chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching and appearance of hives around neck, on stomach.  During next couple of weeks would appear on legs and arms.; Itching and appearance of hives around neck, on stomach.  During next couple of weeks would appear on legs and arms.; This is a spontaneous report from a non-contactable consumer or other non-Health Care Professional.A 70-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 10:45 at the age of 70-years-oldas DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. The patient's concomitant medications were not reported.On 03Feb2021 16:30  the patient experienced itching and appearance of hives around neck, on stomach. during next couple of weeks would appear on legs and arms. The outcome of events was recovering. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
(L) Deltoid has been warm since vaccine. She Noticed redness to injection site on 1/5/2021
5Aug96 Pt recv 1st dose vax. 16Jan98 Pt exp chickenpox w/approx. 12-24 lesions. No fever. Lesions scabbed over within a wk & Pt recovered.
COVID Breakthrough Case  Pfizer Dose 1 3/12/21 (EN6204) Pfizer Dose 2 4/7/21 (ER8737) COVID Positive 9/26/21  9/30/21: -Patient is a 65 yo female with medical history of DMT2, HTN, HLD, Obesity, Anxiety  -She is presenting with worsening COVID symptoms  -She has had symptoms for about 2 weeks now but got tested positive at outpatient clinic on 9/26  -Symptoms comprises of SPB, cough , chills, anorexia , diarrhoea  -She has not been taking any of her home medications since sunday because she was not feeling well  -Denies chest pain , fever , nausea, vomitting  -Multiple family members testing positive for COVID  -She is COVID vaccinated  -Initial vitals significant for saturation 87 % on room air which is improved on 2L oxygen . Other vitals stable  -CXR showed patchy atelectasis or infiltrate at the lung bases.  -Lab sinificant for AKI Cr 1.7 , D dimer 0.60 ( age appropriate), glucose 122, normal troponin, normal CBC and coagulation profile  -Patient received 1L normal saline in the ER  10/2/21: -Patient is a 65 yo female with medical history of DMT2, HTN, HLD, Obesity, Anxiety  -She is presenting with worsening COVID symptoms  -She has had symptoms for about 2 weeks now but got tested positive at outpatient clinic on 9/26  -Symptoms comprises of SPB, cough , chills, anorexia , diarrhoea  -She has not been taking any of her home medications since sunday because she was not feeling well  -Denies chest pain , fever , nausea, vomitting  -Multiple family members testing positive for COVID  -She is COVID vaccinated  -Initial vitals significant for saturation 87 % on room air which is improved on 2L oxygen . Other vitals stable  -CXR showed patchy atelectasis or infiltrate at the lung bases.  -Lab sinificant for AKI Cr 1.7 , D dimer 0.60 ( age appropriate), glucose 122, normal troponin, normal CBC and coagulation profile  -Patient received 1L normal saline in the ER  -On admission was managed with IV steroids, IV antibiotics  -Improved respiratory status today with less symptoms  -Home O2 eval  showing she needs 3L with activity  -Discharged with po steroids, po antibiotics and supportive medications
a few hrs p/vax 19OCT94 pt was lethargic & devel a high fever w/a temp up to 105;MD notified about 2months later & felt it was a rxn to DTP;mom gave more APAP & was fine by next day;no other sx reported
I had stuff nose and sore throat. The next day I had chills and fever. I had SOB breath the next week. I went to get a Covid-19 test, positive. I had a chest pain and SOB. I went to the ER. They did an EKG, chest X-ray, and blood work. The X-ray show that I had pneumonia. They gave me steroids and released me. I am still having heart problem, SOB, and headaches.
Cough, extreme fatigue, weakness, dehydration, bad long term pain in arm,  aggravation of Migraine and tendinitis. In bed all week. Still ill on 11/25/2020
first dose of Shingrix in Oct 2020 and has not received the second dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on October 2020, batch number-J3CD5, expiry date-26th March 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 03-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Severe body aches Pain in and around injection site, unable to use arm Extreme fatigue Shortness of breath Nausea Congestion Diarrhea  Pain in kidney and abdomin Lightheadedness dizzy spells
Sugar levels high 280 and above; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Sugar levels high 280 and above) 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 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Sugar levels high 280 and above). At the time of the report, BLOOD GLUCOSE INCREASED (Sugar levels high 280 and above) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.
This spontaneous report was received from a registered nurse and refers to a 5 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 03-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 54 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided. On an unspecified date in 2014, the patient was vaccinated with the first dose of ZOSTAVAX which had a lot number of J011213 and expiration date on 14-NOV-2014 (route of administration and anatomical location were not reported). Then, on 03-NOV-2016, reported as "today", the patient was vaccinated with the second dose of ZOSTAVAX 0.65ml, subcutaneously, which had a lot number of M026876 and expiration date on 26-JUL-2017 (anatomical location was not reported). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Pt vaccinated /w DTP/OPV received 1st DTP 1AUG90 at 2mo of age. Screamed w/a higher than usual cry unconsolably for approx 1 hr & laid quietly against mom for about 2 hrs pale & clamy & cold. Then perked up, ate & has been fine since.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient reported generalized rash during appointment for the 2nd dose. Rash appeared 1 week after the 1st dose. Patient did not seek medical care
On 7/27/09 presented with rash on face then spread to entire body. Had a high temp 7/25/09 seen at E. R.
Pt apparently had a heart attack  and died according to the news article.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An adolescent male patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose dose number=1), for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (death), outcome "fatal", described as "Pt apparently had a heart attack  and died according to the news article.". It was unknown if therapeutic measures were taken as a result of myocardial infarction. The patient date of death was unknown. The reported cause of death was myocardial infarction. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Pt apparently had a heart attack  and died according to the news article
Patient fainted and was dehydrated. No injury occurred and patient blood pressure was checked multiple times and was in normal range. She was observed for 30 minutes and felt better. She stated she gets dehydrated easily, no medical treatment was necessary.
I ran a fever, body aches, tired and ringing in my ear after the vaccine for three days but the ringing in my ears lasted a month. I tested positive for COVID-19 on 07/17/2022via a home test. I had a fever, tired and bad headache. I went to a clinic and they tested me again and put me on Paxlovid.  I felt better after starting the Paxlovid.
I cant stand up, as my legs are bucking up; fatigue; felt weak; soreness at injection site of left arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), DYSSTASIA (I cant stand up, as my legs are bucking up), VACCINATION SITE PAIN (soreness at injection site of left arm) and FATIGUE (fatigue) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Cholesterol, NORTRIPTYLINE for Depression, LISINOPRIL and FUROSEMIDE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (felt weak) and VACCINATION SITE PAIN (soreness at injection site of left arm). On 09-Mar-2021, the patient experienced DYSSTASIA (I cant stand up, as my legs are bucking up) and FATIGUE (fatigue). On 10-Mar-2021, ASTHENIA (felt weak), DYSSTASIA (I cant stand up, as my legs are bucking up) and FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE PAIN (soreness at injection site of left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included Blood pressure pills.   This case was linked to US-MODERNATX, INC.-MOD-2021-056729 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056729:cross-linked case
Diffuse myalgias, radicular left arm pain, L chest wall spasms, brachial neuritis for 48 hrs after injection.
feeling like a truck hit; Extreme fatigue; Joint Pain; Muscle pain; injection site itchiness; injection site pain/tenderness; injection site swelling. It is pretty expansive almost the size of a small child fist; Injection site redness; Headache/ bad headache/ horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling like a truck hit), VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE PAIN (injection site pain/tenderness), VACCINATION SITE SWELLING (injection site swelling. It is pretty expansive almost the size of a small child fist) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hair loss.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE PAIN (injection site pain/tenderness), VACCINATION SITE SWELLING (injection site swelling. It is pretty expansive almost the size of a small child fist), VACCINATION SITE ERYTHEMA (Injection site redness) and HEADACHE (Headache/ bad headache/ horrible headache). On 09-Mar-2021, the patient experienced FATIGUE (Extreme fatigue), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle pain). On an unknown date, the patient experienced FEELING ABNORMAL (feeling like a truck hit). In March 2021, VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE PAIN (injection site pain/tenderness), VACCINATION SITE SWELLING (injection site swelling. It is pretty expansive almost the size of a small child fist), HEADACHE (Headache/ bad headache/ horrible headache), FATIGUE (Extreme fatigue), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle pain) had resolved. At the time of the report, FEELING ABNORMAL (feeling like a truck hit) had resolved and VACCINATION SITE ERYTHEMA (Injection site redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included a medication for her hair loss three times a week. No treatment information was provided.   This case was linked to MOD-2021-162218 (Patient Link).   Reporter did not allow further contact
#1: I received a flu shot on 11/02/2010 at my Dr.'s office; within 4 days I began the symptoms of shingles, despite getting the ZOSTAVAX in 2007. I now have a full-blown case of shingles, which I have never had before. I noticed on the internet that I am not the only one, with a variety of people reporting the same effect of shingles following the flu shot. #2: In 2009 I also received some CELEBREX from my PA-C; within a month I developed a very low platelet count. I immediately stopped the CELEBREX, but my platelet count is now in the low normal range, but never returned to the "pre-CELEBREX" era.
diarrhea; nausea; soreness at the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at the injected arm), DIARRHOEA (diarrhea) and NAUSEA (nausea) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE PAIN (soreness at the injected arm) and NAUSEA (nausea). On an unknown date, the patient experienced DIARRHOEA (diarrhea). The patient was treated with CANNABIS SATIVA (CBD COMPLEX) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (soreness at the injected arm), DIARRHOEA (diarrhea) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I had a fever that started an hour or two after the shot, then the next morning I woke up around 9am with fever, chills, nausea, body aches, weakness, and dizziness if I tried to walk. I called off work, went back to sleep, and by 1pm the nausea and dizziness were gone. I had a fever, body aches, and chills for the rest of the day. This morning I woke up and my fever was gone.
Red, swollen and itchy rash around injection known as  covid arm started today - 1 week after injection
C/O chills, aches (new onset), headache (chronic) 12 days after COVID dose #1. Patient found to be hypotensive and tachycardic in ED, was admitted due to complex medical history. Hypotension, tachycardia, and AKI resolved after 1L LR.
Information has been received from a physician's assistant (PA), concerning a 21 year old female patient, who on 20-FEB-2007 was vaccinated with the first dose of Gardasil (Lot #653736/0689F). Concomitant therapy included hormonal contraceptives (unspecified). On 20-FEB-2007, following the vaccination, the patient experienced itching from head to toe for 3-4 days, but no rash was present. Treatment involved Benadryl. On approximately 24-FEB-2007 (after "3-4 days"), the patient recovered. The PA felt that the itching was "from the vaccination" and related to therapy with Gardasil. Additional information has been requested. Follow up information confirmed that the patient was vaccinated with the second dose of GARDASIL (date not specified), with no problems reported. No further information is expected.
The pt got 1st dose of Moderna on 9/12/21 and was fine. However, the night of 9/20/21 she developed a small rash/swelling/redness at the injection site but no where else. The area got three times bigger than the night before. The area is painful and feel hot to touch. The pt also feel nauseated, lightheadedness about 4 days ago (9/17/21). She went to her PCP today, the PCP marked the swelling area with a market and instructed pt to monitor it - if it spread outside of the line, she will need to return to PCP.
Super sick 2-6 days after shot. Fever, chills, aches, headache, vomiting
49 hours after I began to feel dizzy, my ears clogged and I felt generally bad. I was sent to a doctor who sent me to a hearing test. My right ear got damaged and cannot hear below ~40-50 decibel on all frequencies. + I got tinnitus. The treatment I got is Prednisolone 60 mg daily for a week. 4 days, nothing changed so far
Patient developed chest pressure which prompted him to visit the ER. Patient was treated for Acute Coronary Syndrome. He was ultimately shown to have an elevation of Troponin I. Chest pain began about 15 minutes after Flumist vaccine.
50 year old male patient with a history of well controlled T2DM and HLD who presents to the Emergency Department with chief complaint of syncope after 1st dose of Pfizer COVID-19 vaccine 30 minutes prior to arrival.   Patient reports that while he was waiting after receiving his first dose of the COVID-19 vaccine, he developed a feeling of dizziness and reports that "things were going black slowly". He called for help. Per triage note, he was observed by the staff passing out. He did not fall/there was no head strike. He was found to be hypotensive with SBP of 69, followed by an SBP of 100 after sitting up, then again to the 60s. He received 250cc bolus fluid en route. Patient remembers feeling better after sitting up and now reports that he is at his baseline mental status and feels "completely normal".   Patient received 1L normal saline in the ED.
Came to clinic with mom for sibling's TB test to be read.  Complained of reaction to shots left thigh. Received DTAP & IPV left thigh on 01/16/04.  Left thigh (+) redness, swelling, hot to touch, itching. Redness and swelling measure approximately 10x13cm.  Going from anterior thigh to inner thighs.  Not sure of onset because pt was with father.
Patient said the day after she received the vaccine, there was a big red bump on the her arm below the injection site and she felt like there were cockroaches crawling on her skin.  She had to miss work for two days. She reported feeling more sick from the vaccine than the COVID infection she had a few months ago.
Information has been received from a registered nurse concerning her 16 year old daughter with a history of irritable bowel syndrome who on unspecified dates were vaccinated with a first and second dose of Gardasil. On 23-FEB-2008 the patient was vaccinated with a third dose of Gardasil 0.5 mL IM. There was no concomitant therapy. The registered nurse reported her daughter completed the Gardasil series on 23-FEB-2008. Since her daughter has started the vaccination series she developed intermittent abdominal spasms, nausea, vomiting and diarrhea. The symptoms were severe on 03-JAN-2008 and the daughter was taken to the ER. She was found to be dehydrated; was treated with IV fluids, and was then released. The patient had an abdominal X-ray performed and was negative. A complete blood cell count was performed and was normal. The patient was positive for dehydration. At the time of the report the patient was recovering. This report is one of two sources. Additional information has been requested.
Symptoms and symptom onset date not reported. Case admitted to hospital on 10/24/21. She tested positive for Covid-19 with a respiratory panel on 10/24/21.
Body/joint pain Headache Joint Stiffness Injection site pain and soreness of the arm malaise Symptoms begin approx. seven hours after the injection and continues
No additional adverse events reported; The patient accidentally received an expired doseof VAQTA; This spontaneous report has been received from a nurse via office manager regarding on a 21-year-old female patient. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On 14-JAN-2021, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA), at a dose of 1 milliliter (ml), intramuscularly (IM), as prophylaxis, lot number reported and validated as S036494, expiration date reported and validated as 09-JAN-2021  (strength, anatomical site of vaccination, and vaccination scheme frequency were not reported).  It was reported that the patient was accidentally vaccinated with the expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (expired product administered) however, the vaccine was reported to be properly stored. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Rash all over body. Burning itching, eyes burning, itching. I did not have this until I got the shot. Doctor said it was eczema. This shot was on 12-15-06. Today 3-12-07 I still itch. I which I had not taken shot. Big Mistake.