chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Conditions of the excursion 12.3 C for 3 and half hours with no reported AE; product administered to patient with no adverse event reported.; Initial information received on 06-Dec-2022 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 8 years old male patient and it was reported Conditions of the excursion 12.3 c for 3 and half hours with no reported ae and IPV (VERO) [IPOL] administered to patient with no adverse event reported.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (PROQUAD) for Immunisation; hepatitis a vaccine inact (HAVRIX) for Immunisation; and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) for Immunisation.  On 21-Nov-2022, the patient received a dose 4 at dosage 0.5 ml of suspect IPV (VERO), Suspension for injection, (lot number: V1B891M; expiry date: 01-Jun-2024) (strength, frequency: not reported) via intramuscular route in the right deltoid for immunization with Conditions of the excursion 12.3 c for 3 and half hours with no reported ae (product storage error) (unknown latency).  On an unknown date the product administered to patient with no adverse event reported (poor quality product administered) (unknown latency) following the administration of IPV (VERO).  Action taken was not applicable.  The outcome was 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 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.
2/18 vaccination 2/23 @ 2:30ish AM, I was asleep and woke up, feeling really nauseous. I ran to bathroom; vomiting, diarrhea, feeling really ill. This lasted for 30 minutes and decided to ER as I was 'leaking fluid'. Being so close to due date, we decided to go to labor and delivery to make sure it wasn't amniotic fluid (result; urine). Discharged home after a couple of hours. No lingering episode.  Third pregnancy, EDD 3/6 but I was induced; prescheduled. Birth weight 7lbs 8 ounces.
Moderna COVID-19 Vaccine EUA. Fever of 100 degrees, really sore arm, fatigue, more intense hunger than usual. Fever started about 24 hours after vaccination. Sore arm about 4 hours after. Hunger and fatigue within two hours. Taking occasional Tylenol for sore arm, not sure how effective it is.
Case number PHEH2014US024353, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 19 Jan 2015. This report refers to a 76-year-old male patient. Past medical history and concomitant medication were not reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 19 Jan 2015: Vaccination history and site of FLUVIRIN vaccination were updated.
Patient had an allergic reaction. Onsite EMS was called vitals BP 118/64  100%O2  HR 74 Patient refused evaluation or care and released against medical advise.
Headache began the evening after receiving the vaccine by the next day, headache pain more than a 10. After consulting dr who told her  to take Tylenol.  Tylenol has brought the pain level to about 7, 2 weeks later.
Phone call received from school nurse 0900. Pt presented in office with left deltoid pain. Nurse states it is red/warm to the touch. Redness appears "golf ball" sized. Slight elevation. Icepack given to pt for relief.
Per mom, child received HIB on 09-15-09. At home developed skin redness and hot to touch from waist up. Last until the next day (approx 24 hours).
This spontaneous report as received from a registered nurse via company representative refers to a 18 year old male patient. The patient did not have pertinent medical history or drug reactions/allergies. On an unknown date, the patient who had received the three dose RECOMBIVAX HB series "as a baby" (lot number, dose and route were not reported). The patient was not taken concomitant medication. On an unknown date recently, the patient had titers performed for admission to college, and his titers "were less than 5" and considered to be too low for evidence of immunity. The outcome of the event was reported as not recovered. Additional information has been requested.
Discharge Provider: Medical Doctor  Primary Care Provider : Medical Doctor   Admission Date: 7/29/2022 Discharge Date: 08/03/2022  PRESENTING PROBLEM:  Weakness generalized Weakness Acute cystitis without hematuria COVID-19 AMS (altered mental status)   HOSPITAL COURSE:   Patient is a 74-year-old female with  PMH significant for generalized anxiety disorder, depression who presented to the ER on  7/28, was diagnosed to have COVID but her vitals and oxygenation was within normal limits and was discharged with Paxlovid.  Again presented to the emergency department on 7/29 due to persistent generalized weakness.  In ER, vitals were all within normal limits, labs are also mostly unremarkable.  During the hospitalization treated with supportive care, IV hydration, electrolyte replacement, did not require any oxygen, evaluated by PT and OT recommended home health, eventually discharged home on 08/03/2022 with home care.
Health Department received a death certificate on this patient.  Cause of Death 1. Myocardial Infarction 2. Acute Kidney Failure 3. Rhabdomyolysis .  Health Department is filing a VAERS since this was only 22 days after vaccination
11/27/09 Pt called to report injection sites red hot and sore and itches. Since rec'd Vaccine 11/24/09. Pt came into office 11/27/09 4pm. Reddened areas warm to the touch noted Right arm 5cm x 4.5cm; Left arm 6.5cm x 7cm (localized) / Assessed by NPC.
VACCINE DTAP (RT DELTOID) AND PPD ARE GIVEN ON 12/06/05, COMES BACK 12/08/2005 FOR PPD READING AND RT UPPER ARM RED AND SWOLLEN FROM MEDIAL TO LATERAL AREA OF UPPER ARM. AREA MARKED, BENADRYL GIVEN, MOM TOLD TO CALL PCP TODAY FOR F/U. CHILD IS WITHOUT DISTRESS, NO FEVER, DOES NOT APPEAR ILL. WILL CALL MOM TOM TO F/U. MOM CALLED 12/07 REGARDING ARM AND WAS TOLD TO USE ICE AND TYLENOL FOR DISCOMFORT.
Urinary Tract Infection; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 29Jan2021 (Batch/Lot number was not reported) as 1st dose single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, got her first dose of Covid-19 vaccine last January 29. The next dose will be tomorrow; however, she was diagnosed with Urinary Tract Infection and prescribed by her doctor with Cefuroxime 250mg, she took 1 tab today. She was asked  if it is okay for her to get the vaccine tomorrow. On an unspecified date Patient had urinary tract infection with outcome of unknown. Therapeutic measures were taken Cefuroxime 250mg as a result of urinary tract infection (urinary tract infection).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning, a female patient who "10 days ago", on approximately 18-MAY-2008, was vaccinated SC with a first dose of ZOSTAVAX (Oka/Merck). The patient was taking concomitant medications (unspecified). About 48 hours after vaccination, on approximately 20-MAY-2008, the patient experienced unilateral paralysis. At the time of this report, the patient's unilateral paralysis persisted. No product quality complaint was involved. Upon internal review, unilateral paralysis was considered to be an other important medical event. Additional information has been requested.
Patient was awakened by itchiness on left arm from elbow to wrist. Increased in severity to feeling as though on fire and being bitten by a thousand mosquitoes. Spread to other arm, both becoming bright red and blotchy. Some areas became raised. The itchy red began to creep up to injection site. Next day, February 21, legs began to ache, swell, and itch. Developed bright red, splotchy hives similar to arms spreading from knees to ankles before creeping up thighs. Large, hard, itchy area behind both ankles, and navel also became inflamed and itchy. Today (March 1) arms and legs are still red, though it has faded in some areas, and the itchiness is persistent but has subsided.
severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (severe reaction). At the time of the report, VACCINATION COMPLICATION (severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Chills, weakness Shoulder and arm pain Joint pain Fatigue  Fever 100.1-100.2 Brain fog Tinnitis Felt like the Flu, and would not describe as mild. Symtoms began the evening after the shot. Fever gone but still unusually tired as of 3/12/2021 at 4:00 pm. Missed 3 days of work.
Leg/feet swelling (edema); Aches; Wheezing; Difficulty catching my breath (like the patient had bronchitis); Headache; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in left arm on 16Mar2021 at 14:15 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history included diabetic, blood pressure, cholesterol, neuropathy and depression. The patient had allergic reaction to original MMR vaccine in 1965. Concomitant medications included insulin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), LYRICA and ZOLOFT for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 17Mar2021 at 12:00, the patient had leg/feet swelling (edema), headache, aches, wheezing and difficulty catching breath (like she had bronchitis). The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of leg edema, headache, aches, wheezing and difficulty breathing was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
She was kind of still fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "was getting over a cold" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 03Apr2021, outcome "not recovered", described as "She was kind of still fatigued". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that she had antibodies 3 months after having the virus and then was checked again a month ago and had antibodies but this time there was a number. Caller stated that it has been a while since she had her 2nd dose, and she is now ready to get her booster. She had called because she wanted to plan her booster dose accordingly if she was going to have similar reactions as she did to the 2nd dose. She stated that she had her 2nd dose in the afternoon, so her side effects probably began like 12 to 15 hours later. she said that it was  Saturday because she didn't feel right. She says that she had about 32 hours of side effects. She was kind of still fatigued the following day, but she could function the following day, so they probably ended about 36 hours later.  No follow-up attempts are possible. No further information is expected.
Bloody nose. Have not had one in years; This is spontaneous report from contactable consumer or other non-HCP (patient). A 42-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 21May2021 (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 vaccine, via an unspecified route on an unspecified date (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included Claritine (Loratadine). Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, the patient experienced Bloody nose. Have not had one in years. No treatment was received. The outcome of the event was recovered on an unspecified date May2021.  Information on the lot/batch number has been requested.
SICK; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned an adult female of an unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 06-DEC-2022.  The patient's weight, height, and medical history were not reported.  The patient previously received two doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, administered for covid-19 prophylaxis.  It was unknown whether patients had any adverse event following vaccination with covid-19 vaccine (unspecified manufacturer) (Dose number in series 1). The patient received third dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis, which was associated with revaccination with different covid-19 vaccine (Dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was sick (Dose number in series 2). It was reported that "My entire fam has had1,2,3x's- that's extended fam- on my side adult niece- all jabbed- All sick now". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with a product quality complaint. The suspected product quality complaint has been confirmed to be voided (there was no product quality issue described in the information reported as there was insufficient information to determine vaccination failure. There was no timeline for date of vaccination to contracting covid and no confirmatory test reported) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20221210446, 20221210598, 20221210961, 20221211116, 20221212903 and 20221210980.
pt devel fever up to 103.5ax-lasting 48hr;dec w/APAP-given every 4hr;
pt devel erythema, induration, swelling @ inject site p/recvd flu vax; in addition exp pain in arm & hand, numbness & tingling of hand, tetany of the fingers & palm of hand & dermatitis on back of the same hand;
Myalgia, Fever, LEFT ARM SORE AND PAINFUL, WEAKNESS, CHILLS Narrative:
Vaccine failure - received TDaP on 3/21/06 4 yrs later Dx with pertussis - confirmed case. Sending Dr history and physical dictation.
Severe headache that persisted for  10 days following vaccine.  CT Venogram was negative for sinus thrombosis.
5/9/2015 developed small red bumps on chest that continued to increase and spread outward for 3 days and then faded away. No fever-eating drinking well.
This non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degrees Celsius for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Celsius for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 05-Nov-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).
Tinnitus began in right ear.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El9625) via unspecified route of administration in the right arm on 03Feb2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no allergies to medications, food and other products. Concomitant medication included telmisartan (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ej1685) via unspecified route of administration in the right arm on 13Jan2021, at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 16Feb2021 at 08:00, the patient experienced event of tinnitus in right ear and that had not gone away as of 31Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for event. The clinical outcome of the event tinnitus in right ear was not resolved (as of 13Mar2021) at the time of this report.  No follow-up attempts are needed. No further information is expected.
low grade fever, arthralgias, myalgias, joint effusions, rash, adenopathy;
Approx 5 mins after vaccination, patient developed rash on bilat arms with hives. Assesed by NP, vital signs stable, breathing clear. Benadryl 50mg IM given. Reassesed after 3 mins and patient developed angioedema in lips and tongue. Epi-pen administered, EMS notified. Pt continued to be alert and oriented and vital signs stable. Transported to hospital via EMS.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-JUN-2014, the patient was inoculated by a physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 07-MAR-2016, she was treated by nurse practitioner a for a vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient received in RN observation area, post-COVID vaccination administration. Observed for 30 minutes as recommended per guidelines an policy on post-vaccination RN monitoring. At around 15:36 patient reports nausea, feeling palpitations, and cough. Denies any shortness of breath, chest pain/throat tightness. No mouth, tongue, or facial swelling. Vitals documented in flowsheets.  Reports Hx of anaphylactic reaction to shellfish.  Patient denies adverse reactions to vaccinations in past.   16:00: Patient states that her throat feels like it is getting tight, O2 sats remain in the 98-100% at this time. Rapid response called. Vital signs as documented in flowsheet. Dr and RT arrived. Patient transferred to ER per Dr orders.
Full body hives.  Started on my right arm, then spread throughout the day. Still have some hives on my head, face and legs. Very itchy, warm to the touch.
Patient had upper arm extremely swollen and may be edemic. Upper arm was intensely erythemic and patient is in a lot of pain. This occurred a day or 2 after ZOSTAVAX was given. I advised to take a BENADRYL if it may be an allergy, talk with CDC, who said it was not.
Beginning roughly May 15th, I began tapering off of diazepam to stop taking the medication at 0.5 mg a week (from original 5 mg dose); beginning around the week of July 5th, I started experiencing significant fatigue, balance issues, and memory problems. This has not resolved, but has not gotten worse. I strongly suspect this is due to withdrawal, but got the CDC phone call and decided it was worth reporting anyway, in case the vaccine increased the severity of my withdrawal symptoms.