chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in the arm of injection; Redness in the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm of injection) and VACCINATION SITE ERYTHEMA (Redness in the site of injection) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (discharged on 25Mar2021) on 12-Mar-2021. Concurrent medical conditions included Arthritis and Loss of smell (started when diagnosed with COVID and not after the first dose of the vaccine) since 12-Mar-2021. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm of injection) and VACCINATION SITE ERYTHEMA (Redness in the site of injection). On 07-May-2021, PAIN IN EXTREMITY (Pain in the arm of injection) and VACCINATION SITE ERYTHEMA (Redness in the site of injection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, COVID-19: positive (Positive) COVID-19 positive.         Doctor took an X-Ray of patient's nose a week ago and results are pending.  Treatment medication information was provided, however patient was not sure if it was Tylenol or naproxen.   This case was linked to MOD-2021-143359, MOD-2021-142705 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: No new information was received. On 01-Jul-2021: report - X-Ray done. Sense of smell has not come back completely.
Patient had temperature with 2 inch diameter rash at injections site.  Rash is hot to touch and sensitive to pressure
A few minutes after getting vaccine, while still sitting in chair, pt fainted. Never left chair. Came to quickly, and was helped to a cot. VS: P=76  BP 120/72  P. Ox=98%  He was given a juice box, declined crackers. Was initially very pale, but pinked up nicely once he was prone. After 5-10 minutes, he sat up, with VS: P=80  BP 128/70  P. Ox=99%  After 5 minutes, he stood up, felt fine. VS: P=80   BP=136/82  P. Ox=99%.   Per mom and pt, this has happened with other vaccines in past, most recently earlier this year with a Men B vaccine. We advised giving next COVID vaccine (and others) while laying down. VAERS form completed. Pt left without further incident.
2 wk visit in office hematoma seen around area Hep B vax given 1 mo exam raised red lesions @ 5 wks petechia & appears as hemangioma;
Awoke on morning of 3/18/2021 (48 hours after the vaccine) with florid generalized rash, most notable on neck, bilateral forearms and umbilicus. No itch, swelling or pain associated with the rash. Rash extended to include upper arms and (R) cheek and (L) 5th toe. The rash had been preceded by left upper arm pain, headaches, joint aches and pains, chills, nausea and fatigue. These symptoms started about 10 hours after the vaccine and continued for 24 hours. By the following afternoon, 3/17/2021 (29 hours after the vaccine), fever of 100.8. Patient took an Advil PM on the evening of 3/17/2021.
Immunocompromised patient presented for 4th vaccination injection. Patient received full vaccine dose instead of booster dose (.25ml)
pt called in about getting second dose saying he had shortness of breath for a week, facial swelling and was concerned about second dose. we had not had this reported to us at an earlier date and pt did not report
She developed severe eczema and on 10/05/2008 she had convulsions. She may had convulsions before but they went unnoticed.
Fever onset 5/11/18 continued through 5/12/18. Left deltoid/arm redness/swelling onset 5/11/18 to present. Sore throat 5/14/18.
Several hours after my vaccine, I felt paralyzed, my whole right arm went numb from my shoulder to my fingertips. I could  not move my fingers. I had a fever, cold, chills and muscle aches everywhere. Then the pain started going across my right shoulder blade to my left arm, across the clavicle. I was unable to sleep. I sat in a chair with a heating pad. Then that is when I called my doctor but she refused to see me until I got a COVID test. I felt so bad and did not get a COVID test and my husband and I came to the conclusion that it was not COVID but reacting to the vaccine so I took  OTC BENADRYL. I talked to my doctor on 04-13-2021 and she said to me that her daughter had Hashimoto Disease and that I probably also had Hashimoto Disease and had a reaction to the vaccine. I've had pain at night from 2AM to 6AM since then, and it I lay down I have so much pain. I then use the heating pain and drink coffee which eases the pain for me. I also took prednisone medication which gave me some relief for a few days but do not remember the day I took the medication, have only taken four doses of prednisone form April 6 2021 to present. On June 8,2021 did an x-ray of my shoulder at a hospital. The doctor referred me to an orthopedic surgeon on 11-17-2021. They all sent me for an MRI of the right shoulder and got it on 11-30-2021. The doctors said my shoulder did not require surgery and normal for my age. My doctor said it was possible serum reaction.
This spontaneous report has been received from a physician via a company representative referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history. On an unspecified date (reported as many years ago), the patient was vaccinated with two doses of GARDASIL (doses, lot # and expiration dates were not reported) for prophylaxis.  The patient's concomitant medications were not reported. In addition, the reporter stated that a dose of GARDASIL or GARDASIL 9 would be administered on an unspecified date. No adverse effects have been reported. No  PQC was involved.
Information has been received from a licensed practical nurse concerning a 64 year old male patient with diabetes, hypertension and dyslipidemia and with no drug reactions or allergies who on 12-OCT-2010, was vaccinated IM in the left arm with a dose of PNEUMOVAX 23 (Lot# 665400/1315Y). Concomitant therapy included sitagliptin phosphate (MSD), allopurinol, LOVAZA and ACTOPLUS MET. It was reported that the patient developed joint pain and muscle aches after vaccination with PNEUMOVAX 23. The pain was asymmetrical over his body and he was walking with a cane. The patient had severe right thigh pain. The patient had not had a fever. He was prescribed TYLENOL and ice application. The day of vaccination the patient was seen for a small superficial abscess in front of his left ear. He was prescribed LEVAQUIN for the abscess. On an unspecified date the patient had a complete blood cell count and erythrocyte sedimentation rate (no results provided). At the time of the report, the patient was recovering. The patient sought medical attention. Additional information has been requested.
fast heart beat, 150; uncontrollable shivering; cold; I woke up later that night; This case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 72-year-old 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 a day after receiving Shingrix, the patient experienced heartbeats increased, shivers, cold and sleep disturbance. On an unknown date, the outcome of the heartbeats increased, cold and sleep disturbance were unknown and the outcome of the shivers was recovered/resolved.   It was unknown if the reporter considered the heartbeats increased, shivers, cold and sleep disturbance to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingrix and had uncontrollable shivering which went away but, patient woke up later that night with a fast heart beat 150 and had cold.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX, with lot number L050957 with expiration date of 17-DEC-2017 or lot number M006724 with expiration date of 08-FEB-2018 (strength, route of administration and dose were not reported), which was stored at -6.9 Celsius degrees for 2 hours (The temperature excursions were detected by a data logger). There was no previous temperature excursion. No concomitant therapies no adverse effect were reported. This is one of two cases from the same reporter. Additional information has been requested.
Booster dose of 0.25ml was inadvertently administered to staff member during a staff member/resident clinic at an assisted living facility on day 108 rather than than six months following second dose.
At 8:24 A.M. pt received PPD, HEP A, and TDAP.  Pt started feeling light headed and sweating.  Pt passed out and came to, about 15 seconds later.
fatigued; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Jan2021 17:45 (Lot number: EL1284) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sjogrens syndrome" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing); "Known allergies: Salicylates" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE.  The following information was reported: FATIGUE (non-serious) with onset 05Jan2021 20:45, outcome "recovered", described as "fatigued". Therapeutic measures were not taken as a result of fatigue.  Additional Information: The patient received the vaccine at the hospital and did not receive other vaccine within four weeks prior to vaccination. The patient was very fatigued for 12-24 hours after each dose of vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient received the second dose on 26Jan2021 (Lot number: EL3302) in the left arm for COVID-19 immunization.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021494997 Same reporter, patient, and product; Different dose and events
COVID+ 1/15/2023.  Vaccination Status -J&J x1 Discharge Physician: MD, MPH Primary Care Physician: DO Date of Admission: 1/15/2023 Discharge Date: 1/19/2023    BRIEF OVERVIEW:   Active Hospital Problems   Diagnosis Date Noted POA ? COVID-19 01/15/2023 Yes  DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   72-year-old male with with a past medical history significant for coronary artery disease, CKD, and diabetes who presents due to complaints of shortness of breath as well as cough.   In the ER, patient was hemodynamically stable but diastolic blood pressure was notably low in the 40s to 50s.  He required 5 L of oxygen to maintain adequate oxygen saturation.  Labs were remarkable for elevated BUN to creatinine ratio and D-dimer was high; patient did undergo CT PE study which was negative for PE but which showed bilateral ground-glass opacities.  Patient tested positive for COVID-19.  Patient was empirically started on ceftriaxone and azithromycin and was given dexamethasone and admitted to the hospital for further treatment. On 01/17/2023 the patient's empiric antibiotic therapy was discontinued as his imaging and symptomatology more closely resembled a viral etiology. The patient reported high anxiety with occasional panic attacks triggered by the fact that he has to be in isolation and unable to leave his room to ambulate the hallways, in addition having a bed alarm added to the patient's anxiety and frustration and feeling of confinement.  Xanax 0.5 mg 3 times daily as needed was started on 01/17/2023 and titrated upwards to 1 mg 3 times daily on 01/18/2023 cuff in addition the patient's bed alarm was disabled and he was allowed to transition from bed to chair. Supplemental oxygen requirements improved:  From 6 L down to 3 L via nasal cannula on 01/18/2023. CXR 1/19 no significant changes. Patient had home O2 evaluation which he qualified for o2 L continuous. Patient hemodynamically stable for discharge. CONSULTATIONS: RT PT MSW/CM PROCEDURES: Home O2 Eval
Reports feeling "dizzy"  and "anxious" post vaccination, Monitored x 40 minutes w/symptom improvement; BP 136/93 P 88, Released from facility home.
He developed hives and itching all over his body, face, everywhere/ bothersome; itching all over his body, face, everywhere; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (He developed hives and itching all over his body, face, everywhere/ bothersome) and PRURITUS (itching all over his body, face, everywhere) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported.On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced URTICARIA (He developed hives and itching all over his body, face, everywhere/ bothersome) and PRURITUS (itching all over his body, face, everywhere). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (He developed hives and itching all over his body, face, everywhere/ bothersome) and PRURITUS (itching all over his body, face, everywhere) had not resolved. Concomitant medications were not reported.
This spontaneous report as received from a physician assistant refers to an unspecified number of patients of unknown age and gender. No historical conditions, concurrent conditions or concomitant medications were reported for these patients. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot #, expiration dates and doses were not provided). The vaccine was exposed to a temperature of 33 degrees F for 23 minutes. The excursion was captured via a Digital Data Logger. There was no previous temperature excursion. There was no adverse effect reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013043.
PATIENT STARTED FEELING DIZZY, FAINT, NAUSEA, PALE,  AND CLAMMY.  PATIENT LAID DOWN ON COT. OBSERVED
01/11/2021 11AM Palpitations, increased pulse, feeling very hot, feeling like in a fog, and headache T=99.7, Staff monitored me for 45min..  1230PM.  I called out sick and had to use a vacation day because still had headache, fogginess, and temp of 98.8.  At 3pm I started to have a lower back ache that went in to my mid back.  I was tired.  Then on Tuesday, 01/12/2021 I started with diarrhea at 11AM.  I called work and explained that it was a side effect of the Covid vaccine.  They still would not let me go to work even though I was covid negative.  I took 2 Imodium tablets. I will email you tomorrow, 1/13/2021 and continue to monitor.  Yes I am a RN.
This spontaneous report was received from a nurse regarding an unspecified patient of unknown demographics. Information on pertinent medical history and concomitant medications were not reported. On 18-JAN-2018, the patient received improperly stored VARIVAX lot# N020016 with expiry date of 17-JUL-2019 for prophylaxis. The patient also received a properly stored sterile diluent  lot# M037020 with expiry date of 02-MAY-2019. Temperature: -14 C to -10 C. Timeframe: 10 minutes. There was a previous temperature excursion. -14 C to -10 C for 327 minutes. The call was because of data logger. No adverse effect was reported. Follow up information has been received on 30-JAN-2018 from the registered nurse (R.N) referring to a 13 months old female patient in regards to the letter received. The registered nurse stated that this patient did not experience any adverse events. The request for information was reviewed with the registered nurse in light of vaccine storage events. At the time of report, the registered nurse was able to inform regarding the patient who received VARIVAX Lot N020016 was a female. The registered nurse had no further information. The registered nurse would not be sending back the form. Additional information was not expected.
Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm.  Has tingling in hand, head ache, spinning, body aches.  Has been a week since covid vaccination.
This spontaneous report as received from an other health professional refers to unknown number of patients of unknown age. The patients were vaccinated with VAQTA which was stored as low as 24F on multiple occasions. No treatment information was reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to obtain follow-up information have been unsuccessful.
This case was reported by a healthcare professional via a sales representative and described the occurrence of intussusception in a male subject of unspecified age who was vaccinated with ROTARIX (GlaxoSmithKline). On 23 August 2011 the subject received 1st dose of ROTARIX (oral). On 11 October 2011, 49 days after vaccination with ROTARIX, the subject experienced intussusception, vomiting, diarrhea and dry heaves. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Adominal pain & cramping on first day of second dose.  Pain stopped and returned more intensely on day 5 after receiving the second dose.  Menstrual bleeding has also returned intensely after a 5 month absence.
Difficulty breathing, rattling cough that wouldn't stop, red/hot face & neck. Diagnosed with anaphylaxis reaction.  A couple more anaphylaxis episodes in 48 hrs hours.  Led to cardiac event. Still in hospital.
The pt complained of a fever, soreness from elbow to bottom of ear, right upper arm. The pt also complained of fatigue, limited range of motion in right arm, very painful at injection site. No other symptoms.
PCR Nasal Swab: Positive/ stuffy nose, general ache, diarrhea and loss of taste; PCR Nasal Swab: Positive/ stuffy nose, general ache, diarrhea and loss of taste; This is a spontaneous report from a contactable nurse. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 31-years-old, intramuscular in right arm on 15Feb2021 at 13:00 at dose 1, single (lot number: EL3248) and intramuscular in right arm on 08Mar2021 at 12:45 at dose 2, single (lot number: EL3248) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Known allergies were unknown. The patient has no COVID prior to vaccination. It was unknown if the patient received any other vaccines in four weeks. The patient's concomitant medications were not reported. Facility type was reported as a workplace clinic. On 15Apr2021, the patient began to experience stuffy nose, general ache, diarrhea, and loss of taste. His PCR nasal swab for COVID on the same day was positive. Treatment for the events was unknown. The outcome of the events was recovering.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported vaccination failure / COVID-19 cannot be ruled out.
Developed clots after her booster dose; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed clots after her booster dose) in a 60-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 THROMBOSIS (Developed clots after her booster dose) (seriousness criterion medically significant). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Developed clots after her booster dose) outcome was unknown.            Concomitant medications were not reported.  The patient developed clots after booster dose and was ordered Aspirin for the blood clots. Company comment: This spontaneous case concerns a 60-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of Thrombosis. The date of onset of the event and date of administration of third dose of mRNA-1273 were not specified, hence latency could not be assessed. There was no information provided on the previous two doses of mRNA-1273. The patient was treated with Aspirin for the blood clot at an unspecified dose and frequency. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-522801 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow-up received included reporter's contact details.; Sender's Comments: This spontaneous case concerns a 60-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of Thrombosis. The date of onset of the event and date of administration of third dose of mRNA-1273 were not specified, hence latency could not be assessed. There was no information provided on the previous two doses of mRNA-1273. The patient was treated with Aspirin for the blood clot at an unspecified dose and frequency. The benefit-risk relationship of mRNA-1273 is not affected by this report.