chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The second dose of Jynneos administered on day 14; Case reference number US-BN-2022-002329 is a spontaneous case report initially received on 09-Sep-2022 from a nurse via agency (reference number: USBAV22-1342) and concerns a 33-year-old female patient.  The patient's current medical condition included HIV.  The patient's concomitant medication details were not provided.  On 26-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00003), at a dose 0.5 mL, administered subcutaneously, for monkeypox prophylaxis.   On 09-Sep-2022, 14 days after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: FDP00003) at dose 0.5 mL, administered subcutaneously (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from Bavarian Nordic on 09-Sep-2022 included the local BN case ID.; Reporter's Comments: A 33-year-old female patient was vaccinated with the second dose of Jynneos vaccine, administered subcutaneously, 14 days after the first dose which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's current medical condition included HIV and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 33-year-old female patient was vaccinated with the second dose of Jynneos vaccine, administered subcutaneously, 14 days after the first dose which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's current medical condition included HIV and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
1. typical injection site soreness & tenderness lasting 3 days 2. very dark bruise at injection site (I normally do not bruise easily)
Patient reports swelling and redness around the area of the vaccine. Patient also experienced dizziness, vomiting and a fever the night after the vaccine. Symptoms improved by 9/6/13, when she came into the pharmacy. The redness on her arm was still there on 9/6/13, taking up a large portion of her upper arm, but the swelling had gone down.
no adverse effect; one dose of an improperly stored vaccine, VARIVAX, was administered; route of adminsitration was intramuscular; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/ allergies were not reported. Concomitant therapies included sterile diluent which was used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored in the correct storage temperature range. On 10-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot # S002877 and expiration date 29-JAN-2021, at a dose of 0.5 milliliter once via intramuscular route for prophylaxis (product storage error) and (incorrect route of product administration). The storage temperature was reported as 8.1 Fahrenheit (F) for time frame of 20 minutes. Previous temperature excursions included 8.1 F for 17 minutes and 9.5 F for 21 minutes. The call was because of a data logger. No adverse effects reported. No product quality complaint (PQC) present.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for Obesity, pericardial effusion, dyslipidemia, malignant tumor of prostate, vitamin d deficiency. PT was 74 years of age at time of death. Pt suffered a stroke in June 2020, and Occasionally faints . Per note on 4/22, wife stated that the pt began to sleep more often, stopped eating, started calling his wife by his mother's name. Also complained of difficulty swallowing. Pt was placed into inpatient hospice on 4/21/2021. The note also stated that PT was unlikely to live past 72 hours. Per note 4/29/21 pt was deceased on 4/27/21. No further cause of death documented.
I am a very regular person in my 28 day menstrual cycle.   After my first shot on march 31st. I had a sore for about 4 or 5 days. I was fine. But my period came unexpectedly 5 days early on April 15. It was a very light flow and only 3 days long. My regular period is about 7 days.  My next period came on May 8th. At first spotting, then full period. This was a more normal 7 days.  I had my second dose vaccine injection on May 17th at 11am.  I had a fever for 3 days with shivers and body pains. Suddenly the fevers and chills just stopped after 3rd day.  No one else in my family in our household got obvious side effects (all men).  I got a vaginal yeast infection which was treated at home with over the counter medication on May 27th.  Very rare to get for me.   My 3rd period started on June 2nd. Very heavy flow with a lot of back pain.   My periods are now random and just not normal.
Cellulitis R arm within 24 hours of flu shot-hospitalized for IV antibiotics 1/29/07 Received medical records from hospital which reveal patient experienced pain, circumferential redness, swelling of the entire right arm w/limited elbow flexion s/p flu & pneumovax both received right arm.  Also had chest pain & was hypotensive on admit.  Afebrile on admit.  Developed a brief run of atrial fib.  Treated w/antibiotics & improved significantly. D/C to home w/continued oral antibiotics & to f/u w/PCP day after d/c.  FINAL DX: right arm cellulitis.
itchy, red hot rash 2-3 inches in diameter at the injection site; A spontaneous report was received from a consumer concerning who received Modern's COVID-19 vaccine (mRNA-1273) patient who developed itchy, red hot rash 2-3 inches in diameter at the injection site.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) ON 03-FEB-2021, approximately eight day prior to the onset of the events for intramuscularly in the right arm prophylaxis of COVID-19 infection.   Treatment information was Benadryl.   The second dose of mRNA-1273 was not given yet in response to the events. therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events itchy, red hot rash 2-3 inches in diameter at the injection site were recovered/resolved.
01/12/2004 @ 14:11: Mom calling describing large amount of swelling, redness to right arm from shoulder to elbow.  Started 24 hours after shot.  Given et cont today although better today. Encouraged use of Motrin/Advil every 6 hours as needed.
Patient with hx of CAD s/p CABG in 2017, PCI 2020 had NSTEMI 5 days after second dose of moderna. Site of stent was restenosted. S/P baloon angioplasty
Rash on upper arm, but not at injection site. Started 2 days post-injection. Itchy. Currently resolving, but not yet completely gone.
After the first vaccine I started have pain in my hands and feet and inflamation, especially in the morning when I woke up and as the day wore on it got less painful. After the second vaccine the pain has spread to my knees and my neck as well. I also have wrist pain. My right hand feels numb when I hold anything in it and then it tingles.
Patient has been in and out of hospital; Patient has not received second dose within the appropriated window of time between two doses; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (Patient has been in and out of hospital) in an 81-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.     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 an unknown date, the patient experienced MALAISE (Patient has been in and out of hospital) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose within the appropriated window of time between two doses). At the time of the report, MALAISE (Patient has been in and out of hospital) and PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose within the appropriated window of time between two doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MALAISE (Patient has been in and out of hospital) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose within the appropriated window of time between two doses).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on reporter's causality, the events are assessed as unlikely related to mRNA-1273.
Acute erythema  and edema extending 10 cm X 4 cm around injection site. Decreasing edema and erythema daily.
90 minutes after vaccine administration, patient developed hives over neck and face and severe itching on face, neck, and scalp, as well as a significant lump on the right side of neck; the following morning, severe facial swelling in cheeks and around eyes that made it difficult to open eyes; facial swelling and itching has improved but is still present (as of today, 3/23/21, four days after vaccine); lump on neck is still present but is smaller; patient has been taking Zyrtec, Benadryl, Tylenol, and topical cortisone cream.
sore arm; Off label use; Drug use in unapproved population; This is a spontaneous report from a contactable a nurse reporting for herself and for her baby. This is the mother case. This 35-year-old female patient who was breastfeeding her 7-month-old infant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient had sore arm with outcome of unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021025730 baby case
stroke; Bells Palsy; Developed severe left sided facial droop involving eye and mouth with drooling; slurred speech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mentally disabled" (unspecified if ongoing); "HTN" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: BELL'S PALSY (disability, medically significant) with onset 11Aug2021 at 08:00, outcome "recovered with sequelae", described as "Bells Palsy"; DROOLING (disability) with onset 11Aug2021 at 08:00, outcome "recovered with sequelae", described as "Developed severe left sided facial droop involving eye and mouth with drooling"; DYSARTHRIA (disability) with onset 11Aug2021 at 08:00, outcome "recovered with sequelae", described as "slurred speech"; CEREBROVASCULAR ACCIDENT (disability, medically significant) with onset 11Aug2021 at 08:00, outcome "recovered with sequelae", described as "stroke". The events "stroke", "bells palsy", "developed severe left sided facial droop involving eye and mouth with drooling" and "slurred speech" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: covid test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident, bell's palsy, drooling, dysarthria.  Additional information:  Developed severe left sided facial droop involving eye and mouth with drooling and slurred speech. Aide thought was a stroke, taken to ER and diagnosed with Bells Palsy. Adverse event resulted in: (Emergency room/department or urgent care, Disability or permanent damage). Patient received treatment with unspecified medication. Patient did not have Covid prior vaccination and patient tested with Covid post vaccination with nasal swab. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
8 minutes after the vaccine was administered,  he started to act funny.   At first, he looked like he was having a vasovagal/ syncopal episode: he became non-responsive, stared straight ahead.  then shortly thereafter he started to take be gasps for air, his lips turned blue.  It soon became clear that he was having an anaphylactic reaction. we called for an ambulance,  we administered one dose of an Epipen, and administered oxygen. His pulse ox was in the low 80's.   within a minute or two, he started to react and started to moan, breathe more normally, then began to speak to us.  His BP was checked and was 118/83.  His oxygen sat went up to 100%. after a few minutes,  We took the oxygen off and his sats dropped into the 80's so we restarted the oxygen.  We are rural, so it took the ambulance 30 minutes to arrive. He was very stable at the time that he was  taken to an emergency room for further evaluation.
Hives around injection site of (R) thigh abt 4 in square, chest 2-2 1/2 size hives and stomach, quarter size hives. Pt advised to take BENADRYL.
The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 17 October 2013. 4 pregnant female patients had inadvertently received FLUZONE High-Dose. It was a wrong vaccine administered. No adverse event was reported. List of documents held by sender: none.
Numb face approximately 30 minutes after shots 1 and 2.; Fever of 100.6 after second dose; Severe headache; Severe hives on neck, torso, arms,upper legs after shot 2.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 49-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0185, Expiry date: not reported ), via an unspecified route of administration in Arm Left on 21May2021 09:00 (at the age of 49-years) as DOSE 2, SINGLE for covid-19 immunisation in Public Health Clinic. Medical history included Raynaud's phenomenon, high cholesterol and hypothyroidism. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included Levothyroxine sodium (SYNTHROID), Rosuvastatin calcium (CRESTOR), Ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL, Colecalciferol (D3), Calcium taken for an unspecified indications, start and stop date were not reported, the patient has received first dose. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167, Expiry date: not reported ), via an unspecified route of administration in Arm Left on 30Apr2021 08:15 (at the age of 49-years) as DOSE 1, SINGLE for covid-19 immunisation. The patient also received Flu vaccine, via an unspecified route of administration on an unspecified date for Influenza immunisation. On 21May2021 17:00 the patient experienced numb face approximately 30 minutes after shots 1 and 2, fever of 100.6 after second dose, severe headache, severe hives on neck, torso, arms, upper legs after shot 2, 8 hours after shot. Went to urgent care next afternoon. Fever resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature increased: 100.6 Fahrenheit on 21May2021. Therapeutic measures were taken as a result of numb face, fever, severe headache, severe hives on neck, torso, arms, upper legs (prednisone for 7 days).The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Following morning,  fatigue, 100 degree temp, body chills, headache for 10 hours
had a temperature excursion. The excursion lasted for 157 hours and 30 minutes. The high temperature was fro 49 degrees Fahrenheit.; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 12 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] while INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC], HIB (PRP/T) VACCINE [ACT-HIB], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]also had the temperature excursions.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to  incorrect product storage temperature excursion lasted for 157 hours and 30 minutes. the high temperature was fro 49 degrees Fahrenheit.  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.  List of documents held by sender: none.
PFIZER COVID #3 VACCINE GIVEN 9/10/21, LOT #210910-44; the only records we have is a positive COVID test was done on 1/7/22 at Medical Center and another one post-mortem on 2/25/22 at a research facility.
Patient says that he has not felt well since vaccine. Patient states that he felt heat at the injection site after receiving vaccine. Patient's face turned red and he felt dizzy. He also complained of bone pain. Patient is still feeling bad at this time.
Shooting pain down the arm to the finger-tips and up to the neck, cannot lift arm over head. Headache.
Weak; She cannot get up; Confusion; Shortness of breath; Loss of appetite; Lethargic; Temperature of 99'F; Could not taste anything during dinner; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AGEUSIA (Could not taste anything during dinner), ASTHENIA (Weak), DYSSTASIA (She cannot get up), CONFUSIONAL STATE (Confusion) and DYSPNOEA (Shortness of breath) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperthyroidism. Concomitant products included METHIMAZOLE for Hyperthyroidism, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced AGEUSIA (Could not taste anything during dinner). On 11-Mar-2021, the patient experienced ASTHENIA (Weak), DYSSTASIA (She cannot get up), CONFUSIONAL STATE (Confusion), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Loss of appetite), LETHARGY (Lethargic) and PYREXIA (Temperature of 99'F). At the time of the report, AGEUSIA (Could not taste anything during dinner) had resolved and ASTHENIA (Weak), DYSSTASIA (She cannot get up), CONFUSIONAL STATE (Confusion), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Loss of appetite), LETHARGY (Lethargic) and PYREXIA (Temperature of 99'F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: 106/69 mmHg (Low) 106/69. On 11-Mar-2021, Body temperature: 99°f (High) 99°F. On 11-Mar-2021, Heart rate: 126 (High) 126 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pain, which initiated within few days after vaccination and still present a few weeks out after vaccine(s) were administered. (Pain/soreness on arm which vaccines were given).
6OCT93 pt recvd vax & lt arm swollen- 7OCT93 w/redness; fever 100-101 6OCT92; t100 7OCT93 & reported some diarrhea; subsided by itself;