chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was supposed to get FLUZONE HIGH-DOSE QUADRIVALENT but got FLUBLOK QIV/No AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient's daughter) via call center via Medical Information (Reference number- 00356636) and transmitted to Sanofi on 12-Nov-2020.  This case is linked to case 2020SA322320 (same reporter).  This case involves an 87 years old female patient who supposed to get INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] but got INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [lot number: QFAA2054 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination [wrong product administered].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of an actual medication error due to wrong vaccine administered (latency: at the time of vaccination).  At the time of report no adverse event was reported.  Caller asked is there any booster available.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (route, dose, lot number and expiration date were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
One hour after receiving vaccine, my entire body became bright red and hot, the thick black lines on my tattoos on my right arm became so hot they felt like a burn and became raised, and the lymph nodes in my neck became swollen. My skin was hot to touch for the next 20 hours.  The next 4 days I felt very lethargic. On Sunday (day 4), I developed a rash to the front of my abdomen that was in clear lines not extending to my abdomen. The rash also spread to my anterior neck. My hands also became bright red within an hour of the rash developing. This all disappeared with in 2 hours. My arm was extremely sore until I woke up yesterday morning (almost like I never received the vaccine). On Sunday as well, I had diarrhea and extremely painful gas. This stopped by 1600 Sunday night. Today, Monday, I feel generally back to normal other than mild lethargy.
Information regarding Flumist was received from a 32 year old female who developed nose bleed, runny nose, sinus pressure, wheezing, nasal swelling, difficulty breathing and walking pnuemonia. At 32 years of age, the pt received a dose on 10/21/03. Immediately following immunization, both of her nostrils swelled then closed completely. Twenty minutes post immunization, she developed bleeding from both nostrils which continued for 2 days. She also experienced sinus pressure, wheezing, and a runny nose with clear discharge. She was treated with Sudafed, Nyquil Cold and Flu, and amoxicillin but indicated that none of these medications relieved the sinus pressure, swelling, or runny nose. On 11/9/03, she reported her "lungs filled up with fluid and she couldn't breathe." On 11/15/03, she was seen by the physician and diagnosed with walking pneumonia. She was treated with a steroid taper and her symptoms cleared almost immediately. No additional info was available at the time of this report.
First occurrence of heavy menses 24 hours post HPV. Patient normally not menstrual yet.
Narrative: Pt is a 68y.o. Male who died on 02/03/2021 w h/o DM. CKD, pernicious anemia, cocaine dependence. Pt received Moderna Covid-19 Vaccination 1/2 on 01/13/2021. Pt presented to ED on 01/29/2021 after missing dialysis the day before and not taking BP meds, pt discharged later that day once stable. Pt died on 02/03/2021 at HOSPITAL/FACILITY per AOD. Unlikely that Moderna Covid-19 vaccine caused/contributed to pt death.
Small fluid filled rash all over body spreading in clusters, itchy, fluid cloudy.  Breakthrough chicken pox.
This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with an unspecified doses of GARDASIL (doses, lot numbers, expiration dates, routes of administration were not reported), that had undergone multiple unspecified temperature excursions. The information regarding temperature, time frame and previous temperature excursions were unknown. The digital data logger was involved. There were no adverse effects reported. The product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004383: US-009507513-1705USA004379: US-009507513-1705USA004380: US-009507513-1705USA004381: US-009507513-1705USA004382: US-009507513-1705USA004377: US-009507513-1705USA004376: US-009507513-1705USA004378:
Increased symptoms with autoimmune disease. I now have to take methotrexate. Had an autoimmune disease for 20yrs and have never had to take a prescription until after receiving this vaccination. My methotrexate also known as a chemo drug needs to be increased due to the ineffectiveness. I am miserable and wish I had never received this awful vaccine!!!
patient went to ER on 8/18/2022 complaining of left leg pain and vomiting. patient admitted on 8/18/2022 and was started on IV antibiotics for cellulitis of the left leg with erythema. Labs showed a white count 18.2 with 84% neutrophils, creatinine 1.34.  He was started in cefepime and vancomycin empirically. His cellulitis improved significantly and vancomycin was stopped. He was eventually transition from cefepime to Cephalexin 500 mg q6 hr for a 10 day course.  During physical therapy it was noted that he was having significant amount of pain on weight-bearing on the left foot. CT left foot showed diffuse soft tissue edema about the left foot and ankle, greatest surrounding the midportion of the achilles tendon with overlying skin thickening.  Orthopedics was consulted and conservative management was recommended. Cam walker boot for comfort was ordered . He also received a short burst of prednisone 20 mg x 3 days for anti-inflammatory effect after which he will go back on his home dose prednisone 5 mg.  He also had elevated BNP of 17535 and was on nasal cannula 2 L. Chest x-ray showed mild pulmonary vascular congestion. He was diuresed with improvement in his respiratory status. He was off oxygen at the time of dismissal. His home dose Lasix was restarted at the time of dismissal on 8/18/2022.
temp 99;crying excessively 22+hr per day;unrelieved by comfort measures & APAP;
Product packaging issue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT PACKAGING ISSUE (Product packaging issue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT PACKAGING ISSUE (Product packaging issue). At the time of the report, PRODUCT PACKAGING ISSUE (Product packaging issue) had resolved.        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.   Additional information: 1 vial short 1 dose, 1 vial short 2 doses, stated patients received all other doses in either vial.  Concomitant and treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: email received
pink papular lesions w/5-7 vesicles;began 13JUL97 total 25 lesions;no fever no cough no known exposure;
Patient received first dose Moderna 4/17/21, second dose Pfizer 5/19/2021. Troubleshooting: Scribe and vaccinator did not look at card to see what was given prior; he did not present card until after vaccine; first vaccine at different location so no clear record. Counseled by staff that he had received two doses of mRNA vaccine and there was no need for a third dose. Possible language barrier, but pt checked Moderna in the computer.
Frozen Shoulder,  Extreme pain ,  it hurts mainly at night and early morning hours the pain is listed as a 10.
3 inch long, two inch wide, raised itchy rash. Appeared 8 days after 1st shot and lasted about 4 days. Reappeared 2 days after 2nd shot.
Chest pain - onset 6-8 hours post vaccination, persisting for 2+ weeks. Unresolved at time of reporting. Intermittent nausea, shortness of breath, heart palpitation, hypotension, dizziness. Unresolved at time of reporting.
The 10yr old patient received an adult dose of the Hep A vaccine. The person making the error did not realize the error until going to chart the injection later in the day.
A report received from a health care professional on 11/19/03, concerning an unspecified number of children aged less than 4 years of age of unknown sex who inadvertently received Fluvirin on an unspecified date. On an unspecified date, an unspecified number of children aged less than 4 years of age inadvertently received Fluvirin. The reporter did not know if any of the children had experienced adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
After recieved vaccination within three minutes, patient complained of itching and tingling throughout body, followed by tightening of the throat one minute later. Vital Signs are as follows: P105 O2 Sats 95% decreased to 91% on room air Blood Pressure 152/82. Hives noted to develop to upper extremities and the trunk of the body. Addministerd EPIPEN 0.3mg auto injector, high flow oxygen through non-rebreather mask, Oxygen saturation improved to 100%, Pulse remianed at 110 BPM. EMS was notified and arrived within ten minutes and transported patient to hospital.
Dose 1 received on 8-Mar-2021 and Dose 2 received on 16-Apr-2021; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 8-Mar-2021 and Dose 2 received on 16-Apr-2021) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 8-Mar-2021 and Dose 2 received on 16-Apr-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 8-Mar-2021 and Dose 2 received on 16-Apr-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 8-Mar-2021 and Dose 2 received on 16-Apr-2021).    Concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD-2022-675268 (Patient Link).
Information has been received from a nurse concerning an about 18 year old female who in approximately May 2008 was vaccinated with GARDASIL vaccine (yeast). That same day, the patient developed injection site soreness which was still sore one week after vaccination. The patient sought medical attention by a phone call. The patient outcome was not reported. Additional information has been requested.
Information has been received from a Nurse Practitioner (N.P.) concerning a patient's sister who was vaccinated with a dose of Gardasil.  It was reported that the patient's sister had "seizures and convulsions" post vaccination at another facility.  No other information was available.  It was unknown if patient sought medical attention.  The outcome was unknown.  Upon internal review "seizures and convulsions" was determined to be an other important medical event.  No further information is available.
11:10 Mother approaches front desk and tells the PSR that child has a rash. I was paged overhead to front desk, mother shows me rash. I take mother with child to exam #4 to examine child. Rash seen on trunk and (R) thigh. No other symptoms or signs. Advise supervisor.
Bronchial spasms; Itching on the site; This spontaneous case received on 25-Mar-2021 from other non-health professional (consumer)(reference number: SEQW21-01069) and concerned an adult female patient. At the time of this report, the patient was 68-year-old.   The patient's relevant medical history and concomitant medications were not reported. The patient's historical vaccines included Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine) on 01-Oct-2010 after which the patient experienced bronchial spasms and itching (see case 202102077).   On 13-Sep-2011, the patient was vaccinated with Fluvirin (dose, route of administration and anatomical location: not reported) for flu prophylaxis. The batch number reported was 11053P (batch number unable to be matched), expiration date: 30-May-2012.  On the same day, within 10 minutes after receiving Fluvirin, the patient started developing symptoms of itching and bronchial spasms. Itching was severe and at site. These symptoms improved with antihistamines and inhaler.   The outcome of events of itching and bronchial spasm was not reported.   The reporter did not provide causality assessment to Fluvirin. The reporter thought it was related to thimerosal, but her allergist did not believe that thimerosal was the reason and preferred to have the list of ingredients.   The case was assessed as non-serious.  This case is linked with case 202102077 (the same patient).  Company comment: An adult female patient was administered Fluvirin. On the same day, within 10 minutes after receiving Fluvirin, the patient started developing symptoms of itching and bronchial spasms. Itching was severe and at site. These symptoms improved with antihistamines and inhaler. Based on provided information, causality is assessed as possibly related for both events, due to plausible chronology.; Sender's Comments: An adult female patient was administered Fluvirin. On the same day, within 10 minutes after receiving Fluvirin, the patient started developing symptoms of itching and bronchial spasms. Itching was severe and at site. These symptoms improved with antihistamines and inhaler. Based on provided information, causality is assessed as possibly related for both events, due to plausible chronology.
- Uncontrollable Shivering - Fever - Sore left Arm - Tiredness and fatigue - Kept me up at night
Dose #1 = 4.1.21 = got Moderna  Dose #2 = 4.22.21 = got Pfizer  Patient was scheduled for a dose 2 COVID vaccine, however, her 1st dose was Moderna and has Pfizer. Patient was given the dose of Pfizer before it was noticed she needed Moderna.  Patient was originally scheduled thru a scheduling system.
Lost hearing in right ear on morning of 2/8/22. Eventually diagnosed with sudden sensorineural hearing loss in right ear. Given two courses of oral corticosteroids (prednisone). Had little effect. Have 30%? hearing loss in right ear with distortion and tinnitus
Vaccine administration error: Wrong product selected for age. Patient was in with her younger sister for their Pfizer Bivalent COVID-19 vaccinations. The nurse (RN who is also their grandmother) selected the 10mcg/0.2 mL Pfizer Bivalent COVID-19 formulation (for 5-11 yr olds) and administered it to the 16 yr old granddaughter instead of the 10 year old granddaughter. The 10 mcg/0.2 mL dose was given in the Left Deltoid and the error was immediately recognized. The nurse reported the error to her supervisor (RN) and the supervising physician (DO). The local DOH was called and a voicemail left regarding the error and documentation. Based on the CDC guidance to complete the dose, a
MENACTRA and ADACEL were given at 0800 in each leg. (MENACTRA in right leg and ADACEL in left leg). Patient returned to clinic around 1130 c/o eye swelling and itching that began an hour prior at school. Rec'd Xyzal and Prednisone at clinic.
Elevated heart rate, dizziness, nausea, body aches, 100.5 F fever.  Increased heart rate started  2/11/2021. 96 bpm at rest on 2/11/2021 and now has resolved to 64 bpm today 2/12/2021.
Patient tested positive for COVID 19; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Patient tested positive for COVID 19) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced COVID-19 (Patient tested positive for COVID 19). At the time of the report, COVID-19 (Patient tested positive for COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Coronavirus test: positive positive.   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 assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Date: 1/23/2022    HPI:   Patient is a very pleasant 87-year-old male, well-known to my outpatient practice.  He presented to the emergency room with abdominal pain, predominantly right upper quadrant and fever.  He does report 1 episode of emesis yesterday.  Noted with temperature of 102 degrees.  Took Tylenol prior to coming in.  Patient globally weak. He has had recent anorexia, fatigue. Challenged getting out of bed at home today. He is COVID vaccinated x3.  He has had family exposures to COVID illness.  Not wearing a mask.  Seen in the emergency room setting in which he appears to be comfortable.  He did have a brief hypoxic event with a decline  In O2 saturation to 88% .
Hospitalized;  COVID-19 positive (10.9.21);  Fully vaccinated Attending Physician: MD Date of Admission: 10/9/2021, Hospital Day: 5 Date of Discharge: 10/13/2021 PRESENTING PROBLEM: COVID-19 virus infection [U07.1] COVID-19 [U07.1] HOSPITAL COURSE: Patient is a 88 y.o. female with a history of chronic expressive aphasia secondary to TBI in 2018 as well as hypertension, B12 deficiency, chronic osteoarthritis with hip pain, who lives with her daughter and son-in-law.  At baseline the patient has expressive aphasia, but is able to understand speech and follow commands.  Patient is able to feed herself and is independent in her ADLs.  Patient's daughter reports that she had noted the patient to be panting yesterday, and also noted decreased appetite.  She also observed her mother to be sleeping most of the day yesterday.  Today she had an episode of explosive diarrhea with nausea and vomiting.  The patient did have C difficile in May of 2021, and because of her diarrhea she was brought to the emergency department. The patient nausea, vomiting and diarrhea slowly improved.  Likely due to COVID-19.  She was treated supportively.  Her diet was advanced and tolerated. Her diarrhea resolved. Hematology evaluated her due to her anemia and thrombocytopenia which they feel is reactive. Her folate and B12 levels were checked and were normal. SPEP pending. Patient will follow up with PCP. Daughter indicated that she is looking for a nursing home for the patient as her husband (daughter's) just had a heart attack and has hip pain and inability to take care of patient for too long. The patient will isolate until 10/19. PT/OT evaluated her and recommended home with assist. She was discharged with daughter to her home in the meantime in stable and improved condition.  Active Issues Requiring Follow-up Issue: covid infection Recommended follow-up provider/specialty: pcp for cytopenias What is needed: CBC, possible hematology referral if does not resolve (hematology felt that this is reactive due to covid)
Sx: Bilious emesis, currant jelly stools, lethargy. Dx: Intussusception.
0.25mL given for 2nd dose; dose interval greater than 35 days; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25mL given for 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose interval greater than 35 days) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 084J21A) for COVID-19 vaccination.     The patient's past medical history included Neutropenia and COVID-19 (First diagnosed in November 30, 2020) on 30-Nov-2020. Concurrent medical conditions included Diabetes and Penicillin allergy. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 02-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (0.25mL given for 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose interval greater than 35 days). At the time of the report, ACCIDENTAL UNDERDOSE (0.25mL given for 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose interval greater than 35 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient medical history includes other mental health issues.  It was reported inmate received a 0.25 mL for a 2nd dose of Moderna instead of 0.5 mL. Asked if he should gave another 0.25 mL to make a full dose.  No treatment information details were reported.
Nosebleed. No treatment. Happened 1 day after 4 mo and 6 mo shots. Pt's mother report this to me on 4/12/2017.