chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am a post menopausal woman and have not a period in 20 months.  I received my Omicron booster on the evening of Wed. 10.19. 22 at 6pm and the next morning at 9am, noticed I began bleeding  (like the start of a period). My lower back began to ache severely and my bleeding increased in heaviness.  I passed three medium sized clots and the backache increased in severity.  I had slight pain in my arm at injection site, but no swelling, redness or rash.  I called my clinic's nurse line today, Fri 10.21.22 and consulted with a nurse who told me to monitor symptoms and call back if they worsened.  My GP had left for the day and I decided to wait until next week to consult with him about next steps rather than see the on call physician.   I will track the length and flow of my bleeding and follow up with my GP/OBGYN. The nurse line urged me to file this information with the CDC.
Myalgia Injection site pain, Fatigue Narrative:  Other Relevant History:
About 5 min after admin. pt. started sweating profusely. She reported palpitations & tinnitis and was pale in color. We immediately called 911 & her vitals were taken.
Extremely dizzy, severely nauseated, headache........couldn't move all day (because if I moved I would get so dizzy).
No adverse event; patients received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patients received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date).    No concomitant medication were reported.  Vaccine was administered on  22-Apr-2023 (3 patients) 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr- 2023 (1 patient) and 12-Apr-2023 (1 patient) The Pharmacist said that the patients involved are all over the age of 65. No other adverse events have been reported. No treatment information was provided by the reporter.  This case is of for patient 11 out of 12 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:patient 1
A headache developed around 2:30 the afternoon of the vaccine. The headache started across my general forehead. Within an hour or two, it migrated and focused on the right side of my head, specifically behind my right eye and in the area behind my right ear - above the nape of my neck. These are the spots where my chronic migraines tend to originate.  At 4pm, the headache started to feel like a migraine, so I took 10 mg of Rizatriptan.  The medication didn't help initially, so I took another 10 mg before going to bed. I slept fitfully and work up with a full blown migraine with nausea. I couldn't eat or drink anything and slept off and on most of Saturday. I also vomited in the morning; in the afternoon and again around 7:30 pm. When I vomited at 7:30, there was blood so we went to the ER for treatment.
This spontaneous report was received from a healthcare worker refers to an unknown number of patients of unknown ages and gender. Since an unknown date in November 2012, the patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (lot#, expiration date and route not reported). No adverse event reported. This is one of the several reports from the same source. Additional information is not expected.
Within 48 hours a rash & bumps developed over her entire body (arms, lower stomach & back and legs). They got better but more are now starting
Info has been received from a physician concerning a 60 day old pt with "underlying mastocytosis" who was vaccinated by injection with a dose of Hep-B vaccine. Concomitant therapies received included injected doses of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, Haemophilus B conjugate vaccine and poliovirus vaccine. The pt developed urticaria, which covered the entire body, 4 days post vax, at the injection site, and had eventual dx of mastocytosis. Unspecified medical attention was sought. This was originally reported by a consumer. Follow-up info indicated that the pt was being treated with Hep-B vaccine (MSD) and not (mfr unk) as previously reported. Additional info has been requested.
This spontaneous report as received from a a medical assistant refers to a 4 year old patient of an unknown gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. On 27-APR-2017, the patient was vaccinated with an expired dose of M-M-R II recombinant human albumin (rHA), lot# M001200, expiration date 28-AUG-2016, subcutaneously. The sterile diluent used for reconstitution was not expired. The patient experienced no adverse reactions. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000202:
Information has been received from a physician concerning a 14 year old female patient with no known pertinent medical history or drug reactions/allergies who on approximately 13-APR-2010 was vaccinated with a first dose of GARDASIL (lot # not provided). There was no concomitant medication. The physician stated that on the same day of vaccination, the patient developed axillary lymphadenopathy. On an unspecified date, a complete blood cell count was performed with normal results. The patient sought unspecified medical attention. On an unspecified date, the patient had recovered. Additional information has been requested.
developed sepsis; sepsis effected his spine needed a few surgeries; prevented him from walking for awhile; only received one dose; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (developed sepsis) and SPINAL DISORDER (sepsis effected his spine needed a few surgeries) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEPSIS (developed sepsis) (seriousness criteria hospitalization and medically significant), SPINAL DISORDER (sepsis effected his spine needed a few surgeries) (seriousness criterion medically significant), GAIT DISTURBANCE (prevented him from walking for awhile) and PRODUCT DOSE OMISSION ISSUE (only received one dose). The patient was treated with Surgery for Spinal disorder. At the time of the report, SEPSIS (developed sepsis), SPINAL DISORDER (sepsis effected his spine needed a few surgeries) and PRODUCT DOSE OMISSION ISSUE (only received one dose) outcome was unknown and GAIT DISTURBANCE (prevented him from walking for awhile) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided. Treatment medication were not reported  Patient was hospitalized for one month when he developed sepsis. Patient needed few surgeries that could prevent him from walking for a while. Patient was back to home and wanted to receive the second dose.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION (LITTLE BIT OF A COUGH, LOW GRADE FEVER, BODY ACHES A LITTLE BIT AND CHEST TIGHTNESS, TIRED, DRAINED  AND NO ENERGY); BODY SORENESS THE DAY OF THE VACCINE; TEMPERATURE OF 100.2 F THE NIGHT AFTER THE VACCINE; This spontaneous report received from a patient concerned a 50 year old male The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and alcohol user one glass of wine at night and other pre-existing medical conditions included: patient did not have any known drug allergies and no medical history of chronic illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204AZ1A, expiry: unknown) dose was not reported, 1 total, administered at right arm on SEP-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported.  On an unspecified date in SEP-2021, on the same day of vaccination the patient experienced body soreness and temperature of 100.2 f the night after the vaccine. Laboratory data included: Body temperature (NR: not provided) 100.2 F.  On 20-DEC-2021, the patient woke up with a little bit of a cough, low grade fever, body aches a little bit and chest tightness, tired, drained and had no energy (suspected covid 19 infection). On same day, on 20-DEC-2021 he tested for Covid-19 at home, COVID-19 rapid POC test which was negative. On 20-DEC-2021, the patient experienced suspected clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body soreness the day of the vaccine, and temperature of 100.2 f the night after the vaccine, had not recovered from suspected covid 19 infection (little bit of a cough, low grade fever, body aches a little bit and chest tightness, tired, drained and no energy), and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000207839.  The suspected product quality complaint has been confirmed to be void-Y,this record describes adverse events (coughing, fever, body ache, chest tightness) but indicates a negative covid test. this report does not meet the definition of a product quality complaint or explicitly allege a potency issue. this record will be voided as no pqc.(void: yes) based on the RA evaluation/investigation performed.; Sender's Comments: V0:20211245146 covid-19 vaccine ad26.cov2.s - suspected clinical vaccination 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
Most of the medicine came out of her arm and only a small amount entered the arm; most of the medicine came out of her arm; most of the medicine came out of her arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of accidental underdose in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix (unknown arm). In MAR-2023, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: Most of the medicine came out of her arm and only a small amount entered the arm), exposure via skin contact (Verbatim: most of the medicine came out of her arm) and inadvertent exposure to vaccine (Verbatim: most of the medicine came out of her arm). The outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 10-MAY-2023 The patient self-reported this case. The patient received 1st dose of Shingrix at the end of March. Reported that first injection was lost during administration, the medicine came out of her hand and only a small amount entered the arm. The patient was unaware of the reason, but the regular pharmacist gave the patient a new dose, was administered correctly. The patient got reminder for 2nd dose and asked if she should get that dose now, 2 months after 1st dose or need to until the 6-month mark. The education was provided as per content, medical disclaimer was provided and referred to the health care professional. The reporter did not consent to follow up. The patient received 1st dose was lost during administration, which led to accidental underdose. The medicine came out of the patient arm, which led to exposure via skin contact and inadvertent exposure to vaccine
welts; redness/red spots; itchy; hot/welts" which were hot; Localized rashes at injection site; This case was reported by a nurse via call center representative and described the occurrence of welts in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 13th May 2019).   On 5th August 2019, the patient received the 2nd dose of Shingrix. On 6th August 2019, 1 days after receiving Shingrix, the patient experienced welts, erythema, pruritus, skin warm and injection site rash. The patient was treated with hydrocortisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the welts, erythema, pruritus, skin warm and injection site rash were unknown.   The reporter considered the welts, pruritus and injection site rash to be possibly related to Shingrix. It was unknown if the reporter considered the erythema and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid and experienced welts which were hot, itchy, and red spots. They were behind her knees, and also over her left thigh a day after the 2nd  dose of Shingrix.  The patient was instructed to use hydrocortisone and Benadryl for the symptoms. Two patients out of 10 Shingrix doses resulted the rash with same lot number, the clinic had 5 unused vaccines and had not heard back from 3 out of 10 Shingrix doses. The rash was found in the Product Information as a possible event from Shingrix. The reporter consented to follow up. This case has been linked with case US2019AMR143698, reported by the same reporter.
No adverse effect reported.; a patient was administered a dose of improperly stored MMRll that was reconstituted with Merck DILUENT that did not undergo an excursion.; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, concurrent condition, drug reaction/allergy and concomitant medication was not provided.  On 07-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S005249, expiration date 20-FEB-2021; vaccine dosage detail was not reported) subcutaneously for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. The storage temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was above 47 Fahrenheit (46.9 Fahrenheit) for 37 minutes. There was no previous temperature excursion. No adverse effects reported. No product quality complaint (PQC) was involved in this case. Data logger was involved.
Pain at injection site; Numbness in right hand and left feet and right deltoid; Tingling in right and left hand; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at injection site, numbness and tingling in her right and left hand, numbness in the right deltoid and numbness in her right and left feet.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown, Exp. unknown). On the same day, the patient experienced pain at injection site, numbness and tingling in her right and left hand, numbness in the right deltoid and numbness in her right and left feet. No treatment information was reported.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, pain at injection site, numbness and tingling in her right and left hand, numbness in the right deltoid and numbness in her right and left feet was considered as Not recovered/ Not resolved.  The reporter did not provide an assessment for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Mother reports that approximately 2 hours after receiving the vaccine, patient experienced feeling cold and had "significant rigors that shook the bed for about an hour". He experienced fatigue, body aches and fatigue for approximately 24 hours following this event. She denies that the patient had fever, rash or any other symptoms. Patient's mother is and advanced practice nurse. She monitored the patient and contacted the office where the vaccine was administered the next day so the office was aware. She stated she would report the event to VAERS. Upon a follow up call she then asked the office to report the event. During follow up call she reported no new symptoms and reported patient had recovered from all symptoms within the first 24 hours.
Local infection reaction assoc with severe redness, heat, cellulitis to (L) wrist and hand requiring steroids and antibiotics.
Information has been received from a registered nurse concerning a female, "in her 30-40's ", with renal failure and possible lupus, who on 10-JAN-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) for a workup for a kidney transplant. On 25-JAN-2007 the patient experienced developed a mild case of chicken pox, about 16 lesions. Subsequently, the patient recovered on an unknown date. Unspecified medical attention was sought. No product Quality complaint. Additional information has been requested.
mom reported taking pt to ER on 19APR96 d/t inc temp 102.2, rash on neck shoulders & back & c/o legs hurting on 29APR96 mom reported pt again running fever 102.5 & swollen upper lip & pt c/o cheeks hurting;
46 hours after I received the vaccine I developed severe itching and hives between my left elbow and the site of the vaccine-area around vaccine was about 2 by 4 inches red and swollen--also have muscle tenderness  around left ankle and up to 3 inches above left ankle
Tingling in tongue and alteration of taste with rapid progression to Bell's Palsy following LAV H1N1 Vaccine.
Full body rash /hives. Raised, red and very itchy 10 days later
devel hives next day & recv DPH @ ER;lips swelled 3 days later;
I went to bed on 2/28/21 with fever (as high as 101.7), chills, and a sinus headache. The headache was highly unusual for me. Sometime during the night I had a bilateral nose bleed. I didn't discover the nosebleed until the next morning. It was slight, easily controlled with pressure. It didn't recur thereafter. During a routine checkup not long after, my internist thought this was significant. He asked and I reported no other evidence of abnormal bleeding. He counseled me to consult him before taking any additional COVID-19 booster.
Patient presented because of a fall and had diarrhea and nausea. Ended up positive for COVID-19
got all shots still got shingles/Suspected vaccination failure; Shingles; Painful; This serious 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.   The patient's past medical history included shingles.   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: got all shots still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful).  The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported via interactive digital media. It was reported that the patient had shingles for 30 years had received all the shots still got the shingles and they were extremely painful. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.