chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High-grade solid serous endometrioid-like transitional variant; This is a spontaneous report from a contactable physician. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not provided) via unspecified route of administration on an unknown date in Jan2021, as unknown dose, single for COVID-19 immunisation.The patient medical history included COVID infection in Jan2020. Concomitant medications were not provided. The patient reported that in Jan2020 she had covid infection, after that in Jan2021 she received BNT162B2 and on an unknown date, she was diagnosed with high-grade solid serous endometrioid-like transitional variant. Recently she reviewed the below mentioned article. Comorbidities and inflammation associated with ovarian cancer and its influence on SARS-CoV 2 infection. She cited an article and asked "is in your expertise could be a direct correlation between my ovarian cancer and my covid history. how it will be the effect of chemotherapy in further management ovarian cancer do I have to get coming winter in immunization again". Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events ovarian cancer and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.
Vertigo type feelings; Woosey and a little nauseous; This is a spontaneous report received. A contactable consumer (patient) reported 80-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unknown route of administration, administered on left arm on 10Mar2021 10:00 (at the age of 80 years old) (Batch/Lot Number: not reported) as 1st dose, single dose, for COVID-19 immunisation. Patient's medical history included benign prostatic hyperplasia (BPH)  on an unspecified date and penicillin allergy. Concomitant medications were not reported. The patient has not had COVID before vaccination nor tested after vaccination. On 12Mar2021 06:00, the patient experienced vertigo type feelings. The patient felt woosey and a little nauseous. The patient did not receive treatment for the reported events. The outcome of the reported events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2/8: Onset of extreme headache (lasting through today, 2/16, with ZERO relief) which has spread into my eye sockets.  Extreme nauseous, 6 days of diarrhea, unalbe to even keep water down at day 4.  Body aches, heart constrictions on 2/12. On 2/12 the heart constrictions and severe deydration resulted to call to Advise Nurse with direction to report to ER. In ER EKG, CT of chest and lungs.   2/12: Returned home and slept for several days and continued to attempt to relieve massive entire head pounding.  2/14: Head ache traveled  into eye sockets creating massive eye pressure.  2/16: Sudden pain in left tongue and vision change. Noticed facial drooping and eyes glassy. Called and then 911 as concerned.
Localized edema erythema; afebrile; TX w/ice effective to decreased edema, provide comfort  post 48 hours, edema gone; 4"x4", circular area of erythema fading.
pt recv vax 16FEB99 & devel elevated temp 23FEB99;devel rash like chickenpox on 25FEB99 trunk & diaper area;mom reported possible lt ear infect too;
covid shot estimated at Feb 1st between 1-2 PM, first shot, and then had a trip and fall that day. 3-5 days later noted cellulitis on his leg with redness, swelling, pain, edema and went to urgent care on the 10th, given some antibiotics which he is currently taking and the site is looking much better. Patient notes also painless nodules going down his bicep, but not where lymph nodes are (more in the middle of the arm from the site, not near elbow or armpit). Pt also noted some bruising initially at the injection site which is better. Should he still get his second shot even with the abx and cellulitis?  Adv cellulitis on the leg more related to the fall than the shot. The nodules could be from the shot but as they aren't where I would typically expect to see lymphadenopathy would rec FU with PCP if the nodules persist or worsen. None of this is a contraindication to getting the second dose of the vaccine, but inform the vaccine providers that you are on elliquis so they can be aware to watch for additional bruising/bleeding, which is common after the shot. Discussed also Q518.
Subsequent to receiving varicella virus vaccine live the pt experienced chickenpox consisting of 10 lesions the largest of which was at the injection site. The diagnosis was confirmed by a dermatologist.
My limbs didnt work for 7hrs. I couldnt move anything on my body.; My limbs didnt work for 7hrs. I couldnt move anything on my body.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 (at the age of 46-year-old), as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis and allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ocrelizumab (OCREVUS), levothyroxine sodium (SYNTHROID), citalopram hydrobromide (CELEXA), gabapentin (MANUFACTURER UNKNOWN) and baclofen (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received cefaclor (CECLOR), amoxicillin (MANUFACTURER UNKNOWN and vancomycin (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and experienced drug allergy. On 20Mar2021 at 03:00, the patient experienced that patient's limbs did not work for 7 hours. The patient could not move anything on her body. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events limbs did not work and could not move anything on body was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Student started getting chicken pox on the evening of 09/13/05.  They started on his face and under one arm.  Scabbing started within a few days, able to return to school on 09/19/05.
Severe rash with pus filled blister sac, Searing pounding Headache, Itching from head to toe, oral blister , body aches ,nausea,  and weakness lasting 3 weeks Fever for 4 days
After second shot, felt drowsy quickly. Next day I had fever of 101, chills, pounding headache, sharp pain headache, weakness, pain at injection site, aches, couldn't sleep.  Did not treat with any medication. Felt fine the next day, except a little fatigue.
9 year old patient inadvertently received a dose of Flublok quadrivalent with no AE; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 9 years old female patient who received 0.5 ml once dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: UJ448AA, expiry date: 22-Mar-2020) via intramuscular route on left deltoid on 05-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  No laboratory data was reported.  Action taken was not applicable.   It was not reported if the patient received any corrective treatment.  Event outcome was not applicable.  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 and Module VI of the 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.  No further information was reported.  No further information was reported.
Pt came to ER with SOB, cough, difficulty breathing onset 1 day ago.
grogginess; chills; severe headache; having the flu; dizzy; tightness in the chest; body aches; slight cough; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (having the flu), DIZZINESS (dizzy), CHEST DISCOMFORT (tightness in the chest), PAIN (body aches) and COUGH (slight cough) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GLIMEPIRIDE and AMLODIPINE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INFLUENZA (having the flu), DIZZINESS (dizzy), CHEST DISCOMFORT (tightness in the chest), PAIN (body aches), COUGH (slight cough), CHILLS (chills) and HEADACHE (severe headache). On 21-Mar-2021, the patient experienced SOMNOLENCE (grogginess). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 20-Mar-2021, INFLUENZA (having the flu), DIZZINESS (dizzy), CHEST DISCOMFORT (tightness in the chest), PAIN (body aches), COUGH (slight cough), CHILLS (chills) and HEADACHE (severe headache) had resolved. At the time of the report, SOMNOLENCE (grogginess) had resolved. Not Provided           Action taken with mRNA-1273 in response to events were not applicable.
Pain Left arm; Tingling; Burning pain; Pain in neck radiating to arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 05Oct2022, outcome "not recovered", described as "Burning pain"; PAIN IN EXTREMITY (non-serious) with onset 05Oct2022, outcome "not recovered", described as "Pain Left arm"; NECK PAIN (non-serious) with onset 05Oct2022, outcome "not recovered", described as "Pain in neck radiating to arm"; PARAESTHESIA (non-serious) with onset 05Oct2022, outcome "not recovered", described as "Tingling". The events "pain left arm", "tingling", "burning pain" and "pain in neck radiating to arm" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, paraesthesia, pain, neck pain.  Additional Information: It was unknown if patient had other vaccine in four weeks. It was reported unknown if patient was tested for COVID post vaccination or had COVID prior vaccination.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Developed local allergic reaction appx 5 x 6 cm (L) deltoid red, indurated, hot at the shot site.
This spontaneous report was received from a registered nurse and referred to an unspecified number of patients of unknown age and sex. On an unknown date, the unspecified number of patients may have received improperly stored PROQUAD (Merck) (lot #, expiration date, strength, dose and frequency were not reported). No adverse effects were reported. This is one of four reports from the same source. Additional information has been requested.
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number unknown, 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.   In January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. In 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 by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's comments: A pharmacist had called up to ask for information regarding the expiration date of Twinrix. The reporter had asked if there was information about extended stability after the expiration date of Twinrix. The reporter had mentioned that her vaccine got expired on 1st January 2023. The reporter had confirmed that the expired dose was administered to a patient. However, she declined to share information about the patient and the vaccine lot number. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received an expired dose of Shingrix, which had led to expired vaccine used.
No additional Adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 31-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S023499 and expiration date 24-AUG-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Patient vaccinated with expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient vaccinated with expired Moderna Covid-19 vaccine) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient vaccinated with expired Moderna Covid-19 vaccine). On 31-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient vaccinated with expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomittant medications and treatment was reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow up received contains new information included updated demographic information of patient.
Shoulder pain at injection site; Pain spread into upper shoulder and neckabout a week after injection; Pain spread down into arm about 2 weeksafter injection; Pain spread down into arm about 2 weeksafter injection with tingling in fingers; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 06Mar2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any past medical history. The patient had no allergy to medications, food, or other products. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021, the patient experienced shoulder pain at injection site continues 3 weeks after shot. On an unknown date in Mar2021, about a week after vaccination, the patient experienced pain spread into upper shoulder and neck. On an unknown date in Mar2021, about 2 weeks after the vaccination, the patient experienced pain spread down into arm with tingling in fingers. The patient added that the nurse who administered the injection stuck the needle a lot higher than normal. She used one hand to locate the shoulder bone and stuck the needle in immediately below that bone. Most shots are usually lower in the muscle area. Doctor seemed to think this might have irritated a nerve.  The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events which included treatment with pain medicines, muscle relaxers and steroid pack. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shoulder pain at injection site, pain spread into upper shoulder and neck, pain spread down into arm with tingling in fingers was not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 11:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Patient with history of Alzheimer's dementia, prostate cancer. He was brought to the ED by EMS on 1/21/23 for evaluation of urinary incontinence and generalized weakness. His wife reported that the patient had a fever that morning, and overall has been generally weak. His wife recently tested positive for COVID. She tested the patient at home which resulted negative. A COVID PCR test performed in the ED resulted positive. Ultimately patient admitted 1/21/23 - 1/26/23 for COVID-19. Patient was without any respiratory distress or hypoxia. On day of discharge, patient was afebrile with stable vitals. Patient has received the primary COVID vaccine series and booster x3.
Patient describe pressure related to the ear drum which is mild in nature.  Patient described during his 2nd appointment.  Patient took second dose and has not taken any medication for this symptom
Migraines; Persistent cough; Aches/pain for 48 hours following administration; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0188) via an unspecified route of administration on 18May2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included finasteride (PROPECIA) for unknown indication started on an unknown date. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 27Apr2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021, the patient experienced aches/pain for 48 hours following administration. On 28May2021, the patient experienced migraines, persistent cough lasting 6 weeks post administration. Therapeutic measures were taken as a result of cough and included treatment with cough suppressant. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event aches/pain was recovered on an unknown date in 20May2021 after the duration of 48 hours and the events migraines and persistent cough was not recovered at the time of this report.
Info has been received from a health professional concerning a 14 year old white male with a shell fish allergy who on 10/9/95, was vaccinated with a SC, 1st dose, in the right arm of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. I was reported that the pt presented with break through chickenpox at an office visit on 4/4/05. The pt had approximately 50 lesions with the rash all over his body including his trunk, scalp, face and extremities. It was noted that the pt also had a fever of 100. Treatment and comfort care was performed as needed. It was reported that the lesions are crusted and the pt is recovering. No lab or diagnostic tests were performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info from a health professional indicated that on 4/3/05, the pt developed a rash over his trunk, scalp, face, and extremities of approximately 50=75 lesions. The pt's status was reported as recovered. Additional info is no expected.
administration of dose more that 12 hours post puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of dose more that 12 hours post puncture) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of dose more that 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of dose more that 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.