chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's Palsy; This is a spontaneous report from a contactable physician and consumers reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not reported), via an unspecified route of administration on 09Jan2021 at a single dose for Covid-19 immunization. The vaccine was administered at a nursing home. Medical history included dementia, hyperlipidemia, hypothyroid, and drug allergy to penicillin; all from an unknown date. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took iodine and experienced drug allergy. The patient experienced bell's palsy on 15Jan2021. The reported event was resulted in Emergency room/department or urgent care. No treatment was provided for the event. The outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Hospitalized (10.13.21);  COVID-19 positive (10.13.21);  fully vaccinated   Admission Date: 10/13/2021 Discharge Date: Oct 21, 2021  Discharge Disposition:  home or self care  Active Issues Requiring Follow-up:  Acute hypoxic respiratory failure secondary to COVID-19 pneumonia Follow-up with primary care provider Patient was discharged on 2 L nasal cannula with activity, wean as able DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypokalemia [E87.6] Acute kidney injury [N17.9] Acute respiratory failure with hypoxia [J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: Patient was admitted to the hospital with COVID-19 pneumonia.  She had acute hypoxic respiratory failure needing up to 8 L nasal cannula.  Patient is given remdesivir which she finished 5 days of.  Patient was also on Decadron for which she finished her course as well.  Patient was weaned down to room air at rest and 2 L of oxygen with activity.  Patient was subsequently discharged home with supplemental oxygen to use only with activity.  Patient is instructed to follow-up with her primary care doctor in the next week and determine if she can completely wean off of oxygen at that time.  She also had an acute kidney injury during her stay so her lisinopril and hydrochlorothiazide were held temporarily.  These were restarted the day prior to her discharge.
Severe case of zoster involving entire right arm and hand. Referred to Dermatologist for dx. Prescribed Zovirax, orally.
My nose started running a lot, coughing and wheezing. I thought it was seasonal allergies. It felt like it was in the back of my head, I noticed my lungs were clear and so were my sinuses. I was achy all over, running hot to cold but no fever, I felt fatigued. I went to the doctor on May 18, 2022, who had a chest x-ray's ran a complete blood panel. Chest x-ray came back negative, we are still awaiting results for blood work. I was prescribed prednisone, albuterol inhaler, azithromycin on May 18, 2022. As of today May 23, 2022, this first day I am not wheezing all the time.
Pt recvd 2nd dose of Hep B vax between JUL91 & SEP91; 1 to 3 days later, pt devel flu-like illness including fatigue, fever & chills; sx lasted from two to five days;
4/20/2010 Moderate, other. Mother reported redness to left the size of a baseball the day after vaccine was administered.
Shortly after receiving vaccination patient noticed sore right arm. Next arm became swollen, red and painful. Next day (today, 1/3/2019) patient came to see doctor, prescribed OMNICEF.
This is a spontaneous report from a contactable pharmacist. A 18-year-old male patient received TRUMENBA on 13Jul2018 in the evening, at single dose for immunization in left deltoid. The patient medical history and concomitant medications were not reported. The patient experienced episode of passing out, high fever, chills, vomiting, headache, muscle pain, hot flashes on an unknown date in Jul2018. The day after, in the morning, the patient had to go to urgent care due to the events and in the afternoon he was better.All the events are serious as medically significant.The final outcome of the event was recovering.Causality between TRUMENBA and all the events was reported as related.Information on the batch number has been requested. Sender's Comments: Based on the information currently available, the known adverse event profile of the suspect vaccine and the pathophysiology of the events, the Company cannot completely exclude that the suspect drug contributed to the development of the reported events.
No Adverse Event; HCP called to report t/e on case 02411801 and ROTATEQ was administered. No additional AE/No PQC.   ROTATEQ- 1968378 EXP 5/2/2024 Temperature 48F Time frame 2hours 0minutes 0seconds Previous temperature excursion? No; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUN-2023, the patient was vaccinated with one dose of improper storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1968378, expiration date: 20-MAY-2024, 2 milliliters for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of 48 degrees Fahrenheit for 2 hours. No previous temperature excursion had occurred. There were no additional adverse events reported (product storage error, no adverse event).
Before receiving the vaccine, patient stated that she had a history of fainting and lightheaded after receiving a vaccine. Patient received vaccine at 12:30pm then at 12:40pm, patient said she had an adverse drug reaction after receiving vaccine. She felt lightheaded and fatigue. She was dozing off and on afterwards. We had her sit in a chair with her legs propped on another chair. We gave her water and juice to help hydrate her. We also checked her blood pressure and it was normal. Pharmacist called 911 and EMT arrived to check her out. They took her vitals: blood pressure 162/90, pulse 94 and 106, and O2 stat 98-99. EMT determined this was a panic attack and patient agreed to be transported to Hospital at 1:25pm but changed her mind to not go.
FEELING/SENSATION IN ARM GOING DOWN INTO HER HAND; PAIN GOING DOWN TO HAND WHEN VACCINE WAS ADMINISTERED; FEELS TIRED; BLOOD PRESSURE INCREASED; This spontaneous report received from a patient concerned a female of unspecified age. 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced blood pressure increased. On SEP-2021, the patient experienced pain going down to hand when vaccine was administered. On SEP-2021, the patient experienced feels tired. Laboratory data included: Blood pressure (NR: not provided) 120/80 or 128/81 (units unspecified). On 22-SEP-2021, the patient experienced feeling/sensation in arm going down into her hand. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 110/70 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling/sensation in arm going down into her hand, and the outcome of feels tired, pain going down to hand when vaccine was administered and blood pressure increased was not reported. This report was non-serious.
Headache, Arthralgia,  FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, Narrative:  Other Relevant History:
Information has been received from a male consumer who on an unspecified date was vaccinated with PNEUMOVAX 23. Subsequently, he experienced swelling in his arm. At the time of the report the patient's outcome was not specified. No further information is available.
LARGE RED SWOLLEN AREA WITH PAIN, WARM TO TOUCH THE DAY AFTER THE INJECTION.  PATIENTS CAREGIVER CALLED THE CLINIC TO REPORT.  WAS INSTRUCTED TO USE ICE, BENADRYL, IBUPROFEN.
This spontaneous report as received from a physician refers to a patient of unknown age. In September 2013 the patient was vaccinated with the first dose of GARDASIL, injection, (lot #, expired date, dose and route unspecified). On 02-DEC-2014 (at the reporting day) the patient was vaccinated with the second dose of GARDASIL, injection, (lot #, expired date, dose and route unspecified). No adverse effects reported. Additional information has been requested.
I had a sore arm after receiving the vaccine. I went hiking and I couldn't catch my breath. I was short of breath and my chest felt heavy. I had flu like symptoms, I was fatigued. It was very unusual and not like me. I kept getting unsteady which caused me to faint twice. I've fallen quite a few times within the past year as well. I've also experienced some left side weakness. I did visit a cardiologist who found some issues with my heart. I had the chest pains for an entire year but recently I can tell I'm feeling better.
Fever, chills, headache, nausea, body aches, redness and sore left arm, lack of appetite, couldn't sleep, fatigue, rash at injection site and down the arm and then several days post injection rash on thigh
about 14 hours after vaccination I experienced what appeared to be a severe case of Cytokine storm. I had a moderate case of COVID in May 2020 and had positive IgG AB in August. The symptoms started with heavy shaking chills, lasting 1 1/2 hours , fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of Vtach and complex ventricular dysrythmia, low BP, profound weaklness, head aches and joint and muscle pains ( similar to the experienced COVID symptoms )
16-year-old received the first dose of Moderna Covid-19 by accident; A spontaneous report was received from a consumer concerning a 16-year-old, male patient who received the first dose of Moderna COVID-19 vaccine (mRNA-1273) by accident/MedDRA PT: Product administered to patient of inappropriate age.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient received first dose of Moderna COVID-19 vaccine by accident.   Action taken mRNA-1273 in response to the event was unknown. However, it was reported the patient was taken to receive the second dose of Moderna COVID-19 vaccine but was denied to him because he was a minor  The event, 16-year-old received the first dose of Moderna Covid-19 by accident, was resolved on 13 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (Lot # 013L20A) with no associated AEs.
Cerebrovascular accident (stroke after every shot moderna vaccine); This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident (stroke after every shot moderna vaccine)) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product INSULIN GLARGINE (LANTUS) solution for injection for an unknown indication.    The patient's past medical history and family history were not provided.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and INSULIN GLARGINE (LANTUS) (unknown route) at an unspecified dose once a day. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident (stroke after every shot moderna vaccine)) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebrovascular accident (stroke after every shot moderna vaccine)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was  provided. The patient said something was wrong with brain. She was told that it needs to be reported she said its because she had a stroke. The patient was on lantus prior to stroke. The patient said stroke had nothing to do with lantus. She stated she got the moderna vaccine and had a stroke after each shot (cerebrovascular accident) (unknown latency). It was not reported if the patient received a corrective treatment for the event (stroke after every shot moderna vaccine). Strength of lantus was reported as 100 iU/mL. No treatment medication information was provided.  Company Comment: This is a spontaneous case concerning an elderly female patient with medical history of Insulin glargine use, who experienced the unexpected, serious (medically significant) adverse event of special interest of Cerebrovascular accident, on unknown date after receiving a dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical condition for the use of Insulin glargine remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an elderly female patient with medical history of Insulin glargine use, who experienced the unexpected, serious (medically significant) adverse event of special interest of Cerebrovascular accident, on unknown date after receiving a dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical condition for the use of Insulin glargine remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
could not get out of the couch; she has a enlarge spleen; had the vaccine and every time, she got very very sick/ Got sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (had the vaccine and every time, she got very very sick/ Got sick), MOVEMENT DISORDER (could not get out of the couch) and SPLENOMEGALY (she has a enlarge spleen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2022, the patient experienced ILLNESS (had the vaccine and every time, she got very very sick/ Got sick). On an unknown date, the patient experienced MOVEMENT DISORDER (could not get out of the couch) and SPLENOMEGALY (she has a enlarge spleen). At the time of the report, ILLNESS (had the vaccine and every time, she got very very sick/ Got sick), MOVEMENT DISORDER (could not get out of the couch) and SPLENOMEGALY (she has a enlarge spleen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had no history relating to mentioned adverse event. Patient did not have any acute and chronic illnesses at the time of vaccination.  Patient never had COVID positive test or diagnosis.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant medication included unspecified thyroid medication.  Patient received booster dose.  Patient sought medical care and went to the treating physician.  Patient had enlarged spleen and had to get surgery to get it out, and the reason for the enlarged spleen could not be found. Patient wanted to know if the vaccine affects the spleen.  Patient did not experience any similar event in the past.  No treatment information was provided.   This case was linked to MOD-2021-009124, MOD-2022-619331 (Patient Link).
arm capillaries burst in flight; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (arm capillaries burst in flight) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PETECHIAE (arm capillaries burst in flight). At the time of the report, PETECHIAE (arm capillaries burst in flight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Left leg swelled from knee cap to groin to be twice the size of Right leg.  Area was red and warm to touch, Instructed by nurse to immediately go to ER, second opinin from On-call Dr, was to treat with cold compress and tylenol / motrin.  COmplaint of lef hurting from time of injection through 2 days after.
No appetite for days. The smell of food made patient sick. On week two after vaccine, oxygen stayed at 84%, patient couldn?t stand as he had no energy. Patient began to eat after lots of convincing and seemed to be doing at least 20% by week 3, but oxygen was still in mid 80%. On day 20 after vaccine patient had to be rushed to the ER due to sepsis. All vital organs  began to fail and on transport patient suffered a mild heart attack.   Patient was a healthy 78 year old male that lived alone and drove and had no major health issues before the date of the vaccine.
Initially I experienced nerve pains across my body, including under both of my armpits, in my groin area, in my arms including my triceps, forearms and they were very sharp pains. Then I started to get a severe headache that was pretty constant. After multiple days, my face became paralyzed. I also experienced severe fatigue. This was over 10 days. Once paralysis happened we went to the Medical Center. I was treated with IVIG for many days and oral steroids. I was in the hospital for 6 days. I also experienced my BP spiking. I had an abnormal EKG. I'm still unable to chew properly. I was told that now I have Encephalitis and GBS (Gillian Barres syndrome).
Severe chills, body aches- particularly legs, dizziness, beginning 9 hours post-injection. Worse than ever experienced, even during the flu. These progressed until awakened around 10:30pm and fainted on floor after urinating. Woke up several minutes later vomiting. Nausea and severe body aches continued until the following morning, when they started to subside. Resolved completely the following day, around 48 hours post injection. Mild fatigue in the following days.
pt recv vax 22JAN97 & 2JAN98 pt devel a herpetic rash @ the inj site;pt was treated w/Zithromax;
profound effusion in the left knee that was determined to be secondary to a Crohn's flare. unsure if the vaccination resulted in the Crohn's flare or if it was already "brewing", however, the knee effusion started within roughly 12 -18 hours of the vaccination and progressively worsened over the next week. Medical care was sought 1 week after vaccination. 70mL of synovial fluid was drained from the left knee. Effusion was submitted for analysis and a profound elevated white count was found. The fluid cultured negative for infection and lyme testing was negative. Patient responded to a high dose tapering course of steroids. The Crohn's flare was confirmed to be the cause on October 11 via colonoscopy and biopsies.
This information has been received from a registered nurse concerning a 14 year old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that on 19-SEP-2016, the patient received a dose of GARDASIL with lot number M014929 and expiration date on 27-MAY-2017, and on 15-JUN-2017, the patient received a dose of GARDASIL 9 with lot number N004798 and expiration date on 31-OCT-2019 (doses, dose numbers, routes of administration and anatomical locations were not provided), administered for prophylaxis. The nurse also stated that the patient had not experienced an adverse effect. Lot number N004798 has been verified to be a valid lot number for hpv rl1 6  11 16 181 31 33 45 52 58 vlp vaccine (yeast).
Forgot to skip a day prior to taking the third dose; Spontaneous report received on 05FEB2020.  A nurse reported that a female consumer who "forgot to skip a day prior to taking the third dose" (PT: Inappropriate schedule of product administration), while being on Vivotif capsule for immunisation. The consumer took her first and second dose of Vivotif on 01FEB2020 and 03FEB2020 respectively according to schedule. However, she forgot to skip a day prior to taking the third capsule and took it on 04FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer forgot to skip a day prior to taking the third dose (Inappropriate schedule of product administration). Vivotif doses should be taken every other day. Considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to skip a day prior to taking the third dose (Inappropriate schedule of product administration). Vivotif doses should be taken every other day. Considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.
p/vax pt exp severe cephalgia & was hosp for poss encephalitis;  Annual follow-up received on 11/27/00 provided no additional data.
Initial unsolicited report received from a physician on 17-Mar-2017. This case involves a 50-year-old female patient who was vaccinated with first dose of ADACEL (Batch number: U5552AA, expiry date, dose form frequency and route of administration not reported) in the left deltoid on 03-Mar-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as seizure disorder. Illness at the time of vaccination was reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 03-Mar-2017, the same day following the vaccination, the patient developed pain in left arm and shoulder. The patient visited the physician due to the events. Relevant laboratory investigations and corrective treatment was not reported. The outcome of the events was reported as unknown. List of documents held by the sender: None.