chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee reported to this writer that after receiving the flu shot, her left arm became red, hot to the touch and tender. There was no shortness of breath, rash, no swelling of the eyes, lips or tongue; no drainage, denies pain. This continued for 24 hours after receiving this vaccine. Employee was instructed if symptoms worsened, to seek care at her primary physician.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment during unspecified dates in Oct2023. Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352989 Same patient, different product, different event (Paxlovid case);
Profuse Vomiting; chills; dryness; This is a spontaneous report from a contactable Nurse. A 81-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: Unknown; Expiry Date: Unknown) dose 1 intramuscular, administered in Arm Left on 06Feb2021 16:00 as SINGLE DOSE for COVID19 immunization. Medical history included If covid prior vaccination: Yes. Concomitant medications included apixaban (ELIQUIS); propranolol; chlorthalidone; pravastatin sodium for an unspecified indication. The patient did not receive any other vaccines within 4 weeks. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested positive post vaccination. The patient experienced on 06Feb2021 16:00 profuse vomiting, chills, dryness. The patient did not receive any treatment for adverse event. The outcome of the events were unknown.
IMMEDIATELY AFTER VACCINATION PT FELT HER HEART RACING AND LIGHTHEADEDNESS. STAFF ASSISTED PT TO FLOOR. TRANSPORTED TO MED OBS AT 0823 VIA WC. VITALS OBTAINED AND MONITORED. VITALS REMAINED STABLE. SYMPTOMS RESOLVED. PT CALLED FOR RIDE FROM PARENTS. PT RELEASED TO HOME AND ESCORTED TO EXIT AT 0858 BY STAFF WITH NO FURTHER ISSUES. VITALS AS FOLLOWS: INITIAL BP 155/99 HR 75 SPO2 97 SITTING BP 135/89 HR 80 STANDING BP 141/98 HR 80
Vaccine given in LD IM - pt became stiff - had mild shaking then LOC for approx 20-30 seconds, then became awake, alert (B/P & BS was checked) oriented x3 - observed in office for 30 min.
The patient's spouse reports the patient had a local reaction to the left arm with redness and swelling at the injection site.
Myalgia Left Axillary Lymphadenopathy Narrative:  Employee reported to EOH today 7/12 with complaint of L axillary lymph node swelling and tenderness. reported symptoms are improving; will f/u with PCP if no improvement, worsen,persist
Male patient received a dose of vaccine that had been punctured from for more than 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Male patient received a dose of vaccine that had been punctured from for more than 12 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 10:05 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022 at 10:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Male patient received a dose of vaccine that had been punctured from for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Male patient received a dose of vaccine that had been punctured from for more than 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had received booster dose. No concomitant medication information was reported. Pharmacy store manager stated that the vial was initially stored in the refrigerator 07-Mar-2022 placed into freezer. They took it out of the freezer and stored in refrigerator on 09-Mar-2022 at 8:30pm and date and time vial was first punctured on 10-March-2022 at 10:25 am. Administration time was at: 10:05am. The vial left out over night on the night of the 10-Mar-2022. The vial did not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature was about 24 hours. No treatment information was reported.   This case was linked to MOD-2022-509154 (Patient Link).
Not feeling well; Slight fever; Throwing up; Chills; A spontaneous report was received from a consumer concerning himself, a 67-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight fever/pyrexia, throwing up/vomiting, chills and not feeling well/malaise.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 011L20A) intramuscularly in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient experienced slight fever, throwing up, chilling and not feeling well. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown    The outcome of the events, slight fever, throwing up, chilling and not feeling well, were considered as unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
RASH TO BODY, LOW GRADE TEMP, LOOSE STOOL AND VERY FUSSY PER MOM.
after vax 1/28 pt devel welts/hives, m.d. gave benadryl 1/29 rash still apparent.1/30 rash gone
I developed frozen shoulder; Initial information was received on 27-Sep-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced "I developed frozen shoulder" (periarthritis), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious event I developed frozen shoulder (periarthritis) (unknown latency) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received any corrective treatment for the event.  It was reported "Last time I got a flu shot, I developed frozen shoulder. It's lasted 2 years".  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
This spontaneous report as received from a registered nurse refers to a 66 years old female patient with congestion from a cold. The patient was vaccinated with lot # (672962/0025AE) dose 1, 0.5 ml PNEUMOVAX23, IM into her left arm on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-JUL-2012, since administration the patient experienced pain at the injection site. Redness and rash developed at the injection site on 13-JUL-2012. The patient self-treated with unspecified topical steroid cream and the rash improved. The patient called the office on 16-JUL-2012 and was advised to take ibuprofen or TYLENOL for pain relief. There was no lab diagnostic studies performed. The outcome of rash, redness and pain at the injection site was reported as recovering/resolving. The relatedness for pain, rash and redness at the injection site is unknown for PNEUMOVAX23. This is one of several reports from the same source. Additional information has been requested.
left leg pain and swelling, redness, increased warmth worsening over 1 week
felt little achy; arm was pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt little achy) and PAIN IN EXTREMITY (arm was pretty sore) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02BA21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic obstructive pulmonary disease (she has COPD and she uses oxygen 24/7). Concomitant products included HYDROCODONE, CLONAZEPAM, FLUOXETINE HYDROCHLORIDE (PROZAC), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), TOLTERODINE and ROFLUMILAST (DALIRESP) for an unknown indication, PROPRANOLOL.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced PAIN (felt little achy) and PAIN IN EXTREMITY (arm was pretty sore). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 13-Apr-2021, PAIN (felt little achy) and PAIN IN EXTREMITY (arm was pretty sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included - patient drank a lot of water.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Significant follow-up appended
Worsened with second vaccine.; transverse myelitis; L-sided hemisensory numbness from torso at level of ~T4 to toes; developed over course of weeks after COVID vaccine. Worsened with second vaccine. MRI findings showing demyelinating process, concernin; This is a spontaneous report received from a contactable reporter (Physician).  A 30-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 04Mar2022 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years, in left arm and on 25Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Allergy", notes: known allergies: Penicillin. The following information was reported: HYPOAESTHESIA (hospitalization) with onset 11Mar2022, outcome "recovering", described as "L-sided hemisensory numbness from torso at level of ~T4 to toes; developed over course of weeks after COVID vaccine. Worsened with second vaccine. MRI findings showing demyelinating process, concernin"; MYELITIS TRANSVERSE (hospitalization, medically significant) with onset 11Mar2022, outcome "recovering", described as "transverse myelitis"; CONDITION AGGRAVATED (hospitalization, medically significant), outcome "recovering", described as "Worsened with second vaccine.". The events "transverse myelitis" and "l-sided hemisensory numbness from torso at level of ~t4 to toes; developed over course of weeks after covid vaccine. worsened with second vaccine. mri findings showing demyelinating process, concernin" required emergency room visit. L-sided hemisensory numbness from torso at level of ~T4 to toes; developed over course of weeks after COVID vaccine. Worsened with second vaccine. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: transverse myelitis, notes: MRI findings showing demyelinating process, concerning for transverse myelitis. Therapeutic measures were taken as a result of myelitis transverse, hypoaesthesia, condition aggravated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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 and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Erythema Multiforme rash started on 5-22-09 started in groin area spread allover started on BENADRYL change to ZYRTEC on 5-26-09 PRELONE  started on 5-24-09 by ER
An expired dose was administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 28th June 2022, the patient received Havrix. On 28th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's comments:  The reporter reported that the patient received expired dose of Havrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix which was expired on 24th May 2022, which led to expired vaccine used.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 10-JUL-2013 the patient was vaccinated with PROQUAD (Merck) 0.5 ml, subcutaneously, lot # unspecified. The reporter stated that the PROQUAD (merck) was stored at 46F for 10 days. The reporter also states that the PROQUAD (Merck) was put into the refrigerator on 09-JUL-2013. No adverse effect reported. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Nausea, fatigue, soreness and swelling in shot site. Took Tylenol. That evening extreme fatigue, migraines, fever, joint pain, dizziness that lasted about a week.
flu like symptom, fever, headache, sore throat, the injection site was red, swelling and painful.
Fever 104.2. Took pt to ER at 11:00 PM 6/5/03. Crying. (Unconsolable crying for 2 hours with 2 month shots 4/7/03).
Narrative:  89yo male patient died on 10/2/2021 at Medical Center due to complications after a fall and injuries to left hip & arm/shoulder. Pt had received covid vaccines on 2/23/21 & 3/23/21. Pt also had hx of end stage renal disease, CHF, HTN, DM, anemia, basal cell carcinoma of nose. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
I have been having persistent pain in my upper left arm at the site of injection. Pain has been registered at 4-6 on the pain scale of 10 and has been going on for 2 weeks. There is no swelling or discoloration but the pain is very uncommon for me.
INITIALLY FELT AN ITCHING NEAR HER FOREHEAD/EYES. NO S/S OF ANGIOEDEMA. NO SOB, NO SCRATCHY THROAT. BLOOD PRESSURE AND HEART RATE ELEVATED.  AFTER INITIAL ANXIETY OVER POSSIBLE REACTION, HER HEART RATE WAS DECREASED BUT BP REMAINED IN HYPERTENSIVE URGENCY RANGE.
Rash on the arm; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH (Rash on the arm) and PYREXIA (Fever) 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, the patient experienced RASH (Rash on the arm) and PYREXIA (Fever). At the time of the report, RASH (Rash on the arm) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 18 years old patient who received vaccine FLUZONE HIGH DOSE (batch number, expiry date, dose, route and site of administration were unknown) on 26-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Inappropriate age at vaccine administration and overdose. It was reported that one of their staff pharmacists injected FLUZONE HD into an 18 years old patient. Caller did not have information to provide regarding the event or the lot number of the vaccine that the patient received. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Had AVA #2 about the time of conception. Term infant born with fetal Sacral Teratoma and multiple Vertebral and rib abnormalities.
Expired Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 41-year-old female patient who received HAB (Twinrix) (batch number x239d, expiry date 7th August 2022) 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.   On 10th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 04-OCT-2022 Reporter's Comments: The reporter was Practice manager. The reporter stated that the expired twinrix administered on 10th Aug 2022. The reporter gave consent to follow up. Additional Supportive Information: The patient received expired twinrix vaccine which lead to Expired vaccine used.
Patient was dizzy and fainted.  Patient was nauseous and vomited. Patient's fingers felt numb.  Patient has had this reaction to other vaccines in the past. Patient was feeling  better after staying in the pharmacy area and we provided supportive call to her.  She went home after feeling better
Initial report was received on 08 November 2011 from a health care professional with additional information received on 11 November 2011 from a consumer who is also the patient's parent. A 15 year-old female patient with no reported past medical history had received on 04 October 2011 a left deltoid injection of DECAVAC, lot number U3421DA (route of administration not reported) and an unspecified amount of time later the day of vaccination, experienced leg pain, swollen lymph glands, left thigh muscle pain, paleness, fatigue, felt feverish (temperature was not taken or documented) and a feeling that the left side of the face was bruised with no overt sign. The patient was evaluated by a physician. Diagnostic tests included a negative strep test and a negative mono test. No treatments were prescribed. It was reported some signs and symptoms were resolving. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received on 30 December 2011 from a consumer who is also the patient's parent who reported that the patient can not walk for long. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. According to the parent, the patient has been experiencing leg and muscle pain since October. The patient is an organist and has a difficult time with the pedals. The parent states that all other symptoms have resolved except the leg and muscle pain. The patient has been treated with acupuncture and has seen a chiropractor. The patient had not been on any medications but the patient underwent some "blood tests" including WBC and connective tissue (results were not reported). The patient has a referral to see a physiatrist. According to the patient's mother, the patient was not hospitalized. No further information was available at the time of the event. The patient's outcome was not recovered. Documents held by sender: none.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated intramuscularly with 0.5 ml of first dose of GARDASIL (lot# and expiration unspecified) on 03-OCT-2012, second dose (lot# and expiration unspecified) on 05-DEC-2012 and the third dose (lot# reported as h01465, exp 27-MAR-2015) on 07-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unknown if the patient had sought medical attention. At the time of the report, the patient outcome was unknown. Additional information has been requested.
Swelling, warmth, pain upper L arm progressively worse over next few d and inducing pain and tenderness in proximal thorax and shoulder girdle.  Lasting over 10 d.
Initial report received from healthcare professional on 26 NOVEMBER 2013. A female patient whose age, medical history and concomitant medications were not reported, received ADACEL (lot number, expiration date unknown) intramuscularly at the left deltoid on  25-NOV-2013. On 26-NOV-2013, patients reported large swollen lymph node under the left armpit. Laboratory investigation and corrective treatment were not reported. As of this report, outcome of the event was unknown. Documents held by sender: none