chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling sensation on the lower right side of my face.; Weak feeling in my right forearm.; Increased heart rate; irregular heart rate; feeling extremely anxious.; Ringing in my ears.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11May2021 (Lot number: EW0164) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PARAESTHESIA (medically significant) with onset May2021, outcome "not recovered", described as "Tingling sensation on the lower right side of my face."; MUSCULAR WEAKNESS (medically significant) with onset May2021, outcome "not recovered", described as "Weak feeling in my right forearm."; HEART RATE INCREASED (non-serious) with onset May2021, outcome "not recovered", described as "Increased heart rate"; HEART RATE IRREGULAR (non-serious) with onset May2021, outcome "not recovered", described as "irregular heart rate"; ANXIETY (non-serious) with onset May2021, outcome "not recovered", described as "feeling extremely anxious."; TINNITUS (non-serious) with onset May2021, outcome "not recovered", described as "Ringing in my ears.". The patient underwent the following laboratory tests and procedures: heart rate: (May2021) increased; (May2021) irregular. Therapeutic measures were not taken as a result of paraesthesia, muscular weakness, heart rate increased, heart rate irregular, anxiety, tinnitus.  Additional information: The patient had no other vaccine in four weeks, no other medications in two weeks. The patient no tested covid tested post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
4 days after vaccination, suffered diplopia that resolved, recurred again 7 days after vaccination, lasted 20 minutes and then recurred 8 days after vaccination with associated headache.  Patient to emergency department and noted to have orbitopathy with asymmetric swelling of rectus muscles of left eye.
Admitted with high blood glucose, intermittent nausea, decreased appetite.  Subsequently found to be COVID1-9 positive.  >14 days post vaccine completion.
Phone call from pt reporting left arm from shoulder to elbow hot, hard and sore. Went to ER on AM of 6/16/03 and seen. Treated for cellulitis with Cipro 500 mg for 5 days. 6/19/03 phone call made to pt's home. No answer. Message left to return call.
went home & took nap for 30-45mins; refused lunch; woke up & was shaking & twitching; very irritable;
Acute Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 38-years-old male patient received bnt162b2 (BNT162B2) at the age of 38-years-old, dose 1 via an unspecified route of administration, administered in arm left on 05Aug2021 15:00 (Batch/Lot Number: FA7485) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included penicillin allergy. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks, no other medications in two weeks. There were no concomitant medications. No Covid prior vaccination. The patient previously took cephalex [cefalexin] and experienced drug allergy. The patient experienced acute appendicitis on 06Aug2021 01:00. Adverse event: Acute Appendicitis was observed within 24 hours and intensified to go to the emergency room where it was officially diagnosed resulting in an Appendectomy. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for acute appendicitis for 1 days. Covid tested post vaccination included Nasal swab: negative on 07Aug2021 Nasal Swab. The event outcome was recovering.
itchy pins and needles all over his body/ scratching; he had a few pains; This is a spontaneous report from a non-contactable consumer. This 85-yeard-old male consumer (patient) reported. A 85-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 25Feb2021 as a single dose for covid-19 immunization. Medical history included nephrolithiasis, blood cholesterol. Concomitant medication(s) included allopurinol (ALLOPURINOL) taken for nephrolithiasis; carvedilol (COREG). Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on 04Feb2021 as a single dose for covid-19 immunization. It was reported patient had no side effects after the first dose. He received his second dose on 25Feb2021 and the first night he had a few pains here and there. The next day he took a Tylenol felt better but then he started having itchy pins and needles all over his body and he continues to have these symptoms. He has seen at least 2 or 3 doctors including his primary care provider, cardiologist and urologist and they don't know what to do for him either. He read on the internet that these side effects are being reported now. All he is doing is scratching. He used to take the prescription medication allopurinol for prevention of kidney stones and another medication for cholesterol that he cannot remember the name of at this time but he cannot take these anymore because they make the scratching, pins and needles feel worse. He denies having any sort of redness or rash on his skin associated with the itching. He states that he had this experience before when he tried to take the generic form of Coreg so now he can only take the brand name of Coreg so that this does not happen. The caller wants Pfizer to tell him what to do about these side effects because his doctors cannot tell him what to do or help him with his side effects. Outcome of the event was unknown. No follow-up attempts are needed; Information related to batch/Lot number could not be requested.
2 diluent mixed as single dose; 2 diluent mixed and administered; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: 2 diluent mixed as single dose) and inappropriate dose of vaccine administered (Verbatim: 2 diluent mixed and administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 The reporter stated that 2 doses of Shingrix diluent mixed and given instead of 1 of each of the 2 parts.  No adverse events were reported when nurse followed up with patient.  The dose was repeated. The reporter stated that 2 doses of Shingrix diluent mixed and given instead of 1 of each of the 2 parts, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Fever, body aches, chills, diareab, nausea, severe headache
Patient claimed she had nausea, vomiting, aches all over, very bad chills. She called 3rd shift pharmacist around midnight and informed him that she had gone to hospital for treatment.
Headache, Fever, SENSITIVITY TO LIGHT (W/MIGRAINE HA) Narrative:  Other Relevant History:
aspirin 81 mg PO QD clopidogrel 75 mg PO QD gabapentin 600 mg PO TID glipizide 2.5 mg PO QD levothyroxine 200 mcg PO QD nifedpine ER 30 mg PO QD warfarin 1 mg PO QD
T cell count abnormally high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "lost 60 to 70 lbs" (unspecified if ongoing), notes: who lost 60-70 lbs; "cholesterol down right" (unspecified if ongoing), notes: cholesterol down right. There were no concomitant medications. The following information was reported: T-LYMPHOCYTE COUNT INCREASED (non-serious), outcome "unknown", described as "T cell count abnormally high". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts completed. No further information is expected.
~approximately 30 min after vaccination received a funny feeling in my head not quite like a headache and pain around my nose and between my eyes which lasted about 5 minutes followed by ear popping which ceased after about 5 minutes followed by ear pain for about 15 minutes
headache; upset stomach; soreness at injection site/ site soreness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd December 2019, the patient received Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced headache, upset stomach and injection site pain. On an unknown date, the outcome of the headache, upset stomach and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the headache, upset stomach and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 68 years or 69 years. The patient never experienced side effects to any vaccine before. The day before the reporting date, the patient received Shingrix. The patient had headache, site soreness and upset stomach. The patient asked about the duration of these side effects.
She had minimal side effects with the 2 previous Moderna (Monovalent) COVID-19 boosters; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (She had minimal side effects with the 2 previous Moderna (Monovalent) COVID-19 boosters) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: J&J COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with J&J COVID-19 vaccine.   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 IMMUNISATION REACTION (She had minimal side effects with the 2 previous Moderna (Monovalent) COVID-19 boosters). At the time of the report, IMMUNISATION REACTION (She had minimal side effects with the 2 previous Moderna (Monovalent) COVID-19 boosters) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Additional Information provided test results and a possible cause for the reported events. Information regarding PREVNAR was received from a healthcare professional regarding a 4-year-old female patient who experienced poor appetite, fever spiking to 104 degrees F., abdominal pain and possible community acquired infection. At 4 years of age, the patient received the third dose on 22-Sep-2008. The patient experienced poor appetite in Sep-2008 and fever spiking to 104 degrees F. and abdominal pain on 22-Sep-2008. The reporting healthcare professional stated that community acquired infection could be a possible explanation for the reported symptoms of poor appetite, pyrexia and abdominal pain. Outcome was reported as not recovered. No additional information was available at the time of this report.
Info has been received from a physician concerning an 18 month old male who in 11/04, "6 months ago", was vaccinated with a dose of varicella virus vaccine love. At a later date, the pt developed a mild case of chickenpox and is now completely recovered. No product quality complaint was involved. Additional info has been requested.
Patient received Covid vaccine at approximetely 12:40pm.  An employee noticed patient not feeling well.  Patient was reported to be very sweaty, pale and had a low heart rate. The patient then lost conciousness.  An epipen was administered at 12:52pm in patients right thigh.  Ambulance was called and was sent to Emergency Department at Hospital.
Ruled out myalgia. Shingles pain in upper left thigh. Same location as shingles dermatome in December 2020.
MOTHER REFERS THE PATIENT PRESENTED WITH VOMITING, ITCHING AND RASH IN SKIN WHICH GOT WORSE. THE DERMATOLOGIST DIAGNOSED TINEA VERSICOLOR AND RECEIVED TREATMENT.
1355 - Vaccine administered. 1413 - Itching and redness at injection site. 1417 - Epinephrine administered. 1428 - EMS transported to ER. 1530 - Given BENADRYL at ER and discharged.
Developed hives 8 days after the second vaccine. The hives were all over back, neck and torso. Lasted approximately 3 days.
Narrative:  COVID infections following completion of COVID vaccine series 02/02/21 COVID vaccine dose #1 02/22/21 COVID vaccine dose #2 07/20/21 Pt reports headache, muscle pain - swab performed; COVID positive 07/21/21 Pt reports chills, cough, fatigue, fever, headache, muscle pain, runny nose; temp 98.6; rx for albuterol, DM/guaifenesin 07/22/21 Pt reports chills and sweats at night, occasional cough, fatigue, low grade fever, headache, muscle pain, runny nose, SOB with exertion 07/23/21 Pt reports very mild cough, muscle pain 07/24/21 Pt reports fever (99.7), muscle pain 07/25/21 Pt reports chills at night, loss of taste or smell, loss of appetite, muscle pain; fever resolved 07/26/21 Pt reports improving but continued loss of appetite; chills and fever resolved 07/27/21 Pt reports reappearance of chills and sweats, continued muscle pain but symptoms are improving 07/29/21 Quarantine end 08/02/21 Pt reports no respiratory symptoms but continued low energy and body aches, and occasionally sore throat
PATIENT STATED SHE HAD "HIVES AROUND WAIST AREA ON THE LEFT SIDE. SHE TOOK BENADRYL AT THE TIME REACTION WAS NOTED. HIVES WERE RESOLVED AND HAS NOT HAD ANY FURTHE ISSUES.
Patient called store to report having side effect from shingles vaccine administered on 9/16/22. Patient reports getting at the site of injection a red knot, itching, soreness, tenderness. It was not hot to the touch. Symptoms started after injection on same day and has continued to today. Patient has been applying warm compresses to her arm, but still complains of itching. Patient counseled to try applying Benadryl cream to the area.
Flu-like symptoms including fatigue, myalgia, congestion, chills. I also had a tingling sensation on the left side of my face. All symptoms lasted for 10 hours.  Some mild diarrhea from 3/18-3/20/21.
Severe nosebleed; This is a spontaneous case reported by other non health professional to agency reference number: SEQ19-01801) and initially received on 14-Aug-2019, concerning a 79-year-old, female patient.   The patient's medical history included occasionally, slightly elevated blood pressure.  On 13-Aug-2019, at 11:00 am, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, at a dose of 0.5 ml, route of administration, anatomical location, batch number and expiration date: not reported] for influenza prophylaxis.  On the same day, at 7:45 pm, approximately 9 hours after vaccination, the patient developed severe nosebleed. The patient put ice on her nose and later was advised by a nurse to pinch her nose.  Later that day, at 8:45 pm, the patient recovered from the event epistaxis'.  The reporter assessed the case as non-serious. The reporter's causality assessment was not reported, however, the patient's pharmacist advised her, that her nosebleed might be due to high blood pressure.  Company comment: A 79-year-old, female patient experienced epistaxis after receipt of Fluad (TIV). Chronology seems plausible. The patient's medical history included occasionally, slightly elevated blood pressure which, along with advanced age, may provide alternative aetiology for the event. With information provided, casual role is set as not related to the product.; Reporter's Comments: A 79-year-old, female patient experienced epistaxis after receipt of Fluad (TIV). Chronology seems plausible. The patient's medical history included occasionally, slightly elevated blood pressure which, along with advanced age, may provide alternative aetiology for the event. With information provided, casual role is set as not related to the product.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 03-NOV-2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, anatomical location and route of administration were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, pt suffered shingles lesions on the right side of face, arm, neck and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, pt 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. As a direct and proximate result of defendants' conduct, pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the shingles was reported as not recovered. The causality assessment was related.  The event of shingles lesions on the right side of face, arm, neck, diagnosed as herpes zoster was considered to be disabling.
headache, sinus congestion, slight cough, loss of smell, loss of taste starting 10/18/21
Pt returned to the Clinic on 10/18/2019 @ 1345 complaining of injection site reaction. On her right arm just above the Elbow there is a red swollen area that is warm to the touch and very tender.
Within a month of his vaccines, patient quit trying to talk.  Beforehand, he was saying words like "No" when he didn't want something.  He would say "bye bye", "hi" "Mama" "Dada".  After his vaccines, within a month, we noticed he stopped saying most words.  We noticed this especially because he started screaming instead of trying to talk.  This loud high pitched screaming was the only way he would communicate with us.  This lasted until around age 2 1/2.  His doctor was concerned at his 2 year checkup.  Patient could understand what we were saying, he could follow simple directions, but he could not speak for himself.  His doctor believed at his 2 year checkup that he had a speech delay.  There were no other symptoms, as patient was healthy and thriving in every other aspect.  We were told by Dr. to contact a speech therapist, but instead, we worked with him at home.  As of now, he is 3 1/2 and finally speaking.  He started speaking at 3 years old and has slowly progresses since.  Once he starts preschool this fall, I believe he will need speech therapy, as he is still very difficult to understand.  We have not gone back to the doctor since his 2 year appointment.
Approx 6 months after receiving vaccine patient was diagnosed with Alopecia Aereta. Symptoms worsened over the course of a few months, and patient began steroid treatment at Dermatology clinic. Symptoms progressively got better but still has several spots that have not recovered.
I had a IBB flare up. I had diarrhea about 30 times a day. I had some nausea. I called my doctor office. They just gave me some medicine.
Received his 4th BIOTHRAX shot in his left arm. He recalls that it was toward the back of the deltoid, but not directly in the triceps region. He also received a DTaP that day, and believes it was in the opposite arm. There was no site reaction at either site. Complained of a left arm paresthesia since. It is in an ulnar nerve distribution, and predominantly causes a dullness/tingling to the fourth and fifth digits.
I started with a mild headache with chills body aches and fever of 100 degrees, rash and hives and chest pains. Into the next day I had a sever headache, chest pains and BP 176/126 that caused my cardiologist to add two additional meds to try and get me out of the hypertensive episode.
Sore throat; Face feels swollen and hot; face feels hot; Feverish and felt hot; so sick; very tired; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face feels swollen and hot), FEELING HOT (face feels hot), ILLNESS (so sick) and FATIGUE (very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ILLNESS (so sick) and FATIGUE (very tired). On 30-Jan-2021, the patient experienced SWELLING FACE (Face feels swollen and hot), FEELING HOT (face feels hot) and PYREXIA (Feverish and felt hot). On 31-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face feels swollen and hot), FEELING HOT (face feels hot) and PYREXIA (Feverish and felt hot) had not resolved and ILLNESS (so sick) and FATIGUE (very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Body temperature: 98.4 normal. In February 2021, SARS-CoV-2 test: (Positive) one week later after vaccination got tested positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caucasian is the race of the patient. No concomitant medications were reported No treatment drugs were reported   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: Additional initial document received on 17-FEB-2021 had added events like lab data
Paralysis of left hand, little finger and numbness that spread to other hand, legs and toes. Fatigue, stiffness and inability to hold on to small objects. Difficulty climbing stairs and loss of balance. Treatment provided by MD.
A non-serious spontaneous report of can't sleep, hard to breathe, feeling of fluid in lungs, fever, and no energy has been received from a consumer concerning a 19-year-old male, subsequent to FLUMIST. The patient's past medical history included inhaler dependent asthma. Concomitant medications were not reported. The patient received FLUMIST on 30-Sep-2009. The patient received a single dose before onset of the events. On an unknown date, the patient experienced "can't sleep, hard to breathe, feeling of fluid in lungs, fever (105.8), and no energy". Outcome and causality were not reported.
Patient report that 2 hours after the vaccines she got hives on her legs... the next day she got hives on her faces arms and stomach... called her doctor who told to take Benadryl every 4 hours... 2 days later her throat and eyes were swollen...