchitis; Cough; A spontaneous report was received from a consumer concerning an unknown age, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed bronchitis and cough.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 003L20A) intramuscularly for prophylaxis of COVID-19 infection.   On Unknown date, the patient have bad lungs and developed bronchitis which is considered as Medically Significant Event and cough.  Treatment for the events included antibiotics for 6 days, albuterol, Pertussin AC and Z-Pack.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, bronchitis and cough, was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Patient fainted after waiting for 10 minutes. He did not lose consciousness. He responded to RPH commands. He did not have shortness of breath, rash, inflammation. He urinated himself after falling. He remained laying on the ground for 20 minutes, after which he  stood up and had recovered from the dizziness/nausea. Patient and parents did not wish for 911 to be called or to go the hospital. They agreed to call 911 if patient has any further symptoms.
pt devel rash on other wrist & groin area & blister like rash on feet;denies poss poisoning response or any other new products;
Client came to our facility requesting a Modern booster shot.  She explained to the RN that she received her 1st dose of the COVID19 Pfizer vaccine on 12/21/2020, and approximately 5 minutes later, the client experienced a rapid heartbeat for approximately 30 seconds.  She experienced no other side effects from the 1st shot of the vaccine.  The client received her 2nd shot of the COVID19 Pfizer vaccine on 1/11/21 and 5 minutes later experienced numbness in her cheeks, which lasted for approximately 2 minutes.  The client did not experience a rapid heart rate with her 2nd dose or any other side effects.  The RN communicated this information to the Lead RN who conducted a medical consult with Clinical Lead.  Due to the client experiencing reactions to her 1st & 2nd dose of the Pfizer vaccine within the first 4 hours of receiving the vaccine, the Clinical Lead escalated the issue to the County doctor for approval.  The doctor gave approval for the client to receive the COVID19 Moderna booster shot (Lot#FF8841) with a 30-minute observation period.  The RN administered the shot at approximately 13:30 and educated the client on both the potential side effects and adverse effects of the vaccine, when to seek medical attention, and ER precautions.   The client was escorted to the observation area where she observed for 30 minutes, and no issues were noted.
On 5/14/18 patient was given an expired vaccine due to the person that is normally responsible for those duties was on the phone. So they got the person that covers her to give shot and wasn't aware they were expired. The shot were still in the refrigerator because they expired over weekend. What's going to be done so it don't occur again. Nurse 1 will be the only one giving shots, If other nurse is needed to cover nurse 1 due to she is not here. Nurse 1 will make sure to have shots that are approaching expiration date labeled. Patient will be given an extra hep B a next visit.