chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 05-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose,  lot # R000554 with expiration date 08-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter ; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA0103071: US-009507513-1907USA010372: US-009507513-1907USA010373:
Information has been received from a woman in a medical office concerning a 43 month old male with Williams' syndrome who on 9/27/01 was vaccinated SC in the right leg with a first dose of varicella virus vaccine live. In April 2004, the patient developed chicken pox. Medical attention was not sought. Subsequently, the patient recovered. The reporter also mentioned five other patients who developed chicken pox post vaccination with varicella virus vaccine live (WAES0407USA00537, 0407USA00539, 0407USA00540, 0407USA00542, and 0407USA00544). Additional information is not expected.
GARDASIL 9 given on 01-20-16. Pt. states there was a rash to the right arm. GARDASIL 9 given on 4-18-16. Pt. states there was a rash with drainage to the left arm. Pt. reported on 8-18-16 at providers office.
This prospective pregnancy report was received from a healthcare worker via a company representative and refers to a female of unspecified age. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unspecified date, the patient was vaccinated with 1 dose of GARDASIL 9 1 dose (route of administration, lot# and expiration date were not reported). An unspecified time after receiving GARDASIL 9, it was determined by an unspecified method that the patient was pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported and could not be calculated. The pregnancy outcome was pending. Additional information has been requested.
I have serious arthritis.  The reaction to vaccine was that the pain and stiffness in all my arthritic joints became worse than I have ever experienced.  I could barely move my hands and thumbs.  This went on for about 1 week then gradually wore off.
High Fever  Severe Swelling of Injection site(Baseball size) Deep Widespread Redness of Vaccine Site Very sore and HOT to the touch of Vaccine Site  Extreme fatigue  Extreme Nausea  Vomiting  Dehydration  Confusion  Heavily Increased
I have been having ongoing heart palpitations for 3.5 weeks, since during/shortly after the flulike symptoms from my booster wore off.  They are consistent throughout the day and night, coming and going, increasing with activity, especially if I raise my arms up over shoulder height. I *may* be experiencing very mild shortness of breath, but it?s hard to say because the palpitations are so pronounced that they might be what I?m feeling. I have an appointment with a cardiologist.
I went to a family reunion, the next day a family member called to let everyone know they tested positive for COVID-19. I did not have any symptoms but tested to be on the side of caution, it came back positive. Once I received the positive test result, I went to an urgent care, I was prescribed PAXLOVID and started taking it immediately. My case was mild, I recovered within twenty fours with no rebound.
swelling & redness to inj area;h/a;dizziness;numbness from inj site to neck;no treatment;
Began having hand joint pain about 10 days after, this persisted for several months and when the patient asked about it and thought it was related to his diabetes, but when i examined, he clearly had joint bogginess and clear inflammatory changes, then i ordered the labs below.
8/28 - Left are swollen, warm and hard to touch; Shoulder to elbow, Fever. Mom states arm swollen to 3X normal size. Seen in KSB ER. Started on antibiotic. Mother states most of arm swollen, No "under skin" infection, 8/30 states arm is much better today.
Fever 101 for 2 days Headache ongoing (currently day 5) Nausea ongoing  Insomnia ongoing Fatigue ongoing
incredible stiffness; pain in hips, knees, calves, and feet; lower extremity joint pain/joint pain that lingers; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (incredible stiffness), PAIN IN EXTREMITY (pain in hips, knees, calves, and feet) and ARTHRALGIA (lower extremity joint pain/joint pain that lingers) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 032M20A, 016M20A and 050C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), ESCITALOPRAM and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (incredible stiffness), PAIN IN EXTREMITY (pain in hips, knees, calves, and feet) and ARTHRALGIA (lower extremity joint pain/joint pain that lingers). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (incredible stiffness), PAIN IN EXTREMITY (pain in hips, knees, calves, and feet) and ARTHRALGIA (lower extremity joint pain/joint pain that lingers) had resolved.            This case was linked to MOD-2022-544380, MOD-2022-544381, MOD-2022-544329 (Patient Link).
Warm, red at site of injection - size of palms of her hand. Told her to take antihistamine- she gets prescription fixofenadine so she took this. It  reversed by next day-per husband. She has never had any reaction to any vaccine previously.
Left axillary lymphadenopathy.; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6205) via an unspecified route of administration in the left arm on 02Mar2021 at 08:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL 9264) via an unspecified route of administration in the left arm on 10Feb2021 at 08:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was not reported whether the patient received any other vaccines within four weeks prior to the vaccination. On 03Mar2021 at 12:00, the patient experienced left axillary lymphadenopathy. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left axillary lymphadenopathy was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Initial report was received on 04 January 2012 from a consumer who is also the patient's parent. A five year-old female patient with an allergy to OMNICEF and no medical conditions had received on 02 January 2012 a left arm injection of DAPTACEL, lot number C4006AA (route of administration not reported) and a right arm injection of Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later the date of vaccination, experienced a large raised rash at the injection and extends entire length of arm, painful. The patient was treated with BENADRYL with no improvement. No further information was available at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: none.
The incorrect amount of diluent was mixed into the orange vial for 5-11 year olds.   0.3ml diluent was put in the vial instead 1.3ml, the patient received  2 ml of the vaccine IM to left arm. He was watched in the clinic for 15 minutes without adverse reactions. the mother and patient were contacted last night and this morning and he c/o no vaccine side effects or adverse reactions
Chest did not feel to good and Tight on the chest; Short of breath; With some numbness; Back of their neck hurts; Don't fell good; Reaction to the vaccine; Headaches, their head feels heavy; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest did not feel to good and Tight on the chest), DYSPNOEA (Short of breath), HYPOAESTHESIA (With some numbness), NECK PAIN (Back of their neck hurts) and MALAISE (Don't fell good) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced CHEST DISCOMFORT (Chest did not feel to good and Tight on the chest), DYSPNOEA (Short of breath), HYPOAESTHESIA (With some numbness), NECK PAIN (Back of their neck hurts), MALAISE (Don't fell good), VACCINATION COMPLICATION (Reaction to the vaccine) and HEADACHE (Headaches, their head feels heavy). At the time of the report, CHEST DISCOMFORT (Chest did not feel to good and Tight on the chest), DYSPNOEA (Short of breath), HYPOAESTHESIA (With some numbness), NECK PAIN (Back of their neck hurts), MALAISE (Don't fell good), VACCINATION COMPLICATION (Reaction to the vaccine) and HEADACHE (Headaches, their head feels heavy) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown.
Patient received second Moderna COVID  vaccine.  While waiting in waiting area, alerted staff that she was feeling SOB.    States h/o asthma.  Just used inhaler prior to arrival for vaccine.  States h/o COVID and now has blood clots in lungs.  On a blood thinner.  C/o chest pain.  States h/o MI.  Pt was somewhat diaphoretic in face.  C/o some dizziness.  RR elevated.    AA&O.    First responder called with prompt arrival.  Pt transferred to ED immediately.    Transported via wheelchair.  Pt was AA&O when leaving the observation area, still symptomatic.  VSS.
Patient was given 4th dose of Moderna Monovalent vaccine.  Patient should have received Moderna Bivalent vaccine.  Patient was notified by phone of incident and made aware that he can still receive the Moderna Bivalent booster at a later date.
they received shipment not realizing it was a day late and gave one dose of Adacel; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 13 years old male patient who received 0.5 ml  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6273AA via intramuscular route in the left deltoid, on 01-Aug-2019. It was reported that they received shipment not realizing it was a day late and gave one dose of Adacel.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due incorrect product storage.  It was unknown whether the patient had any adverse event.  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.
itching at the site; huge red area extended about 6 inches from injection site; injection site feels a little warm; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching at the site that is getting worse, huge red area extended about 6 inches from injection site and area feels a little warm.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date, the patient experienced itching at the site that is getting worse.Today woke up with huge red area extended about 6 inches from injection site, no fever but area feels a little warm. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, itching at the site that is getting worse, huge red area extended about 6 inches from injection site and area feels a little warm, were unknown.; Reporter's Comments: This case concerns a 74-year-old female who experienced nonserious expected events of vaccination site erythema, vaccination site warmth, vaccination site pruritus. Event onset with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
PT EXP PAIN AND STINGING AT SOI. TREATMENT:  PT COUNSELING.
A non serious, spontaneous report of administration of FLUMIST to a seventh month-old was received from a nurse. There was no adverse event associated with the medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Patient states after shot given at 11:30 am, at about 1:00 pm (L) arm became red and swollen. At 4:00 pm warm and sensitive to touch. No pain or itching noted as stated by patient. 2-20-14 seen at PCP for job physical and was advised to take BENADRYL. Patient states followed instruction given after shots and added BENADRYL advised by PCP. (Cold pack, MOTRIN, BENADRYL). Patient presented 2-21-14 for skin test reading and (L) arm observed with redness, swollen and warm to touch today. Patient states continue to take BENADRYL and MOTRIN and Dr. is prescribing an antibiotic to take. Patient advised to contact clinic if any other problem and contact PCP.
Their arthritis pain improved; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Their arthritis pain improved) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Their arthritis pain improved). At the time of the report, ARTHRALGIA (Their arthritis pain improved) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Patient felt sleepy; fever (100F); chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient felt sleepy), PYREXIA (fever (100F)), CHILLS (chills) and FATIGUE (fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced SOMNOLENCE (Patient felt sleepy), PYREXIA (fever (100F)), CHILLS (chills) and FATIGUE (fatigue). On 25-Feb-2021, PYREXIA (fever (100F)) had resolved. At the time of the report, SOMNOLENCE (Patient felt sleepy), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 f (High) 100 F.         Action taken with mRNA 1273 in response to event was not applicable. No concomitant medications reported.  No treatment medications were provided
severe heart palpitations for 4 months now increased heart rate when at rest severe chest pain increased blood pressure
Reported a pink, non-raised rash to the left side of his neck, left arm, and hand.  He took Benadryl and his rash lessened by the end of his shift.
15-20 minutes after HPV/Flu shots patient fainted, no dizziness. He recovered quickly (2 secs). He was pale, HR 60's. Follow-up phone call, vomited once at 2 hrs, then 5 hrs after. Just a sore injection site.
APPROX. 8 DAYS LATER - ITCHING/REDNESS/SWELLING AT INJECTION SITE
body ache; little tired/ little run down and exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little tired/ little run down and exhausted) and MYALGIA (body ache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01LA21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (little tired/ little run down and exhausted). On 06-Mar-2021, the patient experienced MYALGIA (body ache). At the time of the report, FATIGUE (little tired/ little run down and exhausted) had not resolved and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  The patient received ibuprofen as treatment.
This spontaneous report was received from a registered nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored PROQUAD (Merck) (lot # K007158, expiration date: 12-NOV-2015; lot # K018144, expiration date: 10-APR-2016) (dose and route of administration were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of -6.5 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. The previous temperature excursions were at -7.4 degrees Celsius for 2 hours and 36 minutes. Since dates of PROQUAD (Merck) administration were not known, it was unknown whether the vaccines that at the time of the report (also reported as currently) were expired, were administered to the patients prior to expire or after expire. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient administered expired vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine after the manufacture date of expiration) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vial did not undergo any temperature excursions. Date vial initially stored in the refrigerator was unknown. Total of 173 doses were given from LOT 070H21A with expiration date as 07-Apr-2022. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant live follow-up: Additional reporter added.
Extreme itching for 5 days, then itching slowly decreased over the next 3-5 days.
Mom reports has had red raised warm big blotches over body - off and on - Worse if gets over heated - seen 10/28 - Dx with URI, om.