chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ON Feb 26, I got up with extreme joint pain (much worse that my usual arthritis pain) the gradually developed muscle aches, fever and headache.  Also had a loss of appetite for a few days.  I was mostly off my feet for 2 to 3 full days.  Then I was extremely sweaty for the morning of the final day, like when a fever finally breaks after flu.   The site of the injection (left deltoid) got a softball sized red  hard itchy and somewhat tender spot.
Patient complained of tinnitus in both ears starting the morning after vaccination. Persisted for 48 hours at time vaccinating facility was contacted.
Irregularly shaped area on (L) UE (tricep area) warm to touch, red and slightly tender. Apply cool packs - take OTC antihistamine and pain reliever.
High blood pressure (regular 165/115), small blood vessels burst in back of eyes found in medical optometrist exam, blurry and flashes of light in vision, noticed over several months
ITCHINESS; HIVES; FEVER; HOT; SWEATY; LIGHT HEADED; SHAKY; NAUSEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced shaky. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021 14:30, the subject experienced hot. On 05-APR-2021 14:30, the subject experienced sweaty. On 05-APR-2021 14:30, the subject experienced light headed. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9 F. On 08-APR-2021, the subject experienced itchiness. On 08-APR-2021, the subject experienced hives. Treatment medications included: diphenhydramine hydrochloride, loratadine, and prednisone. The patient recovered from hot, sweaty, light headed, shaky, and nausea on 05-APR-2021, and fever on 06-APR-2021, and had not recovered from itchiness, and hives. This report was non-serious.
Patient stated on 9/29/2021, she started feeling flushed and developed severe body aches. This happened in the evening. She said she took Tylenol and went to bed. She slept through the night and felt fine the next day.
This spontaneous report was received from a registered nurse via medical assistant and refers to a 13-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 06-OCT-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014650: Original Case: 1710USA014649: US-009507513-1710USA014651: Original Case: 1710USA014649: US-009507513-1710USA014649: Original Case: 1710USA014649.
Started to have palpitations, became more frequent over several days. Went to primary care physician who performed an EKG in her office and was found to be in bigeminy. After arrhythmia determined, was started on labetalol per primary care physician. My blood pressure is low at baseline, so I did not tolerate being on the medication as it made my blood pressure even lower, and I was symptomatic. Primary care physcian also referred me to a cardiologist. Was seen in the cardiologist office two days later, who performed another EKG; was still having palpitations and was found to still have frequent PVC's. Was started on metoprolol medication, a beta blocker that wouldn't lower my blood pressure as much so that I would tolerate that medication better than the labetalol.   Also pregnant at the time, so cardiology deferred echocardiogram decision to OBGYN who wished to pursue an echo. Had an echo performed and that was unremarkable for any findings to relate to the frequent PVC's and bigeminy. Still having intermittent palpitations to this day.
inadvertent double administration of fluzone vaccine. first received 10/4/2023. second 10/26/2023.
same night, arm feels very sore, went away and came back after using arm, accompanied by chills
This spontaneous report as received from a Registered Nurse refers to a 4 year old (reported as 4 years 7 months old) female patient. Number of siblings was reported as 3. On 10-MAR-2014 at 13:00 hr, the patient was vaccinated with VARIVAX (Merck) dose 2, lot # J008170 in the right thigh. On 10-MAR-2014 at 16:30 hr, 3 hrs 30 min after onset of therapy the patient experienced right thigh hot hard large area of thigh (1/3) swollen, itchy. The patient was administered BENADRYL and ibuprofen. On 13-MAR-2014, the patient was reported have recovered from the events. The causality was not reported. It was reported that the patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased with public funds. Additional information is not expected.
ACT-HIB was administered with an expired diluent with no adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics and it was reported that act-hib (HIB (PRP/T) VACCINE) was administered with an expired diluent with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Immunization. Batch/lot number requested.  On an unknown date the act-hib was administered with an expired diluent with no adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE. The reporter asked does it have to be reconstituted with that diluent?  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (ACT-HIB was administered with an expired diluent with no adverse event).  At time of reporting, the outcome was Unknown for the 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 the 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.
left arm became red and swollen, and painful: seen be physician and ordered ibupropfen and antihistamine for 5 days
Swollen lymph node underarm; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2022 at 12:30 (Lot number: FK9896) at the age of 37 years as dose 2 (tris), single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: FL3209; Anatomical site: Left arm), administration date: 21Jan2022, when the patient was 37 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Feb2022 at 22:00, outcome "unknown", described as "Swollen lymph node underarm". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). In September 2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of sore arm with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity  received in the Moderna  were missed to be booked-in.
Pt. received Zostavax 0.65 ml subcutaneously in left upper arm on 3/7/08.   On 3/9/08 she presented to her LMD with the following HPI extracted from her chart, " Patient comes to the clinic today with possible cellulitis to her left upper arm.  She received a Zostavax two days ago.  She noticed redness and swelling yesterday.  the area is warm and raised.  She denies fever, chills, sweats, or SOB."  Physician actions are as follows: "Assessment  o Cellulitis   (682.9); left upper extremity, site of vaccine- Zostavax Orders  Cephalexin 500 MG Capsule;TAKE 1 CAPSULE EVERY 12 HOURS DAILY; Qty14; R0; Rx. Plan  1. Monitor area  for further signs of infection as discussed.  Increased redness, swelling, pain, fever or yellow green discharge. 2. Follow up as scheduled. Coun/Edu  Patient is encouraged to call with any questions or concerns.
I woke up with fever and headache and about 24 hours later I had ataxia like vertigo very unsteady and dieahhrea. I was unsteady and achy all over. It lasted about 72 hours high fever and sweating profusely at night and the sweating last like 6 months. I have had tinnitus in my ears  . I did have heart pounding and shortness of breath too.
Client received  the COVID 19 Janssen injection at about 6:15. Client indicates "about 15 minutes later, she felt her throat tighten and was a little SOB". Reports she also has allergies to shell fish and bees that produce the same symptoms. Indicates she does not have an epi-pen and benadryl  seems to alleviate her symptoms. At about 6:25 the client took two benadryl. Reports that after about 30 mins her symptoms were remarkably improved. Before bed client reports taking two more benadryl. Indicates "she woke up in the middle of the night and her throat tightness and breathing were normal, but she had the chills and body aches. When client was interviewed at 11:00a on 04/01/2021, she felt much better and was leaving for work.
BEFORE "LEAVING THE STORE" PATIENT REPORTS ITCHING FROM THE RIGHT SHOULDER TO HER WAIST. ITCHING LASTED FOR APPROXIMATELY 10 DAYS.
When I woke up in the morning, I discovered a lot of big hive welts on my stomach and right thigh. I saw my primary care physician at 9:30 AM that morning. She prescribed 30 tabs of 5 mg Levocetirzine & 14 tabs of 20 mg Prednisone. After taking the medication, the hive welts subsided. It continues to reoccur to this day but also occurring on the neck, back, shoulders, arms, behind the neck, buttocks, inner thigh, legs. After that initial doctors visit, I saw a dermatologist on 4 occasions. They performed a blood test and skin biopsy with negative results. I continue to take the Levocetirzine 5 mg to this day. I visited a doctor today 26 March 2015 who set up a future allergist specialist appointment.
Dizziness, chills, achy started next day.  Redness and tenderness around injection site started Two days following injection
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored M-M-R II lot # M002419/Expiration Date- 12-JAN-2018, lot # L009214/Expiration Date- 17-MAR-2017, lot # L026553/Expiration Date- 16-JUL-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium
The pre drawn syringes were exposed to refrigerated temperature for 24 hours after the source vial was punctured; No Adverse event; Patient received expired bivalent booster Moderna COVID-19 vaccine beyond 12 hours after source vial was punctured, on 30NOV2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired bivalent booster Moderna COVID-19 vaccine beyond 12 hours after source vial was punctured, on 30NOV2022), PRODUCT STORAGE ERROR (The pre drawn syringes were exposed to refrigerated temperature for 24 hours after the source vial was punctured) and NO ADVERSE EVENT (No Adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2022 at 8:30 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired bivalent booster Moderna COVID-19 vaccine beyond 12 hours after source vial was punctured, on 30NOV2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The pre drawn syringes were exposed to refrigerated temperature for 24 hours after the source vial was punctured) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired bivalent booster Moderna COVID-19 vaccine beyond 12 hours after source vial was punctured, on 30NOV2022), PRODUCT STORAGE ERROR (The pre drawn syringes were exposed to refrigerated temperature for 24 hours after the source vial was punctured) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired bivalent booster Moderna COVID-19 vaccine beyond 12 hours after source vial was punctured, on 30NOV2022) and PRODUCT STORAGE ERROR (The pre drawn syringes were exposed to refrigerated temperature for 24 hours after the source vial was punctured).    No concomitant medication information was provided.  They forgot to discard them last night. This morning someone garbed the expired prefilled syringe from the refrigerator and administered a dose. Dose administered greater than 12 hours post puncture. Received it as liquid on 18-Nov-2022, it went into liquid state on transport in a cooler (Refrigerator). On 29-Nov-2022 8:30 AM, vial was first punctured.  The cartons were unbroken cartons, and the vial size was 2.5 mL.  The vial did not undergo any temperature excursions.  Vial did not expose to room temperature for more than 24 hours.  No treatment medication was provided.
This spontaneous report was received from a nurse when refers to less than 10 unspecified patients of an unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored Liquid PEDVAXHIB (lot # L009649, expiration date 29-NOV-2017) and possibly another Liquid PEDVAXHIB) with an unspecified lot number. No adverse effects were reported. Additional information has been requested.
Expired vaccine inadvertently administered to infant by 8.5hrs.  Vaccine expired on 5/3/2021 and given on 5/4/2021 at 0830.
PT STATED, "THERE IS A 4 INCH RED SWOLLEN BAND AROUND MY ARM. A LITTLE BELOW INJECTION SITE." PT DENIED THAT SHE IS ALLERGIC TO ADHESIVE.
Client came for #2 Pfizer Covid vaccine. Was advised to wait 15 minutes after injection. After approximately 3 minutes her son, the driver left with client, approximately 6 minutes later he returns with client stating she complains of dizziness and a " swimmy feeling in her head" and also nausea. Covid nurse assessed client to be alert to self, place and situation. Blood pressure was checked reading was 180/100 client reports she has history of high blood pressure. Client reports she took her meds this morning but her patch for blood pressure is to be changed today by her hospice nurse. Her other son is her designated health decision maker. He was called, nurse supervisor spoke with him and reported her situation. He stated she takes 3 meds daily and a blood pressure patch weekly. Her symptoms were reported. He plans to call her hospice nurse and report the blood pressure reading and the need for the patch to be replaced. She confirmed she did eat and had coffee and states she did take her morning meds. Nurses offered her water while speaking to her son via phone. A second blood pressure reading was taken 190/90 and she states is still dizzy. Advise son driving her that the hospice should direct her care related to medications and any medical decisions such as the option of using emergency room.
pt recv vax; pt threw up, n & d on Friday; sick till Sat; very tired; no further emesis; better on Sun;
Patient was unresponsive for about 30 seconds after administration of both flu vaccine. Patient also received Covid 19 Pfizer vaccine.  Questions were asked of patient and patient was unresponsive and could not answer at all. 911 was called for patient but patient refused transport. Patient was given water.
Covid Arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid Arm) and HEADACHE (Headache) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid Arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid Arm) and HEADACHE (Headache) had resolved.            This case was linked to MOD-2021-020665 (Patient Link).
Amenorrhoea; Abortion spontaneous; Ovulation disorder; Pregnancy; Uterine spasm; This case was received via  VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous) in a 29-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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous) (seriousness criterion medically significant), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy) and UTERINE SPASM (Uterine spasm). On an unknown date, the patient experienced AMENORRHOEA (Amenorrhoea). At the time of the report, ABORTION SPONTANEOUS (Abortion spontaneous), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy), UTERINE SPASM (Uterine spasm) and AMENORRHOEA (Amenorrhoea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the provided. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Sender's Comments: This is a case of product exposure during pregnancy which resulted in Abortion spontaneous, for this 29 years old female. Very limited information has been provided at this time.
This is a spontaneous report from a contactable consumer. A 66-year-old female patient received PREVNAR 13, (lot number: W33491), at the physician's office, intramuscular on an unspecified date at single dose for immunization/pneumonia. Medical history included vasculitis, Sjogren's syndrome both about 16 years ago, anaemia about 12 years ago and chronic kidney disease about 4 years ago. There were no concomitant medications. The patient stated on 23Sep2018. "Whole upper arm about 6 inches long and 3 inch wide swelled up; got really brick red and my under arm in my armpit swelled up and hurt". The patient underwent lab tests and procedures which included blood work on an unspecified date. The outcome of the events was recovering.