chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient recieved Second COVID vaccination around 2:45 pm and was waiting for her 15min . Suddenly became diaphoretic and c/o palpitations to chest. Sweaty and clammy. B/P was 140/101 pulse 82 O2 sat 100 % at 3:20 pm. Was given a cool compress and apple juice to drink. Agreed to be escorted to nearby ER via wheelchair accompanied by RN and a medical assistant.
Information has been received from a female patient of unknown age. She had severe allergies in general. It was also reported that in the past on an unknown date, the patient had received a flu vaccine (manufacturer unknown) and she had experienced an unknown "allergic reaction" to the vaccination. Information about concomitant medication was not provided. Back in July 2016, the patient received the PNEUMOVAX 23 in smaller doses 5 separate times in her arm to reduce her chance of getting an allergic reaction. On an unspecified date after receiving the PNEUMOVAX 23, she got an antibody titer test showing that the PNEUMOVAX 23 vaccine didn't take and didn't work. The outcome of vaccination failure was unknown. Additional information has been requested.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown demographics. The patient's medical history was not reported. On 31-AUG-2017, the patient was vaccinated with ZOSTAVAX (Strength, dose, frequency, anatomical location and route were not reported) of lot # M033910 with an expiry date of 17-OCT-2017 for prophylaxis. Co-suspect therapy included sterile diluent. There were no concomitant therapies reported. On 31-AUG-2017, during administration of ZOSTAVAX to the patient, the pharmacist got a small amount of vaccine in her eye. No adverse effects were reported for the patient or the pharmacist who were exposed ZOSTAVAX. No product quality complaint was involved. Lot number M033910, has been verified to be a valid lot number for ZOSTAVAX.
patient received Twinrix expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) 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 16th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 16th January 2023, 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 16-JAN-2023 Reporter's Comments: The pharmacist was looking information on Twinrix because a patient received Twinrix expired dose. There were no adverse effects detected to date (till the time of reporting). The reporter mentioned that, on 16th January 2023, Monday (closed), a colleague left a VM (voicemail) with this concern, but nobody did a follow-up. No other information was provided by the healthcare professional. The reporter consented to follow up by email. Additional Supportive Information: The patient received Twinrix beyond the expiration date, which led to expired vaccine used.
Patient reported intern gave her the vaccine "higher than previous vaccines" and that she was still experiencing pain in her arm. Patient is waiting to see if it resolves on its own in a few days, may seek medical treatment.
I am pregnant and would like to be a part of the Moderna pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and would like to be a part of the Moderna pregnancy registry) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20a) for COVID-19 vaccination.     Medical history and current conditions were not reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care, HYDROXYCHLOROQUINE for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 29-Jul-2021. On 22-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and would like to be a part of the Moderna pregnancy registry). On 22-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and would like to be a part of the Moderna pregnancy registry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported.
Pt undergoing w/u for breast cancer. MRI breast next day 9/12 showed marked lymphadenopathy with enhancement. LN biopsy 9/19 showed reactive lymph node. However, starting 9/19 or at least 9/25 pt developing sx of Parsonage Turner Syndrome (left brachial plexitis) which worsened post-op on day of lumpectomy 9/29 causing significant left arm weakness/sensory loss/paresthesias, LMN signs, absent DTRs, fascinulations.
Body aches went from mild to severe, chills, high fever (over 103), sweats, headache for   A total of 18 hours before a some or all symptoms stopped.
his body started shaking so much; His whole body was "very very cold" and "extremely cold."; He said his body is in -0 degree temperature; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (his body started shaking so much), FEELING COLD (His whole body was "very very cold" and "extremely cold.") and BODY TEMPERATURE DECREASED (He said his body is in -0 degree temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021 at 6:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced TREMOR (his body started shaking so much) and FEELING COLD (His whole body was "very very cold" and "extremely cold."). 17-Aug-2021, the patient experienced BODY TEMPERATURE DECREASED (He said his body is in -0 degree temperature). At the time of the report, TREMOR (his body started shaking so much), FEELING COLD (His whole body was "very very cold" and "extremely cold.") and BODY TEMPERATURE DECREASED (He said his body is in -0 degree temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature decreased: decreased (Low) -0 degree temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Reporter did not allow further contact
administered an expired MENACTRA with no reported adverse event; Initial information received on 20-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient who was administered an expired meningococcal A-C-Y-W135 (D conj) vaccine [Menactra] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero).  On 20-Jul-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (D conj) vaccine (lot U6878BA, expiry date: 02-Mar-2022; formulation not reported) via intramuscular route in the right deltoid for immunization.  On 20-Jul-2022, the patient was administered an expired meningococcal A-C-Y-W135 (D conj) vaccine with no reported adverse event (expired product administered) (latency: same day).   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the guidelines. 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.
Mistrual isses; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MENSTRUAL DISORDER (Mistrual isses) in a 15-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Mistrual isses). At the time of the report, MENSTRUAL DISORDER (Mistrual isses) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720710 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live Non significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720710:Reporter case
This case was reported by a consumer and described the occurrence of sickness in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness 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 it was selected as adult as per the vaccine indication. The patient was sick for 2 and half days.
Information has been received from a nurse practitioner concerning a 14 years old female with asthma and a history of pulmonary stenosis who on 09-JUL-2009 was vaccinated with the first dose of GARDASIL (lot # 662300/0100Y) in right arm. Concomitant therapy included hepatitis A virus vaccine (unspecified) (manufactured by GlaxoSmithKline) in left arm. Later on 09-JUL-2009 evening the patient developed paresthesia in her left thumb, and it was red and swollen. The ring finger of her right hand and toes on her right foot became red, swollen and itchy. She had no fever or rash. The patient had been seen in office for medical attention. At the time of the report, the patient had not recovered. Information has been received from a nurse practitioner concerning a 14 year old female patient with asthma and a history of pulmonary stenosis and no illness at time of the vaccination who on 09-JUL-2009 was vaccinated with the first dose of GARDASIL (lot # 662300/0100Y) in right arm. Concomitant vaccination administered on 09-JUL-2009 included hepatitis A virus vaccine (unspecified) (GlaxoSmithKline) (lot# AHAVB244AD) intramuscularly in left arm. On the night of 09-JUL-2009, the patient's right thumb became red, itchy and swollen. On 10-JUL-2009 the patient made an appointment to visit the doctor to be evaluated. The patient was found to have the left thumb edema and redness, the fourth finger of the left hand edema and redness, the fourth toes of the right foot edema and redness. The patient also developed paresthesia in her left thumb. There were no relevant diagnostic tests performed. At the time of the report, the patient recovered. Additional information is not expected.
Information has been received from a pharmacist concerning herself, a 59 year old female with latex, iodine, HIBICLENS and Neomycin allergies, who was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # not reported) about 2 years ago, approximately in 2006. On 11/03/2008, the patient was vaccinated intramuscularly with a second dose of PNEUMOVAX 23. There was no concomitant medication. On the same day the patient experienced redness, swelling, itching and pain at injection site in upper arm (period). She also experienced some dizziness. The patient sought medical attention, via phone call to a physician. The patient is taking BENADRYL and an anti-inflammatory medication for these symptoms. At the time of reporting, the patient was not recovered. Additional information has been requested.
Her arm gets a rash / big red rash; Her arm gets / white  spots around the rash; This case was reported by a consumer and described the occurrence of red rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced red rash and skin discoloration. On an unknown date, the outcome of the red rash and skin discoloration were recovered/resolved.   It was unknown if the reporter considered the red rash and skin discoloration to be related to Shingrix.  Additional details was reported as follows: The case was reported by patient herself. The patient received Shingrix and after vaccination her arm gets a big red rash as well as white spots around the rash. The case is linked with US2021067588, by same reporter. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021067588:Same reporter. US-GLAXOSMITHKLINE-US2021067596:FU1 deleted
Approximately 3 months after receiving the booster Covid vaccine, I developed an echo in my left ear resulting in significantly reduced speech discernment. I also had a significant increase in meneires vertigo attacks resulting in missed work. As of December 16th, 2022 I am completely deaf in my right ear.
2nd shot a year after 1st; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 1 year ago prior to the receiving 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: The reporter was a patient. The patient reported that she received her 2nd dose of Shingrix vaccine about 1 year after receiving 1st dose of Shingrix vaccine. The patient stated that there was no other information available. The reporter did not consent to follow up. The reporter did not give permission to contact HCP. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
asymptomatic hyperthyroidism; painless thyroiditis; This is a literature report from the Thyroid, abstracts, entitled: Painless thyroiditis after mRNA vaccination for severe acute respiratory syndrome coronavirus 2 (sars-cov-2).  Thyroid dysfunction has been described following SARS-CoV-2 infection, but data on thyroid dysfunction following SARS-CoV-2 vaccination are extremely limited. The author reported the first 3 cases of painless thyroiditis in patients shortly after receiving an mRNA vaccine for SARS-CoV-2. A 29-year-old female with history of Graves disease in remission and off methimazole, now euthyroid on levothyroxine 25 mcg/day for pre-conception optimization, presented with asymptomatic hyperthyroidism after labs drawn five days after her second dose of mRNA-SARS-CoV-2 vaccine(Pfizer) revealed TSH of 0.01 lIU/mL, FT4 of 3.15 ng/dL, TT3 of 162 ng/dL and a negative TSI index. She was asked to hold levothyroxine and labs obtained four weeks later showed normal FT4 and TT3. Awareness about the possibility of thyroiditis in the post vaccination period can help prevent initiation of medical therapy or large adjustments in thyroid medication doses and invites more frequent thyroid testing in patients in whom thyroid dysfunction is suspected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Hyperthyroidism and BNT162B2.  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.
Complete loss of feeling in left arm (injection site). Continued numbness, tingling, pain and swelling. Unable to pick things up, lift heavy objects, or make a tightly closed fist. Loss of dexterity and muscle function. These symptoms a few hours after getting the J & J vaccine and persist over two months later. As a professional musician, this has led to an inability to do my job.
Four days after second dose: Intense brain fog Days five through ten: Right calf heavy and tight; muscle twitching throughout both legs Day eleven: Chills; intense brain fog and head pressure; dehydration; muscle twitching From day eleven to present: Fatigue and weakness; muscle twitching; head pressure; ear pressure; debilitating brain fog; burning sensation throughout temples and base of head; overactive nervous system responses; heart palpitations; dehydration; irregular menstrual cycle
Gave potentially expired doses from a sealed vial to 9 patients; A spontaneous report was received from a non health professional concerning nine patients of unknown age or gender who received expired product administered.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On an unknown date, prior to the onset of the symptoms, the patient received their (dose unknown) of mRNA-1273 (Batch number: Batch number not provided) route of administration : unknown in the anatomical location for prophylaxis of COVID-19 infection.  On an unknown date,  nine patients received the expired vaccine.  Action taken with the drug in response to the events was not reported.  The outcome of the event was recovered/resolved; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # unknown)  with no associated AEs reported.
patient contracted COVID-19 on 7/18/21. Fully vaccinated on 4/17/21- mild COVID symptoms see below Immunizations       COVID-19 Vaccine, PFIZER, External administration 4/17/2021, 3/27/2021       Dose Site Route Manufacturer Lot # Product    4/17/2021 Given 0.3 mL    ER8735  Delete History  3/27/2021 Given 0.3 mL    ER8732  Delete History
On 2/11/21, watching television sitting on the couch, I felt really warm and started to sweat, slight tunnel vision , started having pressure in the left side of my chest, fluttery sensation in my chest, felt weak, extremely fatigued, arms felt heavy, mild shortness of breath, nauseous then vomited once. Felt better after @ 30-40 minutes.  I made an appointment with my pcp on 2/19/21.  I had an EKG done and it was normal and was given orders for lab work and a chest x-ray. I was referred to a cardiologist. I saw the cardiologist on 3/22/21.  I had an EKG performed and it was normal.  I was scheduled for a stress test, echocardiogram, and nuclear medicine perfusion study for the following week.  On 3/23/21, while driving my car, I started to feel really warm, got tunnel vision, then passed out.  I woke up after crashing my car.  I don?t recall the accident, just woke up with the car on it?s side in a wooded area.  My car was totaled.  I was taken to the Hospital by ambulance.   While at the hospital I had blood work, CT Scans of my head, c-spine, abdomen, and pelvis, chest and shoulder x-rays, carotid ultrasound, stress test, nuclear medicine perfusion study, echocardiogram done.  All results were normal.  I was given a cardiac event monitor to wear. On 4/6/21 at 6:19 pm, while sitting on the couch watching television, I started feeling short of breath and had a fluttery feeling in my chest.  My event recorder recorded my heart rate at 144  and a 4 beat run of nonsustained vtach.  I got a call from the event recorder monitoring service and was told to contact my cardiologist and if I had more symptoms, go the ER. I called my cardiologist on 4/7/21 and was instructed to come straight in to their office and be prepared to be admitted into another hospital for a heart cath.  I was admitted into Grandview and had a heart cath performed on 4/8/21.  The heart cath was normal so my cardiologist implanted a loop recorder at that time per the instructions of the electrophysiologist.  I was discharged from the hospital on 4/9/21. On 5/6/21, my heart paused for 3 seconds and was caught by my loop recorder. On 5/12/21 I had a cardiac MRI and it was normal. On 7/2/21 at 3:57 am, my loop recorder recorded my heart slowing down, then paused for 15 seconds, started to beat again slowly then returned to a normal rhythm.  I was diagnosed with vasovagal syncope. On 7/26/21, I had a pacemaker placed.
She experienced flu/covid like symptoms beginning 1-2 days post vaccination and felt extremely tired. The symptoms lasted for one week after receiving vaccine.
Constant chest pain daily which gets worst when heart rate increases and shortness of breath.Treatment was tylenol, ibuprofen, lidocaine patches. None of the medications that was given to me ever helped the pain stayed persistent.