chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with Bells Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (diagnosed with Bells Palsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029120A and 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, the patient experienced BELL'S PALSY (diagnosed with Bells Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (diagnosed with Bells Palsy) outcome was unknown.            No concomitant medications provided. No treatment medications provided.  Patient was taken Eliquis before got the Moderna vaccine.  Company comment -This case concerns a  male patient 9Age not provided) with no relevant medical history, who experienced the unexpected event of Bells palsy. The event occurred approximately 7 months 8 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after the second dose.. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a  male patient 9Age not provided) with no relevant medical history, who experienced the unexpected event of Bells palsy. The event occurred approximately 7 months 8 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after the second dose.. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine is not affected by this report.
Mother called 2-13-09 reporting ash of left arm day after HAVRIX injection. By 2-13 rash with itching all over body. Mother did not get child to ER as recommended (At Follow up phone call) and she said rash resolved 2-13-09 completely.
Pt vaccinated with Recombivax HB MD reported pt developed multiple sclerosis following vaccination w/Hepatitis B vaccine (Recombinant). Additional details being requested.
received 2 doses of menveo today on accident; received 2 doses of menveo today on accident; mixed the powder from the 2-vial Menveo formulation with the 1-vial formulation and administered it to a patient; mixed the powder from the 2-vial Menveo formulation with the 1-vial formulation and administered it to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA985A) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number 9C2KP, expiry date 31-DEC-2024) for prophylaxis.   On 04-OCT-2023, the patient received Menveo. On 03-OCT-2023, the patient received Menveo. On 03-OCT-2023, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: mixed the powder from the 2-vial Menveo formulation with the 1-vial formulation and administered it to a patient) and inappropriate dose of vaccine administered (Verbatim: mixed the powder from the 2-vial Menveo formulation with the 1-vial formulation and administered it to a patient). On 04-OCT-2023, the patient experienced accidental overdose (Verbatim: received 2 doses of menveo today on accident) and extra dose administered (Verbatim: received 2 doses of menveo today on accident).  The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, accidental overdose and extra dose administered were unknown.   Additional Information: GSK Receipt date: 03-OCT-2023 and 04-OCT-2023 A HCP states a nurse mixed the powder from the 2-vial Menveo formulation with the 1-vial formulation and administered it to a patient.  The reporter states that he/she had a patient who received 2 doses of menveo today on accident.  The reporter asked are there any adverse effects other than what is listed that he/she need to review with patient since he received a double dose. The patient received 2 doses of menveo today on accident which led to accidental overdose and extra dose administered. Nurse mixed the powder from the 2-vial Menveo formulation with the 1-vial formulation and administered it to a patient which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter consented to follow up.
4 yo female with rash and fever 101.1 axillary at home since 09:00, in office 100.1. Patient also with pain along injection site. Rash erythematous, warmth on (L) thigh.
pt given 2nd series(2006-7) of 3 Hep B vac 6 years after 1st series completed (1999-2000)
Then 101.7 approximately 4-6 hrs after DTaP, Hib, PCV.
Approx 5 cm, round, slightly pink area at injections site. No redness, no swelling, tender to touch. Pt reports he noticed this 8/28/17. Instructed to apply ice and use ibuprofen. Go to Urgent care for any new/worsening symptoms.
Right arm soreness at site. Right arm soreness/pain to right axillary. Right breast & nipple pain.
Some hours after receiving the vaccine, maybe some 4 hours later I experienced a severe headache. Took 1 Advil and in an hour the headache went away. Had also minor pain at the injection site.
Patient was administered their 3rd dose (1st booster) on 3/24/2022 and their 4th dose (2nd booster) on 7/14/2022.  The second booster was 10 days early.  No clinical problems were reported.
MULTIPLE (7 OR 8) SEIZURES; PROBLEMS/ISSUE SWALLOWING; NERVE ISSUE; DIZZY; TROUBLE SEEING/VISION PROBLEMS; TINGLING KNEE/TINGLING LEG; NUMBNESS IN RIGHT LEG; SWOLLEN KNEE; SWOLLEN LEG; This spontaneous report received from a patient concerned a 62 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, and marijuana drug abuse (every once in a while). The patient stated that he had no medical history and was very healthy. Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 206A21A, and expiry: unknown) dose was not reported, 1 total administered in left arm on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAY-2021, few weeks after the vaccination, the patient had numbing in the right leg above his knee that has gone into his foot. The numbness was only in the right leg, in the surface of his leg in the nerves or veins and it swelled and got worse because he's a tennis player. On 23-SEP-2021, the patient experienced multiple (7 or 8) seizures on the tennis court while playing and taken to the emergency room (ER) and was admitted to the hospital. The patient said that, doctors could not pinpoint what was going on but there were suspicions, and they were sure that the numbing in his leg was caused by the vaccine. While admitted he received Magnetic resonance imaging (MRI) scan (NR: not provided) result not reported and they put something on his head to record activity for 24 hours and determine if there were any more seizures to came. On an unspecified date, the patient had experienced dizzy, tingling knee/tingling leg, trouble seeing (vision problems) and problem/issues swallowing where if he drinks something very cold, he would gag. He reported that numbness in his leg was nothing that he had experienced before. He was prescribed with Levetiracetam 1000 milligram (mg) twice daily upon discharge. The patient was hospitalized for 4 days and discharged on 26-SEP-2021. The patient had made appointment with his primary care physician for next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from problems/issue swallowing, and had not recovered from numbness in right leg, nerve issue, dizzy, swollen knee, swollen leg, tingling knee/tingling leg, trouble seeing/vision problems, and multiple (7 or 8) seizures. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210955573-COVID-19 VACCINE AD26.COV2.S- Multiple (7 or 8) seizures. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Suspected vaccination failure; Shingles in the same dermatome where the injection was given; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient was return within 3 months with a case of shingles in the same dermatome where the injection was given. At the time of reporting, the reporter did not have specific patient information. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up. This case has been linked with case US2019AMR208349, reported by the same reporter.
Left deltoid/upper arm with redness and tenderness about the size of a softball. No fever and no other treatment ordered. Dad calling and stating child got HPV and Hep A vaccines on Monday and his arm is swollen now. Dad wondering if they should be worried. Dad calls to report pt got vaccines 2 days ago. The area he got the shots is now red and warm to touch. The red area is about the size of a softball per father. Child is not able to raise arm normally. Appt recommended and dad agrees. Child is at school and father is hoping for something after school. Appt  made for 4pm today with Dr. Father will call back before apt time if area worsens at all.
Very bad headache and extremely sore arm for about 3 days. Nausea, chills, dizziness for 2 days.
Severe pain in arm near injection site. Spread the next day to traps and neck and then down opposite arm. Some sharp pains near uterine area (post menopausal)
pt recv vax in JUN95 & wk & half following vax pt devel varicella-like rashes; No further details were provided;
Started with arm pain. Saturday 1/9/2016, started coughing, sweats, chills weakness loss of voice shortness of breathe. Symptoms persistent to the present.
Developed fever of 104.5F (ax) 24 hours, post vax. Addendum: Child had temperature of 103.3F, post vax, and we gave Motrin, immediately, within 5 minutes.
patient called clinic on 09/10/2021 to report 4 hours after taking the pfizer vaccine she had  "a  heart flutter", and "several days latter " the left side of her temple is started to hurt.  Patient states her temple is tender to touch rates  pain 6/10 on pain scale.  Patient states the temple pain is constant and has not stopped with her trying an ice pack or Tylenol.  Patient made an appointment with a provider for further evaluation.
General malaise and weakness x 3 weeks,  deep chills x 2-3 days, medium headache, loss of appetite, loss of weight, hypotension (BP dropped to 91/40 for several days), temp intermittent up to 100.8,.  .  Prednisone dose pack and Augmentum  seemed to help last week.
Information has been received from a physician and a medical assistant concerning a 20 year old female with no pertinent medical history and no drug reactions/allergies who on 07-APR-2010 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 663694/1316Y, exp 10-NOV-2011). There was no concomitant medication. The patient was empty stomach prior to vaccination. On 07-APR-2010 after vaccination, the patient experienced fainting and jerking. The patient's body shake after she passed out. The patient did not urinate. Earlier that day, the patient got her shot then went out to the waiting room. It was in the waiting room that the patient had the event. The patient went to an ER in a hospital, then returned a few hours later to the office. The patient was seen by a physician. By that time the patient had fully recovered. The physician could not say if the patient had a seizure. There were no lab diagnostics studies performed. At the time of the report, the patient had recovered on 07-APR-2010. No further information is available.
On 7-14-09 pt received varicella and hep. a #1 injection while in the office. In late afternoon on the 14th noted redness, edema, pain, and warm to touch. Ice pack applied with no improvement. On the 15th late afternoon; the s/s worsen with redness & pain level increased and now SOB.  Therefore, pt was seen in ER with Benadryl and pain tx given. On 16th pt seen via PCP with orders to continue Tylenol and Benadryl. s/s improved by 19th.
Breath holding w/ 2nd vax. Spont resp after few sec. Breath holding episode w/ 3rd inject, turned husky-1 hr. No resp approx 3 min. Spont resp started w/ O2. Admit to hosp. Pt suctioned. Discharged & readmit-viral pneumonia. Placed on vent.
Boostrix to the same patient twice on the same day; Boostrix to the same patient twice on the same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Boostrix, Boostrix Pre-Filled Syringe Device, the 1st dose of Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device and not applicable after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced overdose and overdose. On an unknown date, the outcome of the overdose and overdose were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse manager stated that a certified medical assistants gave Boostrix to the same patient twice on the same day, which led to overdose. The reporter stated  that the patient had a twin and therefore the vaccine was administered to the same patient. This happened about 3 weeks ago and the child was fine. No additional patient demographics or vaccine details (lot, exp) available at time of call. The reporter consented to follow up via email.
severe chills, shaking throughout the day.  Severe right arm pain and lethargy ongoing at time of report.
This spontaneous report as received from a health care worker (medical assistant) refers to a 4 month old patient (gender unspecified). On 02-MAY-2014, the patient was vaccinated with second dose of ROTATEQ, 2 ml once, oral, (lot number J011344, expiry date 20-MAY-2015). Healthcare worker stated ROTATEQ had been improperly stored at 1C for an unspecified number of hours. No adverse effects reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 72-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 21-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) Lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. Marrs# 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Received 1st  Moderna COVID 19 vaccine at UH-Parma  Medical Center, as I am an employee of UH -Medina Pediatrics. Received a timer of 15 minutes to stay after injection, when the timer reached 12 minutes...I started having tingling/numbness in Bilateral hands, feet, tongue, heart palpitations, then noticed having  body heaviness, extreme weakness, disoriented, increased heart palpitations, lightheadedness, ringing in bilateral ears-was admitted to the ER where I received IV fluids. I also received Benadryl IV push , quickly after injection of Benadryl had swelling of tongue, severe slurred speech, chest tightness, increased heart palpitations, shortness of breath, groggy-Non responsive, though could hear people around me. Was given IV Epinephrine, which helped recover from the slurred speech and the non-responsiveness, swelling of the tongue was reduced. Still having body heaviness, weakness, tingling/numbness in bilateral hands, feet, tongue, also face/lips,  hard to concentrate/focus, stagger walking. Symptoms worsen as the day goes on with a use of a cane at times.
Primary complaint: chest pain. Patient received 2nd COVID vaccine and had 2 cups of coffee on an empty stomach this morning. Pain in center of chest. Worsens during inspiration. Stays in one spot. Does not move or change. Patient does not work out and no family history of heart issues. Vital signs taken once. Patient refused a 2nd set of vitals. Patient advised to follow-up with primary care in regards to heart issues.
Four days after I felt a sore area on my shoulder. Next morning I had  a rash on my shoulder and down my arm. The worst areas were my shoulder and inside elbow. It was like a burn. Felt and looked like a motorcycle muffler burn I once had. I waited it out and it began to hurt less and itch. After 6 days it is only a pink area where it was broke out.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 211A21A, expiry: unknown) dose was not reported, dose number in series was 01, 01 in total was administered on 24-SEP-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-JAN-2022, the patient experienced dry cough, headache, nausea, light headedness, weird taste and had suspected clinical vaccination failure. On 04-JAN-2022, Laboratory data included: coronavirus disease (COVID-19) virus test (rapid) which was positive. At the time of reporting patient just had dry cough and headache (dose number in series was 01). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority. This case, from the same reporter is linked to 20220112121.; Sender's Comments: V0:20220109542-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications.   On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # M038847 with expiration date of 27-APR-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47.5-77 degrees Fahrenheit (°F)  for 1 hour. Data logger was involved. There were not previous excursions.  No adverse symptoms were reported. No further information was provided. No product quality complaint was involved. Additional information has been requested.
2 episodes of pallor-1 in afternoon p/recvd vax; pt cried for an hour, nursed then vomited; pt appeared pale to mom again in evening-no other sx;
no adverse reaction-patient received 1 dose of undiluted ped Pfizer bivalent which is equal to 1 dose of adult pfizer so no actual harm to patient
SUBJECTIVE TEMPERATURE 100.0 F, SORE THROAT, OCCASIONAL NONPRODUCTIVE COUGH