chrisvoncsefalvay/vaers-outcomes huggingface dataset:
runny nose; strange illness; has never been this sick on her life; body pain/ body aches/really bad body pain/body pain that was severe; fever/ had a fever/fever of 102; chest pain; tachycardia/120's tachycardia; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHEA (runny nose), ILLNESS (strange illness), CHEST PAIN (chest pain), TACHYCARDIA (tachycardia/120's tachycardia) and ILLNESS (has never been this sick on her life) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049CZ1A and 011D2NA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included FAMOTIDINE for an unknown indication.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced CHEST PAIN (chest pain) and TACHYCARDIA (tachycardia/120's tachycardia). On an unknown date, the patient experienced RHINORRHEA (runny nose), ILLNESS (strange illness), ILLNESS (has never been this sick on her life), MYALGIA (body pain/ body aches/really bad body pain/body pain that was severe) and PYREXIA (fever/ had a fever/fever of 102). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) for Pain, at a dose of 15 mg and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 09-Sep-2021, CHEST PAIN (chest pain) and TACHYCARDIA (tachycardia/120's tachycardia) had resolved. At the time of the report, RHINORRHEA (runny nose), ILLNESS (strange illness), ILLNESS (has never been this sick on her life), MYALGIA (body pain/ body aches/really bad body pain/body pain that was severe) and PYREXIA (fever/ had a fever/fever of 102) outcome was unknown.            Diagnostic results: On 08 Sep2021-D dimer was slightly elevated (it was at 5 58).                            She went to the hospital, to the emergency department, she was all day there with tachycardia, fever of 102 and chest pain and body pain that was severe. she had a CAT scan for that. She was given IV fluids but nothing brought her heart rate down. She was discharged that nigh but was still with chest pain and 120's tachycardia, they just diagnosed that it was vaccine reaction symptoms   This case was linked to MOD-2021-286386 (Patient Link).   Reporter did not allow further contact
Pityriasis rubra pilaris; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PITYRIASIS RUBRA PILARIS (Pityriasis rubra pilaris) 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.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PITYRIASIS RUBRA PILARIS (Pityriasis rubra pilaris). At the time of the report, PITYRIASIS RUBRA PILARIS (Pityriasis rubra pilaris) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment. Lab details were not provided.
Immediately after receiving the vaccine, the patient stood up, felt dizzy and light-headed and was Assisted to the floor with legs elevated.  Slightly diaphoretic.  No loss of consciousness.  Episode lasted approximately 3 minutes.  Observed for 30 minutes, Vital signs monitored.  Discharged to home with companion.
BLOOD IN URINE; BLADDER NEOPLASM; This spontaneous report received from a consumer concerned a 69 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, no tobacco user, alcohol user, fiber glass allergy manifested by rash and itching, and depression. The patient experienced allergy manifested by rash when treated with clindamycin. The patient received rivaroxaban (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for blood thinner. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on FEB-2021 for prophylactic vaccination (dose series number 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 2 weeks, from 2019 for psoriatic arthritis, and moderate to severe chronic plaque psoriasis. Concomitant medications included sertraline hydrochloride for depression, amlodipine for high blood pressure, benazepril for high blood pressure, and hydrochlorothiazide.  On an unspecified date in JUL-2021, the patient experienced bladder neoplasm. On 12-JUL-2021, the patient experienced blood in urine. The patient went to emergency room due to blood in urine but no medication given in emergency room. He was taken off Xarelto when he experienced blood in his urine. He underwent Bacillus Calmette Guerin treatment for six weeks and had the bladder tumor removed on 16-SEP-2021. He was now back in Xarelto after the bladder tumor was removed. He did not know if the bladder tumor was benign or malignant. Laboratory data included: Complete blood count (NR: not provided) not reported, Diagnostic ultrasound (NR: not provided) not reported, and Magnetic resonance imaging (NR: not provided) not reported.  On NOV-2021, Laboratory data included: Tuberculin test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The company causality and reporter considered the causality between xarelto and bladder neoplasm as not related. The patient recovered from bladder neoplasm on SEP-2021, and blood in urine on AUG-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211252666-COVID-19 VACCINE AD26.COV2.S-Bladder neoplasm. This event is considered unassessable. The event 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. 20211252666-RIVAROXABAN-Bladder neoplasm. This event is considered unassessable. The event 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.
No known adverse event. Vaccine administration error: Comirnaty (recommended starting at age 12 years ) administered to a child 3 weeks short of the 12th birthday.
On the morning of 5/1/2013, patient began vomiting through the day and had diarrhea.  She was admitted to hospital where the stool culture was positive for rotavirus.
Around someone with COVID-19. Two days later I had stuffy nose and felt really tired. Went and had COVID-19 test done and I tested Negative, then 2 days later I took a home COVID-19 test and it was positive. I called my Dr and was prescribed Paxlovid. Am now recovered. Breakthrough case.
I am submitting this because I know there has been limited data on the effect of the vaccine on people with autoimmune issues.  I was diagnosed with rheumatoid arthritis March 2020.  Dietary changes have kept my rheumatoid arthritis in check -- not requiring any medication, even ibuprofen -- since May or June 2020.  Within 24 hours of receiving the J&J vaccine, my knees, ankles, hands, wrists, and feet began to hurt.  (I also had a 100 degree fever for 24 hours.)  Unfortunately, 2.5 weeks later, the joint pain persists.  The vaccine clearly triggered a flare up, but I hope that within another 2 weeks, the vaccine will have finishing tweaking my immune system for COVID response and the pain will abate.  I do not know yet if that will be the case.
2 1/2 hours post vaccine she reported headache lump in throat, chest heaviness & raspy voice. "Stabbing chest pain" shakes & chills thru night.
Pregnant 14 weeks due May 8th2022 Experiencing intense and unrelenting vomiting
Information has been received from a physician concerning a 13 year old pt who's 6 year old adopted sister was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (Lot # 644794/0334N) on 09/03/03 at 2:15PM. The 6 year old, who is being adopted into the family, received the vaccination and did not get a break through or rash or lesions. However, when she went home, the 13 year old (name, gender, and demographics were not reported) in the family got active chickenpox along with lesions on 09/15/03.  The chickenpox was described as hundreds of vesicular lesions and a temperature of 103 degrees F.  The teenager had never had varicella. It was noted to be "apparent secondary infection". The 13 year old is the biological child of the family. The biological children of the adopting family have not received any vaccinations because "the mother and father feel that vaccinations are not natural". The child has recovered. Unspecified medical attention was sought. There was no product quality complaint. No further information is expected.
High-pitched hissing Tinnitus (both ears) with intermittent bouts of very loud lower pitched tinnitus in one ear or the other.  Exacerbated rosacea.
liquid running down her arm from the needle to her elbow.; received at least 0.4 ml; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (liquid running down her arm from the needle to her elbow.) and INCORRECT DOSE ADMINISTERED (received at least 0.4 ml) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (received at least 0.4 ml). On an unknown date, the patient experienced UNDERDOSE (liquid running down her arm from the needle to her elbow.). At the time of the report, UNDERDOSE (liquid running down her arm from the needle to her elbow.) and INCORRECT DOSE ADMINISTERED (received at least 0.4 ml) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: New event added.
Pt. states that after receiving the 2nd dose of Phizer 11/02/2021, started experiencing symptoms 12/13/2021 of Neuropathy throughout the left arm spreading to both legs, extreme shakiness throughout the body, chronic fatigue, and shortness of breath. Primary visit 12/16/2021, recommendation  of Blood Work=Normal, Auto-Immune=Normal, CBC=Normal, Urine Test=Normal. Shaking muscle spasms, burning sensation throughout, body aches Emergency Room visit 12/28/2021 ER, EKG = Normal, Diagnosed with Neuropathy. Still experiencing symptoms along with difficulty with motor skills, Primary visit 12/30/2021 Blood Work preformed again = Normal. Primary statement "Tests Normal, Body Reaction as if Auto-Immune Disease is present".
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 57 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination.The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 05-MAY-2021, Laboratory data included: Antibody test (NR: not provided) Negative Antibodies.  On an unspecified date, the patient experienced suspected immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210533620-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
SWELLING, BRUISING, REDNESS, PAIN, DIFFICULTY MOVING ARM.
zoster dermatitis; Information has been received from a lawyer, regarding a case in litigation, concerning a female patient (pt) of unknown age . There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. On or around 10-JAN-2017, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location, and route of administration were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered itching and irritation and was diagnosed with zoster dermatitis (unclear if by a healthcare professional). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the 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 her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence , 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 the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of zoster dermatitis was considered to be disabling.
Starting a few hours after shot local muscle pain.   By evening there was fatigue, chills, and low grad fever.  Patient remained weak for roughly 24-36 hours and then fully recovered.   Side effects appear typical of patients.   Please note similar by milder effects occurred after my first injection at the end of September fro the same Pharmacy.
Arm is sore; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Agency (under reference number - US-SA-SAC20211011001392).  This case involves adult patient of unknown age and gender patient who experienced arm is sore (pain in extremity), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site.  On an unknown date, the patient developed a non-serious arm is sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
On 2nd day after vaccination (Feb. 15th) woke up with red rash over chest, arms, back, upper legs. Approx. 9a took Zyrtec-10mg. Today, Feb. 16th,  rash starting to subside.  No further side effects.  Did have arm soreness, body aches, chilling, temp. of 100.1 & 100.5 for which I took Tylenol 500mg. on Feb. 14th. Did have same rash on day two after 1st Shingrix vaccine.  Took Zyrtec-10mg x2.  Resolved.  No further issues.
1 hr after vaccination weak, headache, dizzy, sweating, hot. 6 or 9 pm 7/11 cooling pad, thermometer drinking water and OJ. 102.? -> 103.5 (1 am).
Pt developed redness and swelling to left thigh and uncontrollable crying. Treated with Motrin, cool compresses and hydrocortisone cream.
A few minutes, post vax, pt collapsed to floor and from 5-7 seconds, eyes were rolled back. Body was stiff and he was not breathing. He then roused. He had a forming ecchymotic and swollen area on his forehead. Ice was applied to forehead. Mother declined anything else.
noticed that the Infanrix vaccine was expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 03-JUL-2023, the patient received Infanrix (injection). On 03-JUL-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: noticed that the Infanrix vaccine was expired). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUL-2023 The reporter who was reporting for the clinic where she worked. The reporter asked another nurse to get her an Infanrix dose out of the system. The reporter retrieved the vaccine and gave it to the account manager as instructed. CMA administered the vaccine to the patient unknown location. After administration, CMA noticed that the Infanrix vaccine was expired. The parents of infant had not called to report any adverse reaction to vaccine at present time.  The parents had not been notified of expired vaccine at present time. The reporter would notify parents after speaking to MI. The reporter consented to follow up. The patient received expired dose of Infanrix, which led to expired vaccine used.
Know people who took the vaccine and still got shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Know people who took the vaccine and still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter had shingles ones, never again, that was 14 years ago and that was way too much pain. The reporter would not take the shingles vaccine. The reporter knew people who took the shingles vaccine and still got shingles. The reporter stated that did your research and asked questions. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
No additional AE details; 1 lot of VARIVAX was administered after non-supported excursion; This spontaneous report has been received from an office manager, regarding an unspecified number of patients of unknown gender and age. Information regarding the patients' historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.   On 19-JUL-2022, the varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U008181, expiration date: 16-JUN-2022 experienced 08-FEB-2023) was administered after non-supported excursion (product storage error). Temperature excursion of 10.2 Celsius degrees (C) for 182 hour. No additional adverse events (AE) reported (no adverse event).  This case was classified as non-valid due to the lack of patient's identifiers.  Follow-up was received from the office manager on 09-SEP-2022. It was updated, that not properly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered to 4-year old female patient, and her sister. There was reported, that temperatures were misread and misrecorded, and that is why the medication error occurred. It was confirmed, that no adverse reactions were reported. This is one from two reports from the same reporter.; Sender's Comments:  US-009507513-2209USA004279:
ZOSTAVAX given 7-16-12 - PT came in on 7-19 with extensive redness from shoulder to elbow at site of injection - PT to see primary MD - PT returned later in day & said MD diagnosed as reaction to vaccine & prescribed antibiotics.