chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme skin sensitivity over entire body. Unable to wear clothing without pain.; Extreme skin sensitivity over entire body. Unable to wear clothing without pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 11:30 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Epinephrine intolerance, notes: epinephrine intolerance. The following information was reported: HYPERAESTHESIA (non-serious), PAIN OF SKIN (non-serious) all with onset 06May2021 16:00, outcome "recovered" (May2021) and all described as "Extreme skin sensitivity over entire body. Unable to wear clothing without pain.". Therapeutic measures were not taken as a result of hyperaesthesia, pain of skin.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the  COVID vaccine. No any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID19. Since the vaccination, the patient had not been tested for COVID-19. COVID-19 vaccine was administered at Hospital  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
LEFT UPPER ARM SWOLLEN WITH ERYTHEMA/TENDERNESS, VESICLE AT POLIO INJECTION SITE, WHEAL AT MMR INJECTION SITE, MOTHER ADVISED TO GIVE IBUPROPHEN EVERY 6 HOURS AND USE COLD PACK FOR 20 MINUTES.
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, 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. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms).    This case contains information for the 32nd of 42 patients described by the reporter.  No concomitant drug was reported.  Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.  Vaccine was given to the patients for long COVID between March 2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms off 50% or more. Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches.  No adverse reactions occurred.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Two days after injection, my period started.  I had just finished my period the week before.  This discharge is thick and mucousy like the lining of my uterus and my blood is red not dark and clotty.  it is not a typical cycle for me.  My cycles are regular and consistent.  This has a smell that i have never had before.
On March 23rd, 2021 I received my first dose of Moderna. After 5 minutes of receiving the 1st dose of Moderna, I began to experience some tightness in my throat. My mouth and lips experienced a tingling sensation.  As  I walked around the store passing time, I began to feel dizzy. After 15 minutes the dizziness subsided and the tightness of my throat was manageable, so I left the store. However, it took another hour for the tingling sensation to dissipate. Later that night I felt better, other than a sore arm. 3 days later on March 26th, I began to experience a small pinpoint rash across my torso and upper thighs.  It became quite itchy. My face also became flush as if I was sunburned. At night I felt as if I had hives trying to pop out across the back of my head along the hairline. I took Benadryl for a few nights and Allegra during the day to manage the itchiness.  The rash has since calmed down, however, there is still a faint rash that has become rough to the touch, and heat still brings it out again.
Reports 24 hours after vaccine administered onset (2/19/16) eyelid swelling, tongue swelling, joint pain, nausea, vomiting and diarrhea. Asymptomatic 2-22-16.
Flu like symptoms; Feeling hot and cold; Body ache; Chills; This case was received via an unknown source, no reference has been entered for a health authority on 11-Apr-2021 and was forwarded to Moderna on 11-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS, FEELING OF BODY TEMPERATURE CHANGE, MYALGIA, and CHILLS in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04A821A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS, FEELING OF BODY TEMPERATURE CHANGE, MYALGIA, and CHILLS. At the time of the report, INFLUENZA LIKE ILLNESS, FEELING OF BODY TEMPERATURE CHANGE, MYALGIA, and CHILLS had not resolved.            The patient called to report adverse events that the patient was currently experiencing. The patient few hours after getting the second shot of Moderna vaccine, the patient felt flu like symptoms, chills, felt hot and cold, and body aches.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-072516.
vaccine was mixed with bacteriostatic saline and provided to the patient, directed by CDC and pfizer to readminister.
Received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.  It was reported that the vial was placed in refrigerator on 13-Jan-2022.
Patient found lifeless in bed; was not resuscitated successfully. Received Autopsy Report which revealed COD as SIDS w/cosleeping as contributing factor.  Manner of death was undetermined.
BLURRY VISION (ALARMED HIM); VERY BAD INSOMNIA; INJECTION SITE ARM PAIN; OXYGEN SATURATION AT 88; HEART RATE OF 105; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: penicillin allergy, and allergic to sulfa and other pre-existing medical conditions included: The patient had known medical conditions and no previous medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: unknown) dose was not reported, 1 total, administered on 14-JAN-2022 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-JAN-2022, post receiving vaccine the patient experienced arm pain in the injection site arm. On 16-JAN-2022, patient blurry vision which alarmed the patient. Patient was not sure whether to contact a physician or go to work. On 16-JAN-2022, patient experienced the very bad insomnia and was not slept at all. In JAN-2022, the patient checked the oxygen saturation and heart rate. Oxygen saturation was at 88 and heart rate was 105.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site arm pain, blurry vision (alarmed him), very bad insomnia, heart rate of 105 and oxygen saturation at 88 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220128712-COVID-19 VACCINE AD26.COV2.S- oxygen saturation at 88. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Chills; Fever; Confusion; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 22Mar2021, dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chills, fever, and low confusion through a week. The patient was scheduled to get his second shot in April. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Information has been received from a medical assistant concerning multiple unspecified patients  of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (dose and route were unknown; lot # M002064 with expiration date 12-JAN-2018 and lot # L034370 with expiration date 08-AUG-2017). The vaccines were exposed under temperature of 5.5 degrees Fahrenheit for 1 hour. The previous temperature excursion was 25.6 degrees Fahrenheit for 13 hours cumulative. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
patient states over the years she has had to hold medication various times due to neutropenia, a biopsy, both covid vaccines.; patient states over the years she has had to hold medication various times due to neutropenia, a biopsy, both covid vaccines.; This is a spontaneous report from a Pfizer-sponsored program received from a contactable Healthcare professional. A 50-years-old female patient received the first and the second dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified dates, at 50 years of age, (Batch/Lot numbers was not reported for both doses) as single doses, for COVID-19 immunization and palbociclib (IBRANCE), oral from 2018 (over 3 years) (Batch/Lot number was not reported) and ongoing, at starting dose of 125 mg for breast cancer, then decreased after few cycles to 75 mg daily for 21 of 28 days due to neutropenia. Medical history included mouth sores, fatigue, joint pain, hair thinning, constipation, nausea and neutropenia, all ongoing at the time of the report. Concomitant medication included letrozole taken for an unspecified indication since an unknown date. The patient stated that over the years she has had to hold medication various times due to neutropenia, a biopsy and both COVID-19 vaccines. She reports her side effects did not go away while she was off medication. Neutropenia onset date was reported as 2021 and it was assessed as medically significant. The patient underwent lab tests and procedures which included biopsy: unknown results and lab test which showed neutropenia. The action taken with palbociclib in response to the event was unknown. At the time of the report the event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of neutropenia  due to temporal relationship. However, concomitant therapy with palbociclib represents an alternative explanation for the neutropenia. In addition, the patent has medical history of recurrent neutropenia. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including baseline CBC with differential, counteractive treatment measures and concomitant medications. This case will be reassessed once additional 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.
Severe body aches and exhaustion started on day 1 and is still present 4 days later
armpit swelling after the covid vaccines; the arm swelling after the first two vaccines; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6198) at the age of 73 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "armpit swelling after the covid vaccines"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "the arm swelling after the first two vaccines". The events "armpit swelling after the covid vaccines" and "the arm swelling after the first two vaccines" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, peripheral swelling.   Additional information: The patient got dose 1 in left upper arm left deltoid. Her doctor sent her for an ultrasound and nothing was detected as amiss. Patient had armpit swelling after the covid vaccines. Patient had no treatment for the event but just had ultrasound for arm swelling after the first two vaccines just to make sure that it was not cancerous lumps. The ultrasound as nothing swollen for nodes or lymph nodes at that time and she did not remember when the ultrasound was but it was probably a couple of months after the doses of vaccine. The swelling was ongoing now (at the time of this report) and was squishy and felt different than the other side. Result of assessment for relatedness of drug to reaction/event(s) was reported as Yes. The report was not related to a study or programme. Investigations were conducted.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201343399 same reporter/patient with different events/product;
PT PRESENTED WITH RASH TO UPPER BODY, STOPS AT HIS KNEES  THAT TINGLED, ITCHED AND BURNED,  TREATED WITH STERIODS WITH NO RELIEF. REFERRED TO DERM,
This spontaneous report was received from a nurse concerning a patient of an unknown gender approximately under 15 years of age. The patient's medical history, concurrent conditions, concomitant medications, and drug reactions or allergies, were not reported. On an unknown date in June 2016, the patient was vaccinated with a dose of GARDASIL (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided) as prophylaxis. Subsequently, on 16-FEB-2017, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided) as prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636, expiration date: 15-FEB-2018, intramuscularly route per reporter (strength, dose and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013139: US-009507513-1701USA013136: US-009507513-1701USA013137: US-009507513-1701USA013138: US-009507513-1701USA013133: US-009507513-1701USA013134: US-009507513-1701USA010177: US-009507513-1701USA013132:
Patient was given Adult Dose Pfizer Bivalent instead of the Pedia Dose Pfizer Bivalent.
Red rash- larger every day  Hot to the touch Rash feels hard/like a bump
SHINGRIX was administered intramuscularly to the right deltoid on 5/20/18 around 1100. No acute anaphylactic reaction was observed during the 15 minutes the patient was asked to wait after receiving the vaccine. The patient had no complaints of pain, itching, or shortness of breath upon leaving the pharmacy. The patient returned to the pharmacy about 5 hours after receiving the vaccine, complaining of severe pain on her right upper arm. Patient rated the pain 9/10. Due to the severity of the pain the patient was initially recommended to be seen at an urgent care center. The patient opted to be seen at her primary care for the following day instead. Patient was advised to take acetaminophen for the pain, diphenhydramine for any itching, and cold compress to the site.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 2:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 2:29 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 61.43 for dose administered on 28-Feb-2021 at 02:13 PM and 61.51 for dose administered on 28-Mar-2021 at  02:29:00 PM. No concomitant medications were reported. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 degrees Fahrenheit at 09:00 AM  and 26 degrees Fahrenheit at 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
On 04/09/2021 had low grade fever (99.3) chills, aches, fatigue.  Resolved in 12 hours
Pt. in observation was feeling dizzy with headache.  Paramedics assessed the Pt. once he was feeling better and symptoms subsided he was released to leave.