chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling, redness, very firm and painful,  from  left shoulder to just above elbow. On day 4 still having these symptom.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: ew0171), in left arm, on 18May2021 as dose 2, single (Lot number: ew0173), in left arm and on 05Jan2022 as dose 3 (booster), single (Lot number: 33036BD), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested on day 4 night, negative; Positive, notes: Tested on day 6 night, positive; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid from 05Sep2022 to 10Sep2022. Patient did not receive other medication in 2 weeks.   No follow-up attempts are possible. No further information is expected.
Patient describes that the vaccination make her "doozy" and achy and sleeping problem on the site of injection. Also, a large red spot on the deltoid area where the injection is place.
Body aches; chills and shivering at night but no fever; Dizziness; Back and neck muscle spasms; Back and neck muscle spasms; Sleeplessness and nightmares; Sleeplessness and nightmares; Sexual arousal at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 09:30 (Lot number: 32030bd) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose lot number: fc3182, prev dose vaccine location: Left Arm), administration date: Sep2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 01Nov2021 23:30, outcome "unknown", described as "Body aches"; CHILLS (non-serious) with onset 01Nov2021 23:30, outcome "unknown", described as "chills and shivering at night but no fever"; DIZZINESS (non-serious) with onset 01Nov2021 23:30, outcome "unknown", described as "Dizziness"; MUSCLE SPASMS (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 01Nov2021 23:30, outcome "unknown" and all described as "Back and neck muscle spasms"; INSOMNIA (non-serious), NIGHTMARE (non-serious) all with onset 01Nov2021 23:30, outcome "unknown" and all described as "Sleeplessness and nightmares"; DISTURBANCE IN SEXUAL AROUSAL (non-serious) with onset 01Nov2021 23:30, outcome "unknown", described as "Sexual arousal at night". Therapeutic measures were not taken as a result of pain, chills, dizziness, muscle spasms, musculoskeletal discomfort, insomnia, nightmare, disturbance in sexual arousal.  Additional information: Adverse event: Body aches, chills and shivering at night but no fever.Dizziness.Back and neck muscle spasms. Sleeplessness and nightmares Sexual arousal at night. Patient did not receive any other vaccine within four weeks. Patient did not test prior to COVID vaccination and post vaccination.  Follow-up attempts are completed. No further information is expected.
01/07/2021 8:30PM-1st chills- Uncontrollable shaking for 2-3 hours.(felt like I was running a marathon in bed) Temp 99.5 9:30PM-Temp of 101 then it went to 102 within an hour. Headache. 10:30 took Tylenol 11:30 Temp 101.5  stopped shaking but still have a temp and muscle aches- probably from the shaking. 12:30 (01/08/2021) Temp 101. Fell asleep 4:30 Temp 100 8:30 Temp 99.5 Still have a headache and muscle pain, and upper back pain Tired, but probably just from roller coaster ride.  01/08/2021 Most of the day and night had low grade fever 99.5-100.7 , headache and sweats 01/09/2021 No Fever, but still have the occasional seats and dizziness
p/24 hrs, pt began to run fever-went up to 103; began vomiting & skin rash appeared & sore throat; MD visit; stated rxn to DTP vax;
Sixth nerve palsy at right eye; Double vision/ CAT scan at ER/ admitted to hospital/ MRI and other tests; Could not drive or work/hard to do anything; This case was reported by a consumer and described the occurrence of vith nerve palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced vith nerve palsy (serious criteria hospitalization and GSK medically significant), double vision (serious criteria hospitalization) and activities of daily living impaired. On an unknown date, the outcome of the vith nerve palsy, double vision and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the vith nerve palsy, double vision and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK receipt date: 15-AUG-2022 Reporter's comment: It was reported that the patient wanted to inform about an adverse event after receiving the Shingrix vaccine.  The patient stated that approximately 4 to 5 weeks after the Shingrix vaccine, the patient started getting double vision. The double vision got worse until the patient could not drive or work. The patient went to an Eye doctor two weeks ago who told that the patient needs to go to the Emergency Room. The patient received a CAT scan at the ER and was then admitted to the hospital to get an MRI and many other tests. The patient stated that the diagnosis was Sixth Nerve Palsy at right eye and at the time of reporting, it had still not corrected itself and the patient cannot work or drive. The patient stated that the double vision persists and makes it hard to do anything without covering one eye. The patient stated that after doing some research, the patient had found that there had been other reports of Six Nerve Palsy after the old 1 dose Shingles vaccine, but the patient could not find anything about Shingrix. The patient requested let him/her know of any other reports of Sixth Nerve Palsy after the Shingrix vaccine. The patient had also reported this to the Vaccine Adverse Event Reporting System.
Headache, Myalgia, Fever & NauseaVomiting Narrative:  Fever, body ache, chills, fatigue, headache, Nausea and vomiting
Fever for one week (7 days) 100.5 with Tylenol-highest was 102.6 with Tylenol and Motrin. Rash for 10 days - saw private MD.
Injection administered 10-17-08, on 10-23-08 pt seen by PA-C for wide spread hives on palms and soles. Tenderness to area of injection, no swelling or signs of infection. Pt seen on 2-17-09 injection site still painful.
fever of 103 degrees with chills, uncontrollable shaking, vomiting beginning  around 8:00 PM, Tylenol did not reduce fever, went to ER and was admitted post chest x-ray, CT scan, dopplers. While admitted was treated for adverse reaction and pneumonitis diagnosed in ER. Treatment included iv fluids, iv antibiotics (Rocephin), magnesia, potassium, anti-nausea mediation, breathing treatments, Lovenox injections, blood draws for labs multiple times per day.
LEFT arm extremely sore day after. Unable to lift arm at all. Shots Wednesday and by FRIDAY it was swollen , tight, hot, and red on a majority of her upper arm well beyond the injection site.  Around SIX inches long and THREE inches wide.
Skin rash, swelling, warm to the touch. Monday morning when I lifted my arm it hurt- felt like it was bruised. Dr. administered a Benadryl injection in left buttocks. She drew the outline of the area. The next day the rash had spread outside the lines. Took 2 Benadryl over the counter tablets and today it has spread more.
Child diagnosed with intussusception as per ultrasound. Child was sent to hospital. The intussusception spontaneously improved without the need for enema.
Administration Error.  Nursing giving injection inserted need too high on my arm, just below my acromnion process. No immediate symptoms. Night of injection began to experience decreased range of motion and difficulty lifting arm and pain with movement of arm.
11/16/22 presents to ED for "GI Bleeding". PMHx of "A. Fib , prostate cancer s/p radiation, COPD on 2 L, hypothyroid, CHF"
This spontaneous report was received from a physician via Company Representative concerning a 19 year old female patient. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (route, lot # and expiration date not reported). The physician stated that recently the patient saw an unspecified physician on an unspecified date that diagnosed her with multiple sclerosis. This unspecified physician stated that the 19 year old patient had had multiple sclerosis for about 5 years, and that time frame correlated to the multiple sclerosis beginning on an unspecified date about a month after the second dose of GARDASIL was administered. Patient's outcome was unknown. This is one of two reports concerning the same source (MARRS # 1311USA009193). Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 10-DEC-2012 was vaccinated with an improperly stored PROQUAD (dose and route unknown, Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Vaccine administration error: incorrect vaccine given for age.  Patient should have received DTaP, but instead received Tdap. No adverse effects reported.
I was just tired, I think my legs ached and heart racing. My head also felt dizzy. I also had swelling and pain and a headache. After the 3rd shot, the heart palpitations became concerning. I had an EKG and sonogram performed and wore a heart monitor for 7 days.
I am having chest pain on the right side; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I am having chest pain on the right side) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (I am having chest pain on the right side). At the time of the report, CHEST PAIN (I am having chest pain on the right side) had not resolved.            No concomitant medications were reported. No treatment details were reported.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 10-JUN-2014, the patient was vaccinated with an improperly stored dose of GARDASIL, lot # J009788 with expiration date of 17-MAR-2016 (strength, dose and route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the reported temperature excursion lasted 40 hours, where the lowest recorded temperature was 32 F (0 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several reports received from the same source. Additional information has been requested.
Onset 10/29/15 to current. Left arm pain, muscle weakness, OTC ibuprofen, ice,  topical BENGAY. Prescribed TYLENOL #3 for severe pain.
Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no medical history and no drug reactions/allergies who on 25-FEB-2011 was intramuscularly vaccinated with the first dose of GARDASIL and on an unknown date was intramuscularly vaccinated with the second 0.5 mg dose of GARDASIL (lot # 667930/1561Z, expiration unspecified). The reporter stated that the patient came in to receive influenza virus vaccine (unspecified) and her second dose of GARDASIL and reported her period being two days late on 02-MAY-2011. Nurse gave both vaccines, but another nurse felt the patient's report of her "period being two days late was normal" warranted confirmation, administered a pregnancy test. The post-vaccine pregnancy test was positive. No treatment was given for adverse events. The patient did not seek medical attention. The patient's date of last menstrual period and the estimated delivery date were unknown. Additional information is not expected.
TOOK VIVOTIF EVERY DAY; This spontaneous case report (PVX2019-2964) was received from a nurse on 03-Dec-2019. It described a male consumer who "took Vivotif every day" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took all four doses of Vivotif on every day instead of every other day. The doses were taken on 23-Oct-2019, 24-Oct-2019, 25-Oct-2019, and 26-Oct-2019.  The action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of reported event was unknown.  Company Comment: A consumer took one dose of Vivotif every day for four days instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took one dose of Vivotif every day for four days instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Pt presented to ER on 1/22/11 complaining of numbness L side face and blurred vision L eye x3 days. Pt was diagnosed with Bell's Palsy and treated with lacrilube eye ointment only.
High fever (measured at 39.4 C) and violent shaking and chills from 10 pm to 4 am, alleviated with multiple doses of Benadryl PO and Tylenol, total of 2.5 g in about 6 hours. Symptoms improved after breaking of fever at around 4-5 AM.
Nurse gave pt 2 doses of Janssen vaccine in the smae arm using a 1" needle, then a 1.5" needle.  Nurse was removed immediately & counseled.    No known adverse reactions noted.
Information has been received from a licensed practical nurse through the Merck pregnancy concerning a female patient with latex allergy and a history of bipolar disorder who on 29-MAY-2007, was vaccinated IM with a first 0.5 ml dose of Gardasil (Lot# 655324/0089U). Concomitant therapy included lamotrigine (LAMICTAL), valacyclovir HCl (VALTREX), aripiprazole (ABILIFY), vitamins (unspecified), garlic extract (+) omega-3 marine triglycerides (+) vitamin E (OPTIMUM OMEGA), calcium (unspecified), ascorbic acid and pyridoxine. Subsequently, the nurse reported that the patient had a positive pregnancy test and will be terminating her pregnancy. Follow up information stated that the patient terminated her pregnancy on 29-JUN-2007. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, terminated her pregnancy was considered to be an other important medical event. Additional information has been requested.
Information has been received from a health professional concerning a 22 year old black female who on 12/27/00 was vaccinated with a first dose of Varivax. On 01/06/01,the patient experienced a "few lesions" which resolved by 01/29/01. It was indicated that the patient presented to the doctor on 02/16/01 with '5 lessions on her forearms" which had started 02/10/01 0r 02/11/01. FOLLOW-UP infromation has been received from a health care professional who reported that on 01/19/01 (previously reported as 01/06/01) the patient developed discrete scattered papules. It was noted that the papules resolved and then reappeared one month later. A reactive RPR and FTA were performed,but the results werenot provided. The patient recovered. No further information is expected.
vial was reconstituted incorrectly.  Only .8mL was mixed with the powder
I had my vaccination on 12/27/2022. On 01/30/2023 I started to experience a scratchy throat and mild body aches. I tested COVID-19 positive on 01/31/2023. I went to urgent care on 02/01/2023 in which I had a second COVID-19 positive test. They prescribed PAXLOVID. I am presently feeling good on 02/08/2023.
Back pain, Dizziness, Headache, Arm pain from elbow to shoulder.
Headache, fever 102, nausea, severe muscle and joint pain, full body rash , chills
SLIGHT HEADACHE; SORE ARM AT SITE OF INJECTION; CRAWLING SENSATION; COLD; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 19/MAY/2021) dose was not reported, administered on 06-MAR-2021 13:15 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced crawling sensation. On 06-MAR-2021, the subject experienced cold. On 06-MAR-2021, the subject experienced sore arm at site of injection. On 07-MAR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crawling sensation, and cold on 07-MAR-2021, slight headache on 08-MAR-2021, and sore arm at site of injection on MAR-2021. This report was non-serious.
erythematous, well circumscribed macular lesions w/edema underlying some confluent areas on chest, lower extremities;
Soreness in the arm more than any other vaccine in the past; This is a spontaneous report from a contactable Other Health Professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, via an unspecified route of administration in the left arm, first dose on 19Dec2020 14:15 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant. She had not had other vaccines within four weeks prior to vaccine  and she had no other medications in 2 weeks. Adverse event reported was soreness in the arm more than any other vaccine in the past. The onset was on 20Dec2020 with outcome of recovered in Dec2020. She took an over the counter ADVIL. She did not have covid prior vaccination nor had she tested post vaccination. The event was reported as non-serious.
SWELLING AND PAIN FROM INJECTION TO ELBOW, WARM TO TOUCH. SAW DR WHO RECOMMENDED APPLYING ICE AND USING OTC PAIN RELIEVERS FOR SYMPTOMS.
6/9/16 (3 days after vaccine) - hives starting head and trunk. Next day started to clear on trunk and break out on arms and legs. No wheeze. No fever. Was treated immediately with BENADRYL 50mg and Prednisone 20 mg and several times after.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The nurse reported that on unspecified dates the patients received improperly stored RECOMBIVAX HB (Lot# reported as K0177321, 0.5ml/once) intramuscularly. No adverse effects were reported. This is one of two reports received from the same reporter (other linked MARRS # 1505USA000525). Additional information has been requested.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV vaccine. Subsequently, following vaccination, the patient fainted.  The patient fully recovered.  No further details were provided.  Additional information has been requested. This is in follow-up to report (s) submitted on 2/14/2007.  No futher information is available.
This spontaneous report as received from a medical assistant refers to a 65 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L018503, expiration date: 16-MAR-2017) (dose and route of administration were not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
About 4 hours after the shot (on Monday), I developed pain in my left leg--particularly the left buttock and left shin. The pain rapidly became worse. Walking became quite difficult.  Tuesday, I received a steroid injection from my doctor. The pain got slightly better over the next few days. Saturday, I started a course of oral steroids: 20mg prednisone, three times per day. Symptoms have been improving significantly, although as of today (Tuesday) there is still some pain.  The pain was specific to my leg. I didn't get any other aches.
0.25ml booster administered as first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (0.25ml booster administered as first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 28-Dec-2021, the patient experienced INCORRECT DOSE ADMINISTERED (0.25ml booster administered as first dose). On 28-Dec-2021, INCORRECT DOSE ADMINISTERED (0.25ml booster administered as first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
Approximately 30 minutes after receiving vaccine patient's eyes became red (appeared as if she had been crying). She complained of being dizzy and cold. No trouble breathing. Referred to instore clinic - vitals: BP: 98/60, HR: 55, regular, O2 sat 96% on room air, BS. 103 clear breath sounds. Increasing confusion paramedics arrived due to acutely altered mental state given BENADRYL at hospital.
Client came to my pharmacy 14 days after flu shot was given and stated he was experiencing a rash on his left side of neck and left arm. Same arm shot given.
THE PATIENT CALLED THE PHARMACY 2 DAYS AFTER ADMINISTRATION AND REPORTED A 3 INCH AREA OF RASH AROUND THE INJECTION SITE, EXPANDING ABOUT 1 INCH ABOVE AND THE REST BELOW. THE PATIENT DID NOT REPORT PAIN OR ITCHING AT THE TIME, BUT SAID IT WAKES HER UP AT NIGHT WHEN ROLLING ON IT. SHE ALSO STATED THAT IT WAS WARM TO THE TOUCH. THE PATIENT WAS RECOMMENDED TO BE SEEN BY A HEALTH CARE PROVIDER AS SOON AS POSSIBLE, AND WOULD MOST LIKELY 1-19-19 DUE TO A SNOW STORM. USE OF ANTIHISTAMINES, COLD COMPRESS AND OTC ANALGESICS WERE DISCUSSED FOR SYMPTOM MANAGEMENT MEANWHILE.