chrisvoncsefalvay/vaers-outcomes huggingface dataset:
face had swelled up; diarrhea; hard coughing; bad headache; chills; nauseous; weak; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (hard coughing), HEADACHE (bad headache), CHILLS (chills), NAUSEA (nauseous) and ASTHENIA (weak) in a 72-year-old female patient 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced COUGH (hard coughing), HEADACHE (bad headache), CHILLS (chills), NAUSEA (nauseous) and ASTHENIA (weak). On 03-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 04-Feb-2021, the patient experienced SWELLING FACE (face had swelled up). At the time of the report, COUGH (hard coughing), HEADACHE (bad headache), CHILLS (chills), NAUSEA (nauseous), ASTHENIA (weak), DIARRHOEA (diarrhea) and SWELLING FACE (face had swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Patient went to the emergency room on 06-FEB-2021 and was given a shot and medications for the swelling (patient unsure of the names).  She was also given medication to pre-medicate for the second vaccine and was instructed to take them the day before, day of, and day after - Banophen 25mg and Famotidine 20mg.
unilateral axillary lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Aug2021 (Lot number: EW0202) at the age of 32 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 21Aug2021, outcome "not recovered", described as "unilateral axillary lymphadenopathy". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient reported vaccine was injected in L arm. 24 hours later, she began experiencing unilateral axillary lymphadenopathy. The axilla was tender. They persisted 48 hours post-vaccine. No other vaccine was given in four weeks. The patient was not diagnoses with COVID prior vaccination and not tested post vaccination  No follow-up attempts are possible. No further information is expected.
Pt recvd measles vax mid AUG91 & on the evening of vax pt devel fever & urticaria; utricaria was treated w/Atarax; fever resolved; however urticaria recurred ea time Atarax was interrupted;
PAIN AT INJECTION SITE X 2 DAYS FOLLOWING SHOT AND THEN I WOKE UP ON 12/31/20 WITH MY LEFT UPPER ARM SWOLLEN, RED, AND ITCHY FOR THREE DAYS. TODAY IS 01/06/20 AND REDNESS IS GONE BUT MY ARM IS STILL VERY ITCHY
Headache, nausea, vomiting, diarrhea,  fever,  and body aches.
Patient noticed an uneasy, general sense of feeling not right. Took an ambulance the first time; admitted to the hospital with a stroke, hospital stay of 3 days. Two days later ambulanced back in with the same stroke, for which the patient was in for 21 days. Occupational therapy sessions led to patient taking to driving assessment and patient lost his license.
Day after shot - low grade fever 99.5,  extreme fatigue & body aches.   That evening - pain under left arm, could not sleep on left side. Next morning swelling under arm.  Large area swollen, still painful.
lt upper arm around inj site; 2 1/2-3 inches (diameter) swollen, reddened hard (per patient)
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 18-JAN-2017 at 13:00, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457
EE reports she received the Covid 19 Modera vaccine lot number 039K20A on 01/08/2021 at 0600 in her left deltoid. EE reports she noted a rash the next day but then it resolved the next day. EE reports she noted redness and itching on her left upper arm on 1/16/21. EE reports the rash and itching has mostly resolved today 1/19/2021.
Sudden onset of multiple painful joints without swelling or redness. Pain level 7-8 out of 10. Joints included bilateral mid foot and ankles, base of both thumbs and R shoulder and neck. I have had pain with osteoarthritis with a rheumatoid factor for many years but this pain was very intense and occurred in multiple joints.   Saw my functional medicine Nurse Practitioner after 2 months of putting up with pain and not getting any relief - she treated me with low dose Naltroxone and Boswellia and symptoms started to resolve after 1 week and then resolved back to usual aches and pains after 3 weeks of treatment.
During 15 minute wait period after simultaneous vaccine administration with Tdap and influenza vaccine, patient began to experience throat blockage and facial itch. Thought throat blockage might be something else, so tried to drink water and had difficulty swallowing. Reported sensation to clinic staff and after a brief exam by provider was escorted to hospital ED. During transfer to ED, patient noted her facial itch was becoming worse, and began feeling nauseous as well. Upon arrival to hospital ED, and after being checked in, patient's symptoms worsened further and she developed full blown anaphylaxis requiring aggressive treatment.
tired/wiped out; Arm redness/ redness at injection site; Swollen arm/swelling at injection site; Arm hurts/ pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in April 2019).   On 17th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On 18th August 2019, the patient experienced tiredness. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were not recovered/not resolved and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The caller was the patient. The patient stated that she got the 2nd dose of Shingrix shot in her left deltoid. The patient did not know if it was intramuscular or subcutaneous.  The patient's paperwork did not show the lot and expiration date. The patient said that her arm was still red and swollen and hurts at time of reporting. One day after vaccination, the patient experienced tiredness or wiped out. Outcome of redness, swelling and pain at injection site was reported as recovering in the source document however, it was reported as not recovered. Outcome of tired/wiped out was reported recovered/resolved with sequel the source document however, it was reported as recovered/resolved. The reporter was consented to follow up.
Migraine, vomiting 5-10 times, shakes, chills, profuse sweating for about 1 day
pt recv vax & devel fever @ 3AM p/vax on prev day-fever to 101-105-sz occurred;pt taken to pvt MD not adm to hosp;
COVID-19 symptoms started 05/06/22 and tested positive same day. Symptoms include sore throat, congestion, headache, fever, and that's mostly it. I had aches and chills with the fever but when the fever is gone, I don't have it. I have terrible congestion with ear clogging and a headache that has lasted longer than any migraine I've ever had. The fever is gone so I don't feel as bad. I still have a headache and I'm super congested, and my ears and face hurt. I have no cough and I'm not super fatigued. I did speak to a doctor just to see about protocol with medications and what was current. I am only taking Tylenol and cold medications.
You came to the ER today because of a passing out episode after you got your first covid vaccine. Your exam was reassuring. Your labs and EKG are unremarkable. The cardiologist recommends continuing outpatient testing. Please call your doctors today to set up follow-up appointments. Please return to the ER if your symptoms change or worsen.,
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.  The date of refrigeration was 07 May 2021.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 12/30/2020, 01/20/2021, and 10/19/2021. The first dose was administered at the facility indicated in Item 15 of this form. The second dose was administered at a Pharmacy. The third dose was administered at a Clinic.   The individual tested positive for COVID-19 on 01/27/2022 via antigen test at the long term care facility at which they were a resident. They died on 02/11/2022. It is unclear if this individual was hospitalized or not. COVID-19 is listed on the death certificate.
Circumferential redness and pain and swelling in the upper arm - both shots given in left arm.
Pt recvd vax & exp pain & stiffness p/each dose; pt recvd 2nd & 3rd dose of Hep B vax & the sx recurred; No further details were provided;
After vaccines given at 1pm, patient stated her arm at the injection site ((L) deltoid) got pink & warm. Dr. assessed site today (11/18) & Dx a "local reaction" - pink circle noted on (L) deltoid - no swelling or bruising. Warm compresses advised - no other treatment.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated by the intramuscular route with ZOSTAVAX 19400 plaque-forming units (PFU) injection, lot # N020938, expiration date 31-JUL-2018 (dose was not reported) for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) lot # N020938, expiration date 12-AUG-2019, (strength, dose, frequency, route of administration, indication were not reported). No adverse event was reported. The outcome of the event was unknown.
a patient received regular strength Fluzone Quadrivalent instead of Fluzone High Dose Quadrivalent, no adverse event; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a 70 years old male patient received a 0.5 mL dose INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiration date not reported) via intramuscular route in unknown administration site for prophylactic vaccination on an unknown date (reportedly 2 weeks ago) instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.   No concomitant vaccines was not given to the patient.  It was a case of actual medication error due to wrong vaccine administered. (Latency: same day of vaccination).  The reporter requested to revaccinate the patient.  At the time of report no adverse event was reported.  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.
Had vaccine and had shingles/Suspected vaccination failure; shingles; hospitalized with excrutiating pain, never came out of hospital; hospitalized with nerve damage, never came out of hospital; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria death, hospitalization and GSK medically significant), shingles (serious criteria death and hospitalization), pain (serious criteria death and hospitalization) and nerve damage (serious criteria death and hospitalization). On an unknown date, the outcome of the vaccination failure, shingles, pain and nerve damage were fatal. The reported cause of death was vaccination failure, shingles, pain and nerve damage.   It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve damage to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The reporter said you could not prevent shingles with a vaccine.  The patient had that Shingles vaccine and had the worst case of shingles ever.  The patient landed up in the hospital in excruciating pain and nerve damage.  The reporter stated that the patient never came out of the hospital, the reporter said god rest her soul. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.; Reported Cause(s) of Death: hospitalized with nerve damage, never came out of hospital; Had vaccine and had shingles/Suspected vaccination failure; Had vaccine and had shingles/Suspected vaccination failure; hospitalized with excrutiating pain, never came out of hospital
Doses were administered after 12-hours in syringes; Doses were administered after 12-hours in syringes; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) and PRODUCT STORAGE ERROR (Doses were administered after 12-hours in syringes) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) and PRODUCT STORAGE ERROR (Doses were administered after 12-hours in syringes). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) and PRODUCT STORAGE ERROR (Doses were administered after 12-hours in syringes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Aches worsening each day through 4th day after, significant stuffy and runny nose, significant fatigue, coughing, headache, difficulty taken deep breath
pnuemonia; flu; Initial information was received on 22-Nov-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media.  This case involves adult patient (age and gender not specified) who had flu (influenza) and pnuemonia, while patient received INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE   Medical history, medical treatment(s), past vaccination(s) concomitant medication, concomitant disease and family history or risk factor were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer and PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu (influenza) and pneumonia (unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE. The patient was ended up in intensive care unit for a week and assessed as medically significant for pneumonia event.   It is unknown if the patient experienced any additional symptoms/events.  Patient should have listened to gut instinct and not trust them.   Each individual is different genetically. It affected patient adversely. Never again. The same with the rona vaccine.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown for both events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns adult patient who had influenza and pnuemonia after vaccination with INFLUENZA VACCINE (unknown manufacturer) and PNEUMOCOCCAL VACCINE .The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Noticed red itchy, hive like area on right arm below the injection site.  Warm and itchy.  I'm not sure the vaccine was administered correctly.  Didn't feel like it went into the deltoid.
Experienced flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Experienced flu symptoms) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), VITAMIN B NOS and ASPIRIN [ACETYLSALICYLIC ACID] 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. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (Experienced flu symptoms). The patient was treated with FLUDROCORTISONE at an unspecified dose and frequency; METOPROLOL TARTRATE at an unspecified dose and frequency; THIAMINE at an unspecified dose and frequency; CALCIUM ACETATE at an unspecified dose and frequency; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. In April 2021, INFLUENZA LIKE ILLNESS (Experienced flu symptoms) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No medical history was reported. The patient experienced symptoms for around three weeks, after that patient got better.   This case was linked to MOD-2022-473822 (Patient Link).