chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hard on hearing/lost his hearing; pain in his right ear; Chills; headache; Fever; Weakness; lacking appetite; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810, expiration date was not reported) (at 86 years of age), via an unspecified route of administration in the left arm on 03Feb2021 15:00 at a single dose for COVID-19 immunization. Medical history included ongoing chronic lymphocytic leukaemia, ongoing blood pressure abnormal and ongoing thyroid disorder. Concomitant medication included hydrochlorothiazide which he was taking for years, ibrutinib which he was taking for 7 years, levothyroxine which he was taking for 10 years and losartan which he was taking for 8 years. The patient had no any other vaccine prior to covid vaccine. It was reported that the patient received the Pfizer covid vaccine on 03Feb2021. 24 hours later (04Feb2021), he experienced pain in the ears, headache, chills, and fever up to 101.5 for almost a week now, and currently is hard on hearing and had been feeling weak and lacking appetite. It was added that a week ago he received the first dose of the Pfizer COVID 19 vaccine on 03Feb2021 at 1500PM in the left arm. Within 24 hours the side effects started. He had a pain in his right ear and a headache. Since then he has gradually lost his hearing in that ear and they are following up with an ear nose and throat doctor. On 04Feb2021, he got a fever of 101.5, chills, weakness and no appetite. Since then in the evening he had been having kind of a fever of 100 to 100.5 and she has treated with TYLENOL. The fever comes and goes. In the morning he was normal. Adds his appetite was better but he still has to force himself to eat. She queried if should the patient get the second dose of the vaccine. Patient is scheduled to receive the second dose on 04Mar2021. The patient did not visit the ER. The patient underwent lab tests and procedures which included body temperature: up to 101.5, fever of 100 to 100.5, and 101.5 on 04Feb2021.  The outcome of the event loss of hearing, fever, weakness, and pain in his right ear was not recovered; headache and chills are recovered on 05Feb2021; while recovering for lacking appetite. The loss of hearing was reported as worsened. Therapeutic measures were taken as a result of fever (pyrexia).
arm is in tremendous pain; confused; tremendous problem sleeping at night; Very tired and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is in tremendous pain), CONFUSIONAL STATE (confused), SLEEP DEFICIT (tremendous problem sleeping at night) and FATIGUE (Very tired and fatigued) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Radiation therapy since an unknown date. Concurrent medical conditions included Breast cancer and Diabetic. Concomitant products included LEVOTHYROXINE, ATORVASTATIN, MELOXICAM (MELICAN), GABAPENTIN and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm is in tremendous pain), CONFUSIONAL STATE (confused), SLEEP DEFICIT (tremendous problem sleeping at night) and FATIGUE (Very tired and fatigued). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency; IBUPROFEN for Pain, at an unspecified dose and frequency; NAPROXEN for Pain, at an unspecified dose and frequency; TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) for Pain, at an unspecified dose and frequency and MENTHOL, METHYL SALICYLATE (SALONPAS [MENTHOL;METHYL SALICYLATE]) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm is in tremendous pain), CONFUSIONAL STATE (confused), SLEEP DEFICIT (tremendous problem sleeping at night) and FATIGUE (Very tired and fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Fever of 106 treated with Tylenol by mom, patient discharged home; Coronavirus infection; Coronavirus test positive; This non-serious case was received during monitoring on 12-APR-2023 with the following Primary ID 2559597-1. The original narrative from the sender is the following:  Fever of 106 treated with Tylenol by mom, patient discharged home.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Fever of 106 treated with Tylenol by mom, patient discharged home, coronavirus infection, and coronavirus test positive".  No further information is expected.
I was very fatigue after receiving the vaccine. I had chills and a fever. I was pregnant and my estimated delivery for the baby would've been May. I lost my child.
Breakthrough COVID infection in fully vaccinated patient. Positive date 07/20/2021.
Day 2/after injection: sore arm, muscular and joint aches.  Day 3, same, including headache.  Day 4, same, including scratchy throat, small cough.  Day 5, same, full blown sore throat, terrible hacking cough, fatigue, stolen neck glands.  Day 6, same. Day 7: diminishing. Treatments/Daily:  gargle with salt water, 3000 mg vitamin C, green tea, tons of water.  First 3 days, Advil for headache and aches.  Day 4, 5, 6;  OTC Flu medicine.  This seemed to work the best, day 7, feeling almost normal.
Died Narrative: Pt has a diagnosis of: Parkinson's Disease, severe AS, heart failure Symptoms include: dyphagia, aphagia, excessive secretions. Agency patient has been referred to: Hospice Code Status:DNR/DNI 90M with PMH notable for Afib, chronic aspiration, and dysarthria, severe aortic stenosis who presents3/5 with 2 weeks of generalized weakness and in ED noted to be in AFib w/ RVR to 130s, CT findings suggestive of volume overload with exam supporting this at time of admission, and also noting nonspecific generalized weakness. DC Home 3/9 Hospice
48 hours after 2nd vaccine on 4/6/2021, my upper body was in excruciating pain. Lower body had moderate pain only. Did not get medical attention. Pain lessened to a manageable level after 24 hours.  In April, 2021, I had sharp abdominal pain in the upper right quadrant. 2nd ultrasound showed gallstones. cholecystectomy performed on 4/26/2021  On 5/31/2021, I had a bout of vaginal bleeding that I thought was a miscarriage. Pregnancy test was negative at the emergency room. Unknown cause of heavy, sudden bleeding. No treatment given/taken.             In April, 2021, I had sharp abdominal pain in the upper right quadrant. 2nd ultrasound showed gallstones. cholecystectomy performed on 4/26/2021
DAYS 0-2 AFTER INJECTION:  MODERATE SWELLING AND REDNESS AT INJECTION SITE + SIGNIFICANT TOUCH-TENDERNESS DAYS 7-10 AFTER INJECTION:  "COVID ARM" (SLIGHT SWELLING + RED RASH + ITCHINESS AT INJECTION SITE)
Started evening of  01/027/2021Body Aches , fever chills , headache, on01/28/2021 2and 01/27/2021  nausea and  diarrhea, arm soreness
Patient reported upper part of left arm (where she got PNEUMOVAX) is red, swollen, and warm to the touch from the vaccine injection site down to the bend in her arm. Patient is contacting her physician. That is all information available at this time.
IPOL vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event; Initial information received on 15-Jun-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 5 years old male patient who experienced ipol vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event while receiving vaccine IPV (VERO) (IPOL).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine); and hepatitis a vaccine (Hepatitis A).  On 13-Jun-2022, the patient received a dose of suspect IPV (VERO) at a dose of 0.5 ml with lot U1C571M and expiry date: 17-Jun-2023 via intramuscular route in left deltoid for Immunization.  On 13-Jun-2022 (latency: same day) the patient developed a non-serious ipol vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event (incorrect dose administered) following the administration of IPV (VERO).   Action taken: not applicable.  Outcome: Unknown    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 guidelines. 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.
A FEW DAYS AFTER ADMIN OF VACCINE PT COMPLAINT OF SORE ARM. TINGLING OF LEFT ARM.  WENT TO DR. HE RECOMMENDED OTC ADVIL
Woke up in the middle of the night.  In the morning a rash appeared on back.  By the evening of 4/10/2013 entire back and chest was covered in a rash that was red and very hot to the touch.  Had to take to back the Dr to figure out what is going on.  Got checked for strep and all was negative.  Most likely thought to be a reaction to vaccination.
Postpartum lochia returned after having nearly diminished both times after my Covid vaccine. First was at 2+ weeks postpartum. The second was 5+ weeks postpartum.
2.5 cm x 1 cm localized reaction. BENADRYL 10mg.
This spontaneous report as received from a 70 year old female consumer with no pertinent medical history and no drug reactions or allergies reporting on herself. On 26-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # reported as 00006496341) (dose and route not reported). Concomitant therapies included WELLBUTRIN. The consumer reported that in November 2013, she experienced pain in her left insertion from shoulder to her fingers. She also stated that her fingers were still numb. She stated her neurologist had diagnosed her as having Parsonage Turner syndrome. The patient was treated with anti-inflammatories and VICODIN. There were no Lab diagnosis or studies performed. The patient would follow up with her clinician. The outcome of Parsonage Turner syndrome was unknown. Additional information has been requested.
No issues reported but patient was administered a dose that is not approved. She received Janssen 3/14/21, Moderna 0.25 booster 10/25/21, then a booster Moderna 6/21/21. She is under 50 and not immunocompromised
A consumer report has been received via medical representative. The report concerns a 6 years 1 week 3 days old female patient, height: 120.0 centimeters; weight: 50.0 pounds. No information regarding the relevant history, concomitant disease and concomitant drug was provided. The patient had received nasal FLUMIST QUADRIVALENT (intranasal) on an unknown date during Oct-2017 for prevent the flu. Mother reported that the child was diagnosed with Influenza A at the health professional's office on 22-Dec-2017. The child was given Tamiflu 6 mg per ml and instructed to take 10 ml orally twice a day for 5 days. The outcome of influenza A was unknown. Company physician considered the event influenza A to be non-serious.
This report is due to administration of expired vaccination. Patient was given a vaccine that had a BUD of 12/1/21. The vaccine itself expires on 1-29-22, but due to being in the refrigerator from 11/1/21, it expired on 12/1/21 and this was missed.
Fever and chills started 16 hours after 2nd Moderna vaccine.   Syncope occurred morning after (Approximately 22 hours after vaccine).
Patient called the 10/26/23 pharmacy reporting a localized reaction on her left arm in which Arexvy was administered on 10/24/23. She reported redness and swelling, feeling nauseous, fever and sometimes lightheadedness and feeling faint.
60 year old male was administered with Fluzone High-Dose/no AE; 60 year old male was administered with Fluzone High-Dose/no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA274359 (same reporter).  This case involves a 60 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route.  It was of actual medication error case due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate age) and overdose (overdose).  It was unknown whether adverse event was noted or not.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.  List of documents held by sender: none.
opened Ipol vial that was exposed to a temperature excursion; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  It was linked with 2019SA130411, 2019SA130412 and 2019SA130377.  This case involves a 4 months old male patient who that was exposed to a temperature excursion, while he received 0.5 ml vaccine IPV (VERO) [IPOL] on 24-Apr-2019 (lot: P1A242M)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HIB VACCINE (HIB) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was of actual medication error due to incorrect product storage. It was reported vaccine underwent the following elevated temperature excursion on 23 Apr 2019: at 1:05 pm the temperature was 46.4 degrees F, at 2:05 pm the temperature 46.7 degrees F, and by 2:35 pm it had returned to within range at 45.8 degrees F.  It was unknown whether adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.  List of documents held by sender: none.
severe headache, abdominal pain, body aches, tired,  highest fever 100.2 ( her normal temp is 97.7). severe headache lasted approximately 3-4 days. abdominal pain lasted approximately 1 day, body aches lasted approximately 9 days.  tired still ongoing. fever would fluctuate between 99.5 and 100.2 for  10 day--9/2 thru 9/11.  on 9/12 the temperature fluctuated between 98.4 and 99.5.  9/13 temperature fluctuated between 98.4 and 99.6  as of 5:25 PM CST.  Dr advised to give Motrin for aches starting 9/3.  Dr advised taking ibuprofen staring 9/7 when we sought medical attention.
painful arm around injection site, low grade fever, strong headache, nausea, generalized joint pain
Information has been received from a certified nurse practitioner for GARDASIL and VARIVAX, two Pregnancy Registry products, concerning a 12 year old female patient with no pertinent medical history who on 20-OCT-2010 was vaccinated IM with 0.5 ml GARDASIL (lot number 666595/0096Z, expiration date 14-OCT-2012), subcutaneously with 0.5 ml of VARIVAX, IM with 0.5 ml of Tdap and 0.5ml of FLUZONE. It was reported there was no concomitant medication. On 20-OCT-2010, urinalysis was performed (results not provided). On 27-OCT-2010 bloodwork was performed (results not provided). On 27-DEC-2010 the patient went to the physician's office reporting that she was pregnant. A "sonogram" performed by the physician on the same date confirmed that the patient was pregnant when she received the vaccinations on 20-OCT-2010. At time of the report, the patient's outcome was unknown. The nurse practitioner also mentioned that the patient took one dose of ED-A-HIST DM on 15-OCT-2010 and the patient experienced an anxiety attack, requiring the patient to seek medical treatment at an emergency room. Follow-up information has been received from a completed questionnaire. The lot number of VARIVAX was 669723/0835Z. The patient was vaccinated at private doctor office/hospital. The patient was not tested for varicella antibodies before vaccination with VARIVAX. The date of the patient's last menstrual period was unknown and the estimated delivery date was 05-MAY-2011. No amniocentesis or Maternal Serum Alpha-Fetoprotein Screening (MSAFP) was performed. There was no previous pregnancy. No birth defect, no miscarriage or stillbirth occurred in any previous pregnancy. There was no local reaction at vaccine site. There were no varicella symptoms and no herpes zoster symptoms after vaccination. The patient was used FeSO4/prenatal vitamins daily (start date unknown) and azithromycin 1 gram from 06-JAN-2011. Additional information has been requested.
Injection site is red, itchy and slightly raised.; Injection site is red, itchy and slightly raised.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 73-year-old female patient received (who was not pregnant, at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3302 and expiry date was unknown) via an unspecified route of administration, in Arm Left, on 26Jan2021 15:00, as single dose for COVID-19 immunization, at hospital. Patient's medical history was not reported. Concomitant medications were included women's Multi-Vitamin, Calcium and Fish Oil (within two weeks of vaccination). Patient previously took sertraline and citalopram; had allergies with these two medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, Prior to vaccination. Since the vaccination, Patient has not been tested for COVID-19. On 02Feb2021, 23:00, patient experienced Injection site is red, itchy and slightly raised. Patient was not received treatment for the events. Seriousness of the events was reported as non-serious. Outcome of the events was reported as not recovered.
Twenty fours hours after receiving the vaccine your arm was red, hot swollen, itchy. During the night I scratched my arm leaving lesion and about four inches from the injection site there was red circles. I was seeing my dermatologist for another issue and he took a look my arm and advised me to use hydrocortisone cream as it looked like I was having an allergic reaction to the preservatives in the vaccine. I have mostly recovered just some peeling of my skin.
This spontaneous report as received from Nurse Practitioner refers to a 24 years old female patient with no pertinent medical history and no drug reactions/allergies. On 20-AUG-2012 the patient was vaccinated intramuscularly with the first dose of GARDASIL (Product Lot # reported as 0636AE, Exp Date: 01-JAN-2015). No concomitant medications were reported. On 27-AUG-2012 (one week after receiving her first dose of GARDASIL) the patient developed fatigue and weakness. No treatment information was reported. No lab diagnostics studies were performed. The patient had sought unspecified medical attention. The outcome of fatigue and weakness was reported as recovered/resolved. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-DEC-2015, the patient was vaccinated with ZOSTAVAX, (lot#, expiry date, dose, frequency and route of administration not reported). On 07-DEC-2015 (also reported as today), the patient telephoned to say that he was unsure if he has had the ZOSTAVAX vaccine before 04-DEC-2015. No adverse effects reported. No product quality complaint (PQC) was involved. No further information was reported. Additional information has been requested.
Patient felt faint and fell to the floor within 15 minutes of vaccination.  Patient was transported to ER by EMS.
Patient 16 y/o and received dose that is only approved for 18 y/o and older
45 min after immunization when patient returned home her arm started swelling turned red and is hot to the touch.
This spontaneous report was received from a Certified Medical Assistant (CMA) referring to an unknown age female patient. The medical assistant reported that the patient received the first dose of GARDASIL on 31-JAN-2011 (no dose and route specified) (lot number and expiration date not provided) and the second dose of GARDASIL on 17-JAN-2012. (No third dose of GARDASIL has been administered). No adverse event reported. Additional information has been requested.
Chills; fatigue; muscle aches so bad it made me cry; muscle aches so bad it made me cry; pain everywhere even clothes against my skin hurt/it was all I could do to physically get to bed, which hurt with every step; temp of 99.7; malaise; profound sleepiness; Arm pain at injection site; Arm pain at injection site; This is a spontaneous report from a contactable Physician reported for herself. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at Left arm on 08Jan2021 09:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historic vaccine included the first dose of BNT162B2 on 18Dec2020 08:00 AM intramuscular at Left arm for covid-19 immunization. The patient experienced Chills, fatigue, muscle aches so bad it made her cry, pain everywhere even clothes against her skin hurt, temperature of 99.7, malaise, profound sleepiness, and it was all she could do to physically get to bed, which hurt with every step. Arm pain at injection site for 2 days now, could not sleep on that side, adverse event start date was provided as 08Jan2021 09:00 AM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Clotted blood and four stroke. Currently my mother is bedridden and cannot speak. As time passes, the situation becomes very sad.