chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2- doses of Fluzone High-Dose during the same season, No AE; accidentally administered the Fluzone High-Dose in error not the pneumonia vaccine, no AE; Initial information received on 11-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 67 year old female patient who received two doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] during the same season due to the consumer was to receive a pneumonia vaccine but was given a dose of Fluzone High-Dose instead.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On 01-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ301AA and expiry date 24-Jun-2020) via intramuscular route in the left deltoid. On 10-Dec-2019 she also received an extra dose of the same vaccine  with an unknown batch number via intramuscular route at an unknown administration site.  It was a case of actual medication error due to extra dose administered and wrong vaccine administered. The patient received 2 doses of Fluzone High-Dose during the same season due to the consumer was to receive a pneumonia vaccine but was given a dose of Fluzone High-Dose instead. The nurse reported that the CMA accidentally grabbed the HD not the pneumonia vaccine.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Localized redness, hard, warm erythema 11 cm x 6 cm size, left deltoid.
Information has been received from a 31 year old male physician who on an unspecified date in March 2008, was vaccinated with his first dose of GARDASIL (Lot #, site and route not reported).  On 28-MAY-2008 the patient was vaccinated subcutaneously in the right arm using an 18 gauge needle with his second dose of GARDASIL (Lot #, site and route not reported).  The physician stated that he felt a little flushed, malaise, and a little tachycardic post vaccination, "but feels fine now".  On 28-MAY-2008, the patient recovered from being a little flushed, malaise and a little tachycardic.  The patient sought unspecified medical attention.  No additional information was provided.  No further information is available.
Pt seen at ER on 01June07 with severe cellulitis to the L upper arm from smallpox vaccination, he was given Erythromycin and Motrin at that time. Follow up at the Clinic on 04June07 with extensive cellulitis to the left upper arm extending to the elbow. Given IV Rocephin and follow up on 05June07 noted worsening of cellulitis, was given Rocephin.
Dr's office called to say child had adverse reaction in (R) arm. Large red. Swollen area. Size of baseball in (R) arm. Started 24 hr after injection by 36 hr was very large hot and swollen-spreading.
I received the vaccine Monday and didn't notice anything Tuesday however I did not look at myself on Tuesday so I can't say if anything started Tuesday or not.  Wednesday morning I noticed red blotches all over my neck, torso/stomach, back, arms, top of legs.  It started off as red spots, then turned to very large darker red splotches over the rest of the day into evening.  No itching, burning or pain.  I did not take any medication for it or put anything on my skin.  Thursday the blotches were less noticeable.  Friday the blotchy areas were a very faint pink.
64-year-old female presents emergency department plan of shortness of breath.   Patient complains of shortness of breath for the past 3 days with associated cough fever chills body aches.   Patient denies any chest pain nausea vomiting.  Patient denies any diarrhea.  Patient states shortness of breath acutely worse today.  Course of symptoms constant degree at onset minimal degree of present moderate.  Patient denies any significant  alleviating factors.  Exacerbating factors include any activity.  Patient by emergency department covid-19 positive CT scan shows evidence of viral pneumonia.  Patient upon arrival was initially O2 sats of 93 patient's O2 sats dropped to 90 and then upon ambulation dropped into the 80s.  Patient was placed on nasal cannula and patient will be admitted for further treatment
Within a day of getting the shot she had pain in the area. It persisted for the last 3 weeks, she has trouble lifting anything. If she tries to lift her arm too high she has "fall to the ground" pain. After talking with RPh will seek Dr visit ASAP.
The day after I received vaccine shot 2 on 3/30/21, I had terrible sinus issues. Pressure, congestion, runny nose, worse if I sat down or laid down. Tried allergy meds, sinus pressure meds, nasal sprays by Mucinex and Xlear. Issues worsened after Covid booster on 12/7/21. After the booster I have not felt myself. Lethargic for the past 3 weeks, tired, restless, on 12/22/21 I thought I was having the onset of a heart attack. Numbmess and pain in left arm, shoulder, hands. I got up from bed, walked around, sat up for a good hour, subsided.
Left arm soreness; Soreness on left side of breast as well as right; Lymph nodes enlarged; spotting; 1 week early than normal menstrual cycle; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in the left arm on 09Mar2021 12:00 (Batch/Lot Number: Eng205) as SINGLE DOSE for covid-19 immunisation. Patient had no medical history. Concomitant medication included ashwagandha (ASHWAGANDHA) taken for an unspecified indication, start and stop date were not reported.  On 11Mar2021, the patient experienced Left arm soreness for 2 days. Soreness on left side of breast as well as right. (Lymph nodes enlarged) spotting noticed 6 days after vax, 1 week early than normal menstrual cycle. The outcome of events was reported as unknown.
Immediately post vaccine patient complained of metallic taste in mouth, itchy tongue, diaphoresis and shortness of breath. On VS Heart rate and blood pressure were elevated O2 sat was WNL. Patient w as placed in a supine position and VS were repeated after 15 min and she felt better and VS were now WNL
FACE WAS BREAKING OUT WITH LITTLE BUMPS UNDER THE SKIN THAT WERE PAINFUL; FACE WAS BREAKING OUT WITH LITTLE BUMPS UNDER THE SKIN THAT WERE PAINFUL; SPIKES IN INFLAMMATORY MARKERS SHORTLY; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (FACE WAS BREAKING OUT WITH LITTLE BUMPS UNDER THE SKIN THAT WERE PAINFUL), RASH (FACE WAS BREAKING OUT WITH LITTLE BUMPS UNDER THE SKIN THAT WERE PAINFUL) and INFLAMMATORY MARKER INCREASED (SPIKES IN INFLAMMATORY MARKERS SHORTLY) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 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 started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced RASH PAPULAR (FACE WAS BREAKING OUT WITH LITTLE BUMPS UNDER THE SKIN THAT WERE PAINFUL), RASH (FACE WAS BREAKING OUT WITH LITTLE BUMPS UNDER THE SKIN THAT WERE PAINFUL) and INFLAMMATORY MARKER INCREASED (SPIKES IN INFLAMMATORY MARKERS SHORTLY). At the time of the report, RASH PAPULAR (FACE WAS BREAKING OUT WITH LITTLE BUMPS UNDER THE SKIN THAT WERE PAINFUL) had not resolved and RASH (FACE WAS BREAKING OUT WITH LITTLE BUMPS UNDER THE SKIN THAT WERE PAINFUL) and INFLAMMATORY MARKER INCREASED (SPIKES IN INFLAMMATORY MARKERS SHORTLY) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Inflammatory marker test: Spike in Inflammatory Markers.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of face was breaking out with little bumps under the skin that were painful and spikes in inflammatory markers shortly after the first and second covid vaccines with rinvoq (upadacitinib) was no reasonable possibility.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Information was received from a registered nurse concerning a 50 year old female who on 24 JAN 2005 was vaccinated with a dose of Varicella live virus.  Subsequently the patient developed ten vesicular lesions on her body mostly at teh injection site.  Not other symptoms were noted. Unspecified medical attetntion was sought.  The outcome was repoted as recovered.  There was no product quality complaint.  Additional ifnormation was requested.
Initial reaction sore arm, off balance, tingling in arm, around 2 hours later lower extremities painful - body aches
Itching, redness, swelling, soreness, no treatment received. 11.5 X 7 cm.
got sick; Initial information received on 25-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional via social media.  This case involves female patient of an unknown age who got sick (illness), while she received vaccine Influenza Vaccine.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got sick (illness) (non-serious).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
He reports that in July of 2011 he received an Anthrax dose (IM dose number 5) in his left shoulder with only local redness, pain and swelling at the site. Denies nasal, ocular, cutaneous, lip/tongue/oral/throat, pulmonary, GI and CV symptoms. Denies fever/chills, muscle/joint pain/swelling. Over the next week after vaccination he noted a "lump" at the vaccination site that has persisted without change since that time. Denies pain, warmth, tenderness and drainage from site. Denies issues with prior doses of Anthrax (he has not received subsequent doses) and has tolerated all other prior and subsequent vaccine doses without adverse reactions. US of affected area read as consistent with lipoma.
Diagnosed with Posterior Leukoencephalopathy.; This spontaneous case was reported by a consumer and describes the occurrence of LEUKOENCEPHALOPATHY (Diagnosed with Posterior Leukoencephalopathy.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LEUKOENCEPHALOPATHY (Diagnosed with Posterior Leukoencephalopathy.) (seriousness criteria hospitalization and medically significant). At the time of the report, LEUKOENCEPHALOPATHY (Diagnosed with Posterior Leukoencephalopathy.) outcome was unknown.            Concomitant products include Cholesterol medication. Treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Reporter described the event as Brain inflammation and delirium.  Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.
Roughly a month after receiving the 2nd Pfizer COVID-19 dose (4/13/21), I started experiencing irregular menses. This was significant, as I am on the Nexplanon birth control implant, and have been for 4 years. During those 4 years, I have had essentially no periods, with some very irregular light spotting (roughly 1-3 days a year). Since June 2021, however, I started spotting for multiple days, and experiencing bleeding that seemed to be menses. The timing, however, was irregular. For example, I would bleed for 6 days with a normal menses flow, and then 9 days later, I experiences 4 days of light bleeding/spotting. Then 8 days later, I experienced two days of spotting. Then I experienced nothing for 3 weeks, after which I experienced 15 days of spotting/bleeding. I sought out medical attention in early July.
Shingles outbreak on left side of face/ head beginning ~ 5 weeks after Janssen Covid vaccine (fever, inflammation, blisters, rash, swelling, nerve pain, headache, occular complications)
Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 24Jan2023; No adverse event; expired doses were given to 7 patients/Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 24Jan2023) and NO ADVERSE EVENT (No adverse event) in an adult 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. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-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. On 24-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 24Jan2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 24Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 24Jan2023).    Concomitant medication was not reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vial was initially stored in the refrigerator on 06-Dec-2022 and patient received vaccine on 24-Jan-2023. Vial did not undergo any temperature excursions. Caller stated that they received the vaccines they were refrigerated so they put them in the refrigerator, they were not put it in the freezer.   Treatment medication was not reported.  This case contains information for the 6th of 7 adult patients described by the reporter.
Pt. started becoming weak 2 days after receiving both H1N1 & seasonal vaccine on 12/10/09. She progressively became weaker requiring assistance with ambulation. She also reports loss of appetite. She was admitted to hospital 12/18/2009 with a "shock like syndrome". According to Dr. also, was very anemic requiring 3 units of blood. Has past hx of bleeding but all tests done show no obvious signs of active bleeding.
Presents for hypoxia, tested positive for COVID x4 days PTA. Admit for acute respiratory failure, COVID pneumonia. Tx: steroids, O2, zinc, vitamin c, abx, vitamin d. DC back to assited living facility.
C/o (L) thigh pain. Redness and swelling appeared 3-4-15 afternoon.
I believe I caught COVID but tested negative. I had flu like symptoms, runny nose, fever, fatigue. Also, lost my sense of smell for two weeks.
Approximately 1 hour after receiving the vaccine I began to itch and break out on my right leg.  This hive moved down my right leg to calf and across to the other leg as well.  It then spread to my trunk, back and right side of neck.  I took 50 mg of Benadryl po and call clinic where I received the vaccine.  Approximately 2-3 hours later I took another 50mg of Benadryl secondary to no change in rash/hives.  The itching stopped but the rash/hives remained.  At bedtime I took another dose of Benadryl and woke with the rash/hives still on my lower extremity.
Erythematous maculopapular rash extending from face to feet. Soles & palms spared. No vesicles or scabbing.
Fever, soreness at site of vaccine and headache were only present early on and resolved in 48 hours of the vaccine. Then after a few days, these symptoms started (below):  PAIN in every joint, large and small, including vertebral spine, shoulders, hips, knees, elbows, hands and feet, fingers and toes, as well as costochondral joints in the ribs; SWELLING and REDNESS in many joints including most of right foot, some of left foot, knees, hips and sacroiliac joints. On and off headache.  Slight reduction, but still present after 3 weeks.
No additional adverse events reported; dose of VARIVAX was administered during a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-SEP-2020, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection, subcutaneously, 0.5 ml, lot# T008129, expiration date 06-MAR-2022 (strength was not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 7.8 Fahrenheit degrees (F) for 6 hours and 46 minutes. There was no previous temperature excursion reported. The call was not due to digital data logger. No additional adverse event was reported.
Your vaccines (Unspecified vaccines) for your corona virus killed my grandmother and father; killed my family members; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), 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: DEATH (death), outcome "fatal", described as "Your vaccines (Unspecified vaccines) for your corona virus killed my grandmother and father; killed my family members". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073523 same product and event, different patient;; Reported Cause(s) of Death: Your vaccines (Unspecified vaccines) for your corona virus killed my grandmother and father; killed my family members
The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 22-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
pt recvd vax & 20 mins p/3rd dose exp blisters on lips; pt was seen by MD sx have not resolved;
B/P 72/40, P 42 with frequent PVCs up to 20 / minute, and 102 temp.  I was unable to stand, literally crawled to the bathroom.  This was for over 24 hours.
Tingling " like novocaine at the dentist" on one side of face. Itching at same sight. Tounge itching as well though never experienced that before in life. Lasted 25 min. Numbish cheek lasted for a day. Arm pain severe and lost ability to lift it for days. In good health and strong normally.
1 patient received Fluzone Quadrivalent and/or Fluzone High Dose was injected subcutaneously, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown demography who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and/or INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] injected subcutaneously (incorrect route of product administration).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE and/or INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via subcutaneous route in unknown administration site.  It was a case of actual medication error due to inappropriate route of vaccination.  At the of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  Information on the batch number was requested.