chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours), 26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour); and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours), 25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 27-NOV-2017. This is one of several cases reported by the same reporter. Sender's Comments: US-009507513-1801USA006569: Original Case: 1801USA006569.
11/2/17 PM PPT noted redness and warmth at injection site that was the width of the arm. She applied a cold pack to area and denied fever. 11/3/17 PPT reported reaction to facility by phone call. PPT reports was advised to take TYLENOL by staff member. PPT also applied cold pack to injection site. 11/6/17 PPT came to facility, injection site assessed. Area slightly reddened, 5cm in diameter. No warmth or swelling noted.
This non-serious medically confirmed report (initial receipt 29-OCT-2014) concerns a 53 year old female patient who had no known allergies and no relevant medical history. On the 29-OCT-2014, the patient received AFLURIA (batch number T58506) 0.5 ml via the intramuscular route. AFLURIA had been stored incorrectly and reached a maximum temperature of 50.5 F for an estimated duration of seven hours. The patient received the AFLURIA at the clinic without any complaints.  Outcome was unknown.
Pt received primary Moderna doses on 2/3/21 & 3/3/21. Pt received monovalent booster on 2/4/22. Pt received bivalent booster on 10/27/22. Pt is immunocompromised due to chronic steroid use and should have received a 3rd primary dose instead of booster doses.  Spoke with the patient after 10/27/22 booster dose and advised she should have received a 3rd primary dose due to her immunosuppression. Patient stated she only wanted the booster dose and refused to return to clinic for a 3rd primary series dose.
arm got real sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2021 (Lot number: EL3248) at the age of 71 years as dose 1, single for covid-19 immunization. Relevant medical history included: "alcohol" (unspecified if ongoing), notes: he drank 3-4 alcoholic drinks. Concomitant medication(s) included: TYLENOL taken for premedication. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "arm got real sore". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The day before patient got his first dose of Pfizer COVID-19 Vaccine he drank 3-4 alcoholic drinks that day. He usually drinks about 1-2 per day. But the day of he didn't drink any because he took a Tylenol to keep his arm from getting sore and he doesn't drink when he takes medicine.   No follow-up attempts are possible. No further information is expected.
Patient develop fever of 101.9 F 3 days after receiving FluMist which progess to peak of 104.4 5 days after FluMist administration.  Patient tx'd with Motrin.
15 minutes post vax, the pt complained of nausea, chest tightness, cool clammy skin, P-100, BP 140/90. Ambulance was called, but the pt was not transferred anywhere. Pt returned home.
Tonic/clonic activity 10-15 minutes after immunization. Last few seconds.
pt recvd vax & exp a local react described as a macula, & queasiness; pt contends that the tetanus has settled in gallbladder; pt feels natural herbs are better than synthetic medications;
I tested positive for COVID-19 on 3/25/2022. I had a headache and I took some Aleve and it didn't go away. When I woke up the next day, the headache was quite a bit worse. I found out that a meeting that I had attended, others that were there ended up testing positive and that is when I decided to test myself. I spoke with my doctor and was prescribed Paxlovid. I also had a runny nose. I have had the remanence of a cold up until today, 6/13/22.
Clogged ears (patient has no history of/never experienced this before), "warm" sensation up and down both sides of neck. Ongoing after 6 days, though perceived lessening with time. Fatigue and mild headache, lasted for 3 days.
Patient reported cramping described as "charlie horses" She said she has had these before but it has been a while. She was unsure if the immunization could have "triggered" this. They resolved over night. She said if they comeback she will contact her doctor.
other zoster-related conditions; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In or about November 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) as prescribed and/or administered by a healthcare provider at the physician's office for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will 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 will continue to suffer such losses, and damages in the future. The outcome of the event shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
Pt was administered MMR & approx 1-2 hrs later pt did not feel well, lost consciousness; Pt was lowered to floor, entire body stiffened & upper extremities jerked; Pt then immediately became responsive; MD present @ time;
MEDICATION ERROR; PRODUCT QUALITY ISSUE; WRONG TECHNIQUE IN DRUG USAGE PROCESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On an unspecified date, the subject experienced wrong technique in drug usage process, medication error, and product quality issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrong technique in drug usage process, medication error and product quality issue was not reported. This report was non-serious.   Additional information was received from patient on 16-MAR-2021. The following information was updated and incorporated in to the case narrative: Patient demographic details (DOB, age group, height, weight and Age at the time of vaccination). Product quality number was added, (90000173614).
sickest; nightmare; Tinnitus/her ears started ringing really bad.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 (Lot number: EW0179) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot Number: EW0179, Left arm), administration date: 18Jun2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset Jul2021, outcome "recovered", described as "sickest"; TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "Tinnitus/her ears started ringing really bad."; NIGHTMARE (non-serious) with onset Jul2021, outcome "unknown", described as "nightmare". The event "tinnitus/her ears started ringing really bad." was evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), MIGRAINE (non-serious) all with onset 09Apr2021, outcome "unknown" and all described as "terrible headache, migraine headache"; PHOTOPSIA (non-serious) with onset 09Apr2021, outcome "unknown", described as "Flashing lights". The events "terrible headache, migraine headache", "terrible headache, migraine headache" and "flashing lights" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of headache. Additional information: On Wednesday of this last week, I had my second shot and I was fine on the day I got it the next day was fairly good and then on Friday, Saturday and Sunday, I had terrible headache and I had flashing lights like a migraine headache and now I did go to urgent care because the headache was so bad and the flashing light the migraine headache was bad, they had to give me a medication to help that. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling -> size of hand, lasted 2 days, warm to touch, redness.
Client received first dose of COVID vaccine at 11:00 am in zero-gravity chair due to history of fainting with injections.  Client complained of feeling faint and vison and hearing going out @ 11:05am.  Client provided with water and cold pack, reported feeling better, also reports not eating prior to vaccination.  Client complained of headache @ 11:30am.  Vital signs within normal limits.  Client reports feeling better, headache only symptom @ 11:40am.  Client able to leave observation area with steady gait, her friend present to drive home @ 11:45am.  Client advised to follow up with primary care.
AFTER VACCINE ADMINISTRATION THE PATIENT RESTED FOR 15 MINUTES IN A CHAIR. AFTERWARD SHE STOOD UP AND SUDDENLY FELL DOWN (BACKWARD) AND HIT HER HEAD. SHE WAS UNCONSCIOUS AND HAD CONTRACTIONS IN THE EXTREMITIES.
she experienced fever and allergic reactions in the form of painful and burning lesions on tongue, palate and mouth; she experienced fever and allergic reactions in the form of painful and burning lesions on tongue, palate and mouth; she experienced fever and allergic reactions in the form of painful and burning lesions on tongue, palate and mouth; she experienced fever and allergic reactions in the form of painful and burning lesions on tongue, palate and mouth; she experienced fever and allergic reactions in the form of painful and burning lesions on tongue, palate and mouth; she experienced fever and allergic reactions in the form of painful and burning lesions on tongue, palate and mouth; This is a spontaneous report from a contactable consumer (herself). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 07May2021 15:18, (age at vaccination: 54 years), as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection, Batch/Lot number was not reported, age at vaccination: 54 years), dose 1 via an unspecified route of administration on 07May2021 15:18), as DOSE 1, SINGLE for covid-19 immunisation and experienced unwell, headache and bone pain. The patient experienced experienced fever and allergic reactions in the form of painful and burning lesions on tongue, palate and mouth on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Not feeling well; Slight flu; Fatigue; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 07Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient was not feeling well; had a slight flu; and fatigue. The outcome of the events, 'not feeling well', 'slight flu' and 'fatigue', was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
?Moderna Arm? - extreme  pain, redness, swelling, and itching  around injection site from 1/11 thru 1/15. Body aches, migraine and nausea/vomiting from 1/11 - 1/14. Hives on face, chest and neck from 1/12 - 1/15.
Two weeks after 2nd shot, extreme vertigo..and it is ongoing.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2, via an unspecified route of administration, administered in left arm on 02Jun2021 11:00 (Lot Number: EW0178) as dose 2, single at the age of 47-year-old for covid-19 immunization. The patient was not pregnant. Medical history included known allergies: Penicillin from an unknown date. 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. No other medications the patient received within 2 weeks of vaccination. Historic vaccine was bnt162b2, via an unspecified route of administration, administered in left arm on 11May2021 14:30 (Lot Number: ew0167) as dose 1, single at the age of 47-year-old for covid-19 immunization. Two weeks after 2nd shot, the patient experienced extreme vertigo..and it was ongoing on 17Jun2021 23:00. The adverse event result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of event. The outcome of event was not recovered.    No follow-up attempts are needed. No further information is expected.
Received call from patient's mother reporting she had obtained a rash on (R) arm yesterday after getting vaccine 8/16/16. Patient came in and this RN assessed. Has faint red, flat rash to right upper arm to antecub and left upper inner thigh. Denies itching. Rash pinpoint. States rash to arm appeared yesterday and to left thigh today. Denies any further issues. Instructed to monitor and call Dr or seek medical attention if S/S worsen.
Information has been received from registered nurse concerning an infant who was vaccinated with a dose of RotaTeq (lot# 657666/1391U). Subsequently the patient spit up the vaccine into his father's eye (WAES# 0711USA02988). It was unknown whether medical attention was sought. The outcome was unknown at the time of this report. There was no product quality complaint. This is one of two reports from the same source. Additional information has bee requested.
On 12/4/18, patient contacted pharmacy and detailed a severe reaction post-vaccination to the FLUZONE HD flu vaccination (NDC#49281-0403-65). Patient stated that she had severe flu-like symptoms. She also reported having nausea, vertigo, loss of equilibrium, depression and difficulty walking long distances. Patient states that these symptoms have persisted for several months after the vaccine was administered on 9/17/18. Patient states that she has made multiple visits to various physicians to address these symptoms.
Headache, fatigue, sore arm   34 weeks pregnant; due June 11th
Malignant neoplasm of fallopian tube; Shingles vaccine shot site was infected; Received shingles vaccine and arm swelled up and experienced a fever of 101.7; Received shingles vaccine and arm swelled up and experienced a fever of 101.7; Received shingles vaccine and arm swelled up and experienced a fever of 101.7; Taking niraparib 100mg by mouth daily; UTI infection; This case was reported by a consumer via patient support programs and described the occurrence of vaccination site infection in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for product used for unknown indication.   Co-suspect products included Herpes zoster (Shingles vaccine) for product used for unknown indication.   On 16th December 2019, the patient started niraparib (oral) 100 mg once daily (100 mg daily). On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, an unknown time after receiving niraparib and Shingles vaccine, the patient experienced vaccination site infection, fever, vaccination adverse reaction, swelling arm and underdose. Niraparib was interrupted. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the vaccination site infection, fever, vaccination adverse reaction, swelling arm and underdose were unknown.   It was not reported if the reporter considered the vaccination site infection to be related to niraparib and Shingles vaccine. The reporter considered the fever, vaccination adverse reaction and swelling arm to be unrelated to niraparib. The reporter considered the fever, vaccination adverse reaction and swelling arm to be related to Shingles vaccine.  Additional information: Due to patient experiencing swollen arm and fever of 101.7 after receiving Herpes zoster (Shingles vaccine), the patient's doctor instructed the patient do not take niraparib that evening (date was not reported). The patient's doctor also believed that her vaccine shot site was infected and prescribed an antibiotic (medication name, dose and route of administration was not provided).  Follow up information was received from consumer on 9th January 202 On an unknown date, the patient received Shingles vaccine and experienced urinary tract infection. On 12th December 2019 the patient was receive niraparib at 17:39:19 to 17:39:20.   Follow up information was received from the consumer on 31st January 2020: On an unknown date the patient was diagnosed with Malignant neoplasm of fallopian tube. On 16th December 2019  at 17:39:19 the patient Start to received Zejula and had advise that no longer taking the zejula based on the fact that her cancer has started to spread and patient was discontinued on 17 January 2020 at 10:49:13.
In February I have been having abnormal vaginal bleeding, it was pretty frequent and it would last as long as three weeks of bleeding. Also during this time I had experienced fever, chills and was very fatigue. I sought care from my ob/gyn and she ordered for me to receive a trans vaginal ultra sound to make sure everything was okay, and the results came back everything was fine I was just experiencing abnormal bleeding.
cerebrovascular accident; This spontaneous report was received from a lawyer and a male patient of unknown age regarding a case in litigation on 31-JAN-2020. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or around 12-MAR-2015, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, on an unspecified date, he suffered left sided weakness and numbness, also suffered left sided facial droop and slurred speech. In consequence, he was hospitalized and was diagnosed with cerebrovascular accident. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient's symptoms had resulted in physical limitations not present prior to the vaccine, also mental and emotional distress due to resulting physical limitations and seriousness of his condition. Patient sustained severe and permanent personal injuries. Further, as a tragic consequence, patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. He also had suffered and incurred damages, including medical expenses, loss of accumulations, and other economic and non-economic damages. At the reporting time, the outcome of cerebrovascular accident was considered as not recovered. The reporters considered cerebrovascular accident to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporters considered cerebrovascular accident to be a disability event. Upon internal review, cerebrovascular accident was determined to be medically significant.
Extremely nauseated, dehydration, heart palpitations, massive rash on body, very fatigue, low blood pressure, fever.
Feels flushing in face. Gave Benadryl 25mg/10ml with improvement in symptoms within 15 minutes. Left with son in stable condition.
I woke up 2/22/2021 about 5:00 a.m. which is close to my normal  time to get up.  A little muscle soreness, a little tired feeling but not enough to keep me from my morning routine of going to church at 7:00 a.m.   I got home around 8:00 am, muscles ache now, and tired feeling more pronounced.  I took two Advil around 8:30 a.m..  but by 10:00 a.m. I had a low grade fever of 100.2.  which subsided for a few hours, then returned late afternoon  around 4:00 pm at 100.4 degrees.  Tired and achy feeling continued the rest of 2/22/2021.  Morning of 2/23/2021, did not get up at regular time nor go to church...general "washed out" feeling, muscle aches improved.  Long nap in the afternoon and woke feeling better.  Today, 2/24/2021  I am back to normal. Went to church, grocery store and plan on doing my 3 mile walk later today if it warms up enough!