chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information had been received on 10-MAY-2017 from a lawyer and the daughter of the deceased female regarding a case in litigation. It was alleged in litigation that a female patient (decedent) of unknown age was inoculated with ZOSTAVAX vaccine (Date, dose, route, site of administration, lot # and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 05-JUL-2016, the patient was treated in the emergency room, and later by urologist (as reported)(also reported as family nurse practitioner (FNP)) for an excruciating rash that spread to the female patient's genitalia and inside her body.  The female was diagnosed with severe shingles. On or about 06-JUL-2016, the female patient was treated at a family medicine facility, by a physician assistant (PA) for an ongoing and exceptionally severe outbreak of shingles. The patient was prescribed gabapentin to manage her symptoms.  On or about 09-JUL-2016, the female died at her home due to unknown causes, which her estate believes was attributable to the unmanageable pain of her atypical shingles outbreak.  At the time of death, the female was actively suffering from an active outbreak of Herpes Zoster on her body.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The event of died at her home due to unknown causes was determined to be a medically significant event. Additional information has been requested.; Reported Cause(s) of Death: died at her home due to unknown causes.
Information has been received from a physician via field representative concerning a female patient with an unspecified age, pertinent medical history or drug reactions / allergies. On 03-JAN-2012, the patient was vaccinated with PNEUMOVAX23 (lot H018441) (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. On 04-JAN-2013, the patient had significant "pain, swelling and soreness at the injection site and a lack of mobility. As a treatment, the patient received physical therapy and oral steroids. On an unspecified date, the patient recovered from the events. There was not laboratory test performed. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Chills, headache,  body aches, slightly elevated body temperature, extreme fatigue,  (2 days, so far).  (Unable to participate in dailay activities)
Swelling, redness, heat and itching in the arm where I received the injection. The unusual thing is that is was delayed 1 week after getting the shot.  Just thought it should be noted.
GUILLAIN-BARRE SYNDROME. CLOSTRIDIUM DIFFICILE ENTEROCOLITIS.
PATIENT STATES NERVE PAIN RADIATING DOWN TO FINGER, SWOLLEN FINGER, NERVE PAIN RADIATING DOWN LEG, EVEN 3 MONTHS AFTER VACCINATION
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 11th of 43 adult patients described by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number.
I63.9 - Acute ischemic stroke (CMS/HCC) R29.810 - Facial weakness
I received the Pfizer Bivalent COVID-19 booster on 9/22/2022. On 12/13/2022, I developed a sore throat in the evening. On 12/14/2022, I had a cough, an increasingly sore throat, and a runny nose.  I took a home antigen test daily at about 10 AM from 12/13/2022 to 12/16/2022. I got a positive result for the first time on 12/16/2022. Between 12/14/2022 and 12/16/2022, I developed a low-grade fever, fatigue, body aches, and chills. On 12/16/2022, I had a virtual visit with a PA, who prescribed me Paxlovid, which I began taking that day. On 12/17/2022, my symptoms were pretty much the same as the day before. I began to get better on 12/18/2022, and my condition continues to improve. My fever, chills, and muscle aches have gone, my nose is less runny, and I am coughing less. I still have some fatigue, though.
Patient is a 36 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: other - pruritus on left  lateral  upper arm from the  allergy injection site. presents for itching on her left arm from the allergy shot 5 days ago. Endorsed that she's been having the itching after the allergy shot. Endorsed that she already took 2 tabs of her zyrtec at 1030am today. Patient came here, drove by herself. Denies chest pain, sob, swelling of throat/lips. Physical exam unremarakable. vitals sign stable. sent home and instructed to take benadryl 50 mg PO. called patient with improved pruritus.
Patient responded in the negative when asked screening questions, right after patient received vaccination, he tilted his head back & los consciousness. Some bubbles in mouth & body movement. Pt. came to after about 15 seconds. Paramedics called. Patient regained consciousness. Pt. pale. Vomited. Patient came in with 2 brothers for ADACEL for school. They had just recently returned from another country 8 weeks ago and recently had a TB test placed. Patient filled out the form and the pharmacist screened patient for adverse reactions (Are you feeling well today? Have you ever had a serious reaction to any vaccines? Have you ever had any seizures?) Patient answered yes for the first question and no for the second 2 questions. Pharmacist administered ADACEL (Lot C3976AA exp: 3/30/2014) into the patient's left deltoid. Band-Aid was placed and pharmacist asked patient to remain in area for 10 minutes. Immediately after, patient's legal guardian (older brother) reported patient turned pale was having a seizure. Pharmacist attended to patient and called 911. Patient was unconscious for about 15-20 seconds, having involuntary body movements and bubbles in the mouth. Patient regained consciousness and was very uncomfortable. He was very pale and vomited. 911 ordered patient to be laid down on his side until the paramedics arrived. When the pharmacist interviewed the patient further, the patient remembered that he had a reaction to an unknown shot about three years ago where he fainted and had a similar reaction. Paramedics arrived, interviewed patient and took him to hospital.
Site redness, Slightly swollen. Spoke with mom at 08:15 AM today. PCP notified. No SOB, no rash/hives, no facial swelling. Advised to observe, check with PCP for Meds, ER if conditions worsens.
My lymph nodes under my right arm (arm pit) were swollen with fluid. I am being observed and told to returned in a week unless pain or the side effect worsens.
chills; I woke on and off; feeling achy and feverish; feeling achy and feverish; Also I bit my tongue; she feels her tongue acting like its weird/ Its like acting weird, she feels like its numb, not flexible; Ache; Pinch; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 05Jun2021 (at the age of 52-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Patient historical vaccine includes received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), 1st dose via an unspecified route of administration, administered in on unspecified date as 1st DOSE, SINGLE DOSE for covid-19 immunization. The first shot no reaction whatsoever. The reaction was only the pinch. The patient medical history was not reported.  There were no concomitant medications. On an unspecified date the patient experienced chills, i woke on and off, feeling achy and feverish, also i bit my tongue, she feels her tongue acting like its weird/ its like acting weird, she feels like its numb, not flexible, ache, pinch. Therapeutic measures were taken as a result of feeling achy and feverish, feeling achy and feverish. The outcome of events was unknown.  Information about lot/batch number is requested.
pt recvd vax 7JUL92 & died of SIDS on 23JUL92; no hx of any adverse events following vax;
having been taking an antibiotic for a week now because of her UTI; This is a spontaneous report from a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient experienced having been taking an antibiotic for a week now because of her uti (urinary tract infection) (non-serious) on an unspecified date. Caller was asking about her mom that is scheduled today for her 2nd dose, having been taking an antibiotic for a week now because of her UTI. Therapeutic measures were taken as a result of event includes antibiotic. The outcome for event was unknown.   Follow-up attempts completed. No further information expected.
Information has been received from a Registered Nurse (R.N.) concerning a patient who on 19-MAY-2009 was vaccinated with a 0.5 ml dose of VARIVAX (Merck) subcutaneously. It was reported that the patient was supposed to received ZOSTAVAX (Merck) (MSD). It was reported that this was related to human error and not product confusion. No adverse effect reported. Follow up information was received from a registered nurse on 28-MAY-2009. It was reported that the patient was inadvertently given VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). It was a human error. The administrator of the vaccine just grabbed the wrong bottle. The patient was doing fine and would receive ZOSTAVX (Merck) (MSD) sometime next month. Follow up information has been received from a registered nurse. It was reported that the 60 year old female patient with no pertinent medical history, no drug reactions/allergies, no illness at time of vaccination on 19-MAY-2009 was vaccinated subcutaneously in the left deltoid with a dose of VARIVAX (Merck) (Lot # 660495/0431X) in the morning. Concomitant therapy included vitamins (unspecified), baby aspirin, ALEVE, TYLENOL ARTHRITIS PAIN and calcium (unspecified) (+) vitamin D (unspecified). There were no adverse reactions per patient. There were no laboratory or diagnostic tests performed. Additional information is not expected.
Nausea, vomiting, fever, diarrhea - After 2 oral typhoid pills.
Had not menstruated for one year.  About a week after the shot, I began bleeding and have bled intermittently since then.
Extreme nausia & vomiting;  insomnia; shaking (adrenaline); extreme anxiety; fever conditions: chills; shortness of breath; muscle contractions; hallucinations; delrium; racing heartbeat; ?burning? feeling in muscles and bones.  Loss of appetite.  Symptoms extreme for first 48 hours - tapering off in days to follow; still some weak symptoms on  day 7.
This spontaneous report was received from a registered nurse referring to a 12 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 18-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Patient received vaccine in left deltoid at 1000. Around 1015 patient notified pharmacist that she was having a hard time swallowing and felt slightly light headed. Pharmacist provided a chair to help elevate the patient's legs and provided patient with water. After 2 minutes pharmacist double check with patient and patient said she didn't feel worse but still felt like she was having a hard time swallowing, but did not complain of any shortness of breath. The pharmacist then called the medical team and after further assessment, the medical team transferred the patient to the Emergency Room for further review. Patient was treated in the ER for anaphylactic reaction and discharged.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  In 2008, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions.  Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles and was treated by a healthcare provider at the emergency room; and was hospitalized due to the event (date unspecified). As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was reported as not resolved.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Arm weakness, progressed over days to total quadraplegia, diagnosed with likely transverse myelitis, with excess gray matter involvement compared to typical transverse myelitis. Involved spine from C2 to T12.
no adverse effects; a patient received a dose of GARDASIL 9 while pregnant; She received her first dose of the series on an unspecified date "in December of 2015"; This spontaneous prospective pregnancy report as received from a nurse refers to a 14-year-old female patient. The patient historical conditions included depression due to desogestrel (+) ethinyl estradiol (APRI) and headaches. Concomitant medication included ethinyl estradiol (+) norgestimate (TRI LO MARZIA) for birth control.  On an unspecified day in December 2015, the patient was vaccinated intramuscularly with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (lot number #1602284, expiration date: 26-SEP-2021) (strength, exact dose and frequency were not reported). On unknown date in 2019, the patient became pregnant with last menstrual period (LMP) of unknown date in September 2019. On 31-OCT-2019, the patient was vaccinated intramuscularly with a third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (lot number #1602284, expiration date: 26-SEP-2021) (strength, exact dose and frequency were not reported), while being pregnant (diagnosed by urine pregnancy test on an unspecified day; gestation: 6 weeks and 1 day) (exact start date of the pregnancy and estimated delivery date (EDD) were not provided). No adverse events were reported. The pregnancy outcome was pending and the fetus outcome was unknown at the time of the report.   The relatedness between the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Right arm red, hard, swollen. C/o pain with touch. ER 1/24/06. Doctor office 1/25/06 dx cellulitis given Keflex
Began experiencing dizziness on 12/26/2020 at around 10:30 am. Dizziness was initially off/on for the remainder of the day. By 12/27/2020, I began experiencing dizziness and feeling ?swimmy headed? with no periods of relief (even when sitting still or laying down).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt rcvd vax; t 104; malaise & vomit once ; pt was crying;
Delayed injection site reaction. Day 5. Redness, swelling and warm to touch. Mild itching at site.
On fifth day after first dose, tenderness under left armpit and hives both lasting for 2-3 days
pt did not have a reaction to vaccine. Vaccine given was beyond use date of refrigeration. Lot number was not expired.
On 4/29/99, the pt received her first (IM-Left Deltoid) dose of Lymerix for prevention of Lyme disease.  One week later on 5/6/99, the pt experienced a muscle pull behind the knee. This adverse event resolved.  On 5/27/99, the pt received her second dose of Lymerix.  Approximately 3 days later, on 5/30/99, the pt experienced severe pain after walking. He left leg was swollen, she was seen by an orthopedist and Motrin was prescribed. Aching persists. The most recent information received on 6/23/99, reports the condition of the pt is ongoing.
GOING TO BATHROOM FINE SINCE VACCINATION, NO NEED OF TAKING LAXATIVE THAT WERE PRESCRIBED; PAIN IN THE LEFT ARM WHERE SHE HAD THE INJECTION; TIRED; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bipolar disorder, bone spurs, migraines, herpes types 1/2, quit smoking prior to vaccination, and grass mold mushrooms allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced going to bathroom fine since vaccination, no need of taking laxative that were prescribed. On 25-JUN-2021, the subject experienced pain in the left arm where she had the injection. On 25-JUN-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Herpes virus test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 26-JUN-2021, and the outcome of pain in the left arm where she had the injection and going to bathroom fine since vaccination, no need of taking laxative that were prescribed was not reported. This report was non-serious.
Pt states that they are having a hard time seeing.  Pt noted to be diaphoretic and c/o N/V within 5mins of vaccination. @15:07 BP 84/39, HR 69-73, RR 20 -- > @1515 111/64, 74, 20, Temp 97.7 and 99% on RA.  Pt given H2O, juice, and crackers.  Pt states that they have a hx of anxiety w/ vaccines.  Did not take any PO intake since the AM (vaccination @ 15:05).  By 1515, pt states that they are feeling better.  Advised pt to take next vaccine in observation room.  Pt stable and released from the vaccination site @1535 w/ father.  Pt was ambulating, speaking in full sentences.
Initial unsolicited report received from a non-healthcare professional (office staff) on 07-Sep-2018. This case involves a 17 years old male patient who was vaccinated with a dose of FLUBLOK QIV (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration (FLUBLOK vaccine was administered to a 17 year old patient). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.