chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concomitant products included TOFACITINIB CITRATE (XELJANZ) from May 2022 to an unknown date for Rheumatoid arthritis.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In December 2021, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 6 to 7 6 to 7 on scale of 10.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for RINVOQ(UPADACITINIB) with respect to the events of MIGRAINES and PAIN was not provided.  opinion was that there is no reasonable possibility that the events MIGRAINES and pain are related to RINVOQ(UPADACITINIB).  Treatment details were not given   This case was linked to MOD-2022-586870 (Patient Link).
Developed red rashes (spots): beginning from hip area, then spread to abdomen, chest, thighs, arms, and legs.
Fever 101.7 degrees F, vomiting, irritability, pallor, poor feeding, sleepy presented to ED approximately 7:30pm on 5/25/2009.
Immediately experienced tingling in my arm up to my neck. When I left, I noticed my mouth and tongue were numb. My throat was tighter than usual. I took Benadryl when I got home and my symptoms were improved. I had a sore throat later that evening.
4/9/21-30 minutes to 1 hour after receiving 2nd dose of vaccine patient had bloody nose, clots, with bleeding sores on tongue and side of mouth. Began to have bruises on arms, feet and legs.  Blood in urine and bruises on back. Presented to emergency department on 4/11/21.  CT brain revealed a right sided posterior temporal hemorrhage. Patient was emergently treated with platelets, DDAVP, factor VII, Decadron, IVIG. 4/12/21, patient denies headache, changes in vision, double vision, change in sensation, including burning, pinprick, numbness, no focal or motor weakness.  No change in bowel or bladder control.  No sensory changes.  Patient states she is now back to her normal state of health, save for the bruising described.
no adverse event; A pharmacist reported that a dose of MMR II vaccine was administered to a patient via the intramuscular route instead of the subcutaneous route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 17-FEB-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) use as directed to prevent measles, mumps and rubella infection as prophylaxis, lot #U017524, expiration date: 03-JUN-2023 (strength was not provided), via the intramuscular route instead of the subcutaneous route (incorrect route of product administration). There was no additional adverse event (no adverse event).
Other side effects as mentioned; pain; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Other side effects as mentioned) and PAIN (pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced ADVERSE DRUG REACTION (Other side effects as mentioned) and PAIN (pain). At the time of the report, ADVERSE DRUG REACTION (Other side effects as mentioned) and PAIN (pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications was included. It was not reported if the patient was received any corrective treatment for the event.
Shingles and severe nonstop headache. May 3, 2021: Severe headache at night, persisted for next 5 days. Other symptoms included nausea, sensitivity to light and sound. I took Excedrin; however the pain stayed. I also took ibuprofen. May 7, 2021: Visited my doctor, prescribed these medicines: promethazine, sumatriptan and butalbital-acetaminophen-caffeine. May 8, 2021: Visited urgent care. May 9, 2021: Visited ER. By now, I noticed rashes on my chest and back were severe and filled with liquid. This caused nervous pain. May 12, 2021: I visited my doctor again and they confirmed it was shingles. They prescribed steroids.
This spontaneous report was received from a licensed practical nurse and refers to a 44-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD (dose, frequency, route of administration were not reported) lot # N015623 with expiration date: 15-NOV-2018 and a dose of VARIVAX (dose, frequency, route of administration were not reported), lot# N008077 with expiration date: 09-MAR-2019 instead of M-M-R II. The vaccines were reconstituted with sterile diluent (manufacturer unknown). No adverse effects were reported. No causality assessment was provided.
Nausea; Throw up at dinner time; This is a spontaneous report from a non-contactable consumer or other non-health professional.   A patient of unspecified age and gender received dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a Pfizer vaccination yesterday and he threw up today, still he feels nauseous. He wants to know is that a side effect of the vaccine. He had an assisted living and took resident living to get his first Pfizer vaccination yesterday. Today he said he feels nauseous, and he even throw up at dinner time. So, is that a side effect of the first vaccination, nausea, throwing up. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt  received, TDap, Hep B and Mem B, after the administration of the TDap, her head went back, her arms went limp, she started to snore and have jerking motion of upper body.  Pt was immediately removed from the chair and lowered to the floor and supine  by the staff and her legs were elevated.  Pt immediatley was able to state her name and where she was currently.  Vital signs taken: B/P 120/73 to right arm, pulse 62, O2 sats 99 and temp 97.1.  Patient stated she had not eaten.  Patient remained awake and alert.  Patient moved to sitting position after approximately 5 minutes of being  supin  Pt stated she felt ok, a little light headed, Vital signs: B/P: 127/98, Pulse 88, O2 sats 99 and temp 97.2. after approximately 5 minutes of sitting up, Pt was moved to chair.  VItal signs: B/P 125/100 Pulse 74, Temp 97.3.  Patient states she felt a little light headed. Pt was given chips, water, and coke (only P.O items available at site).  Pt observed for approximatley 40 minutes without any other adverse events.  Mom arrived to the site.  Pt stated she felt ok,  No longer light headed.  Pt was able to stand, walk, and leave site without other events observed.  Vitals before she left: B/P 118/81, Pulse 81, Temp 97.3.
Pediatric dose administered to adult; Pediatric dose administered to adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 66-year-old female patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis.   On 17th January 2023, the patient received the 1st dose of Engerix B pediatric. On 17th January 2023, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 18-JAN-2023 Reporter's Comment: The reporter reported that the adult patient received a pediatric dose of Engerix B instead of the adult dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The adult patient was administered a pediatric dose of Engerix B, which led to underdose and adult use of a child product.
I had a seizure in the early morning  2 days later. I have had seizures for several years and am on anti seizure medication (Vimpat) but have not had any for at least a year. I recovered quickly and am fine now.
Dr.  SNF Nurse:   Station 1 B Medical Center:  COVID Pool Name: P SNF COVID19 LAB NSA   Chief Complaint (reason for call):  1. Pt is req'g transfer to Er for paracentesis and abd pain, 8/10, declined pain med             Sensation is similar to 08/11/2023 and transferred             rec'd coumadin last night   08/11/2023 parcentesis, removed approx 5 liters       Pt voiced has same feeling and req'g paracentesis   Lung sounds clear, no wheezing/cough, no sob/dyspnea Dialysis tues/thurs/sat, had dialysis yesterday   No order to measure abd girth No order for freq weights   Prev weight:        08/12/2023: 185.68 lbs       08/10/2023: 190.08          Nurses' Request: Transfer    OTHER: REQUEST TRANSFER FOR PARACENTESIS    Current meds: coumadin, fluid restriction 1500ml/day, cefepime iv during dialysis for cellulitis   Significant medical: (as it related to symptoms) .Patient Active Problem List:          HX OF GASTRIC BYPASS SURGERY       HX OF STROKE     ATRIAL FIBRILLATION, UNSPECIFIED   DM 2 W CKD STAGE 5 (GFR <15) W HTN     ESRD ON DIALYSIS     RECTAL BLEEDING     PRESENCE OF CARDIAC PACEMAKER   PULMONARY HTN  CELLULITIS    DM 2 W ULCER OF RIGHT MIDFOOT       DM 2 W GANGRENE   DM 2 W ULCER OF RIGHT FOOT, BONE INVOLVEMENT WO NECROSIS   HX OF LEFT BELOW KNEE AMPUTATION   AMPUTATION STUMP DEHISCENCE, LEFT LEG     HEMODIALYSIS CATHETER INFECTION   PRESSURE ULCER OF COCCYX STAGE 3 (FULL THICKNESS SKIN LOSS)   INFECTION OF THE EXIT SITE FOR CENTRAL VENOUS CATHETER   Medication Route: Oral   Allergies: Nsaids, non-selective [non-steroidal anti-inflammatory agents]; Lisinopril; and Metformin   Vital signs: T 98.0, HR 80, R 18, B/P 132/72, O2 Sat 97, on ra, Pain 8/10, declined pain med   POLST: Date of POLST 05/15/2023 scanned: full   Advised to call Clinic if no orders within 2 hours.  Advised to call back anytime for new or worsening symptoms or for any other questions or concerns.     AMBULANCE INFORMATION:   Patient Room #: 113 bed B Weight (less than 350 lbs.): 185.6 lbs. Equipment needed: None Isolation precautions: None Closest ED:    COVID Screening Questions:  2. Is the patient COVID 19 positive or a PUI? No 3. Is the patient currently under isolation for COVID 19?] No 4. Is anyone in facility COVID + or PUI? No 5. Does the patient have a fever? No 6. Does the patient have a cough? No         Note Details  Author Jun, (R.N.) File Time 8/13/2023 11:57 AM Author Type REGISTERED NURSE Status Signed Last Editor Jun, (R.N.) Specialty GENERAL, OTHER  Continuing Care Telephone on 8/13/2023  Continuing Care Telephone on 8/13/2023   Detailed Report  Note shared with patient Additional Documentation  Encounter Info:  Billing Info, History, Allergies, Detailed Report   Linked Episodes  Skilled Nursing Facility - May 2023 Noted 5/14/2023  Orders Placed  None Medication Renewals and Changes   None  Medication List  Visit Diagnoses
This spontaneous prospective pregnancy report was received from an adult female patient of unknown age. The patient's medical history and concomitant medications were not reported. On an unknown date in December 2014 (reported as "yesterday") the patient was vaccinated with a "shot" of GARDASIL (dose, route of administration were not reported). On the same day, in the afternoon, the doctor called back the patient to inform her that she was pregnant. The LMP (Last Menstrual Period), date of conception, and EDD (Estimated Date of Delivery) were unknown. There was no adverse event reported. Additional information has been requested.
I started noticing the numbness on a Friday, 01/14/2022.  The bumps appeared on Monday, 01/17/2022.  On 01/18/2022- I chatted with Dr. over an app. She said it sounded like I had shingles. She prescribed, Valacyclovir.  I picked  it up on 01/18/2022,  I took 3 pills a day,  for 7 days, and the last dose was 01/25/2022. My 1st time having shingles. I never had it before.  No, I have not recovered from the AE, it is not completely cleared up yet, but it's getting better.
Information has been received from a nurse practitioner concerning a 15 year old who was vaccinated with a first 0.5 ml dose of GARDASIL vaccine (yeast). Subsequently the patient experienced a high blood pressure of 200/100. Unspecified medical attention was sought. It was reported that the blood pressure eventually started to decrease after a week. At the time of the report, the patient was recovering. Additional information has been requested.
Two days after patient received vaccine developed rash on back left shoulder. Then started to blister and wrapped around to left chest. Patient called doctor and was given acyclovir which reduced the blister/rash and gabapentin for the pain. Patient is in some pain still but rash has reduced greatly.
Had HPV vaccine on 10/5 the next day felt fatigued and developed hives first on extremities and then on her face. No self care for this. Denies respiratory or throat symptoms. Now has hives only on her face. 10/5 was her second HPV vaccine. Has never had hives in the past.
Pt mother called health center on 8-11-09 stating child had reaction to immunization. Red with swelling per provider informed pt mother to apply ice to area to decrease swelling and return to clinic if worse.
Continuous soreness at injection site. Intermittent tingling from upper arm down to tips of fingers. Have lost significant strength in arm.
[Swelling of arm the size of a small plum with] bruising at injection site; Swelling of arm the size of a small plum; This spontaneous case, initially received from pharmacist on 21-Oct-2018, concerns a 30-year-old, adult, female patient.   The patient's current condition included shortness of breath and concomitant medication included Ventolin.   On 20-Oct-2018, the patient was administered Afluria QIV (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF37806A, expiry date: 18-Jun-2019) for influenza prophylaxis.   On 21-Oct-2018, one day after vaccination, the patient experienced swelling of the arm which was of the size of a small plum (coded as injection site swelling) with bruising at the injection site. The patient did not administer any treatment measure for the events.  At this time of the report, the outcome was not reported.   The reporter assessed the event as non-serious.  Non-significant follow up received from the pharmacist on 27-Nov-2018: The current condition (shortness of breath) and concomitant medication (ventolin) was added. The narrative was amended accordingly.  Significant case amendment (21-OCT-2018): The description to be coded for the event verbatim 'swelling of arm the size of a small plum' was changed to 'injection site swelling' from 'swelling arm'. The narrative and case comment was amended accordingly.; Reporter's Comments: A 30-year-old, male patient experienced injection site swelling and injection site bruising, one day after vaccination with Afluria QIV. The company assessed the causality of the events injection site swelling and injection site bruising as related considering the plausible temporal relationship and due to site specific reaction.
pt given vax 12noon, by evening of same day c/o nausea, vomiting, fever; next day seen in clinic & sent to ER-given TIgan, Phenergan, TOredol & IV fluids;
ON THURSDAY, PATIENT WOKE UP FEELING BAD.  AS DAY PROGRESSED, MENERE'S FLARED. EXTREME JOINT PAIN, MUSCLE SORENESS, ACHES, DIARRHEA,VOMITING, FEVER AND NAUSE.   SYMPTOMS PROGRESSED TO A POINT WHERE SHE CALLED A FRIEND TO TAKE HER TO HOSPITAL ON FRIDAY 10-7-2022.  PATIENT COULD NOT BE STILL, SHE HAD ANXIETY, AND FELT TERRIBLE.   SHE ENDED UP ANEMIC WITH AND HAD TO HAVE 3 PINTS OF BLOOD DESPITE NOT HAVING ANY ANEMIA ISSUES PREVIOUSLY.
14 year old male with no significant past medical history received second COVID vaccine on 7/24/2021. On 7/25/2021, he woke up with flu-like symptoms including malaise, tactile fever and intermittent chest pain that escalated over the next 24 hours to the point that he needed to go to the emergency dept. Pain was alleviated with ibuprofen and tylenol. Troponin was found to be elevated in the ED so he was admitted to pediatric cardiac at Health facility. Chest pain described as left-sided midsternal. EKG normal and ECHO showed trace physiologic tricuspid and pulmonic insufficiency. Troponin once admitted was 0.52, then 0.36. Admitted on 7/26 at 12:05 and discharged on 7/29. To F/U with cardiology.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 54.39  Concomitant products were not provided.  15-Apr-2021Excursion time was reported at 9am with temperature as 34 degrees Fahrenheit respectively , total doses given for the day was 188 ,condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
patient developed dermatomal right buttock-leg  rash consistent with shingles.  developed pain also.  started on antiviral therapy
History of Present Illness  Patient is a 24 year old female PMH of HTN-noncompliant with medications, stroke, migraine headaches who presents to the emergency department for the above complaints.  History is provided primarily by the patient's boyfriend, who is at her bedside.  He states that the patient commonly has migraines and had been complaining of a headache last night.  She woke up this morning and still had a headache and spent much of the resting day in bed.  Sometime this evening, the patient's boyfriend heard her getting out of bed and running into things.  He went to go check on her and he said she asked him why it was so dark in the room, however the lights were on.  He then asked her if she was able to see anything and she said no. He therefore summoned EMS and she was taken to our ED for further evaluation.  Patient is unsure of when exactly her visual loss started.  She denies striking her head at any point.  Immediately upon arrival, the patient underwent noncontrast head CT in this demonstrates acute left occipital hemorrhage measuring 1.6 by 1.6 cm with mild surrounding vasogenic edema.  There is also acute subdural hemorrhage along the left cerebral convexity and left tentorium.  CTA head and neck was also performed and this did not show any vascular abnormality or aneurysm.  Upon initial exam, the patient is alert and oriented.  She looks in the general direction of the examiner, however states that she is unable to see anything in either eye.  She has a flat affect, however there is no other focal neurologic deficit. During my exam, the patient had a short episode of unresponsiveness and jaw twitching, but returned back to her baseline within minutes and participated in the remainder of the interview.  Shortly after I left the room, she had a generalized tonic clonic seizure witnessed by myself as well as the emergency department staff.  Patient states that she might have had a fever this morning with some chills, however otherwise no recent illness shortness of breath, nausea, vomiting, diarrhea, chest pain, palpitations, abdominal pain, unilateral weakness, difficulty speaking.