chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The provider ordered VARICELLA vaccine to a patient with negative titer. On May 19, 2016, the patient was given Zoster instead of Varicella. On June 1, 2016 the same patient came into the clinic and requested for her IZ records. Med error was discovered. The provider was informed and gave an order for Varicella vaccine. Another staff gave the patient Zoster vaccine. (ZOSTAVAX lot number L039096)
Swelling of throat and tongue.  Chewed some Benadryl Tablets, about 20 minutes after taking Benadryl issue went away
Patient arrived to the ED with complaints of altered mental status. She was found to have a CVA and was admitted for further management. She was discharged home 3 days later with home healthcare.
My CNS system started to feel like it was shutting down. I started have anxiety and felt like I was passing out all day. Couldn't work for weeks. Had several visits to the urgent care and primary doctors office after me 2nd dose of GARDASIL.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Mar2022, outcome "recovered" (06Apr2022) and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; negative; positive; negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was reported that patient took Paxlovid to treat a covid infection, felt better and tested negative after a week. Then a week after testing negative, patient began to feel sick and tested strongly positive for covid again for 8 or 9 days after which felt better and finally tested negative again. Patient seem to have relapsed or reinjected a week after recovering for the first round of covid. No Other medication in 2weeks.
We were at a community event offering vaccines and testing.  when asked if the patient had received any covid vaccines in the past she stated no.  We did not have internet access to access WIR.
She got the second dose of GARDASIL on 24-MAY-2011; Her arm felt "a little bruised"; "may have hit a nerve"; Her arm "hurt a lot"; patient thinks the 1st shot "may have hit a nerve."; This spontaneous report was received from a currently 18 year old female patient regarding herself. The patient had no concomitant medications, no concurrent conditions nor medical history and no drug reactions or allergies.      On 20-JUN-2008, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (Lot No.0152X has been verified to be a valid lot number for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), expiration date not reported, but upon internal validation established as 09-NOV-2009), with a dose of 0.5 milliliter, intramuscular, for human papillomavirus (HPV) prophylaxis (frequency was not provided).  On the same date (reported as "after receiving the first shot"), the patient recalls that her arm "hurt a lot" (pain in extremity), because she thought that the 1st shot "might have hit a nerve" (nerve injury) and her arm felt "a little bruised" (contusion). Furthermore, it was also reported that the patient did not seek for medical attention and also that no treatment was given for the experienced events. On approximately June 2008 (reported as "lasted  a couple of days"), the patient recovered form the experienced events.    On 24-MAY-2011, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (Lot No.1569Z), for human papillomavirus (HPV) prophylaxis (strength, dose, route, frequency and expiration date were not provided) with no reportable side effects occurring and on 20-DEC-2011,  the patient was vaccinated with the third and final dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (Lot No.291AA has been verified to be a valid lot number for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), expiration date not reported, but upon internal validation established as 12-APR-2014), for human papillomavirus (HPV) prophylaxis (strength, dose, route and frequency were not provided) with no reportable side effects.        The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the reported events was not provided.
Pt reported vomiting, dizziness, and headache 9 minutes after vaccination Vitals: 101/56, 71, 18 Patient stable and released from vaccination site at 10:20AM
Positive left thigh erythema about 6cm. Warm to touch and no drainage.
Fatigue began 26 hrs. after injection. About 1 hour later heart palpitations began. I checked my BP and the systolic was 170. My normal reading is 130 systolic. I took one of my wife Lisinopril / hctz and that helped.  Symptoms lasted about 10 to 12 hours and the next morning , I felt better and BP has been within normal range since.
71 y.o. female with a history of HTN, HLD, DMII, CVA, mild intermittent asthma, hyperactive bladder, GERD who recently tested + for COVID 19 w/o any pulmonary sx's p/w confusion and found to have + UA w/o dysuria/hematuria.  COVID 19 PNA, no pulm sx's. 11/29/21 ID physician's note: "Monoclonal Ab infusion: REGN-COV x1 given pt's age/comorbidities and high risk of progression   Discussed with patient re: investigational use of casirivimab/imdevimab, explained the rationale of blocking SARS-CoV2 at the onset of disease and the benefits observed with less progression of disease and need for hospitalization; also explained the risk of infusion allergic reactions and the need for monitoring. Pt agreed to proceed"
About 1 hour after vac. was administered child broke out in a rash and face and eyes got swollen. Pt was given a shot of Benadryl and Epinephrine for allergy.
Developed acute appendicitis on 2/1/2022 requiring appendectomy on 2/2/2022
Vestibular migraines lasting several days, rare chest tightness, muscle weakness, dehydration, alternating chills and fever at night without changes to sleep arrangements
I did have reaction that wasn''t so pleasant; make me little concern; It was more extreme than panic attack; I couldn''t for a second bare what I looked out; when I looked basically all I thought was white.; I felt sick; where I was gonna throw up twice; and then I thought I was  gonna passed out and faint.; This is a spontaneous report from a contactable consumer (patient) reported for herself that.   A 31-years-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: 30155BA; Expiration Date: 31Dec2021), via an unspecified route of administration, administered in right deltoid on an unspecified date (at the age of 31-years) as dose 1, single for covid-19 immunization. The patient medical history included Psoriatic arthritis. The patient's concomitant medications were not reported. On an unspecified date after vaccination, the patient stated that she had a reaction that was not so pleasant and did make her little concerned. The patient also stated that was more extreme than panic attack and she could not for a second bare what she looked out and when she looked basically all she thought was white. The patient also felt sick, was going to throw up twice and also was then going to pass out and faint. The patient queried if that happened to anyone else and why was that happening to her. Also stated that seeing white for a good two minutes had cured and was enquiring whether she had to visit emergency room as she was feeling fine that time. The patient had not received any treatment for the events. The outcome of the events was recovered on an unspecified date at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient vaccinated with Janssen vaccine on 03/29/2021 Covid + on 09/19/2021 and hospitalized Per ED Note: Patient is a pleasant 77year old male presented today to emergency department for evaluation of shortness of breath.  He has been feeling this way for the past 2 days.  He does admit to fevers and cough at home.  He took Tylenol prior to coming in.  Patient denies any chest pain, abdominal pain, vomiting, focal paresthesias or weakness, headache, change in bowel or bladder habits, dizziness, leg pain or edema or history of blood clots, or changes in medications. He denies any other modifying precipitating or relieving factors.
Spouse called to report vomiting, the patient had told her he had fainted, and hit his head.
On 7-18, 5 days after vaccination, I started noticing shortness of breath. On 7-19 I started having a cough and sneezing. On 7-20, I went to the PA and they tested me for flu, RSV, Covid19. He also ordered albuterol inhaler and dexamethasone. 7-21, I noticed significantly less endurance. On 7-23, the flu and rsv tests came back negative. I went back to see the PA on 7-26 and he had me retested for Covid19 due to the first one not being done correctly and he also had to re-presribe the medications because they did not go thru for some reason. I found out thru my health portal at the PAs office that my Covid19 test was negative. I am starting the dexamethasone today, 7-28-2022. I am feeling fair today with still a lingering cough, slight chest congestion and fatigue.
no adverse advent recorded patient was given booster shot, patient had already received 2 other injections 2/23/21 and 3/23/21
This spontaneous report was received from a 73 year old female patient concerning to herself. The patient's medical history was reported as none. The patient's concomitant medications included losartan(manufacturer unknown), levothyroxine (manufacturer unknown), ZETIA and SYMBICORT. The patient drug reactions/allergies were reported as side effects to drugs. On 17-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 injection for prophylaxis (route, lot# and expiration date were not provided). On 17-NOV-2017 in the night, the patient had her right arm red, swollen and painful and she stated that it "looked like cellulitis". On 18-NOV-2017, the patient was seen at an unspecified urgency care facility and was prescribed with MEDROL PACK. After the MEDROL PACK was finished the patient "started with the joints and muscles". In November 2017, the patient's right jaw got stiff and everything tightened behind the right ankle also, the patient's right ear, right knee and little finger on the right hand were sore. The patient is still in pain and the little finger is still bent over. The patient visited her physician and was on NAPROSYN 500 mg twice daily, that helped with the pain. The patient saw little improvement and she is walking a little better. The reporter did not assess the relatedness between PNEUMOVAX 23 and the adverse events. Upon internal review, the cellulitis was considered to be medically significant.
Soreness in my shoulder; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Soreness in my shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Stent placement. Concurrent medical conditions included Hypercholesterolemia. Concomitant products included ATORVASTATIN for Hypercholesterolemia, CLOPIDOGREL for Stent placement, LISINOPRIL and METOPROLOL for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ARTHRALGIA (Soreness in my shoulder). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency and MENTHOL, METHYL SALICYLATE (ARTHRITIS HOT) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Soreness in my shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-211636 (Patient Link).
This spontaneous report was received from a Medical Assistant referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. It was reported that, GARDASIL 9, was stored to a temperature of 1 °C for 12 hours. Data logger was involved. Furthermore, it was reported that no adverse effects occurred and that no product quality issue was involved. Additional information has been requested. Sender's Comments: US-009507513-1705USA002381: US-009507513-1705USA002380: US-009507513-1705USA001712: US-009507513-1705USA002382: US-009507513-1705USA002384.
Developed fever on march 23, 2022- the day following chemo treatment. Developed cough and headaches over the following week. Admitted to hospital on 3/30/22 with pneumonia and positive for COVID. Treatment in hospital for pneumonia.
Patient contracted COVID after being fully vaccinated.  No Booster Cough, Headache, sweats, congestion, loss of taste and loss of smell.
Patient?s friend called for assistance. Upon the nurses arrival, patient noted slouched backward unconsciously on chair. Ammonia immediately placed under patients nose, bilateral legs elevated on chair. Patient noted urinating on herself prior to regaining consciousness. Paramedics immediately called to the scene and took patient to the ambulance for further evaluation and work up. .
Patient can not raise her arm since her flu shot. This started right after the shot was given. Her arm is very sore still a month later. We recommended she see her doctor.
3/7/2017 patient came to the pharmacy and said that week after his flu shot he got tennis elbow.
At about 12 hours from injection I started to get the chills and then high fever. Took an aspirin to reduce it. Felt tired and run down for the next 36 hours. Soreness of arm for about 3 days.
High blood sugar: 216 Vasovagal syncope: heart rate dropped to 40, bp 70/30
heart pounding; Dull headache; very elevated Blood pressure,Blood pressure of 165/130which is very abnormal; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart pounding), HEADACHE (Dull headache) and BLOOD PRESSURE ABNORMAL (very elevated Blood pressure,Blood pressure of 165/130which is very abnormal) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028O20A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included HYDROCHLOROTHIAZIDE, ATORVASTATIN, SERTRALINE, LORAZEPAM (ATIVAN), FLAXSEED, LORAZEPAM and ESZOPICLONE (LUNESTA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PALPITATIONS (heart pounding), HEADACHE (Dull headache) and BLOOD PRESSURE ABNORMAL (very elevated Blood pressure,Blood pressure of 165/130which is very abnormal). At the time of the report, PALPITATIONS (heart pounding) and HEADACHE (Dull headache) outcome was unknown and BLOOD PRESSURE ABNORMAL (very elevated Blood pressure,Blood pressure of 165/130which is very abnormal) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: abnormal (abnormal) 165/130.         This case was linked to US-MODERNATX, INC.-MOD-2021-090634 (E2B Linked Report). This case was linked to MOD-2021-090634 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090634:Dose 1
I tested positive for COVID-19 on 01/05/2023 after traveling. My throat was getting scratchy before coming home. I came home and wore my mask. My sister had called me and she noted she tested positive, and my husband tested positive later that evening. I had a sore throat, congestion, and coughing. I called my doctor right away on the 01/05/2023, and I spoke to someone right away. I took PAXLOVID and I went out of the house the following Wednesday 01/11/2023. I tested negative that Tuesday before 01/10/2023 and that Friday 01/13/2023.
Information has been received from a physician concerning a 2 month old male who was vaccinated with an oral 2 ml first dose of Rotateq.  Subsequently, "7 days after administration." the patient experienced diarrhea.  The patient visited the physician and an unspecified test was done and the results were negative for rotavirus.  It was reported that the patient recovered.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Severe vomiting for several hours and a headache/light sensitivity.  Also irritation/rash at the site
patient came to the  Clinic today to get her first dose of Pfizer.  Within 5 minutes of receiving the vaccine she became light headed and dizzy.  She did have a syncopal episode.  We laid her on the floor, elevated her feet and she recovered quickly.  She stayed another 30 minutes and left without any further problems or residual effects.  Pt was instructed to f/u with PCP if any symptoms returned or if she had further questions.  She also was instrtucted to let the vaccinator know at her 2nd dose of her response with the first dose so we can watch her closely.  Please don't hesitate to let me know if you have any questions
Client ran a fever of 101.6 Sunday November 11th then he had a seizure.
This spontaneous report was received from other health professional (licensed practical nurse) and refers to a unspecified multiple patients of unknown demographics. There was no information on patient's medical history, concurrent condition, concomitant medication and drug allergies/reactions.  On an unknown date, unspecified multiple patients were vaccinated with improperly stored GARDASIL 9 (dose, frequency, lot#, expiration date and indication not provided). No adverse effects were reported. The vaccine was stored at temperature of 0.3 degree Celsius for 6 hours. Data logger was involved. There was no previous temperature excursions. No additional information provided. No product quality complaint was involved. No further information provided. This case has been linked with the 1709USA004997, 1709USA004998 and 1709USA004999 as same reporter link. Sender's Comments: US-009507513-1709USA004998: US-009507513-1709USA004999: US-009507513-1709USA004997.
This spontaneous report was received from a physician assistant via a company representative concerning an unspecified adult female patients greater than 26 years old (specific ages were not provided). Patient's concurrent conditions and medical history were not provided. On an unknown date, the patients who are greater than 26 years of age were vaccinated with GARDASIL 9 (dose, route, frequency, Lot No. and expiration date not provided). There was no concomitant medication described. No adverse symptoms were reported. This is one of two reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 54 year old female patient with no pertinent medical history and no drug reactions/allergies. On 30-SEP-2013 the patient was vaccinated with 0.65 milliliter (ml) a dose of ZOSTAVAX (lot # J002865, expiration date 07-JUN-2014) subcutaneously. No concomitant medications were reported. On 06-OCT-2013, the patient developed rash on her legs and high blood sugar on an unknown date in 2013 after receiving a dose of ZOSTAVAX. The patient also received a cortisone injection (unknown name and location) on the same day and stayed for one night due to high blood sugar level. She recovered from high blood sugar on an unknown date in 2013 but she still had rash on her legs. Patient sought medical attention for the event went to hospital. It was unspecified whether laboratory diagnostic studies were performed. Additional information has been requested.
Sinus pressure; headache; Nausea; Sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (Sinus pressure), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), HEADACHE (headache) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Sulfa), Blood pressure high, High cholesterol and Hypothyroidism. Concomitant products included LISINOPRIL, ATORVASTATIN and LEVOTHYROXINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2022, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). On 12-Apr-2022, the patient experienced HEADACHE (headache) and NAUSEA (Nausea). On 13-Apr-2022, the patient experienced PARANASAL SINUS DISCOMFORT (Sinus pressure). On 12-Apr-2022, PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache) had resolved. On 13-Apr-2022, PYREXIA (Fever) had resolved. At the time of the report, PARANASAL SINUS DISCOMFORT (Sinus pressure) and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment details were provided  Patient had headache started on 12/04/2022 at 02.00 am and lasted for 4 hours. Patient symptoms lasted approx 30 hours.   This case was linked to MOD-2022-541582, MOD-2022-541581, MOD-2022-538599 (Patient Link).