chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Facial Drooping; Eye, facial and then shoulder twitching, his neck, nose and legs twitch as well.; facial and then shoulder twitching, his neck, nose and legs twitch as well; Eyes blink repeatedly; This case was reported by a consumer via call center representative and described the occurrence of facial droop in a 6-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number YZ7TR, expiry date 30th June 2019) for prophylaxis.   On 27th September 2018, the patient received the 1st dose of Fluarix Quadrivalent 2018-2019 season (intramuscular) .5 ml. On an unknown date, 5 days after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced facial droop (serious criteria GSK medically significant), blepharospasm, twitching and excessive eye blinking. On an unknown date, the outcome of the facial droop and blepharospasm were not recovered/not resolved and the outcome of the twitching and excessive eye blinking were unknown.   It was unknown if the reporter considered the facial droop, blepharospasm, twitching and excessive eye blinking to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The case was reported by patient's father. The patient had eye, facial and then shoulder twitching.  The patient's eyes blink repeatedly and that his neck, nose and legs twitch as well. The patient also experienced facial drooping. The patient was referred to health care professional (HCP) and provided medical information (MI) phone number for HCP reference. The reporter inquired about post-marketing experience regarding how many patients reported nervous system disorders and how symptoms were managed. The reporter consented to follow up.
L Deltoid ache and mild weakness not resolved since 11/29/2006. Ache is at injection site. No visible atrophy. Normal strength, full ROM on exam.
Excruciating back pain, headaches, insomnia, restlessness, hot/cold flashes, injection site pain, can't think/concentrate, sense of impending doom.
Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3.5 years old patient (gender not reported) who accidentally received QUADRACEL (lot- C5248AA, expiration date - 21-Aug-2019) via intramuscular route in the left thigh instead of DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (lot number and expiry date was not reported) on 08-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VAQTA; and RECOMBIVAX HB. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was not reported if patient had any adverse event. 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.
Received vaccine 10-22 7 AM. Friday eve developed neurologic symptoms from neck down-tingling in all parts of body, aching from neck down back, mild headache, shakiness.
Patient began having back pain on Friday but by Saturday was having a hard time walking.  Having pain at the left elbow, both shoulders, left knee and left foot.  Dr. came in to examine patient as well.  Think he is having tendinopathy as pain was not in the joint itself.  Patient having pin point tenderness.  Denies fever.
Immediate onset pain at injection site and shoulder joint with progressive loss of mobility over the next 24-48hrs and worsening pain. Persisted despite home therapy for a month. Complete resolution of symptoms with left glenohumeral corticosteroid injection with recrudescence of pain about 10 weeks later without history of prior symptoms, trauma or mechanism of injury.
Pt rec'd Hep A #1 and Hep B#4 on 2/3/03 and rec'd SPV on 2/4/03. On 3/5/03 was reported to the ER with 3 day history of fever of 103, vomiting, neck stiffness, and headache. She was admitted into the ICU in Hospital where she remained for 3 days.  Received on 03/17/2003: "Patient continues to have extreme fatigue, requiring daily naps.  The fatigue has affected her work and quality of life.  She is unable to participate in family functions with her children.
Started with light headedness and fatigue.  three days later developed vertigo, headache, nausea, heart palpitations, night sweats.
local rxn red, approx 2 inch induration in diameter;said feels sore;
had the Moderna Booster a week ago 11/10/21, I had a slight reaction with chills about 24 hours later.; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (had the Moderna Booster a week ago 11/10/21, I had a slight reaction with chills about 24 hours later.) 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 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced CHILLS (had the Moderna Booster a week ago 11/10/21, I had a slight reaction with chills about 24 hours later.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (had the Moderna Booster a week ago 11/10/21, I had a slight reaction with chills about 24 hours later.) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.
Received a monovalent booster dose after primary series instead of bivalent booster dose. Pt informed and will returned 1-7-23 for bivalent booster.
Within 2 hours of receiving vaccine had chills, malaise vomited x1. Later developed purpura which continues until 10/6/16 at MD visit.
limited use of her arm and fingers; hit me in knee, shoulder, rotary cuff; This is a spontaneous report from consumer via Pfizer-sponsored programmed . A 81-year-old female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date, as a SINGLE DOSE for COVID-19 immunization. The patient previously took first dose of BNT162B2 vaccine for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced limited use of her arm and fingers, and hit me in knee, shoulder, rotary cuff. It was reported that patient was not sure if its a possible side effect due to the second dose of the covid-19 she had about two or three weeks ago. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
COUGH; HEAD HURTS SO BAD; FEVER; BLOOD PRESSURE WENT UP; COULD NOT EAT; GOT A LOT OF THINGS WRONG; ARMS BLACK AND BLUE; LOST WEIGHT; GOT SICK; This spontaneous report received from a patient concerned an 8-decade old female, race and ethnicity unknown. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, hole in chest, clotted artery in heart/ blood clot in artery, intestinal problem, sick, and possible bronchitis, and concurrent conditions included: diabetic, kidney cancer, and antibiotic allergy. The patient was previously treated with azithromycin, doxycycline; and experienced almost died when treated with influenza vaccine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 24-AUG-2021 ,13:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included insulin glargine for diabetes, and insulin Lispro for diabetes. On an unspecified date last year, the patient stated her blood pressure was190/120 units unspecified. The patient stated that after vaccination she felt fine, could not pass out. On 24-Aug-2021, around 17:00 to 18:00 she stated that her head hurts bad, blood pressure went up and got sick. The patient experienced headache, fever and she could not eat. The patient stated that she got lots of thing wrong with her. The patient took Tylenol, and extra blood pressure medicine at night and was able to sleep. The Laboratory data included: Blood pressure (NR: not provided) 188, 186/79/83, 123/54, 186. The patient stated her arms are black and blue. On 25-AUG-2021, the patient experienced cough. Laboratory data included: Blood glucose (NR: not provided) 100, and Blood pressure (NR: not provided) 186/79. The action taken with covid-19 vaccine was not applicable. The patient was recovering from head hurts so bad, and the outcome of cough, blood pressure went up, arms black and blue, fever, lost weight, could not eat, got a lot of things wrong and got sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851803-COVID-19 VACCINE AD26.COV2.S-blood pressure went up. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a 54 year old of male white and  Hispanic or Latino . The patients 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 was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. physician called in to report that his patient received the vaccine on 05-MAR-2021 and done antibody testing done on two separate occasions on 05-APR-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative. On 27-APR-2021, Laboratory data included: Antibody test (NR: not provided) Less than 1 no immunity. On an unspecified date, the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210460431-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Pt. received the first dose of the COVID Moderna vaccine and had a stroke two days later. The day of the stroke, he was found by his family, EMS was called and he was taken to medical center, the nearest stroke center. He spent a week admitted to neuro and was then transferred to rehab where he spent about a month. He has been at home since the end of May 2021 and continues to display post-stroke problems. He is unable to function on his own and requires someone to be with him 24/7 to provide care and assistance.
3rd DOSE OF PFIZER COVID VACCINE GIVEN 8/17/21, LOT #EW0171; pt brought to ED from where he resides; AMS; found to be positive for COVID; CXR showed small bilateral pleural effusions and pneumonia; given ABX; also has a UTI; blood cultures were positive for Klebsiella; CT of thorax, abdomen, pelvis showed cholelithiasis with gallbladder distention; cholecystitis; general surgery consulted; family opted to transition pt to comfort care; pt passed away in the hospital
Patient reported chest pain and headache.  She was evaluated through walk in clinic and saw a MD.  Symptoms resolved without treatment.
The patient received the vaccine on 2/23/21. The next day she experienced dyspnea and wheeezing which was relieved using her inhaler and nebulizer. On 2/27/21, 4 days after receiving the vaccine she developed hives of both arms, her back,  and buttocks. She went to the emergency room and was treated with prednisone which relieved the hives. Today 3/3/21 she has just a small hive at the injection site and no further difficulty breathing.
Developed COVID-19 after receiving Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Developed COVID-19 after receiving Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Developed COVID-19 after receiving Moderna vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Developed COVID-19 after receiving Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: TCR added. Patient declined consent for further follow up and stated "everything is fine".
I am pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I am pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (I am pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (I am pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
At approximately 4 pm, I gave the patient a Janssen covid-19 vaccination. I asked the patient to sit for 15 minutes for observation. About 10 minutes later I was notified someone wasn't doing well. I went to the patient and he was hunched down and looked pale and he stated he was very dizzy. I asked him if he had trouble breathing and he stated he had not. He appeared like he was about to pass out, I was asking him questions about his state and he wasn't being coherent. I told him I was going to give an EpiPen and call 911. I gave him the EpiPen in his outer thigh. EMS came 5 minutes later.  A few hours later I got a call from a close by asking if I had given him a Benadryl because he was feeling drowsy. I asked his status and the nurse stated he was doing fine.
4-24-12 Mom walked the baby outside (baby in stroller) & mom said baby sounded choking & seemed not breathing. Took her out of stroller & run to the clinic. On exam baby appeared sl. dazed but recovered soon. Exam normal. No neuro deficit. Imp. apparent life threatening event.
I received the Pfizer Covid vaccine in March 2021 (1st dose) and April 2021 (2nd dose). In May, I started have breakthrough bleeding. I have had an IUD for 13 years and have not had a period. I was also diagnosed with a vaginal polyp in June 2021 which had to be removed in July 2021. I have had irregular periods every ninety since getting the vaccine.
Patient fainted after being vaccinated B/P 90/60 P126 02-98,Temp 36.4, Dex 88  It is recommended to the mother of the minor that for his next dose, the minor has to eat since the minor had not eaten food.
Systemic: Seizure-Medium, Additional Details: Patient had 3 1-minute seizures while in waiting area after the immunization.  Patient was concious between seizures, and is aware of her condition.    EMS was called and transported patient from the store.  Patient was contacted later in the day.  Patient had been discharged from the ER and would follow up with her neurologist.  Patient reported that she was doing well.
Information has been received from a pharmacist concerning a female patient with avascular necrosis who was vaccinated with a dose of GARDASIL. Subsequently, the patient experienced worsening of her joint pain. The reporter was unable to provide the interval between the vaccine and the onset of the increased joint pain. At the time of this report, the patient has not recovered. No product quality complaint was involved. No further information is available.
4 hours after flu shot, became very weak, unsteady on her feet; evolved sharp headache, sore throat. Called MD on 10/30, still feeling weak but slowly improving. No treatment needed; symptoms cleared 11/1/08.
Patient developed hives on her face approximately 10 minutes after inoculation. Patient was monitored and no other symptoms were noted.
My husband went into the emergency room on 12-12-21 for an abscessed dry socket from a tooth extraction.   The abscess was easily drained and he was started on antibiotics.  But what was alarming for the ER was that his oxygen levels were "dangerously" low.   They opted to keep him in the hospital over night  and added two more inhalers to his daily protocols.
Inappropriate schedule of vaccine administered; tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 15Nov2021 15:15 (Lot number: FH8028) at the age of 34 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162B2 (first dose, Batch/Lot No: FD0809, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 21Sep2021, when the patient was 34 years old, for COVID-19 immunization, reaction(s): "brain fog", "Disorientation", "Headache", "ear fullness", "sensitivity to noise", "tinnitus in both ears and head occurred".  The following information was reported: TINNITUS (non-serious) with onset Nov2021, outcome "not recovered", described as "tinnitus"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Nov2021 15:15, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The event "tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: After second dose of vaccination has increased tinnitus volume slightly. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Daily multivitamin was received within 2 weeks of vaccination. The patient had no known allergies. Prior to vaccination, the patient did not have COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
HCP calling to report AE for ROTATEQ that experienced a temperature excursion and was administered.; No side effects reported.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On unknown day, the patients was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #W0291190 was not valid, expiration date was reported as 28-JAN-2024, exact dose and route of administration were not provided) for prophylaxis (Product storage error).  On unknown day, the suspect vaccine experienced a temperature excursion of 9.3 degrees Celsius (C) for 5 hours and 11 minutes. On unknown day, the vaccine experienced previous temperature excursion of 18.8 C for 2 hours and 55 minutes. No side effects reported (No adverse event). No product quality complaint (PQC).; Sender's Comments:  US-009507513-2308USA005205:
p/vax pt exp pain in knees; ankles; wrists; seen by MD; tx w/ibuprofen; condition ongoing.  The patient has seasonal allergies, and no drug allergies. Concomitant medication: tetanus vaccine administered on 03-Mar-99 and Beconase nasal spray. On 03-Mar-99 the patient received the first .5 cc dose of LYMERIX and the unspecified dose of tetanus vaccine. Twelve days later, on 15-Mar-99, the patient experienced pain in knees, ankles, and wrists, and was seen by a physician. He was treated with ibuprofen 400 mg bid on 15-Mar-99. On 26-Mar-99 his ibuprofen dosage was increased to 600 mg bid. Nine days later, on 24-Mar-99, the patient developed inflamatory polyarthritis and plantar fascitis. Testing has not revealed a specific diagnosis. As of 21-May-99, the patient stated that he was doing well; He had some slight discomfort in his right ankle. He compared it to the feeling one would have had after having sprained an ankle several months ago. It has not kept him from doing anything. He did not think that any joint were swollen, ad, or warm. he no longer had significant heel pain. He was back to work full-time and was taking no medications. Examination showed no swollen joints, including the righ ankle. He was no longer tender under the heels. Impression: acute inflamatory arthritis and plantar fascitis, resolved. Etiology unclear although probably related to the Lyme Vaccine. The most recent information, received on 01-Oct-99, reports the condition of the patient as resolved.
I had Covid six months ago and have not had my booster/ I had Covid twice already and I have had two vaccines. I had covid 6 months ago; I had Covid six months ago and have not had my booster/I had Covid twice already and I have had two vaccines. I had covid 6 months ago; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "I had Covid six months ago and have not had my booster/ I had Covid twice already and I have had two vaccines. I had covid 6 months ago"; COVID-19 (medically significant), outcome "unknown", described as "I had Covid six months ago and have not had my booster/I had Covid twice already and I have had two vaccines. I had covid 6 months ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I had Covid twice already and I have had two vaccines. I had covid 6 months ago."  Follow-up attempts are completed. No further information is expected.