chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the flu; i don't feel good; Initial information received on 24-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/Non-HCP.  This case involves a 80 years old and unknown gender patient who got the flu and i don't feel good after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient who got the flu (influenza) and i don't feel good (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (got the flu, i don't feel good).  At time of reporting, the outcome was Unknown for the events.
Pt received shots at about 11:45am on Friday. By Friday evening at 9pm the child spiked a high fever and lost consciousness for 7-8 minutes. 911 was called and the pt was transported to hospital, where he was admitted and spent one day in the hospital for further observation and fever reduction.
Information was received on 07-APR-2017 from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 06-APR-2017 the patient was vaccinated with ZOSTAVAX (lot number and expiration not reported), subcutaneous for prophylaxis in the hip instead of the arm. The patient had no adverse effects. No additional information was provided. Additional information has been requested.
Patient received vaccines and later the next day broke out in a big rash that later became petechiae. Had several days hospitalization. Patient had severe swelling in legs and arms and was unable to walk for several days. 06/05-07-records received from facility for DOS 12/20/06-ER visit-DX allergic reaction-purpura. edema. Previously seen on 12/6/06 one day after vaccine with purpura and swelling, presents on 12/20/06 with continued swelling and purpura on legs. Treated with benadrl and oraped. Mother states swelling has returned. Patient scratches at rash. No fever, vomiting, diarrhea, change in activity, eating well.  PE: extremities non-tender no effusions no edema, skin has edema non-pitting. Number of areas of papules and purpura on arms legs and face. Torso not involved
NUMBNESS IN BOTH LEGS; LEGS CRUMBLED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-APR-2021, the subject experienced numbness in both legs. On 24-APR-2021, the subject experienced legs crumbled.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in both legs, and the outcome of legs crumbled was not reported. This report was non-serious.
PATIENT EXPERIENCED URTICARIA AND SWELLING OF THE LIPS AND THROAT FROM PREVIOUS PFIZER VACCINATION, FOR 6/23/22 PFIZER DOSE, PATIENT PRE-TREATED HERSELF WITH 25MG BENADRYL AT 10:20AM, RECEIVED PFIZER AT 10:25AM, EXPERIENCED TINGLING LIPS AT 10:40AM, AGENT PROVIDED 50 MG BENADRYL LIQUID (20ML) AT 10:45AM, PATIENT EXPRESSED RELEIF FROM TINGLING LIPS AT 10:55AM. BENADRYL WAS CHOSEN D/T PREVIOUS SUCCESSFUL RESPONSE IN PREVIOUS EPISODES. EPIPEN WAS AVOIDED, UNLIKE PREVIOUS EPISODE; PATIENT WAS RELEASED TO HER MOTHER TO DRIVE HER. WE WILL FOLLOW UP WITH THE PATIENT TONIGHT AND TOMORROW
joint effusion/knee filled back up with fluid again; severe right knee pain; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (non-pregnant) received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ3249), intramuscular, administered in the right arm, on 21Jan2021 16:00 (at the age of 40-years) as single dose for COVID-19 immunisation. The patient was vaccinated at the workplace clinic. Medical history included arthritis, insomnia, Lyme disease, and chronic dry eye. The patien has no known allergies. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the vaccination. The patient had no other vaccine in four weeks but had other vaccine in two weeks. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), intramuscular, administered in the right arm, on 30Dec2020 11:30 (at the age of 40-years) for COVID-19 immunisation. 48 hours after her second Pfizer COVID vaccine, on 23Jan2021 at 04:00 PM, she woke up with severe right knee pain. She had to lift her leg off the bed. Three days later, she had it looked at by an orthopedic PA and was told that she had a joint effusion and if it doesn't get better to come back in 2 weeks. After 2 weeks, she then had to get a joint aspiration and they pulled out 36 ml's out of her right knee. Her knee didn't get better after that, so an MRI was done (on unspecified date in 2021), and it showed that her knee filled back up with fluid again. She is now being referred to (institution name) for a recurrent joint effusions s/p Pfizer COVID vaccine. She will have to fly for that appointment. Prior to vaccine, she didn't fall or have any trauma to her knee. The patient was tested for COVID via nasal swab post vaccination, had negative results on 12Jan2021, 17Jan2021, 26Jan2021, and 09Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. Treatments received were knee arthrocentesis and PRP injection. The outcome of the events was not recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. No historical or concurrent conditions were reported. On an unknown date, an unspecified number of patients received vaccination dose with improperly stored MMR II (lot # L020188, expiry: 30-JUN-2017); (lot# L012480, expiry: 10-APR-2017). The reporter reported a temperature excursion for the product. There was high temperature excursion at 9.5 degrees Celsius for a time frame of 31 minutes and low temperature excursion at 0.5 degrees Celsius for a time frame a 20 hours and 45 minutes. There was no previous temperature excursion. No concomitant medications were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was reported. This is one of several reports received from the same reporter (MARRS# 1602US007729). Additional information has been requested.
on Oct 15th 2021 had facial numbness and left hand numbness.  Increase to mouth numbness and memory difficulty.  Went to primary care Dr. on Oct 19 no testing completed.  Oct 20th 2021 my son had to call EMS for stroke symptoms, slurred speech, droopy gave, difficulty walk standing, cognitive difficulty.  Went to hospital and found to have had Rt MCA stroke.  The had worsening stroke with secondary stroke and received a thrombectomy to my on 10/20/2021.
Right arm swollen, tender, decreased movement secondary to pain. No redness, no warmth, no decreased sensation, NL radial and ulnar pulse, no discolor. Tx: ice, elevation x1 day, then movement.
Patient inadvertently received 0.5 ml dose of Moderna vaccine instead of a booster dose of 0.25 ml.  No adverse reactions noted. Per CDC no need to repeat the dose.
Information has been received from a health professional concerning a 7 year old male who on 12/10/1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck)(lot#622680/0086E).  Subsequently in February 2004, the patient experienced breakthrough chickenpox.  It was reported that there was a total of 45 cases of breakthrough in the patient's school, including the patient, and 17 were vaccine recipients.  Unspecified medical attention was sought.  There was no product quality complaint involved.  The reporter indicated that 16 other patients had similar experiences following exposure to varicella virus vaccine live (Oka/Merck).  Additional information has been requested.
Patient arrived, stated that they were here for their 2nd Moderna dose, and presented a vaccination card that had 9-9-2021 recorded as their recommended second dose date. The patient signed the consent forms, received the 2nd Moderna dose from myself, waited 15 minutes with no adverse side effects, and departed. After the patient departed, while it was identified that the patient was in fact 1 week early for their second dose and the recommended second dose date on their vaccination card was incorrect. The ordering provider, was notified along with the management team. Reports were filed per clinic procedures and Dr. notified the patient of the adverse event.
I experienced my muscles in my throat not wanting to work to where I could not swallow, body aches, nausea, loss of taste/smell, fever, headache, rash and runny nose.
reports rash/hives off and on since vaccine. Hives worse since 11/02/21.
On August 3, 2021 - I awoke feeling light headed and dizzy. I felt very agitated. The agitation would not subside. I went and had breakfast and got ready for work. By 10:00 am I decided it was not usual for me. I had pain in the upper right arm and my hand was numb. I went to the ER to report the symptoms. Several tests were done. Blood clot in my upper right arm - on that same day 8-3. I had never had a blood clot before. I had never high blood pressure before. It was bouncing over150/and over 90 for the bottom number. I usually have low blood pressure. I felt it. They gave me baby aspirin and oral blood thinners. They asked me to return to another office when they realized it was not heart attack. I had follow up appt with doctor at 8/6/2021 - I was given Xarelto 20 mg twice a day and Lisinopril  (20 mg) with Hydrochlorothiazide  - 12.5 mg - one tablet a day. 14 days later, Prescription was changed. Reduced Xarelto to 15 mg and once a day; and kept the Lisinopril the same. I am still taking these now. Low salt; low carb (DASH) diet; drink water every day. I am going to the restroom a lot. I was feeling better this week, I was watching the Dodger game and I could feel additional pains on my right breast and my blood pressure went up 159/80 and then it would drop to 135 with exercise a lot of water a lot of rest. I am restricted from driving distance and from travel right now. I am not working anymore. I had to retire due to the stress of my job and this adverse event.
11/20/21 presents to local ED for "worsening dyspnea". PMHx of "Lambert Eaton, hypothyroidism"
1st dose 13Jul2022, no 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 29-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 13th July 2022, batch number 4F3YY, expiration date 1st January 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-FEB-2023 Reporter's comment: The reporter reported that a patient received first dose of Twinrix. The patient did not present back for the second dose until the day of reporting.  At the time of reporting, the second dose was not yet been administered.  The reporter was consented to follow up. VAERS details captured in product tab belongs to 1st dose. Additional Supportive Information: This case has been linked to the case US2023024466 and US2023024465 reported by the same reporter. Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023024466:Same reporter US-GSK-US2023024465:Same reporter
Vaccine got on the nurse who administered vaccine; A spontaneous report was received from a nurse concerning a 58-year-old nurse, who administered the Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine got on the nurse who administered the vaccine.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021, the nurse administered the vaccine to a patient who received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) for prophylaxis of COVID-19 infection.   On 11 Jan 2021, as the nurse was administering the vaccine to a patient, the hub of the syringe came off while in the patient's arm and some of the vaccine got on the nurse.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine got on the nurse who administered vaccine, was resolved on 11 Jan 2021.; Reporter's Comments: This report refers to a case of Accidental exposure to product for COVID -19 vaccine( mRNA-1273), lot # 011L20A. There were no reported AEs associated with this case of Accidental exposure to product COVID -19 vaccine( mRNA-1273).
1/2 hour after getting the vaccine the patient was experiencing reddness, swelling, tenderness in the left leg and irritability. This lasted for 14 days and ranged from the patients left knee cap to the hip. After 1hr the patient had a fever of 102. The fever lasted for two days and were relieved by tylenol. 4 hours later the patient experienced a rash at the sight and had bruising. The patient experienced decreased mobility for 2 days in the left leg.
PFIZER VACCINE WAS MIXED WITH 0.7 STERILE WATER INSTEAD OF NACL PT. GOT 2.5 TIMES THE DOSE. PT HAVING SOME NAUSEA
pt presented to hospital with weakness and falls. positive for COVID 19 virus. treated with O2 PRN and dexamethasone
Information has been received from a registered nurse concerning a 10 week old female patient who on 31-AUG-2009 was vaccinated with first dose of ROTATEQ (lot# not reported) at a wellness clinic. On 31-AUG-2009 within minutes the patient had large amount of emesis. Unspecified medical attention was sought. At the time of this report,  the patient's outcome was unknown. No further information is available.
Initial report received from a  healthcare professional on 02 AUGUST 2013. A 16-year-old male patient had received an intramuscular dose of ADACEL (batch number: C3070AA, expiry date 02/27/2011, dose number was not reported) in the right deltoid, as intramuscular dose of MENACTRA (batch number: U4583AA, expiry date 11/04/2014, dose number was not reported) in the right deltoid and GARDASIL (manufacturer Merck, batch number, dose number, route and site of administration were not reported) all vaccines on an unspecified date. The patient had no known drug allergies. Patient's medical history was not reported. On an unspecified date, one week following vaccination the patient had swelling of hands and fee. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of event was unknown. List of documents held by the sender: none.
Complaint   EMS was called for lift assist post fall, upon arrival pt was SOB, pale, diaphoretic. Pt given duoneb en route. Pt reports he was supposed to get a covid test today. Pt on 10L NRB  History of Present illness Client is a 74yo M w HTN, HLD, OSA on CPAP, prior CVA, and gout, former smoker, who was brought in by EMS s/p fall. Was found pale, diaphoretic, SOB, found to be covid positive, was experiencing 3 day of progressively worsening SOB and cough, weakness, was transferring from his walker to bed and fell. Did not his his head, did not lose consciousness. Has had three days of SOB with minimal exertion, does have some SOB at baseline as pt is deconditioned due to bad L hip, does not use any home O2. Also w cough productive of brown, frothy sputum. no blood in sputum. Pt also endorses 3d of diarrhea 3x/d, nonbloody, nonpainful.   Pt denies any urinary sx, CP, palpitations\, no nausea, vomiting. reports good PO intake.   Recent sick contacts include wife and contractor who was working in his house found to be covid positive. Of note pt has been vaccinated several months ago got both doses of Pfizer vaccine.   In ED, pt on vapotherm 80% FiO2, 40L, sating low 90s. EKG showing sinus brady, CXR w L basilar atelectasis.
Pfizer-BiNTech COVID-19 Vaccine EUA:  dizziness, that started the morning after the vaccine and still lasts for the 2nd day. Nausea on the morning after the vaccine. Headaches off and on.
Pt recvd 3 doses of Engerix-B on 18JUL90, 2AUG90, & 7JAN91 & was found to be a non-responder;
24 hours post-vax the patient developed extreme pain, redness, swelling and a fever in her arm. The area of redness and swelling expanded to 3 inches in diameter and became very hard. ER doctor diagnosis is cellulitis. The patient also has the same type of swelling with extreme sensitivity on her upper thigh. The patient was treated with ibuprofen and Cephalexin. The patient still has pain and black and blue marks on her arm with a lump underneath. The patient still has excessive muscle pains and is now being treated with Motrin.
Pt recv vax on 2/5/99; on same day pt exp local swelling, erythema, pain of arm; limited range of motion
PATIENT WAS GIVEN THE ENTIRE VIAL, WITHOUT DILUTION.  RECEIVED SIX UNDILUTED DOSES.  PROVIDER DISCUSSED ERROR WITH PATIENT MOTHER AND TOLD TO WATCH FOR HEIGHTENED SYMPTOMS AND CALL IMMEDIATELY IF NEEDED
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
I21.4 - Non-ST elevation (NSTEMI) myocardial infarction ABDOMINAL PAIN VOMITING CHEST PAIN
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 2:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 2:50 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 66.72 for dose administered on 02-Mar-2021 and 66.80 for dose administered on 30-Mar-2021. No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature range 27 to 36 degrees Fahrenheit from 09:00 AM to 03:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Vial moved to clinic on 02-Mar-2021. Total doses given for the day was 177.  Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Vial moved to clinic on 30-Mar-2021. Total doses given for the day was 173.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Localized swelling, warmth and pain. Cefdinir-300mg.-2 caps. po daily x 10 days.
Abdominal pain headache and blurred vision  Neusea and body aches loss of appetite and very tired
Opened vial for ipol is to be stored at 2 Celsius to 8 Celsius.  Temperature excursion for this opened vial at 46.9F converted to Celsius is 8.28 Celsius for 30 minutes while the door was opened to store vaccine shipment in fridge unit.  After the temperature excursion the ipol was administered to the patient.
Received Pfizer vaccines on 5/18/21, 6/8/21. Began feeling ill on 7/21/21 w/ cough, sore throat, vomiting, nausea, myalgias, chills, H/A. Tested positive for COVID-19 by PCR on 7/23/21.