chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Primary 1 on 11FEB2021 and Primary 2 on 4MAR2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1 on 11FEB2021 and Primary 2 on 4MAR2021) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1 on 11FEB2021 and Primary 2 on 4MAR2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1 on 11FEB2021 and Primary 2 on 4MAR2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), 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 (Primary 1 on 11FEB2021 and Primary 2 on 4MAR2021). No concomitant medications were reported. The lot number and the expiration date for both the primary doses were unknown. No treatment information was provided by the reporter.   This case was linked to MOD-2022-631139 (Patient Link).
Patient received first Moderna vaccine on 1/12/2021.  Side effects included sore arm. Patient received second Moderna vaccine on 2/9/2021.  Side effects included chills, myalgias, fatigue, arthralgias.  Side effects lasted between 12-24 hours.  Patient tested +COVID via PCR testing on 3/8/2021 with mild symptoms.
Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Expiry Date of COVID-19 Vaccine: Unknown), for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The niece of reporter just had received the second dose yesterday from Pfizer and she has like a fever today. So, I think she had like a, at one point she had 103 temperature and now it came dropped to 102. Just wanted to know if it does, like does it concern and if we should take her to the hospital right now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
By error the nurse administered Jynneos vaccine beyond use date to 6 patients; Case reference number US-BN-2022-004308 is a spontaneous case report initially received on 24-Oct-22 from health care professional via Communications (reference: USBAV22-1762) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On 21-Oct-2022, six patients were vaccinated with an unknown dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00013, Expiration date: Sept,2024) at an unknown dose, through unknown route of administration, at unknown anatomical location, for monkeypox prophylaxis.  On the same day, as reported by error, the nurse took the box that had a beyond use date of October 18, 2022, and administrated six doses to patients, (explicitly coded as 'Expired product administered'). Vials were not punctured prior to administration.  As reported, patients have not reported any adverse events.  The Reporter did not assess the event per seriousness criteria and assessed causality between the event and Jynneos as possible related.  This case is linked with the case US-BN-2022-004306, US-BN-2022-004307, US-BN-2022-004309, US-BN-2022-004310 and US-BN-2022-004311 (same reporter).  Additional information received from on 31-Oct-2022 included local case ID.; Reporter's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.
Information has been received from a physician concerning a 47 year old "transplant" female patient with allergy to gentamicin, alpha-1 anti-trypsin deficiency and a history of influenza vaccination in September 2009 who on 15-MAR-2010 was vaccinated IM with her first 0.5 ml dose of GARDASIL (lot #663559/1178Y), which was required in order to be put on the transplant list. Concomitant therapy included vitamin D (unspecified), PERCOCET, calcium (unspecified), multi vitamin, albuterol, SPIRIVA, "ALIST", tuberculin purified protein derivative (PPD) and ADVAIR. The patient did not have any problems after receiving the first dose of GARDASIL. On 08-JUN-2010, in the morning, the patient was vaccinated IM with her second 0.5 ml dose of GARDASIL (lot # 662765/0821Y) in her right arm. The patient had the impression that the nurse gave her the second dose of GARDASIL at a higher location than the location of the first dose. In the afternoon, the patient received PPD in her left forearm. On 08-JUN-2010 the patient experienced tingling and numbness of the entire right arm and pain on the entire right arm. It was pretty uncomfortable. The patient sought medical attention by an office visit and telephone calls. At the time of the report, the tingling and numbness persisted. No laboratory or diagnostic studies were performed. The reporting physician considered tingling, pain and numbness on the entire right arm to be disabling. Additional information has been requested.
Covid19 breakthrough.  1st vaccine received on 03/05/2021,  2nd vaccine on 03/26/2021.  78 y/o female presents to ED with c/o Sinus drainage, abdominal tenderness, congestion, chills, cough with clear sputum, and profound N/V/D.  Pt afebrile, room air sat 100%.  Pt with electrolyte imbalances being corrected.
"Report a side effect.; Is it normal where you got your vaccine to be hurting for three days?; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("Report a side effect.) and VACCINATION SITE PAIN (Is it normal where you got your vaccine to be hurting for three days?) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION ("Report a side effect.) and VACCINATION SITE PAIN (Is it normal where you got your vaccine to be hurting for three days?). At the time of the report, VACCINATION COMPLICATION ("Report a side effect.) and VACCINATION SITE PAIN (Is it normal where you got your vaccine to be hurting for three days?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication included.  No treatment medication included.
Leg swelling and discomfort. Saw primary care provider who thought this was varicose veins and referred to vascular surgery. Venous duplex revealed DVT involving left leg. Patient treated with at least six months of apixaban.
2 days following her Pfizer shot, patients face started burning all over and became bright red.  Redness and pain continues but has lessened some to date (3/31/21).  Face started to peel a couple of days ago and is continuing to peel.  Patient describes it as a very intense sunburn, but she has not been out in the sun.  Patient is now on day 12 of reaction.
blood clot in spleen; This is a spontaneous report from a non-contactable consumer (patient reported for herself). An 82-year-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Lot Number: EW0177), dose 2 via an unspecified route of administration, administered in Arm Right on 19May2021 (at the age of 82-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received her first dose of (BNT162B2, formulation: Solution for injection, Lot Number: EW0172), via an unspecified route of administration, administered on 28Apr2021 (at the age of 82-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, a few days after 2nd dose of Pfizer vaccine, the patient was hospitalized with a blood clot in spleen. It was reported that the patient had no prior medical history. The seriousness criteria of the event reported as hospitalization. The outcome of the event was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Cough; This is a spontaneous report from a consumer (patient).  A 94-year-old female (also the age at vaccination) patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number not reported), via an unspecified route of administration in the right arm on 26Jan2021 12:00 PM at SINGLE DOSE for COVID-19 immunization. The patient is vaccinated at a public health department. The patient is not pregnant. No other vaccines in four weeks. No COVID prior to vaccination and not COVID tested post vaccination. Medical history included High blood pressure, High Cholesterol both from unknown and if ongoing. Concomitant medication included amlodipine and simvastatin (reported as other medications in two weeks). It was reported that the patient experienced cough on 27Jan2021 at 12:00 PM. No treatment was given. The outcome of the event was not recovered.   Information about Batch/Lot number has been requested
Burning on forehead & above eyebrows down the sides of my face.  This last for several weeks soothed by Medline Remedy with Olivamine Calazime.  Very sore to the touch as if I was hit by something.  Stinging & intense burning, flaking skin, redness & blisters.  I am still dealing with residual spots that are slowly healing, stopped stinging & burning, but still flakey & sensitive to touch.
Information was received from a consumer referring to an approximately 19 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions, and allergies were not reported. On 17-MAY-2018 at 08:00 AM, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (route of administration, lot number, and expiration date were not reported). On 18-MAY-2018 (one day post injection), the patient experienced itchiness, pain, and some redness at injection site; the outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported.
This spontaneous report as received from a physician via field representative refers to two female patients of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial (dose, lot and expiry date unknown). On an unknown date the patient developed rash, redness and swelling after receiving ZOSTAVAX. The outcome of events was reported as not resolved. Additional information has been requested.
<15 minutes after shot my throat felt constricted, I had difficulty swallowing, was wheezing and had trouble speaking. Staff checked my vitals - BP was 165/118 (my normal is 100/60) and my pulse was 129.  The doctor gave me 50 mg of Benadryl. They rechecked my vitals to find my BP had plummeted to what they deemed ?dangerously low.? Their EpiPen malfunctioned so the paramedics were called. I was transported to the ED via ambulance. The doctor I saw was trying to avoid having to use an EpiPen so started with 40 mg Pepcid, high dose IV Prednisone and 8 puffs of albuterol. I showed no signs of improvement, so she ordered the EpiPen. Within 5-10 minutes of administering the EpiPen, my breathing was back to normal, I could swallow normally and was able to speak. I was discharged a couple hours later and sent home with 2 EpiPens in case it happened again.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with lupus and no drug reactions/allergies. On 15-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number reported as K003600, expiration date 19-MAR-2015) (dose and route not reported). Concomitant medications included methotrexate, PLAQUENIL and PROLIA. Approximately on 18-AUG-2014, reported as 3 days later, the patient developed an elevated rash at the injection site. The patient saw the pharmacist for medical attention and did not receive treatment for the event. The pharmacist reported that the patient still had the rash at the time of the report. No additional information was provided, VZV packet was declined. No lab diagnostics were performed. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX injection (lot # L012477, expiry date 10-JUL-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Patient was ordered for 15 month  vaccines: Infanrix, PCV13, HIB and Flu vaccine. This RN administered wrong vaccine and patient received Vexalis vaccine instead of Infanrix vaccine. RN immediately notified Dr. and nurse manager of error.  RN called patient's mother and informed her of vaccine  error.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY ACUTE DVT OF LEFT TIBIAL VEIN LEFT FACIAL MUSCLE WEAKNESS 1/19/2023  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient son stated today that 4 days after vaccine patient arm sore between shoulder and elbow and still is in pain/sore today 27 days later.
I woke up Saturday morning 5/21 and thought I was getting a sinus infection. But I went ahead and did a home Covid test and the line was very faint so I wasn't sure on the results. I did another and the results were still unclear so I went to the pharmacy to be tested and those results came back positive on Monday, 5/23. I was pretty sick that Saturday night and was up coughing most of the night. I called my health care provider after receiving my positive results. The nurse I ended up speaking with informed me that they would refer my information to their Covid team for review. A few hours later they called and informed me of a PAXLOVID prescription that was being called in for me. I began taking that yesterday on 5/23. I am still feeling tired and winded, I also have a headache and coughing. I also have been experiencing a terrible taste in my mouth.
SUSPECTED  COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 24 year old male. The patient's weight was 195 pounds, and height was 72 inches. The patient's past medical history included exposed to covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On FEB-2021, Laboratory data included: Antibody test (NR: not provided) High Antibodies. On 21-MAY-2021, the subject experienced suspected covid-19 infection. On 24-MAY-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Pt has a rash on the arm/site of injection. it is not itchy or bothersome. Told patient to contact dr and let them know what is going on
Breakthrough case admission after 3 vaccines MOderna 2/8/21 lot# 037K20A;  Moderna 3/8/21 lot# 032H20A ; Pfizer 11/29/22 lot# GL0446
Truly sick; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Truly sick) and VOMITING (Vomiting) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Truly sick) and VOMITING (Vomiting). At the time of the report, ILLNESS (Truly sick) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Significant delayed arm swelling, rash and pruritus which began 5 days after the vaccine was given.  Also systemic symptoms of fatigue, headache, chills, low grade temps and severe arthralgia (knees, elbows and back).
approx 2JUL92 recvd 1st Engerix-B vax & 2-3 wks later devel rash & migratory polyarthralgia; pt is taking Naprosyn for joint pain;
My son was given a shot of HIB instead of his DTP.  This is his 5th shot of HIB.  He was given HiB on the following dates: 6/2/2004, 8/5/2004, 9/29/2004, 4/6/2005 and then again at 10:30am on 7/18/2005.  It is too early to tell if there are any adverse reactions. I have notified the nurse and have called the Center for Disease Control and was told to file this report.
4/20/21 - herpes simplex - treated with otc Abreva - resolved after 10 days 10/7/2021 - shingles - treated with acyclovar and oral steroids after seeing my PCP - resolved after 18 days
Upon injection patient developed a hematoma. Complained of pain, no SOB or allergy. Inflammation went down & patient said she felt ok. Waited 15 min before she left.
Brief Summary of Hospital Stay:  Patient presented to our ED for primary complaint of shortness of breath. On initial workup in the ED, patient was evaluated for a multitude of comorbidities and was noted to be recovering from a COVID infection.  Patient was subsequently transferred to the inpatient unit for appropriate medical care and treatment.  While in the unit, the patient underwent treatment for their primary diagnosis of shortness of breath with complicated urinary tract infection and additional supraventricular tachycardia, which was treated as an inpatient for 13 days.    The patient was given multiple therapies to assist with each of these comorbidities that he presented with.  A full course of ceftriaxone therapy was completed for suspected urinary tract infection, his SVT had resolved spontaneously, and AKI had resumed with IV fluids.  No reoccurrence SVT with identified, and no urinary symptoms were endorsed on repeat interviews.   However, the patient proceeded to develop debility in his lower extremities due to extended hospital stay with a new finding of an atrial flutter rhythm that was in rapid ventricular response.  Therapies worked with the patient and found that he would be a candidate for IPR, but he was ultimately denied this because the inability to tolerate 3 hours of therapy per day.  Additionally, Cardiology was consulted for management of atrial flutter with rapid ventricular response.  His atrial flutter took multiple days to manage, but the patient had his rate controlled with a regimen of high-dose oral diltiazem and oral metoprolol tartrate.   Due to his size and comorbidities, difficulties were had by the care management team to find appropriate placement for the patient.  After diligent efforts, the patient was accepted for skilled nursing care.   With shared decision-making, the optimal location for this patient to be discharged to was to skilled nursing. Patient was discharged to the SNF via third part transport.
Dizziness, Headache, Fever, NauseaVomiting, chills, sweats Narrative:
Bells Palsy right side of face (V1, V2, V3) area noted 23.5 hrs after immunizations. Head CT 12 hrs later=WNL. Prescribed Prelone + ACV orally. Improving but not resolved at the time of report.  Nurse follow up on 08/19/04 states: "Right sided facial weakness."
PHARMACIST REPORTED ON BEHALF OF PT 24 HOURS POST FIRST MODERNA SHOT,SWELLING IN VACCINATED ARM DESCRIBED AS "POPPYE." PT REPORTED TAKING TYLENOL AND SWEELING WEND DOWN AND RESOLVED 24-48 HOURS. PT REPORTED NO NEED FOR ADDITIONAL MEDICATION AND IT RESOLVED.
Fever, elevation in inflammatory markers, worsening of neutropenia and anemia requiring hospitalization for PRBC transfusion
Dizziness, NauseaVomiting & HYPERtension Narrative:  The employee started feeling sick after the first ten minutes post- vaccination. Her s/sx Nausea, Vomiting, Dizziness. Employee had two episodes of dry heaving. Employee was given the oral challenge which she passed. Employee  was sent home in stable conditions. She was advised by the ED provider to take  PO Zofran that she has at home PRN, increase oral intake.
Lymph node swelling in armpits (especially left/injection side) and left side of throat, resulting in severe pain in left ear and left side of throat for 6 days, which made it difficult to eat, swallow, and sleep.  OTC remedies did not help (Advil, Tylenol, Chloraseptic, warm washcloth, tea w/ honey).  Went to dr, ruled out strep throat and ear infection.  Was prescribed Tramadol and higher doses of Tylenol and Advil for pain.  Tramadol did not help at all, and OTC pain meds only helped briefly.  Saw primary dr and was prescribed 20mg Prednisone 2x/day for 5 days to reduce swelling.  Started to help by 10/24 but still not completely gone.  Did not have this throat issue with first 2 Pfizer doses.