chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sepsis; Pyrexia; This regulatory authority case was reported by an other health care professional and describes the occurrence of SEPSIS (Sepsis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Vaccination: Flu (seizure like activity). Past adverse reactions to the above products included Seizure with Flu. Concurrent medical conditions included Sulfonamide allergy (sulfa (Bactrim) facial swelling), Allergy (environmental allergies), Factor V Leiden mutation (TSVT) and Asthma. Concomitant products included METOPROLOL, WARFARIN and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SEPSIS (Sepsis) (seriousness criterion medically significant) and PYREXIA (Pyrexia). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, SEPSIS (Sepsis) and PYREXIA (Pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Blood test: 1750 (Inconclusive) 1750. On 08-Feb-2021, White blood cell count: 2.4 (Inconclusive) 2.4. On 14-Feb-2021, Blood test: 26200 (Inconclusive) 26200. On 14-Feb-2021, White blood cell count: 5.82 (Inconclusive) 5.82.     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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
This spontaneous report has been received from a 60 years old female patient referring to herself. The patient's concomitant medication included unspecified flu shot. The patient had none pertinent medical history or drug reactions/allergies. On 03-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (batch/lot#, expiration date and route were unknown) for prevention of pneumonia. On the same day, the patient's arm started to hurt and it became full body pain for about 48 hours. The patient couldn't move and felt like paralyzed. No treatment was given for all the events and no lab diagnostics/studies were performed. The patient didn't sought medical attention. The outcome of all the events was reported as recovering. The causality between PNEUMOVAX 23 and all the events was unknown. Upon internal review, the event of paralyzed was considered to be medically significant.
This spontaneous report as received from a nurse via company representative refers to a 27 year old female patient. On an unknown date/dates the patient was vaccinated with dose 1 and dose 2 of GARDASIL 9 (dosing regimen, lot number and expiration date not reported) intramuscularly for prophylaxis. On 29-JAN-2018 (reported as recently) the patient had a positive pap smear which was performed by an unknown practitioner. The patient was seen at the provider's office for this event but no treatment was given. There was no product quality complaint involved. The status of the patient and the outcome of the event was unknown at the time of the report. Causality assessment was not reported.
patient received  Engerix-B and Shingrix vaccines both on the same day in the right arm. Patient said he developed a fever, blisters and warmth at injection site, and pain in the upper arm area. Patient said that he called the pharmacy and spoke with one of the pharmacists and was instructed to either take ibuprofen or acetaminophen, apply a cold compress, and to contact his doctor if there was no improvement. Patient stated he took either ibuprofen or acetaminophen (he doesn't remember) and used a cold compress. He said the fever and blistering went down, however he was still experiencing pain and figured it would eventually "go away". He also stated that because it was during the pandemic he was not 100% comfortable going to the doctor's office. Patient presented today still with arm/shoulder pain, after having an appointment today (6/15) with an Orthopedic doctor and states he was diagnosed with frozen shoulder or SIRVA
pneumonia; sick; chills; headache; body aches; rash; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. Medical history included rash which he gets anytime of the year. Concomitant medications were not reported. The patient had the first shot and got sick eight days later. He was in the hospital for two days and saw his primary doctor when he got out. The doctor told them that everything with the blood tests was good, and also with his kidneys, then he prescribed medication for pneumonia. With the first dose of the vaccine, the patient also experienced chills, headache and a little body aches without fever. When he came home from the hospital, the patient had a rash. Outcome of the events was not reported.   Information on the lot/batch number has been requested.
Discomfort. Increased discomfort with movement home remedies of ice/heat only analgesics.
10-17-07 1:00 pm 3 hr post injection swollen lymph nodes under arm (left). 3:00 pm Lymph nodes neck swelling 8:00 pm Lymphodes neck totally swollen 10-18-07 5:00 am neck, face swollen to eyes difficulty swallowing, spleen pain.
Vial first puncture was on 5/12/22 @ 10:00 AM so vial expired 12 hours after , vaccine given to patient on 5/13/22 @ 9:07 AM
3/17/04. 10:30 DTAP 4TH, stayed 20 min. At 2am low grade fever, MD gave tylenol. 6AM seizure. 911-EMT temp 103. ER temp was Temp 101. Febrile seizure, related to DTAP -pertussis in DTAP. Give DT next dose.
blood pressure was sky-high, high 290 or whatever/ ended up in the hospital; dizzy; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was sky-high, high 290 or whatever/ ended up in the hospital) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (blood pressure was sky-high, high 290 or whatever/ ended up in the hospital) (seriousness criterion hospitalization), DIZZINESS (dizzy) and PYREXIA (fever). The patient was hospitalized for 1 day due to HYPERTENSION. The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERINE) ongoing since an unknown date at a dose of 1 dosage form and MORPHINE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, HYPERTENSION (blood pressure was sky-high, high 290 or whatever/ ended up in the hospital), DIZZINESS (dizzy) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 290. On an unknown date, Heart rate: increased.         No concomitant drug information provided. Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information has been requested.
Apporximately 6 hours after receiving vaccine developed non-painful, warm, red, rash on left arm.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 058H21A, 008C21A and 020B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2022, the patient experienced COVID-19 (tested positive for Covid). On 16-Aug-2022, COVID-19 (tested positive for Covid) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2022, SARS-CoV-2 test: (Positive) Positive. No concomitant medications were reported. It was reported that, sometime after 30-Jul-2022 patient tested positive for COVID, and it lasted 16 days. Patient felt like he had strep throat. Further patient stated that it could have been 01-Aug-2022 when he tested positive. No treatment medications were reported. Company Comment: This is a spontaneous case concerning a 65-year-old male patient with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19. SARS-CoV-2 test yielded a positive result approximately 4 months after receiving the fourth dose of the mRNA-1273 vaccine, no further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event has resolved. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 65-year-old male patient with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19. SARS-CoV-2 test yielded a positive result approximately 4 months after receiving the fourth dose of the mRNA-1273 vaccine, no further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event has resolved. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
N17.9 - Acute kidney failure, unspecified Chest pain shortness of breath
1. Almost immediately, my left arm became red and swollen and hot to the touch. This side effect lasted for almost 2 weeks. The arm was quite painful if I touched or bumped it for one week, then gradually got better and was fine on the 14th day. 2. That evening of the vaccine and for the following 24 hours, I felt very, very cold with blue skin under my  fingernails and toenails and mottling of my skin on arms and legs. So cold, that even after/during sitting in a 140 degree sauna for 30 minutes, I did not even sweat.  3. Very fatigued for 2 days, slept most of the second day. 4. I had pulsing in my ears for one day, but this occurred a week or two later as well.  5. A sharp pain in my right kidney area also occurred but did not last long.   The only effect that occurred after the first shot was redness and soreness for 2 days.    Today, there seem to be no lasting side effects.
no additional AEs; MMR II was administered on 6/1/2020 and VARIVAX was administered on 6/4/2020; This spontaneous report was received from Other Health Professional and refers to a 4-year-old patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-JUN-2020, the patient received dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, lot #S023656, expiration date: 30-JUL-2021 with therapy type rHA, administered subcutaneously for prophylaxis (dose unknown). On 04-JUN-2020, administered 3 days after the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, unk, lot #S032357, expiration date: 14-OCT-2021, administered subcutaneously for prophylaxis (dose was not provided). No adverse event were reported.
12/10/21 presents to ED for "nausea vomiting diarrhea, and cough and shortness of breath". PMHx of "type one diabetes, hypertension, ESRD on hemodialysis".
headache; swelling in left armpit; difficulty sleeping; fever; fatigue; body aches; sweating; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received second dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201) via an unspecified route of administration, administered into left arm on 12Feb2021 08:45 (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Patient was not pregnant. It was also reported that the patient was taking unspecified concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249) administered into left arm on 22Jan2021 08:30 AM (at the age of 42-year-old) for COVID-19 immunization. On 12Feb2021 14:00, patient experienced headache, swelling in left armpit, difficulty sleeping, fever, fatigue, body aches and sweating. The patient did not receive treatment for the events reported. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 01Feb2021. Outcome of events was not recovered.
About 24 hours after HPV #2 given in (L) deltoid she developed pins and needles feeling w/itching and pain over entire low back area, most noticeable laying down at bedtime.
2 weeks later after receiving the vaccine, patient was noted to have presented with altered mental status, seizures seen on the EEG (highly abnormal EEG with lateralized discharges) as well as higher cortical deficit of aphasia. She was initially admitted from 7/16 and discharged on 7/22. Workup showed MRI brain w/ w/o contrast done which showed signal abnormality in R precuneus cortex and subcortical white matter. Patient was started on Keppra, received antibiotics initially for possible bacterial infections  but was ruled out. Initially was sent home on acyclovir for possible HSV encephalitis. She had improved and had returned back to baseline at time of discharge. She had then re-admitted on 7/30 for one day only for issues with her midline that she was sent home with for prolonged antiviral therapy. Patient was readmitted again on 8/5 and discharged on 8/11. At that time, she was noted to have had repeat of worsening encephalopathy and aphasia, with new enhancing brain lesion but resolution of older lesion, plus some mild CSF pleocytosis, we treated her with high dose Solumedrol for 5 days and sent her home on a high-dose, slow oral steroid taper.  The working diagnosis remained SREAT/Hashimoto?s encephalitis, but results came back that show that she is positive for anti-MOG (myelin oligodendrocyte glycoprotein) antibodies in her serum. There is some concern for  post-vaccination trigger for this autoimmune CNS disorder?although the diagnosis still remains somewhat unclear.
p/vax pt devel shaking & trembling all over body; chilling; seen in ER; sl temp elevation; blood work/ua tests-nl; ER NP told that vax may have caused symptoms; disch
Information has been received from a registered nurse concerning an unspecified patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not informed. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lots # M000442, M026309, M037248 with expiration dates 02-MAR-2018, 11-NOV-2018 and 21-FEB-2019 respectively, (dosages were not provided),  for prophylaxis. The doses of RECOMBIVAX HB were exposed to a temperature > 46°F but  < 77°F and were out of range for 24 hours. A data logger was not used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA001060: US-009507513-1702USA003013.
All over itching that spread & intensified for several hours after shot given and decreased after taking 2 BENADRYL.
Delayed hypersensitivity around injection site (occured day # 8): swelling, itching, redness (around 9 cm in diameter). Responded partially to oral fexofenadine and topical fluocinonide cream.
I did not dilute the pfizer pediatric vaccine before I gave the shot.   Patient received 0.2 mls of undilted pfizer pediatric  baccine
A report has been received from a Physician concerning a 28 year old, female patient, who received Nasal FLUMIST, 0.2 milliliters. Once/Single administration. Inadvertent administrating during pregnancy and pregnant was given FLUMIST - Doctor was unable that it's a live virus were reported which started on 20-NOV-2015. The outcome of the events of inadvertent administration during pregnancy and pregnant was given FLUMIST - Doctor was unaware that it's a live virus is unknown. The event inadvertent administration during pregnancy was considered to be non-serious by the reporter and the event pregnant was given FLUMIST - doctor was unaware that it's a live virus was considered to be non-serious by the company physician.
1.    Initially only mild pain after first vaccination.  Beginning an hour or so after buster (second vaccination), swelling of shoulder and upper arm, completely ceased/frozen to torso with acute pain and immobility for many days and inability to articulate.  Acute pain at shoulder and upper Humerus region when any motion was attempted. Sleep disrupted when I turned to the right side during sleep. Symptoms lasted for almost a month. Symptoms are better now, but NOT completely gone. Pain is milder, (page 2)  2.    While mild tinnitus existed before the vaccination, post buster the tinnitus has become virtually intolerable. Constant head pain accompany loud tinnitus onset, but constant when arm reaches towards back waist.
pinching and feeling kind of itchy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 Immunisation. Patient medical history include exposed to someone who tested positive for COVID-19. Patient concomitant medications were not reported. Patient previously received flu shot and experienced pinching and feeling kind of itchy. Caller reported that she would like to know how protected she is against COVID-19 after receiving the first dose of the Pfizer BioNTech COVID-19 vaccine on 31Mar2021. She states that she was recently exposed to someone who tested positive for COVID-19 but reports that she herself has not been tested for COVID-19.Caller also mentions that after receiving the flu shot in the past, she experienced "pinching" and feeling "kind of itchy" but states that this is a normal thing for her and also stated that it happened after she received the Pfizer COVID-19 vaccine as well. In response to her enquired that there reported there is no information on efficacy after just one dose of the vaccine at this time and explained how the two doses work. Caller states that she received her first dose of the Pfizer BioNTech COVID-19 vaccine on 31Mar2021 and is scheduled to receive her second dose on 17Apr2021. She wants to know if it is okay for her to get it at this date because it would be sooner than the 21 days, or if she should attempt to reschedule it to be closer to 21 days. Enquired about getting the second dose earlier and later than the recommended 21 days. The Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Second dose: chills; Second dose: muscle aches in his knees; Second dose: warm and cold at the same time; Second dose: throwing up; Second dose: constant headache; Second dose: he's not really eating either, he's not that hungry; Second dose: he was hot; Second dose: fever; This is a spontaneous report from a contactable consumer (patient's mother) reported for her son (patient).  A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 03May2021 at 17:15 (Age at vaccination: 16-years-old) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 12Apr2021 at 16:30 (Age at vaccination: 16 years old) as dose 1, single for covid-19 immunization and Patient's mother reported patient was a little tired and had a tiny bit of soreness in his arm at the injection site. Patient's mother thought the soreness in his arm was because he doesn't like to get shots and doesn't like needles. With the first dose, his side effects started the day after receiving the first vaccine on 13Apr2021. His side effects only lasted that day on 13Apr2021, by the next day, 14Apr2021, he was fine. Patient received his second Covid 19 vaccine yesterday, 03May2021. There was no prior vaccination within 4 weeks, no additional vaccines administered. Patient didn't have that bad a reaction with the first Covid 19 vaccine, but for second dose patient had fever and chills at the same time. On 04May2021 He had muscle aches in his knees and that's weird. He was a little warm last night after he received the vaccine, patient's mother thought it was nothing. This morning, 04May2021, he was a little warm. Patient went to school, and she received a call from his school that he was feeling warm and cold at the same time. His temperature was taken at school today, 04May2021, and he didn't have a fever, but he is throwing up. Patient came home after getting his second Covid 19 vaccine, ate dinner, and later on that night on 03May2021 he said he was hot. He was also having headaches. He has a constant headache. Patient's mother reported that he doesn't ever really get sick. Patient's mother reported that he's not really eating either, he's not that hungry. That started today, 04May2021 because he did eat dinner last night, 03May2021. Events didn't required visit to physician office or emergency room. Outcome of the event fever was unknown and for all events outcome was not recovered.  No follow-up attempts are needed. No further information is expected.