chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 101 F; BP rose to 164/99 mm HG; Pulse 111 bpm; very hot to the touch; signs of flu or COVID; COVID; vomiting; has loose bowels; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (signs of flu or COVID), COVID-19 (COVID), VOMITING (vomiting), DIARRHOEA (has loose bowels) and PYREXIA (fever of 101 F) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concomitant products included PRAVASTATIN and VENLAFAXINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced INFLUENZA (signs of flu or COVID), COVID-19 (COVID), VOMITING (vomiting), DIARRHOEA (has loose bowels), BLOOD PRESSURE INCREASED (BP rose to 164/99 mm HG), HEART RATE INCREASED (Pulse 111 bpm) and FEELING HOT (very hot to the touch). On an unknown date, the patient experienced PYREXIA (fever of 101 F). At the time of the report, INFLUENZA (signs of flu or COVID), COVID-19 (COVID), VOMITING (vomiting), DIARRHOEA (has loose bowels), PYREXIA (fever of 101 F), BLOOD PRESSURE INCREASED (BP rose to 164/99 mm HG), HEART RATE INCREASED (Pulse 111 bpm) and FEELING HOT (very hot to the touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: 164/99 (High) 164/99mmHg. On 15-Mar-2021, Body temperature: 101 (High) 101 Degree Fahrenheit. On 15-Mar-2021, Heart rate: 111 (High) 111 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information was provided.
Four days after the shot my eye someone told me my eye was red. I had a hemorrhage in my left eye. It was the outside of my eye but there was no pain. It lasted about five days. Seven days after the first vaccine I also had an eye hemorrhage in the same are of my eye. The doctor could not find anything wrong with my eye.  Other symptoms included a few waves of Nausea and a low -grade fever.
rash; This is a spontaneous report from a Pfizer-sponsored. A contactable pharmacist reported. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported)), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient who got her 1st dose of the Covid vaccine and to get her 2nd dose today. With her 1st dose, she developed a huge rash, and they want to know if she should get the 2nd dose. Provided PMI number and cold transferred for AE due to wait times, since caller developed a rash after the 1st dose. Fax for AE. CEP 2191. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
1 of 5 pts immunized form the same vial (lot# 326914) who exp a 1-2" area of induration & erythema @ DTP inject site; reaction occurred in this pt w/in 24-48 hrs following immun; required er/MD visit;
Pain and tenderness at the injection site lasted days after the injection. No bruising. Red, inflamed bump at injection site developed approximately 7 days after the shot. Not itchy, but very warm to the touch and getting larger. No physical discomfort. Current rash approximately 3 inches in diameter.
Following the second vaccine - Hepatitis A - became pale, stated lightheaded - no loss of consciousness. Client was seated on exam table for vaccine administration - had him lay back on table with legs elevated. BP 138/68. Client stated had tingling in arms and legs. Remained alert, oriented, skin warm and dry. Had not eaten breakfast. Was given sweet beverage to drink and hard candy. Symptoms resolved, declined further assistance 10:05 AM.
Left arm injection site and area around it became red swolllen hard and warm to the touch and painful and itchy. Swollen hardness and redness increased but redness and hardness of area decreased some on day #4.
Severe dizziness and nausea that kept me in bed the entire day after the vaccine. Pain at injection site on arm.
Soreness in my arm; Hot to the touch; Redness at the injection site; Really painfully sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in my arm), VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Really painfully sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), ROSUVASTATIN CALCIUM (CRESTOR), TAMOXIFEN and VITAMIN D3 for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Really painfully sore). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in my arm). At the time of the report, PAIN IN EXTREMITY (Soreness in my arm), VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Really painfully sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Pt screamed for 2 hrs. Went limp and started gasping for air. Taken to ER. O2 administered. Wheezing, inc. work of breathing.
10 days after varivax administration, devel temp 105 for 24hrs & 3 pox on trunk. Had fever for 3 days more, no addl pox, no other rxn. Now completely normal.
fever; chills; taste ot metallic; headache; tiredness; soreness; red raised injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), CHILLS (chills), TASTE DISORDER (taste ot metallic), HEADACHE (headache) and FATIGUE (tiredness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), TASTE DISORDER (taste ot metallic), HEADACHE (headache), FATIGUE (tiredness), ARTHRALGIA (soreness) and INJECTION SITE ERYTHEMA (red raised injection site). At the time of the report, PYREXIA (fever), CHILLS (chills), TASTE DISORDER (taste ot metallic), HEADACHE (headache), FATIGUE (tiredness), ARTHRALGIA (soreness) and INJECTION SITE ERYTHEMA (red raised injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported  Treatment information was not reported
migraine; severe abdominal pain; diarrhea; Skin rash; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), ABDOMINAL PAIN (severe abdominal pain), DIARRHOEA (diarrhea), RASH (Skin rash) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraine), ABDOMINAL PAIN (severe abdominal pain), DIARRHOEA (diarrhea), RASH (Skin rash) and PYREXIA (Fever). At the time of the report, MIGRAINE (migraine), ABDOMINAL PAIN (severe abdominal pain), DIARRHOEA (diarrhea), RASH (Skin rash) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-034252 (Patient Link).
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (worse lower back pain), GASTROINTESTINAL DISORDER (Worse abdominal issues) and CONDITION AGGRAVATED (Condition aggravated) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Chronic back pain (chronic left lower back pain) in 2012, Bowel movement irregularity in 2012 and Fatty liver. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced BACK PAIN (worse lower back pain), GASTROINTESTINAL DISORDER (Worse abdominal issues) and CONDITION AGGRAVATED (Condition aggravated). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and ACETAMINOPHEN for Pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (worse lower back pain), GASTROINTESTINAL DISORDER (Worse abdominal issues) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: negative (Negative) Negative.
?Moderna COVID-19 Vaccine EUA? side effects experienced are fever, vomiting, body aches, soreness and swelling of injection site, swollen glands in neck, enhanced pain in areas currently being treated for injury.
Pt experienced an episode of pericarditis 2 days after receiving vaccine; had been dealing with on and off pericarditis but this was worst episode he had experienced
-swollen; hot to touch; hard; inflamed; redness; local reaction at injection site.
Information has been received on 21-FEB-2017 from a consumer regarding herself as a 76 year old female patient with allergy to some chemicals and allergy to nickel. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 07-FEB-2017 the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration not reported), 0.5 ml injection for prophylaxis. On 15-FEB-2017, the patient experienced a bad cold. The patient also reported she had a sore throat, headache and a temperature of 100 degrees when she went to her doctor's office. On 16-FEB-2017, the patient went to her doctor's office for her cold and had a temperature of 100 degrees. The patient reported she received unspecified treatment. The patient reported that her cold is almost gone. The patient's present status was reported as recovering. Additional information is not expected as the reporter details were not provided.
Child ran a fever up to 104 with last vaccines and screamed for ten hours nonstop.
Received Moderna Spikevax  (12+ PFS 23-24-INJ MO) at 11:20 AM on 9/26/23.  At approximately 10:30 AM on 9/27/23 experienced nausea with mild abdominal cramps.  Within 15 minutes started diarrhea which resulted in 5 episodes of diarrhea spread out over the next 24 hours.  Diarrhea stopped at approximately noon on 9/28/23.  Prior to this had been feeling well, no illness or other issues.  Previous COVID vaccinations were all Pfizer doses and other than a slightly sore injection site, no adverse issues.
body aches; low grade fever; BP was elevated; began experiencing a headache. Headache got worse throughout the day; Initial information received on 15-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 74 years old female patient whose bp (blood pressure) was elevated,had body aches, began experiencing a headache,headache got worse throughout the day and low grade fever while receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On 15-Oct-2022, the patient received an unknown dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (formulation, strength: unknown) lot number not reported via intramuscular route in unknown administration site as Seasonal Flu Vaccination-recommended care.  On 15-OCT-2022 the patient developed a non-serious events bp was elevated (blood pressure increased), experiencing a headache, headache got worse throughout the day (headache) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On 16-OCT-2022 the patient developed a non-serious events body aches (pain) low grade fever (pyrexia) 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Headache got worse throughout the day prompting patient to check blood pressure using a home BP meter. BP was elevated. patient continued to monitor BP and rest. Late afternoon on 16Oct2022 the headache began to resolve and BP was slightly reduced. Began to develop a low grade fever and body aches which was expected as this is her usual reaction to annual flu shot. Patient did not experience any additional symptoms/events.  Relevant laboratory test results included: Blood pressure measurement - On 15-Oct-2022: [BP was elevated]  The company suspect product was not inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (began experiencing a headache. Headache got worse throughout the day, low grade fever, body aches, BP was elevated).  At time of reporting, the outcome was Recovering / Resolving for the event began experiencing a headache. headache got worse throughout the day, bp was elevated and  was Unknown for others.
Ice cold sensation on upper left arm, gradually extended across upper back.  Also extremely drowsy, taking multiple naps during day, 4/23. Can't find any information regarding this symptom with the vaccine.
Within a minute I felt very numb on my face and it spread to my neck. At the vaccination site they asked me to stay hald an hour instead of the 30 min. I could not think clearly. I went home and felt that my ear drum felt numb as well. Went to my PCP and she said it seems I was having an allergic reaction and she recommended Pepcid and Benadryl for 3 days. The next morning I noticed I slept for 16 hours. and I was very confused, I could not keep my legs underneath me, I went to ER and my BP was 153/33, my pulse was 120. They kept me there I am not sure for how long, they did some labs and gave me some IVs and told me to go home and rest. Next day I woke up and I was throwing up, shaking, I thought I was going to die and I returned to the ER. They gave me some nausea meds. I returned to my PCP and she put me under BP meds she believes all was caused due to anxiety. I am still taking BP meds.
Redness itching swelling. Lump. Started with itching progression to rash covering bicep of left arm
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional, nurse. This case involves a 16 months old patient who received vaccine ACTHIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL and PNEUMOCOCCAL VACCINE. On 17-Aug-2018, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI945AA via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate reconstitution technique. The vaccine was mixed with the wrong Diluent. It was unknown whether adverse event occurred or not. 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.
Information has been received from a physician concerning a 37 year old male patient with an unknown medical history, who on 10/08/2005, was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine 651329/1047P), one year after his first vaccination, which was in October 2004. It was noted that the patient requested the vaccine even through he had been vaccinated one year earlier. The vaccine was administered by the medical assistant with a physician order. One day after the vaccination, on physician order. One day after the vaccination, on 10/9/2005, the patient developed slight erythema and was tender. There was no illness at the time of vaccination. The patient recovered on 10/10/2005. A product quality complaint was not involved. No additional information is expected.
Narrative:  Patient received pfizer COVID-19 vaccine from local private hospital. ~24 hours following vaccination patient reports experiencing hives on hands and feet. Took OTC diphenhydramine.
NSTEMI, treated with PCI, DES evidence of multivessel coronary artery disease PCX 100% occluded submitting out of abundance of caution in case vaccine poses risk of clots in coronary artery disease patients
The patient has a history of DVT, type II diabetes, dementia and CHF. She was seen in the ED and brought in by EMS on 8/8/23. At the patient's TCU facility, she was experiencing shortness of breath and a chest x-ray raised concern for pneumonia. Of note, en route to the ED, the patient's SPO2 dropped to 89% so she was placed on 2L O2 via NC. In the ED, a COVID PCR test resulted positive. Ultimately, the patient was admitted 8/8/23 - 8/21/23. Discharged diagnoses include acute decompensated heart failure and acute hypoxic respiratory failure in the setting of COVID-19 leading to likely stress-induced cardiomyopathy. During admission, she was on supplemental O2 however was able to be weaned off prior to discharge. Of note, she has received the primary COVID vaccine series and one booster.
Administered vaccines at 0947. Observed client after vaccination. Client alert, oriented x 4, and responding appropriately to questions. Skin warm, dry, and pink. Asked client if lightheaded or dizzy; client denied and stated felt fine. Mother asked if could go over to the administrative section of the department for business. Nurse - seeing no issues - allowed. At 0950, while client and mother in the lobby, client suddenly fainted and fell from standing to the floor. Administrative secretary called for nursing support. Client returned to consciousness without intervention as nurse arrived to scene. Client alert and oriented x 4. Client's color became pale while lying. Elevated client's legs on chair while client lying on back on floor. Water and graham crackers provided, able to tolerate. Asked client if hit head; client doesn't remember falling but stated posterior of head hurt as well as intermittent sharp pain in right posterior shoulder and medial left arm from mid-arm to upper forearm focused primarily in crook of elbow; rated pain 4/10. Applied ice to the back of the head. Asked mother if client had passed out from vaccines before; mother stated client never fainted from vaccination before but has had 3 prior syncopal episodes. Mother stated mother and client's brother also are prone to syncopal episodes. Asked mother and client if client had breakfast before coming. Mother stated client had a banana on the way to the immunization clinic, did not have any other intake this morning. Mother also stated that client exercised this morning by riding bicycle. At 0956, checked vitals. Heart rate 89, automatic wrist blood pressure right arm 84/45 lying, manual blood pressure right arm 100/50 lying, O2 SAT 98% room air, eyes PERRLA bilaterally. Skin color pink, warm and dry. Client attempted to sit up but color paled from face and unable to tolerate so returned to lying with legs elevated. Skin color returned to pink. At 0959, client wanted to try sitting, moved to sitting. Color paled from face and unable to tolerate so returned to lying with legs elevated. Skin color returned to pink. At 1002, client wanted to try sitting, moved to sitting. Skin color remained pink and client able to tolerate. Client stated feeling tired and posterior head as only location of pain. At 1006, assisted client to standing, able to tolerate. Nurse and mother escort client from clinic lobby to private vehicle. Instructed mother to not have client fall asleep until evaluated by physician.
Patient called me at the pharmacy on 08/24/2021 after receiving the Pfizer vaccine the day before. He reported "rash on face and itchiness on face and neck" the day after receiving the first dose of Pfizer. I asked him to see a doctor regarding his reaction and unsure if he has yet.
Very sore arm for two days after initial injection.  I felt warm but no high fever.  I also felt like I had very low grade flu symptoms for about a day and a half (i.e. body aches and pains).
This spontaneous report was received from a register nurse concerning a 5 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 05-MAR-2014, the patient was vaccinated with M-M-R II (route was not reported) lot # J006954, expiration date 07-JUN-2015. Co-suspect and concomitant therapies were not reported. The register nurse reported that M-M-R II went through a supported temperature excursion; however 10 doses of M-M-R II were overlooked because they were stored in the fridge. These doses were administered to 10 patients, this case pertain to one of them who had not received repeat dose to date. The case is liked to 1404USA001099, 1404USA001100,  1404USA001101, 1404USA001102, 1404USA010165, 1404USA014293, 1404USA014294, 1404USA014295, 1404USA014296, 1404USA014297, 1404USA014298, 1404USA014299 and 1404US14301.   Additional information has been requested.
After the RotaTeq does at 6 month visit, baby had diarrhea for 24 hours then frequent mucous poops, diaper rash, and eczema for 2 weeks until switching to dairy-free formula. Baby was fed dairy based formula for 2 months before the vaccine without gastrointestinal and eczema issues.  The mucous poop stopped immediately when baby was fed soy formula while the eczema persisted.  After 1 week on soy formula, tried the cow milk based formula again and the mucous poop every 2 hours resumed.  Tried extensively hydrolyzed formula (hypoallergenic) and that solved both gastrointestinal and eczema issues.  Baby is still on the hypoallergenic formula now at 8 months old.