chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events were reported; temperature excursion / temperature: 37.94 F; Route: IM; This spontaneous report as received from a licensed practical nurse referring to an unknown number of patients of unknown age and gender. The patients' medical history, concomitant medications, drug allergies, or reactions were not reported.    Since 25-JUL-2021, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002847 that has been verified to be valid, expiration date 23-JAN-2022, for prophylaxis (dose, strength, and route of administration, were not reported). The vaccine was expose to a temperature of 37.94 Fahrenheit degrees for 100 hours as detected by a digital data logger; no previously temperature excursion were reported. No additional adverse events were reported.  Follow-up information has been received on 20-SEP-2021 from the licensed practical nurse.   The patient's demographics were updated as the following: 14-month old female patient.   On 22-JUL-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) intramuscularly in the left tight.   The reporter stated that the improperly stored vaccine was removed immediately after the reporting and no further vaccine was administered. The patient's parents were notified, and the vaccination would be repeated with new vaccine stock.  This case is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up, it was determined that the case is now valid.; Sender's Comments:  US-009507513-2108USA006311:
COVID-19 VACCINATIONS ARM WAS SORE AT INJECTION SITE; Abnormal pap and sore; FELT LIKE PATIENT BROKE HER BACK; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (COVID-19 VACCINATIONS ARM WAS SORE AT INJECTION SITE), CERVICITIS (Abnormal pap and sore) and BACK PAIN (FELT LIKE PATIENT BROKE HER BACK) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced VACCINATION SITE PAIN (COVID-19 VACCINATIONS ARM WAS SORE AT INJECTION SITE), CERVICITIS (Abnormal pap and sore) and BACK PAIN (FELT LIKE PATIENT BROKE HER BACK). At the time of the report, VACCINATION SITE PAIN (COVID-19 VACCINATIONS ARM WAS SORE AT INJECTION SITE) and CERVICITIS (Abnormal pap and sore) outcome was unknown and BACK PAIN (FELT LIKE PATIENT BROKE HER BACK) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Smear cervix: abnormal.         No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of humira as per reporter for event back pain was no reasonable possibility. No treatment medications were reported. 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.
Reports swelling of fingers few minutes after receiving the vaccine. Swelling resolved few minutes after. Denies Chest pain, SOB. Seen and cleared by EMS
Pt c/o hives on face.   Benadryl  25mg was given po.  EMS evaluated patient and pt declined to go to ER.
Patient is COVID + on 11/4/2021.  Admission dx with cough, malaise and fatigue,  Increased weakness when ambulating.  Pain and swelling of the right knee.  71-year-old female, significant for past medical history for osteoarthritis, status post right knee arthroplasty, which was done on 10/16, presented due to complaint of right knee pain.  D dimer 3185--2091-downtrended--continue with aspirin BID and close PCP follow up  Negative DVT, Negative CT PE---no evidence of pulmonary embolism.  started on Lovenox.  No indications for Decadron, no remdesivir. Pt discharged.
Information has been received from a registered nurse referring to an unknown number of adolescent patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (strength, dose, route, lot# and expiration date unknown). After receiving GARDASIL 9, the patients experienced near syncope episodes. The reporter noted that most adolescent patients who had these episodes did not eat prior to injection and also received concomitant administration of other unspecified vaccination. The outcome of the event was unknown. Causality between event and GARDASIL 9 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
On 4/09/2004 started felling cold four hours post injection. Fatigued. Headache and feeling groogy. T: 97.5 BP: 116/77 P: 62 R: 18. Took Ibuprofen 4/9/04 PM with some relief.
intermittent chest pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date in 2021 (60-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. Patient reports that she received second dose of vaccine on the day of reporting and has started to experience intermittent chest pain. Patient would like to know what she should do about the chest pain. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A non-serious spontaneous report of administration to 52-year-old was received from a non-health professional concerning a 52-year-old male. On 22-Nov-2010, the patient inadvertently received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Nausea started around 6am the morning after the 2nd dose. Vomited around 7am. I was also very dizzy and felt very drained, slept most of the day. I could only sip on  Pedialyte and around 8pm was able to eat some saltine crackers. I only vomited once but was very nauseous and felt drained for about 48 hours.
I had a persistent headache that kept getting worse throughout the night, I developed cold sweats along with leg and pelvic pain. The pain at the site didn?t subside. This morning, I don?t have any cold sweats or headache. The leg pain is very small but the pelvic pain is still there.
Physician accidently ordered for a pregnant patient to get a second dose of Adacel within a month, the patient already had a dose at 27 weeks; Physician accidently ordered for a pregnant patient to get a second dose of Adacel within a month, the patient already had a dose at 27 weeks; Initial information received on 14-May-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves an 18 years old pregnant female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5566AA, expiry date- 13-Feb-2021 via intramuscular route in the right arm on an unknown date, while she was 31 weeks pregnant. the patient already had a dose of same vaccine at 27 weeks.  The date of last menstrual period was reported as 07-Oct-2018.  The estimated due date is 14-Jul-2019.  Previous pregnancy not known.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine exposure during pregnancy.  it was also a case of actual medication error due to extra dose administered.  Prenatal test not reported.  case details: The patient was 27 months pregnant when she received vaccine. Doctor states she inadvertently gave a verbal order for a patient to have Adacel today and the patient is 31 weeks pregnant but the patient had had a dose at 27 weeks. Patient was in for her regular 31 week check up. No other vaccines were given during this visit.  It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.  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.  Documents held by sender: none
Parent wrote wrong DOB on form, patient received adult Pfizer because her mother stated that she was 12 and not pediatric Pfizer, which she should not have received
Soft, palpable swelling under right arm. Mom reports that swelling is getting bigger.
Case given proquad for recent low titers when he should have been given MMR and Varivax separately due to being out of recommended age range on Proquad.
He has covid; He started having a fever of 100-101 range; Sore throat; Stomach ache; Headache; Chills; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received his first Pfizer vaccine on Tuesday 15Mar2021, and starting on Friday on 19Mar2021 he started having a fever of 100-101 range, sore throat, stomachache, headache, chills, and chills was still going on today. The patient and his girlfriend were saying he had COVID. The patient made an appointment for a COVID test. The patient has not recovered from chills. Outcome of the rest of the events was unknown.   Information on the lot/batch number has been requested.
FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 15:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.7 F. Treatment medications included: paracetamol. On 26-MAR-2021 12:45, Laboratory data included: Body temperature (NR: not provided) 102.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever. This report was non-serious.
Pt's mother called MD to see pt. She states that within 1st 2 minutes after PREVNAR #1 given she noticed Pt moving head to right side  it seemed as though her lip seemed to drop on right side. Mom stated it seemed to like a tic. I saw infant about 4-5 minutes after vacc given. Pt was breastfeeding comfortably.
Pt developed 8cm X 4.5 cm warm, erythematous raised lesion on upper arm 2 days after receiving VARIVAX. Itchy. No fever.
Upon removing cap of needle, re tightened needle to barrel, injected dose into pts. arm and noted a significant amount on injectors hand and pts. arm. Conferred with staff who consulted with pharmacy and other individuals. Second dose administered completing pts 2nd dose.
Body ache; Super ventricular tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of SUPRAVENTRICULAR TACHYCARDIA (Super ventricular tachycardia) and MYALGIA (Body ache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced SUPRAVENTRICULAR TACHYCARDIA (Super ventricular tachycardia). On an unknown date, the patient experienced MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, SUPRAVENTRICULAR TACHYCARDIA (Super ventricular tachycardia) and MYALGIA (Body ache) outcome was unknown.            No concomitant medicines were reported.  Action taken with the drug in response to events was not applicable.  About 2.5 months after vaccination (30May2021) patient went to the hospital and was diagnosed with super ventricular tachycardia (SVT) and at the hospital for a few hours until it resolved on its own.and now she is going back on  5Aug2021 for an ablation of the heart.
Excruciating pain at injection site with no range of motion in shoulder. No fever and no visual sign of redness or rash. Patient went to the ER to get an X-ray of arm and chest but findings were inconclusive. Patient was prescribed Norco and Zofran and will follow-up with PCP on 1/27/16 AM.
Syncope and fell out of chair, vital signs stable, first aid provided, EMS called, injured right side of face in fall
On June 29, 2021, I was treated for Dupytren's Contracture with XIFLEX and the next day, with the manipulation.  My left index finger was the digit treated.  My hand started to swell and the pain was unbearable.  I couldn't take pain medication.  It made mr throw up.  Extra Strength Tylenol did not help ease the pain.  I went back in 28 days and received a shot of Cortisone for pain and swelling.  The pain eased up in three days.  My feeling is that the vaccine, perhaps affected the XIFLEX? Two months had not passed since receiving the second dose of the vaccine.  I have AB- BLOOD TYPE.  Perhaps this, this blood type, also has a play in the reaction?  I'm still dealing with the Dupyren's Contracture.  After the XIFLEX injection, I developed trigger finger in the middle finger.  I'm told that rarely, very rarely do people have a reaction as the one I have.   AB- BLOOD TYPE, plus getting the XIFLEX too soon after getting the second dose of the vaccine, could have resulted in my adverse reaction?? I just wanted to alert you to this.
Sore throat 3 days 12/17/2016 - 4 days. Excessive frequent urination 3 weeks! (R) knee joint pain 2 weeks, ADVIL. Tinnitus moderate to very annoying 2 weeks.
PT RECEIVED MONOVALENT INSTEAD OF BIVALENT, NO ADVERSE EVENTS AT ALL. PT WILL GET VACCINATED WITH BIVALENT IN 8 WEEKS
This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB lot # R014263, expiration date 26-MAR-2021 (exact doses, anatomical locations and routes of administration were not provided). There was no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of the lowest temperature below 2 degree Celsius (minimum 1.1 degrees Celsius) for 7 hours. Data logger was involved. There were no previous excursions reported. The outcome of product storage error and no adverse event was unknown. Follow up information has been received from the nurse on 05-FEB-2019. Referring to a currently 3 months and 16 days old patient of unknown gender. The reporter stated that the vaccine was exposed to a temperature excursion in the refrigerator below 2°C. It was also reported that the refrigerator had been checked and the temperature was stable. The reporter spoke with a company representative and the vaccine was considered viable as it was not exposed for a too long period that affect the vaccine adversely. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA002414: US-009507513-1902USA002412: US-009507513-1902USA002413.
Pt developed 1 1/2" x 2" diameter area of redness. Swelling and warmth of (L) thigh around injection site. Pt also had high-pitched crying and inconsolable for at least 3hrs. This began approx. 2hrs after receiving immunizations.
Arm very red swollen, painful. Tx heat pack, Benadryl and Darvocet, resolved over weekend.
contacted by APRN that administered vaccine was 18 days expired.  localized erythema and edema, painful.  Nausea x 3 days
RA-redness, no swelling, sore right arm. No reaction on left arm where flu shot was given.
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Extremely sore arm for 3 days, 4th day still hurts to the touch. Felt shaky and blood pressure became very high. Flu like symptoms, hot and cold, shivering, headache, achy inside, fatigue, nausea, loss of appetite for 2 days and stomach discomfort. Stayed home for 3 days slept a lot as I was exhausted and felt very sick. Wanted to call an ambulance go to ER but husband discouraged me. Today is the 4th day and still feel tired, arm is sore but bearable so I went about my day.
3 x 3 1/2 inch raised erythematous area around TDAP injection site.
About 19 hours after my injection I began experiencing pain and swelling in the injection site and headache.  The following morning on Sunday, 10/24, I was experiencing fatigue, headache, dizziness, chills, slight fever and pain/swelling in the injection site.   The swelling was about 3 inches in diameter.  On Monday morning, the symptoms above were still present but about half as they were on Sunday.
Within 5 minutes of the first vaccine I started to have a burning sensation on my tongue (similar to when you burn it from hot foods).   After the second vaccine this increased.    This has never improved or gone away since the initial vaccine (now over one year ago).
Tachycardia, heart felt like it was beating abnormal high blood pressure, feeling very faint like eyes are going to roll in the back of my head,full body muscle pains and over all extreme weakness , fatigue, nausea, nose bleeds, extreme thirst, back pain, neck pain,changed menstrual cycle, headaches, eyes burning and dizziness, fingers and legs go numb easily tmj also got worse along with with very sore tongue that is very raw no longer able to do simple tasks as before the shot
Bell's palsy; Skin was not clearing up with Humira (Adalimumab); This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis.   On 19-May-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and PSORIASIS (Skin was not clearing up with Humira (Adalimumab)). At the time of the report, BELL'S PALSY (Bell's palsy) had resolved and PSORIASIS (Skin was not clearing up with Humira (Adalimumab)) had not resolved.            No known allergies. No concomitant drugs taken. The stop date for event Bell's palsy was reported as 2022. The causality for event skin disorder for co-suspect Humira was reported as not related and that for Bell's palsy as not reported.  No treatment information reported.  Company Comment: This is a spontaneous case concerning a 44-year-old female patient with concurrent medical condition of Moderate to severe chronic plaque Psoriasis treated with co-suspect drug Adalimumab (Humira), who experienced the expected serious (medically significant) ADR of Bell's palsy and unexpected non-serious event of Plaque psoriasis ("skin was not clearing up with Humira"), both of which occurred unknown number of days after receiving the second dose of mRNA-1273 Vaccine. There is no available information regarding clinical course and treatment medication. The patient's concurrent medical condition of chronic plaque psoriasis remains a confounder for event Plaque psoriasis as this can be symptom of its chronic nature. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 44-year-old female patient with concurrent medical condition of Moderate to severe chronic plaque Psoriasis treated with co-suspect drug Adalimumab (Humira), who experienced the expected serious (medically significant) ADR of Bell's palsy and unexpected non-serious event of Plaque psoriasis ("skin was not clearing up with Humira"), both of which occurred unknown number of days after receiving the second dose of mRNA-1273 Vaccine. There is no available information regarding clinical course and treatment medication. The patient's concurrent medical condition of chronic plaque psoriasis remains a confounder for event Plaque psoriasis as this can be symptom of its chronic nature. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.