chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Horrible horrible headache; Temperature of 103; Chills; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Horrible horrible headache), PYREXIA (Temperature of 103) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 041L20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cerebral amyloid angiopathy since July 2021.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Horrible horrible headache), PYREXIA (Temperature of 103) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, HEADACHE (Horrible horrible headache), PYREXIA (Temperature of 103) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The patient took some Tylenol to alleviate the symptoms and they stopped the morning of 3rd day. The patient explains that her condition, Cerebral Amyloid Angiopathy, is something that happens in brain where it causes to have stroke, the blood vessels in brain will be weak and cause blood to lay around in brain and eventually causes stroke. The reporter added that she was 2/3rds there and will eventually have a stroke It was reported that the AEs were worse after booster dose and that the symptoms stopped the morning of the third day.   This case was linked to MOD-2022-456441, MOD-2021-016657 (Patient Link).
Redness, swelling, welt at injection site that appeared about 24 hours after injection. Welt is hot to touch and itchy and painful.
Appendicitis on 1/31/2022-2/1/2022 Appendectomy on 2/1/2022
Pt was given 0.25ml Moderna for 2ng dose instead of 0.5ml
Patient said the 3 imz he got yesterday gave him HighBloodPressure. Turns out he didn't take his bp med yesterday and then he woke with a headache this morning. Says he knows his bp is high when he has a HA so then he takes a bp pill. At one point he said he takes bp pill when he has HA and later he said he takes everyday. Not really clear but he didn't take it yesterday. Said his bp was elevated this morning. He took it again and it was still elevated but not as much. About an hour ago he decided to take a 2nd bp pill. HA and elevated bp/pulse were his only complaints. We advised him to sit for a bit (because he was currently on the clock and busy working) and then take bp again. I advised him to see his dr, urgentcare, or hospital if bp does not come down. He sat for a bit but then left.
Reaction to vaccine. Pt had a tetanus shot in the office on the 8th of this month and thinks she having a reaction to the shot. Redness started on Sunday 3 days after the shot. Pt has some redness on her arm. No fever, no chills and no real pain. No numbness or tingling.
Patient experienced shot anxiety. Patient took a zyrtec prior to arriving per doctor's orders. Patient's mother is also with her. No further issues.
No Adverse Event; Administered 1 dose of Moderna COVID-19 bivalent 19 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 1 dose of Moderna COVID-19 bivalent 19 hours post puncture) and NO ADVERSE EVENT (No Adverse Event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     It was unknown if the patient ever been diagnosed with or tested positive for COVID-19.  It was unknown if the patient had any acute illness and chronic illnesses at the time of vaccination.  It was unknown other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose.  Concurrent medical conditions included Drug allergy (sulfas).    On 28-Oct-2022 at 10:03 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 28-Oct-2022 at 10:03 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 1 dose of Moderna COVID-19 bivalent 19 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 1 dose of Moderna COVID-19 bivalent 19 hours post puncture) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered 1 dose of Moderna COVID-19 bivalent 19 hours post puncture).    It is unknown if patient was under any concomitant or regular medication.  Details of the first and second dose were unknown.  On 27-Dec-2021, the patient received booster dose (lot number 070H21A, expiration date 18-Mar-2022).  The individual vial size was 2.5 ml.  On 24-Oct-2022, the vial was initially stored in the refrigerator.  On 27-Oct-2022, at 5:18 PM, the vial was first puncture.  On 28-Oct-2022, at 10:03 AM, the vaccine was administered.  Post puncture the vial was stored at RT.  Vial did not undergone any temperature excursions.  Total amount of time the vial was exposed to room temperature range was 19 hours.  No treatment medication was provided.
Headache, low-grade fever, chills, nausea/vomiting.  Resolved by the next day
Pt was administered a second dose Moderna Covid-19 vaccine instead of Pfizer. 1st dose Pfizer was administered on 05/22/2021, second dose should have been Pfizer but Pt was injected with 2nd dose Moderna. No adverse reactions occurred during 15 minute observation time.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 19-JAN-2005, the patient was vaccinated with an improperly stored dose of Gardasil 9, 0.5 ml, intramuscularly, with a reported lot # M0011840 with expiration date 01-FEB-2018 (anatomical route of vaccination was not provided). The patient's concomitant medications were not reported. The office manager stated, that the vaccine temperature excursion had a time frame of 72 hours at 34 degrees F. Data logger was involved. However, no side effects were noted. GARDASIL 9 was not involved on a precious temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female who on 17-AUG-2008 was vaccinated with her first and only dose of GARDASIL. There was no concomitant medication. Within the 3-6 days after the vaccination, which is in approximately 20-AUG-2008 -23-Aug-2008, the patient developed swelling in hands and chin. She recovered from swelling in hands and chin at the time of the report. The patient sought medical attention. Additional information has been requested.
Vaccine was received Friday evening. No effects until I woke up the following morning.  Saturday Only (03/13): Fever (102.3), Chills, Fatigue, Headache, Body Aches in Upper Back & Cervical Area, Knot, Swelling, & Soreness in Underarm Area of Right Arm, No Bruising but Extreme Soreness in Muscle Area of Right Arm Sunday (03/14): Fever, Chills, & Fatigue (Gone) Continuing: Headache, Body Aches in Upper Back & Cervical Area, Knot, Swelling, & Soreness in Underarm Area of Right Arm, No Bruising but Extreme Soreness in Muscle Area of Right Arm  Monday (03/15): Headache (Gone) Continuing: Body Aches in Upper Back & Cervical Area, Knot, Swelling, & Soreness in Underarm Area of Right Arm, No Bruising but Extreme Soreness in Muscle Area of Right Arm   Tuesday-Thursday (03/16-03/18): Body Aches in Upper Back & Cervical Area, Knot, Swelling, & Soreness in Underarm Area of Right Arm, No Bruising but Extreme Soreness in Muscle Area of Right Arm (Most of everything phased away) Tuesday (03/23): Continuing Swelling in Underarm Area of Right Arm, Faint Remaining Soreness in Muscle Area of Right Arm Side effects are phasing away slowly.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (occasional wine,3 per week.) on 25-Aug-2020 and Marijuana use (occasional edible, 1 edible a month.) on 30-Jul-2020. Concurrent medical conditions included Vegetable allergy (Carrots), Soy allergy (soy), Allergy to nuts, Allergy to plants (Sesame), Allergy to nuts (almonds), Allergy to nuts (Hazelnuts) and Vegetable allergy (Pea allergy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Jul-2020 and the estimated date of delivery was 21-Apr-2021. On 27-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy. The vaginal delivery occurred on 23-Apr-2021, which was reported as Full-term. For neonate 1, the birth weight was 375 grams (0lbs 13oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. On 25-Aug-2020, date of positive pregnancy was reported. On 23-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2020, Pregnancy test: positive (Positive) Positive. On 23-Nov-2020, Ultrasound scan: normal (normal) normal anatomy scan. On 05-Jan-2021, Glucose tolerance test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of conception was 29 Jul 2020 No pregnancy complication, no perinatal complication for the infant and no identified fetal abnormalities on delivery were reported. No treatment medications were reported.   This case was linked to MOD-2021-273419 (Parent-Child Link).   See case MOD-2021-273419 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Updated the patient demographics, other relevant history allergic conditions, included lab data. On 02-Aug-2021: Significant Follow up received and medical History added, Pregnancy details delivery date, birth type, fetal outcome updated.
Swelling of lymph node in my left arm pit of my vaccine injection arm to the size of a ping pong ball.  It lasted for about a week getting progressively better each day.  Now this same lymph node in my left arm pit swells periodically when I'm exposed to someone who is covid positive.
Fatigue, body in arms and legs, 1 incident of diarrhea 9:30pm on 3/5/21 which all incidents occur. Fatigue on 3/6/21. No othe issues
Patient received second shingles vaccine on 10/17/20 and reported to pharmacy on 10/22/20 complaining of adverse reaction. Rash from wrist to injection site. Red, swollen, with small rash. Patient stated there were blisters on forearm rash that has since healed.
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for community-acquired pneumonia. Vaccination took place on 1/15/2009. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.
"very deep sleep" 10-20 hrs (awaken once-then back to sleep);
PATIENT HAD SYMPTOMS OF HOT AND TINGLY STARTING FROM HER HEAD DOWN HER ENTIRE BODY. THE TOP OF HER MOUTH AND LIPS WENT NUMB, AND THE INSIDE OF HER LEGS WERE TINGLY WITHIN MINUTES OF THE ADMINISTRATION OF HER FIRST DOSE OF VACCINE.
This spontaneous report was received from a healthcare student referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was inadvertently administered an expired GARDASIL (strength, dose, frequently, route and lot number were not reported) the reporter mentioned it was unspecified GARDASIL. No concomitant medication were reported. No adverse effects noted and no product quality complaint was involved. Additional information has been requested.
Immediate hives around site with itching.  Still present on day 3.  Benadryl 50 mg by mouth  Red spots in mouth (hives).  Presented next day.  Almost gone on day 3  Faint feeling  for a couple minutes post shot
He got his vaccine, the first thing that he noticed that he lost his stamina, lost about 60%, does not have the strength that he used to have, developed a red rash all over his body, and he has a cough that he cannot get rid of.  The rash is kind of like eczema.   He does not have any insurance so he did not go to the doctor.  He has never been sick in his life.  He does still continue to have the symptoms, and the rash has settled down a little bit.  He still has the loss of stamina and cannot get rid of the cough.  He went to the clinic last week, had an X-ray done and the radiologist could not tell if he had pneumonia or some sort of lesions in his lungs like COPD.  He was given some antibiotics to take.
Fever & abdominal cramps w/in 2-3 days of vaccines administration;
5 year old patient received a dose of Flublok vaccine, no AE; 5 year old patient received a dose of Flublok vaccine in left thigh, no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who received a dose of 0.5 mL INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot: QFAA1921 and expiry date. 30-JUN-2020) via intramuscular route in left thigh on 11-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration and vaccine administered at inappropriate site.  At the time of report 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 holders compliance with the requirements set out in Directive and Module VI of the 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.
Strong flu like symptoms.  Irregular heartbeats,  tachycardia,  lightheartedness, chest pain for about 6 hours. Mild irregular heartbeats -no pain or lightheaded- for the next 40 hours. I am athletic. No previous history of heart issues. No family history of heart problems. I do not use caffeine or other stimulants.  First time ever experiencing this symptoms.
Hives on neck, face, upper chest, and back.  Increased heart rate. Metal taste in mouth.  Zyrtec given and monitoring Relief after about an hour
NIGHT SWEATS; PAIN IN ARM; EYES PAIN; EYES SENSITIVE TO LIGHT; FELT LIKE FLU; FEELING BAD; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced eyes pain. On 06-APR-2021, the subject experienced eyes sensitive to light. On 06-APR-2021, the subject experienced felt like flu. On 06-APR-2021, the subject experienced feeling bad. On 06-APR-2021, the subject experienced pain in arm. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 07-APR-2021, the subject experienced night sweats. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes pain, and eyes sensitive to light on 06-APR-2021, felt like flu, and feeling bad on APR-2021, and pain in arm on 07-APR-2021, and had not recovered from night sweats. This report was non-serious.; Sender's Comments: V1: Medical Assessment comment was not required as per standard   procedure as the case assessed as non-serious.
My eyes hurt; Aching in my hand/aching in my elbow/aching in my back/I felt achy all over/I felt achy in my joints/I felt achy in my muscles; Fever of 101F for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (My eyes hurt), PYREXIA (Fever of 101F for 1 day) and MYALGIA (Aching in my hand/aching in my elbow/aching in my back/I felt achy all over/I felt achy in my joints/I felt achy in my muscles) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer Covid-19 vaccine (Patient had doses of the Pfizer Covid-19 vaccine) in April 2020. Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 vaccine.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PYREXIA (Fever of 101F for 1 day). On 29-Dec-2021, the patient experienced EYE PAIN (My eyes hurt) and MYALGIA (Aching in my hand/aching in my elbow/aching in my back/I felt achy all over/I felt achy in my joints/I felt achy in my muscles). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 29-Dec-2021, PYREXIA (Fever of 101F for 1 day) had resolved. At the time of the report, EYE PAIN (My eyes hurt) and MYALGIA (Aching in my hand/aching in my elbow/aching in my back/I felt achy all over/I felt achy in my joints/I felt achy in my muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Body temperature: 101f (High) fever of 101F.         No Concomitant Products were reported.
Temp 101.3, back pain, body aches, stomach pain, chills.  Pt given Toradol injection in office and told to take Aleve at home.
05/15/07 Pt states had nausea, H/A and chills approx 6 hrs after immunization no site redness or swelling. States felt fine approx 10am next day (5/16/07
spot was so painful and sore; left Brest tissue got change it looks like I had surgery or biopsy.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 (Lot number: Ev16200) at the age of 48 years as dose 2, single and administered in arm left, administration date 05Mar2021 02:45 (Lot number: EN9581) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I have fibrocystic Brest" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 20Mar2021 12:00, outcome "unknown", described as "spot was so painful and sore"; BREAST SCAN ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "left Brest tissue got change it looks like I had surgery or biopsy.". The events "spot was so painful and sore" and "left brest tissue got change it looks like i had surgery or biopsy." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, breast scan abnormal. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
FLUZONE HD swelling - eyes. FLUZONE HD vaccination 9-5-14 at 3:10 pm. Next day at 10:20 am (9-6-14) pt called pharmacy had reported - swollen hands, headache overnight (bad), chills, fever, up most of night. No rash - now as of 9-6-14 at 10:20am. No reaction previously.
injection site started itching; injection site got red; arm hurt at the injection site; A spontaneous report was received from a consumer concerning a 66-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurt at the injection site, injection site started itching, injection site got red. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient experienced the event arm hurt at the injection site . On 27 Jan 2021, the patient experienced the events injection site started itching and injection site got red. Treatment details included For the symptoms: none., Other: medicine for her blood pressure, cholesterol and breast cancer., FM 28Jan2021 Action taken with mRNA-1273 in response to the events was unknown.  the outcome of event arm hurt at the injection site was considered resolved on 22 Jan 2021. The outcome of events, injection site started itching and injection site got red were unknown..
Administered past the 30 day refrigeration time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was reported.     On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.