chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Generalized red rash on back of arm at injection site. Itchy, smooth rash with no blistering. Told patient to use Benadryl cr. Patient is nurse and marked location of rash to see if any increase. Patient checked back with me on Monday to say cr has reduced itching and no increase in size of rash.
25JUL pt recvd vax 1130AM had taken APAP approx 1/2 hr a/vax; 26JUL red patches on skin-not raised-didn't itch-only cried when diaper changed;
Vaccination dates 03/20/2021, 04/10/202021 an 12/07/2021. After the shot I develop migraines. Muscle aches and increased ringing in both ears.  Pain in both arms, waist area and back. The shot made me extremely tired. My range of motion in arms seems to be limited. I sometimes have to use a long handle spoon or a spatula to help with reaching. My shoulders and upper arm hurt.  Dr. suggest that I take Excedrin Migraine. I do take Advil occasionally for muscle ache.
Extreme fatigue, dizziness, lack of appetite increase in mucus,  some blood clotting in mucus
The pt apparently fainted, fell to floor and had strong jerking movements of arms and legs, mouth pulled up on left side, eyes rolled back for approximately 30 sec. post vaccination. Also hit back of head on uncarpeted floow when he fainted. States he felt "fine" when he regained consciousness. Upon follow-up the pt had no problems following the episode.
This spontaneous case report was received from consumer (PVX2017-3281) on 24-Oct-2017. The report describes a 25-year-old adult female consumer who "ate food half an hour after VAXCHORA administration". The consumer was receiving VAXCHORA for an unknown indication. It was reported that the consumer ate half an hour after taking VAXCHORA. The consumer took VAXCHORA on 23-Oct-2017. The action taken with VAXCHORA with respect to the event "ate food half an hour after VAXCHORA administration" was not applicable. The clinical outcome of the event "ate food half an hour after VAXCHORA administration" was unknown. Sender's Comments: Company's comment: The causality of the event "ate food half an hour after VAXCHORA administration" was considered as not applicable.
Starting the next morning, patient started noticing slight chest pain with deep breaths. Pain grew significantly over the next three days and mild fever began. Went to the ER and was sent home after doctor ruled out heart attack. Returned to ER the next day with significant increase in pain when breathing, especially when lying down. Fever increased significantly to 102.5. He was then admitted with a diagnosis of pericarditis and discharged two days later. He returned to the ER the day after discharge with increasing pain, ever, and breathing difficulty. CR-P was nearly 200. Diagnosed then with Cardiac Tamponade. About 500 ml of fluid was drained in an emergency procedure. He was admitted again. Over the course of the month of March, he was in the ER five times and admitted four times. He continues to suffer with thickened pericardium and is still being treated with anti-inflammatories, including ibuprofen, colchicine, and Prednisone as of June 30, 2021. Doctors are trying to taper the steroids but have had to increase the dose several times during this process as some symptoms return on tapering.  CR-P has finally started to go down and is currently at 3.
Patient presented to the ED and was subsequently hospitalized for fever and sepsis within 6 weeks of receiving COVID vaccination.
Returned 24 hours later with 4 inch diameter red swollen area at injection site.
Patient states that pain began in her right arm shortly after the shot was given and is still hurtful days later. States pain is radiating up arm, into the neck area, and down the back of shoulder. Hurts to sleep on right side.
Ulcer looking Appearance on her Tongue/ Recurrent Dark Red Patches/ Recurrent White Patches; First vaccine was given beyond the 6 hour expiration.; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE ULCERATION (Ulcer looking Appearance on her Tongue/ Recurrent Dark Red Patches/ Recurrent White Patches) and EXPIRED PRODUCT ADMINISTERED (First vaccine was given beyond the 6 hour expiration.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced TONGUE ULCERATION (Ulcer looking Appearance on her Tongue/ Recurrent Dark Red Patches/ Recurrent White Patches) and EXPIRED PRODUCT ADMINISTERED (First vaccine was given beyond the 6 hour expiration.). The patient was treated with CALCIUM CARBONATE (MYLANTA [CALCIUM CARBONATE]) ongoing since an unknown date for Tongue ulceration, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Tongue ulceration, at a dose of 1 dosage form and TRIAMCINOLONE (oral) ongoing from 16-Jul-2021 for Mouth ulcer, at a dose of 1 dosage form. In February 2021, EXPIRED PRODUCT ADMINISTERED (First vaccine was given beyond the 6 hour expiration.) had resolved. At the time of the report, TONGUE ULCERATION (Ulcer looking Appearance on her Tongue/ Recurrent Dark Red Patches/ Recurrent White Patches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products were not provided.  The ulcer or patches come and go, on different locations on the tongue,  and sometimes they are dark red and sometimes white.   This case was linked to MOD-2021-259033.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: NNI
Admitted to hospital on 9/30/2020 and discharged on 10/28/2020.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of an unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in May-2015, unspecified number of patients received improperly stored VARIVAX, lot number reported as L003216 with expiration date on 30-APR-2016 (dose, strength and frequency were not provided). No doses were administered past the expiration date. No symptoms reported. According to the reporter, there were no previous temperature excursions and the temperature and time frame excursions were reported as: -11.2C for 360 hours, -11.1C for 480 hours and -10.7C for 1296 hours. No Product Quality Complaint (PQC) was involved. Lot number L003216 is an invalid lot number for VARIVAX. This is one of several reports received from the same reporter. On 07-NOV-2016, All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
hypoxic on roon air, loss ob bowel and bladder control, altered mental state, sob, lung infiltrate, pneumonia
Mom states client got ill after receiving vaccine. Denies redness and swelling at injection site. Mom states client c/o dry cough, weakness, fatigue, fatigue, nausea, vomiting, hoarse voice and facial rash. Encourage mom to seek emergency TX if difficulty breathing or dizziness.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-mont-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 20-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-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; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Information has been received from an office medical assistant concerning her approximately 16 year old daughter who on an unknown date was vaccinated with the second dose of GARDASIL. On an unspecified date, after receiving the second dose of GARDASIL the patient learned that she had "mono". The patient was also feeling fatigue so she went to her physician's office and had a blood work done which showed she had elevated liver enzymes. On an unknown date the patient's liver enzymes went back to normal. At the time of reporting the patient had recovered from mononucleosis and elevated liver enzymes. Additional information has been requested.
Client called on 11/-20-03 with a c/o chills, fever, muscle aches, muscle cramps, headache and weakness in which she experienced on 11-19-03 at 11pm. PHN advised client to follow-up with physician. Client states she does NOT plan to follow-up with her physician.
Febrile within 24 hours.  Still febrile 72 after shot.  Temp max = 104.  Very irritable.  Speaking deliriously.  Unable to sleep.
Erythema, swelling and soreness at site as seen on 4/4/03. Rx for Motrin and advised cool soaks.
Patient received FLUBLOK QUADRIVALENT instead of the FLUZONE QUADRIVALENT with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional and physician via agency under reference number 00814649).  This case involves a 8 months old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication included a dose of Hepatitis B vaccine (lot number and expiry date and other dosing details were not reported) on an unknown date for prophylactic vaccination.  On 15-Oct-2021, the patient received a 0.5 ml first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (once in total, lot UJ725AA and expiry date :30-Jun-2022) instead of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiration date not reported) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medical error case due to wrong vaccine administered (same day latency).  It was reported "Medical assistant calling to report that a 8 month old child received the FLUBLOK QUADRIVALENT instead of the FLUZONE QUADRIVALENT. Caller is wanting to know what to do."  No corrective treatment was provided.  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
9-30-19 herpetic eye lesion  10-6-19 TIA inability to speak neg CT/MRI  10-8-19 chest pain 10-11-19 slurred speech weakness fatigue
Before his 2nd dose, he was diagnosed with COVID and was given bamlanivimab; Before his 2nd dose, he was diagnosed with COVID and was given bamlanivimab; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient received 1st dose of vaccine.  Before his 2nd dose, he was diagnosed with COVID and was given bamlanivimab. It was planned to wait 90 days before giving him any additional vaccine. Reporter also asked should patient receive one more dose or restart the series. The outcome of events was unknown.   Information about Lot/Batch has been requested.
chills; fever, up to 100.9; muscle aches; headache; nausea; diarrhea; This is a spontaneous report from a contactable other HCP (patient).  This 54-year-old female reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date were not reported) on 03Jan2021 11:00 (at the age of 54-years) as single dose, Intramuscular left arm  for COVID-19 immunisation. Medical history included no allergies to medications, food, or other products and asthma. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications include DOXYCYCLINE (DOXYCYCLINE), METRONIDAZOLE (METRONIDAZOLE), minerals nos, vitamins nos  (ONE A DAY) and CALCIUM CARBONATE (CALTRATE).  Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 03Jan2021 at 03:30 AM the patient experienced fever, up to 100.9, muscle aches, headache, nausea, diarrhea, chills. Events lasted about 24 hours.  The patient did not received treatment as a result of the events.  Lab data included body temperature up to 100.9 on 03Jan2021. The outcome of event chills was recovered, fever, up to 100.9 was recovered, muscle aches was recovered, headache was recovered, nausea was recovered and diarrhea was recovered all on Jan2021.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccines were stored in freezer, were taken out one to two vials and were placed in fridge each day as needed.
Slight bump (immediate). Larger bump (approximately 3 mins). Dizziness (approximately 4 mins). Diaphoresis (approximately 4 mins). Loss of consciousness (approximately 5 mins) for 15 sec. Confusion (approximately 5 mins) for 10 sec. Pt ok (approximately 7 mins)
Patient reported feeling "sleepy" and having palpitations 15 minutes following vaccine dose. Patient received Benadryl 50 mg PO and symptoms improved.  RRT was called for further workup given NSTEMI history and palpitations. Patient was taken to ED for further are.
Swollen lips, chest pain.  Treated at hospital 10/21-10/23, see MD report, he was supposed to send a VAERS. 12/17/08-records received for DOS 10/22-10/23/08-DC DX: Likely acute allergic reaction to Flu shot, resolved. Dyslipidemia. Leukocytosis. Admitted with throat swelling, lip swelling, difficulty breathing. Also ate shrimp on same day.
I went for a run on March 14,2022 @ 16:25, I ran maybe 10 mins in and I started to have pins and needles symptoms. Like when you sleep on your arm and wake up. It wasn't painful but I have never had this  type of event till today. I do not know if it is related to the shot.
Information has been received from a registered nurse concerning a 24 year old female with no pertinent medical history, drug reactions or allergies who on 07-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (653735/0688F) 0.5 mL IM. There was no concomitant medication used. The patient experienced a dull ache in her wrist, neck and back on 08-JUN-2007 the day after the first dose of GARDASIL vaccine (yeast) (653735/0688F) was administered. Medical attention was sought. No further information is available. At the time of reporting, the patient was recovering. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007.  Additional information is not expected.
Redness, swollen area around shot greater than one inch radius; 100 degree Fahrenheit fever for 4 days after shot, and again 10 days after shot; inconsolable crying at 10 days.
Diarrhea started 2/24/10 with blood noted in stool by 2/26/10 so taken to ER. Blood was only a little bit. Diarrhea was watery and going 2 - 3 x /hr on 2/26/10. Chem 7 was normal. Rotavirus was +. Treated with pedialyte; diarrhea lasted 2 1/2 weeks.
This is an instance of breakthrough COVID-190 after which death occurred.   The individual was vaccinated with the Moderna product on 01/13/2021, 02/10/2021, and 11/08/2021. They became symptomatic for COVID-19 on approx 02/15/2022 and tested positive for COVID-19 on 02/14/2022 (these dates are not inverted, this is as it was reported to the disease investigator). The individual experienced complications of probable bronchial pneumonia and encephalopathy. However, I see no indication the individual was hospitalized.  They were a resident of a long-term care facility. They died on 02/23/2022.
itchy; Rash started on left arm on 07Mar2021, and today spread to both arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (Rash started on left arm on 07Mar2021, and today spread to both arms) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01/A2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PRURITUS (itchy) and RASH (Rash started on left arm on 07Mar2021, and today spread to both arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Mar-2021 for Itchy, at a dose of 1 dosage form. At the time of the report, PRURITUS (itchy) and RASH (Rash started on left arm on 07Mar2021, and today spread to both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Report received at manufacturer on Sept. 16,2002 from a physician. It was reported that a 17 yr old male received a "diphtheria- tetanus booster (lot number U0376AA) in his left deltoid region". 48 hours after vaccination, pt was admitted to the hospital with rhabdomyolysis. Pt experienced pain in both upper extremities but nowhere else and markedly elevated muscle enzymes reflective of his rhabdomyolysis. Pt did not develop renal complications and was discharged. Pt is currently seen by a Pediatric Gastroenterologist for his chronic hepatitis B infection. Follow up on 12/02/03: "From additional info obtained on 11/26/03 through a telephone call to the reporter, he stated that he remembered the medical circumstances of this case, as he was brought in for consultation, but this was never his pt.  Due to missing pt identifying info, the reporter was unable to access any files.  He stated that this pt was hospitalized and that the AE was temporarily related to the vaccine.  No other info was provided at this time." Follow up on 05/17/04 states: "No additional information could be obtained. No further information is anticipated, this case is considered closed."
nausea; headaches; injection site is so sore feels like it has a fever; feels like a knot but the redness is gone and now more pink; body aches; another full 24 hours of fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (another full 24 hours of fever), NAUSEA (nausea), HEADACHE (headaches) and VACCINATION SITE PAIN (injection site is so sore feels like it has a fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (another full 24 hours of fever). On 21-Mar-2021, the patient experienced MYALGIA (body aches), NAUSEA (nausea), HEADACHE (headaches), VACCINATION SITE PAIN (injection site is so sore feels like it has a fever) and VACCINATION SITE ERYTHEMA (feels like a knot but the redness is gone and now more pink). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches), PYREXIA (another full 24 hours of fever), NAUSEA (nausea), HEADACHE (headaches), VACCINATION SITE PAIN (injection site is so sore feels like it has a fever) and VACCINATION SITE ERYTHEMA (feels like a knot but the redness is gone and now more pink) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 99 (High) fever of 99.
Itching on upper torso (front, back), neck, arms. Started in morning and continued all day and night. Continued to next day which is today 9/25/3015. On 9/25 I also have a flem lump in my throat. The itching on my front chest feels hot to the touch and also feels hot inside. I notified my primary care physician who directed me to take Benadryl and if it gets worse with breathing or throat closing to go to the ER. I took Benadryl at 12:25 pm on 9/25/2015.
Chills,,pain on the injection site, the day after I experienced facial swelling  it got worst  the fourth day  after and went to emergency room .  After  being examined , I was given prednisone and sent to dermatologist same day for further examination of pustule development.  The dermatologist took some culture of the puss and punch biopsy.  The culture was negative for  what they were looking  for and the biopsy proved inconclusive and pathologist  did not  See any specific that would support reactions to the vaccine.