chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RIB PAIN; VOMITING; HEADACHE; NAUSEA; INJECTION SITE PAIN; NIGHTMARES/VIVID DREAMS; FEELING COLD; FEELS AWFUL; INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; ARM PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included stroke, alcohol use 1-2 glasses per week, non smoker, depression, and sleeping problem. The patient experienced drug allergy when treated with povidone-iodine, and codeine for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:30 in left arm for prophylactic vaccination. Concomitant medications included fluoxetine for depression, zolpidem for occasion sleeping problems, acetylsalicylic acid for stroke, and atorvastatin for stroke. On 12-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 12-MAR-2021, the subject experienced off label use. On 12-MAR-2021, the subject experienced arm pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 18:30, the subject experienced feels awful. On 12-MAR-2021 19:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced nightmares/vivid dreams. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares/vivid dreams, rib pain, vomiting, feels awful, feeling cold, arm pain, chills, fever, headache, nausea, injection site pain, and fatigue on 15-MAR-2021, and the outcome of off label use and inappropriate route of vaccine administration was not reported. This report was non-serious.  Additional follow up information received on 26-Mar-2021.The following information was updated and incorporated into the case: age, medical history, demographics, concomitant medication, route of administration for suspect product, events (inappropriate route of vaccine administration and off label use) concomitant medications and outcome  was updated.; Sender's Comments: V1: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age with no pertinent medical history and no drug reactions or allergies. On an unknown date the patient was vaccinated with GARDASIL injection (lot # and expiration date unspecified) (dose, route and anatomical location unspecified) for vaccination. Concomitant medications were not reported. The healthcare worker reported that on an unknown date the patient developed heavy periods with cramps after receiving a dose of GARDASIL. At the time of the report the outcome of heavy periods and cramps was reported as recovered/resolved. Patient sought medical attention by seeing the physician. Therapy with MEDRIOL was given as treatment. Laboratory tests were not reported. The reporter stated that this is 4 of 4 cases reported the same day. Additional information has been requested.
Red welt at the site of injection; Fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red welt at the site of injection) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Sore arm). On 17-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red welt at the site of injection). At the time of the report, PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red welt at the site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
Itching, swelling, redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles.; Swelling  redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles.; redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles.; This is a spontaneous report from a contactable consumer, the patient. An 86-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 06May2021 at 14:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included lung cancer, diabetic, arthritis, diverticulosis and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), diclofenac (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN) four more (unspecified medications) & supplement (supplie) (unspecified) from an unknown start date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 17:00, the patient experienced itching, swelling, redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of itching, swelling, redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles and included self-treatment with lavender, ice packs and antihistamine (unspecified) from an unknown start date to an unknown stop date. The clinical outcome of the event itching, swelling, redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles was recovered at the time of reporting.   No follow-up attempts are possible. No further information is expected.
felt pain on the back of my lower neck/upper back. I thought I had a spider bite or some kind of bite. It was painful and then became itchy. After a few more days I started to feel pain on my skin. it started from the spot on the back of my neck and worked it's way toward my right shoulder and eventually across to the middle of my chest. in a gradual pattern over a few weeks the pain turned to burning and then itching and then looked like a rash. The pain and burning was so bad it was hard to wear a shirt and hard to shower. I went to the doctor to see if I was having an allergic reaction to something. They said it was a mild case of shingles and would go away in a few more weeks.  The bumps eventually turned to little scabs. I no longer have pain but still have a bunch of the scabs. They are now only slightly bothersome and seem to be clearing up.  Also, my periods are always regular but after my second shot(moderna) and again after my booster(pfizer) I had an extra period between my cycles. Also, my 11 year old daughter who has not yet begun menstruating got a period few weeks after her second shot. She has not had another period since.
Patient has a lot of redness and warmth to the touch, redness has gotten worse since shot now at day 3. She also reports having to use her inhaler more often than normal.
erythema on upper half of injected extremity (left arm).; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient who was a radiologist reported the case for himself. The age at vaccination was not reported but could be 53 or 54 years. Lot and expiry date were not provided.  The patient developed erythema on the upper half of the injected extremity (left arm).  The reporter did not consent to follow-up.
its been a year since  I contacted your reporting adverse program with my issues and along with the medical professionals dont seem to hear me
don't help you still can get shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that vaccines did not help still could get shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Two days post vax, the pt developed a swollen arm 4 x normal size with erythema present. The arm was described as being hot to touch and spreading down to hand. The pt also experienced a fever, upper respiratory infection symptoms, and general fatigue. She received Rocephin IV and oral dose-pack of corticosteroids for 4-5 days.
Initial healthcare professional report received on 18 Dec 2009: This patient (one year old child) was vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) on 18 Dec 2009. No adverse event was reported.
The patient's first dose of Moderna was administered on 2/3/2022. The second dose of Moderna was administered too early, on 2/15/2022
39 Male tested positive 6/4/2021. Vaccinated with Pfizer 12/22/2021 & 1/12/2021. 6/4/2021 hospital admission for tracheo-esophageal fistula (TEF) transfer from hospital. Diminished breathing sounds, minimally conscious. Removed from ventilator support 6/17/2021. Problems at time of death 6/19/2021 - chronic respiratory failure, COVID-19, history of severe TBI, TEF, trach vent/PEG dependent.
11/20/01 - AM nausea, vomiting, temp 100F, chills. 11/21/01 started to feel better. no vomiting, no temp, ate small amounts. No reaction at site of injection
This case was considered medically important for the event of autism. Information regarding Prevnar was received from a consumer regarding an female patient who received the third dose on 16-Aug-2005 at the age of 6 months and was diagnosed with autism and heavy metals including mercury in the patient's system at the age of 29 months. In Aug-2007, the patient was diagnosed with heavy metals including mercury in the patient's system and autism. Treatment included amino acid powder and DMSA. The patient had not recovered from the events. No additional information was available at the time of this report.
Shaking; Could not eat; Dizziness, lightheadedness; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), DECREASED APPETITE (Could not eat), DIZZINESS (Dizziness, lightheadedness) and PYREXIA (Fever of 102F) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 immunisation.     Concomitant products included INSULIN for COVID-19 vaccination, METFORMIN, PIOGLITAZONE and PRAVASTATIN for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced TREMOR (Shaking), DECREASED APPETITE (Could not eat), DIZZINESS (Dizziness, lightheadedness) and PYREXIA (Fever of 102F). At the time of the report, TREMOR (Shaking), DECREASED APPETITE (Could not eat), DIZZINESS (Dizziness, lightheadedness) and PYREXIA (Fever of 102F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Consumer declined further follow up.
pt recv vax 10JUN98 & mom reported pt became irritable on 13JUN;14JUN98 about 4PM devel T102.6 ear;also shaking chill;given APAP & Motrin;15JUN98 T100.3, shaking, not eating well but taking fluids;dx viral illness;
8/20/08- PT TOLD HER MOM THAT HER LT ARM WAS ITCHING AND HAVING PAIN. SHE CAME INTO THE OFFICE AND HER LT ARM SUB CUT WAS WARM TO THE TOUCH AND HAD SOME SWELLING (3 1/2 x 5 cm in length) PARENT AND PT. WAS ADVISED TO TAKE SOME BENADRYL, USE COOL COMPRESSES, TAKE ADVIL FOR ANY PAIN -PER RANI KOKATNUR NP. ADVISED TO RETURN TO OPFFICE IN NO IMPROVEMENT.
Having allergies/ Respiratory allergie; Perioal dermatitis around mouth (red itchy scaly); This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Having allergies/ Respiratory allergie) and PERIORAL DERMATITIS (Perioal dermatitis around mouth (red itchy scaly)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ETANERCEPT (ENBREL) for Immunosuppression.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Having allergies/ Respiratory allergie) and PERIORAL DERMATITIS (Perioal dermatitis around mouth (red itchy scaly)). At the time of the report, HYPERSENSITIVITY (Having allergies/ Respiratory allergie) and PERIORAL DERMATITIS (Perioal dermatitis around mouth (red itchy scaly)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  Treatment information was not provided.
Within an hour of the vaccine my arm began to have pain in left shoulder that made it difficult to raise my left arm. By the end of the night I could not move my arm at all due to the pain. I could not lay down for bed due to the severity of pain, so I sat on the couch with it prompt up by a pillow. The pain worsened into the night and the following day. By the night of the 17th I had a fever of 101.6 with headaches and nausea. By the 18th the pain worsened even more preventing me from using it at all and the Fever remained into the evening. I then emailed my Doctor that night. I received a response Monday 12/19/2011 with advise to set an appointment. I then called the office the next day on the 20th to set an appointment, but my Doctor was not available and they did not have any available appointments. I received a call about 5:30pm that night from my Doctor and I spoke with him regarding pain and symptoms and he advised me to try and wait until Thursday 12/22/2011 to see if the pain would subside. It did not, so I called the morning of the 22nd of December and got an appointment for 9:00am that morning. I saw Dr. at the same office. She sent me to get some blood work done and x-rays. While I was in the x-ray, she called me back up to the office and proceeded to tell me that she believed the diagnosis to be Acute Brachial Plexus Neuritis (a rare side affect from vaccinations) and prescribed me Generic Viocodin for pain and Prednisone along with physical therapy. The medicine did help with the pain and made it possible to sleep without much pain.
Atrial fibrillation; This is a spontaneous report from a contactable consumer. This consumer reported the same events for himself and two other patients. This is the second of three cases.   A patient of unspecified age and gender received the first and second doses of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that since the patient has been diagnosed with atrial fibrillation on an unspecified date after taking both COVID shots. The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021269817 same reporter, drug and event, different patient;US-PFIZER INC-2021316269 same reporter, drug and event, different patient
Large amount of floaters in vision, both eyes. Noticeable when looking at clear sky, night time.
Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unknown dates, improperly stored doses of PROQUAD (dose, strength, frequency and route were unknown, lot # N002917 with expiration date 24-JUL-2018 and lot# M041508 with expiration date 09-APR-2018) were each administered to the unspecified patients for prophylaxis. The PROQUAD was exposed from -14 Celsius to -10 Celsius for a time frame of 15 minutes. There were no previous temperature excursions. A data logger was in use. No adverse symptoms were reported.
Patient received flu shot and experienced increase in heart rate and blood pressure. Her tongue started swelling and one dose of epinephrine was given. Emergency personnel was called and she was rushed to the emergency department. She was given further treatment and has recovered.
I woke up and couldn't stand up; I had to get a grip on the wall to side. It only happens on my left side; I noticed I was extremely dizzy. I called my doctor and told her I figured I was experiencing vertigo. She made an appointment 2 weeks out (01/25/2022) because she mentioned the vertigo can last 2-3 weeks after experiencing from the vaccine. I was still suffering from it until the appointment. At my appointment, she laid me down to try to relieve some of the tension in my head and constantly turn and rotate my head to the left (where the vertigo) was affecting to do some motion exercises. She prescribed me Meclizine 12.5mg to see if it'll help with the vertigo as it's a motion relief medicine, however, I'm still suffering from vertigo til this day.
c/o rt thigh swelling approx 2" circum x 3 days & leg stiffness; c/o shakes, chills, nausea, severe muscle ache, fever to 102; BP 80/40;
Received expired dose of the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). In November 2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expired vaccine has been administered from  06-NOV-2021 to 16-NOV-2021. No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
metastatic breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CANCER METASTATIC (medically significant) with onset 2021, outcome "unknown", described as "metastatic breast cancer". The patient underwent the following laboratory tests and procedures: investigation: (2022) metastatic breast cancer.  Clinical course: Five months later patient received a diagnosis of metastatic breast cancer.  The lot number for bnt162b2 was not provided and will be requested during follow up.
After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, then I headache started. A minute later fatigue hit and I was starting to fall asleep at the wheel. I live 1 mile away so I made it home. Now my head was getting fuzzy.  Called a co-worker to tell her what was happening and she said my speech was slurring. I felt drunk and hungover at the same time.  I went to bed and slept for an hour. I woke up and felt very fatigued. I  finally went to bed for the night then was awoken with severe arm pain. My entire upper arm felt so tight but I it was soft upon palpation. I fell asleep and awoke to terrible arm pain again. I started crying in bed but fell asleep again. I woke up in the morning with severe upper arm pain and minor headache. I couldn't rotate my arm back to put my bra on so I took some ibuprofen. That had immediate relief for my arm and headache. I ran one errand and was wiped out. The fatigue hit again.  The arm pain came back so I took another ibuprofen with relief. I had no energy so laid around for the rest of the day. I woke up on Sunday and finally felt normal with  just pain at the injection site.  The 2 other medical people that have had similar reactions like mine with dizziness and feeling light-headed have one thing in common with me...we are all vegetarians. I don't know if that makes a difference with protein metabolism or other enzymatic activity, but we are the only 3 that I know of out of all of our co-workers who have received the vaccine to react like this.
Subsequent to receiving two doses of rubella virus vaccine live (second generation) the pt failed to seroconvert.  Additional information has been requested.