chrisvoncsefalvay/vaers-outcomes huggingface dataset:
one of his patients received 2 initial doses of Moderna COVID 19 vaccine 6 months ago and had the 3rd dose of Pfizer COVID 19 vaccine; One of his patients received 2 initial doses of Moderna COVID 19 vaccine 6 months ago and had the 3rd dose of Pfizer COVID 19 vaccine; one of his patients received 2 initial doses of Moderna COVID 19 vaccine 6 months ago and had the 3rd dose of Pfizer COVID 19 vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist reported for a 73-years-old male patient that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunisation. Medical history included benign prostatic hypertrophy and malignant neoplasm of the prostate, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received covid-19 vaccine mrna (MRNA 1273) (MODERNA COVID-19 VACCINE) as initial 2 doses for covid-19 immunisation 6 months ago. He mentioned that one of his patients received 2 initial doses of Moderna COVID 19 vaccine 6 months ago and had the 3rd dose of Pfizer COVID 19 vaccine yesterday. He stated that the patient was qualified to get the 3rd dose because of age and comorbidity - Patient also has benign prostate hypertrophy malignant neoplasm of the prostate. On 12Aug2021, the FDA updated the emergency use authorizations for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals. People who are fully vaccinated against COVID-19 and are not immunocompromised do not need an additional dose of COVID-19 vaccine at this time. As per the updated Information: A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3 mL) administered at least 28 days following the first two doses of this vaccine is authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. The outcome of event was unknown.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021 at 9:06 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:06 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of the patient was reported as 75.99. No concomitant medications were reported. On 17-Feb-2021, 5 vials were moved to clinic. For lot no. 022M20A, the vial was initially moved to the fridge on 11-Feb-2021 and proposed beyond use date was 13-Mar-2021. On the date of administration, at 08:00 A.M., the temperature recorded was 20 degree Fahrenheit and at 09:00 A.M., the temperature recorded was 22 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 17-Feb-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided. This case was linked to MOD-2022-566976 (Patient Link).
Treatment of Paxlovid from 18Nov2022 to 22Nov2022 for COVID-19; Treatment of Paxlovid from 18Nov2022 to 22Nov2022 for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "treated for kidney infection" (unspecified if ongoing), notes: 58 years ago; "appendix removed" (unspecified if ongoing), notes: 54 years ago; "Depression" (unspecified if ongoing), notes: taking Citalopram; "high blood pressure" (unspecified if ongoing), notes: taking Losartan. The patient has no known allergies. Concomitant medication(s) included: LOSARTAN taken for hypertension, start date: Jan2020, stop date: Dec2022; EXELAN taken for depression, start date: Jan2017, stop date: Dec2022; CITALOPRAM taken for depression. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of Paxlovid from 18Nov2022 to 22Nov2022 for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) showed very faint line on COVID, notes: COVID test during this time showed very faint line on COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
No additional adverse effect; the patient received one improperly strored dose of Varivax; This spontaneous report was received from a nurse prescriber refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 26-FEB-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) of lot # S028920 with an expiry date of 16-SEP-2021 for prophylaxis (strength, dose, anatomical location and route were not reported) (Product storage error). The concomitant medication included sterile diluent (MERCK STERILE DILUENT) which was reported to be stored properly. No additional adverse effects were reported. The outcome of product storage error was unknown. It was reported that the vaccine was exposed to a temperature of 6 degree Fahrenheit (F) to 14 degree Fahrenheit (5.69 F) for a time frame of 1 second. The previous temperature excursion reported as 6 degree Fahrenheit (F) to 14 degree Fahrenheit (5.81 F) for 28 minutes. Data logger was involved. No product quality complaint (PQC) was associated with this report.
pt recvd vax;swelling of rt thigh about 6x3,hot,erythematous,won't walk on it;has osteogereis imperfa;x-ray neg;WBC=16,000;blood culture pending;next day much better; thigh still swollen;
Developed hives on trunk of body approximately 4-6 hours post vaccination.  Hives were relieved with Benadryl and lasted approximately 48 hours.
erythema on forearm 12" in length 3" wide & 1/4" induration, itchy & warm @ area; subsided as of 30JUL92;
6/1 She woke up with a severe headache and vomiting. She went to the urgent care and was treated for migraine headache and nausea. She was giving medication for pain and vomiting. Slept until the next day. Felt somewhat better the next day and continued meds. She went to work on 6/3 and towards the end of her shift she told her boss about the severe headache and sat in her car outside and then became unresponsive. The paramedics were called and she was transferred to the hospital and diagnosed with a brain blood clot and brain bleeding. She was flow by air car to another hospital and admitted to ICU. She was in  Neurology ICU until 6/6, and then transferred to a normal neurology bed and released on 6/11. Diagnosis of left venous sinus thrombosis and hemorrhage in the left temporal lobe.
Information has been received from a physician concerning a female who was vaccinated with the first dose of rotavirus vaccine (human-bovine) beyond 12 weeks. No symptoms or problems were reported. Unspecified medical attention was sought.
woke up with sore throat, extreme fatigue, fever of 101.8; I called and notified the doctor office but haven't received a call back yet.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 30-JUL-2015, the patient was vaccinated with PEDVAXHIB 0.5 ml, once, intramuscular. The PEDVAXHIB was improperly stored. The reporter could not specify which lot of PEDVAXHIB was administered to the patient: lot # K026533 expiration date 07-AUG-2015 or lot # reported as L004740 expiration date 16-NOV-2015. There was no adverse effects reported. Additional information has been requested.
Inadvertently administered Bexsero instead of an unknown brand of hepatitis B vaccine; wrong age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Inadvertently administered Bexsero instead of an unknown brand of hepatitis B vaccine) and inappropriate age at vaccine administration (Verbatim: wrong age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-JUL-2023 The reporter reported that the patient was inadvertently administered Bexsero instead of an unknown brand of hepatitis B vaccine, which lead to wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not consent to follow up.
Had a temperature with the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a temperature with the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Had a temperature with the second shot). At the time of the report, PYREXIA (Had a temperature with the second shot) had resolved. Not Provided          No concomitant medication information was provided. No treatment medication were provided.
pt to hosp with AMS, fever, found to be positive for COVID; sepsis; condition worsened; hypoxia; O2 supplementation; treated with COVID protocol (no specific medications listed in medical record for COVID tx); A Fibrillation, tx with medication; transferred to ICU with cardiac arrest; pt intubated; ROSC achieved; AKI; family decided to withdraw support and seek hospice; pt passed away in the hospital
Fatigue; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received COVID-19 vaccine (Manufacturer Unknown), on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient experienced fatigue (mainly in the afternoon) on an unspecified date after the second BNT162B2 dose. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rec'd vaccine on 10/21; 10/23 started getting stiffness in shoulder of vaccinated arm. Still has stiffness 11/3/09. Advised pt to consult with PCP.
Urticaria Multiforme started approximately 2 days after immunization.  Required benadryl, steroids for treatment.
33yo female admitted to the Hospital Mother/Baby Unit secondary to an abdominal incision (post-cesarean section) infection and likely serum sickness reaction (fever, rash, chills, myalgias, arthralgias, cough, and edema) following DTap administration at another Hospital (3/7/11).  The patient was hospitalized from 12/27/10 to 3/10/11 due to recurrent vaginal bleeding, placenta previa (which later transitioned to vasa previa) and early contractions; she had a c-section on 3/4/11.
Rash on neck and feels like throat is swelling. Rash is spreading to arms. Treated with Solu-Medrol 125mg, IM X 1 stat and Prednisone 20mg 3 X po X 4 days and Hydroxyzine 25mg every 6 hours prn.
Received her 1st dose of the Pfizer Covid 19 vaccine on 16Feb2021. got Covid in Jul2021; Received her 1st dose of the Pfizer Covid 19 vaccine on 16Feb2021. got Covid in Jul2021; This is a spontaneous report from a contactable consumer. This 24-year-old female consumer (patient) reported for herself. A 24-years-old female patient received first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on 16Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient never got the second dose and got Covid in Jul2021. She was over it at the time of report with just a lingering cough and she wanted to be fully vaccinated. She did not know if she need to just get the second dose or start all over. Her doctor told her to start over. One pharmacy said to complete the quarantine and then come in and another pharmacy told her to wait 30 days and 14 days. When they say no symptoms, caller stated that she had a lingering cough and stated that was vague. She wasn't hospitalized so she did not know exactly. She stated that she could take it after 42 days. Reporter seriousness for received her 1st dose of the Pfizer Covid 19 vaccine on 16Feb2021 and she didn't get her 2nd dose. The patient underwent lab tests and procedures which included sars-cov-2 test: Covid on Jul2021. The outcome of event drug ineffective was unknown, while the outcome of event Covid was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient presents to the ED with complaints of worsening shortness of breath and fatigue. She was subsequently admitted for further management of COVID-19 pneumonia. She was  admitted to the ICU with suspected bibasilar pneumonia. Neurologic exam showed patient was no meaningful brain activity and she subsequently passed away 4 days after ED presentation.
Patient had pain and redness around injection site after shot was given (4/9/2019) for few days. Patient was in the pharmacy today (4/25/2019). She still has mild pain in the same arm as per patient. Injection site skin looks wrinkly. Primary care office was close today. We will call primary care tomorrow and provide details about allergic reaction.
pt back to clinic approx 15 mins p/vax posterior aspect of lt arm w/numerous dime sized white raised bumps; pt c/o feeling nauseated; c/o arm lt feeling warm BP 152/94;
FEVER OF 102F; This spontaneous report received from a parent concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 29-JUN-2021 11:00 for prophylactic vaccination .The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever. This report was non-serious.
Patient experienced vasovagal syncope about 1 minute after vaccination. Was unconscious for about 5 seconds then regained consciousness. He admitted to changing his diet recently but no new medications or personal history of syncope. States his father does have a history of syncope after vaccinations.
Patient was given the adult tdap (BOOSTRIX) instead of the dtap child dose. Contacting GSK today to find out what interval to wait before giving her the dtap to complete primary series. No physical reactions noted in the office.
Fatigue; headache; left arm pain same arm as injection, arm tingling down arm to pinky finger and palm of hand; low fever; aches and pains in joints and muscles, esp. in legs and shoulders; nausea--all onset an hour after injection and continue to day 4 after injection; flushing of entire body on day 3 for three hours and feeling of skin warmth that resolved.
Patient received the Pfizer COVID 19 Vaccines. "I dont want to do us more harm by getting it after taking the paxlovid but I dont know if you can do that; Patient received the Pfizer COVID 19 Vaccines. "I dont want to do us more harm by getting it after taking the paxlovid but I dont know if you can do that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (172086). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient received the Pfizer COVID 19 Vaccines. "I dont want to do us more harm by getting it after taking the paxlovid but I dont know if you can do that". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She stated that would be their 2nd  booster as they never received that dose. Spent a long time searching the internet before calling. If you don't know then She knew her doctor does not know. They advised to not get the booster. If she would have gotten the booster she would not have gotten COVID so bad. Now she don't know what to do and don't know if its safe to go ahead and get one or if whether we should wait. Caller asked, "Other than her doctor, who led her the wrong way, who could she contact that might know? There was one website, it said something about don't get shot within 90 days after if you have had COVID. She don't know what to do and her husband was in the same boat so anyway. She had 2 doctors, separate who told them to wait for the new vaccine coming in the fall" so that is what her husband and her did. "That did not turn out so well. Now she don't know whether we can go ahead and get the 2nd booster and then the one in the fall due to the wait between, 4 or 6 months." 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.