chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Severe Fatigue; Fever; Chills; Severe Fatigue; Could not sleep; Muscle  ache; Chills; Low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), MYALGIA (Muscle  ache), the first episode of CHILLS (Chills), PYREXIA (Low grade fever) and FATIGUE (Fatigue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 025J20-21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided by reporter.  Concomitant products included TRAZODONE and SERTRALINE for an unknown indication.   On 05-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MYALGIA (Muscle  ache), the first episode of CHILLS (Chills), PYREXIA (Low grade fever) and FATIGUE (Fatigue). On 09-May-2021, the patient experienced INSOMNIA (Could not sleep). On 09-May-2021 at 12:00 PM, the patient experienced the first episode of PYREXIA (Fever), the second episode of CHILLS (Chills) and the first episode of FATIGUE (Severe Fatigue). On 19-Jul-2021, the patient experienced the second episode of PYREXIA (Fever), the third episode of CHILLS (Chills) and the second episode of FATIGUE (Severe Fatigue). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. On 24-Mar-2021, PYREXIA (Low grade fever) and FATIGUE (Fatigue) had resolved. In May 2021, INSOMNIA (Could not sleep) had resolved. On 20-Jul-2021, last episode of PYREXIA (Fever), the last episode of CHILLS (Chills) and the last episode of FATIGUE (Severe Fatigue) had resolved. At the time of the report, MYALGIA (Muscle  ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Added Patients demographic includes patients height, weight, Ethnicity, Treatment medication, event insomnia and Outcome updated for events from Unknown to recovered / resolved and narrative was update accordingly.
The injection site is itchy, red, and hot to touch. I have a small bump that feels like a mosquito bite and a rash that is about 3 inches in diameter around the site.  I must have been scratching at this spot without realizing what I was doing. I plan to take some Benedryl tonight and I will monitor the size of the spot and the amount of itchiness I am feeling.
Large reddened area below vaccine site and is still there. Hotter than other arm Itches
The patient passed out after the second vaccine (HPV vaccine) and had to lay down for over an hour due to dizziness.
pt recv vax 10OCT97 & approx 2-3hr later devel hives & SOB;
Moderate sharp chest pain and chest tightness a few hours after vaccination and it lasted for hours. Then over the next 2-3 weeks, chest pain, chest tightness, and shortness of breath became more frequent, longer duration, and more severe. On 2/6/2022, these symptoms became severe and it was in the ER 6 times. Two of those times were sent by ambulance by my doctors at their offices. I was eventually hospitalized from 2/11 to 2/15/2022 for severe neuropathic pain in the chest and difficulty with breathing. A few doctors believed it was immune mediated hypersensitivity to covid vaccine that resulted in nerve inflammation of my chest. After discharge from the hospital, I am on 9 medications and still have chest pain and difficulty with breathing. Initially, I couldn't eat without shortness of breath. Now I can't talk for a more than a few minutes or walk for more than a few steps without struggling for air. I'm mostly bedridden because of it.
Case received from a healthcare professional on 13 and 14-Sep-05 (MIS/VIS reference numbers # 05-0449 and 05-0451).  A 37-year-old female patient, with no relevant medical history, had received an injection of DECAVAC (lot # U1596AA, on left deltoid) on 06-Sept-05 and 1 day later, she complained of fever, headache, arm edema, warmth, arm pain and injection site pain.  There is no rash.  It was reported that the vaccine was given with a 1" needle.  The patient did not receive any treatment.  The patient recovered on 12-Sep-05.
Once again I seem to have developed Covid arm. I have intense pain in my upper arm muscles, making it uncomfortable to move it, sleep on it and just go about my day. After my first round of Moderna vaccines I developed Covid arm that lasted for about 6 months. I wasn't going to get a booster out of fear of that happening again, I only did because my coworker is going through chemo right now.
It started back in May; I went for an eye exam Feb2021. By May I was having a hard time reading the street signs. I then reached out to my doctor for my eyes on July 9th. I went to see the doctor and they did the Cataract surgery and Lasik surgery in the same day. Since these surgeries I have been able to see 20/20 vision. It all happened so fast I went from having the doctor telling me I had the beginning signs of cataract to being force to get the surgery as soon as possible.
Initial report received from a physician on 15 November 2013. A 10 month old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (Lot number U4693CA) intramuscularly (administration site: Right thigh) on 29 October 2013 and also received DAPTACEL (lot # C4454AA) intramuscularly (administration site: Left thigh) on 29 October 2013. Patient had oral thrush at the time of vaccination. Mother claims child developed diarrhea on 30 October 2013. Mother took child to ER because office was closed and claims the ER Dr stated the diarrhea was due to eggs in the vaccine. Child has no established egg based food issues/allergies. Mother was instructed to bring child in to physician next day 31 October 2013 and did not return for physician evaluation for 2 weeks claiming child still had watery stool. Based on physician evaluation patient was not dehydrated nor had any weight loss. Physician is supposed to see patient again Monday 18 November 2013. Corrective treatment was not reported. At the time of this report the event outcome was unknown. Documents held by sender: none.
pt vax 3times w/ hepta B. after each dose pt ex. dyspepsia, abdo cramps, & diarrhea. sx remitted spontaneously on each occasion.
Reaction started day of injection and progressively getting worse. Redness, swelling, warm, tender around vaccination site and encompassing upper arm area.  She was using cold packs. I also advised Benadryl 25mg stat and bedtime.  Informed her PCP.
red and raised spot-on skin that is 1 1/2 diameter.  Warm to touch and tender.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 12:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) 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 61.37.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM, 10 AM, temperature was 34 and 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021. On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30 January 2020). On 23rd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th February 2018, 1 days after receiving SHINGRIX, the patient experienced shingles and painful rash. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles and painful rash were recovering/resolving. The reporter considered the shingles and painful rash to be probably related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that, on the pre vaccination form, the patient did answer yes to steroid treatment with the last 3 months. The reason was not known. The HCP believed, the patient had completed that treatment approximately 2 months ago. No other known medication or medical history was significant for the patient. The patient did not experience a previous outbreak of Shingles. On 23rd February 2018, at 11:30 hours, the patient received SHINGRIX on right deltoid. The patient developed a painful rash down one side of her back. The patient visited her doctor (date unknown) and was diagnosed with Shingles. The patient was prescribed with Valacyclovir.
Pt. given Sanofi Pasteur -FLUZONE- lot#UH729AB exp. 6/30/2013 flu vaccine in right deltoid via IM route on 12/18/2012. Next day experienced extreme vertigo causing nausea. Immediately went to ER, while in ER experienced hearing loss of right ear. Discharged home with appointment to see ENT specialist, specialist informed pt. that he has had 3 other incidents r/t to Flu vaccine this season. Pt. was given steroids, continues to take meclizine and ZOFRAN. Prednisone has partially reversed hearing loss.
pt recvd vax & devel upper-respiratory symptoms with congestion & wheezing; oxygen was continued; cause of death was acute coronary insufficiency;
Vaccine was administered to patient under the age indicated of 18 years and up. Patient was 17 years old and reports no symptoms at this time or any adverse side effects.
After receiving vaccine, patient went out to dinner & started to feel cold. She felt extremely cold thru the night & was shaky. In morning she felt very tired. Lack of sleep (??).
Localized reaction to flu vaccine at site of injection-discoloration, edema, soreness extending under the arm. Treatment: ice packs prn, Benadryl 50mgm q 4-6 hrs prn.
Had first dose of Shingrix. Two months later to complete the series. 3-4 days after vaccine, started itching all over her body. Still having continuing itching. Is not taking any medicines just antiitch medicine. Pharmacist recommended Benadryl, feels better but still has the itch.
GENERAL MALAISE; TIREDNESS; This spontaneous report received from a consumer concerned an 84 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced general malaise. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and general malaise was not reported. This report was non-serious.
Information has been received from a physician concerning a 6 year old female who on 20-NOV-2007 was vaccinated subcutaneously in the left arm with ZOSTAVAX (lot# 658605/1089U) instead of varicella virus vaccine live (Oka/Merck). The office indicated they have a refrigerator for the pediatric vaccines and a refrigerator for the adult vaccines. On 20-NOV-2007 someone in the office moved the pediatric vaccines to the adult refrigerator. The medical assistant (MA) did not realize this and did not look clearly at the vial to see it was ZOSTAVAX and not varicella virus vaccine (Oka/Merck). The MA states this was clearly a staff error only. Additional information has been requested.
Fever (104 F), chills, whole body aches, extreme vertigo, diarrhea, vomiting. Nurse advice was to stay home and rest, hydrate. Most symptoms went away by 8 pm on February 3, 2021.
administered the Dtap and Polio portion but forgot the ActHib; transfer button was not working; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who was administered the Dtap and polio portion but forgot the ActHib (Preferred term: Product preparation issue) and transfer button was not working (Preferred term: Device issue), while he/she received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment, vaccination and family history were not provided.   No concomitant medication was reported.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, it was reported that the patient was administered the Dtap and polio portion but forgot the ActHib (Preferred term: Product preparation issue) and transfer button was not working (Preferred term: Device issue).  The event outcome was reported as not applicable.
Around 10:45am on July 6, 2018  I started noticing red bumps appearing on my skin. As the day went on there were more and more bumps and they started to look worse. At 3:30pm I called my doctors office where they put me on hold for 15 minutes then was told by the front office to take a Benadryl. I told them I didn't know if I could take Benadryl because I have asthma so they directed me to urgent care. I had to leave work to go to urgent care where they confirmed I could take benadyrl and they also gave me a shot of dexamethasone and another shot for the itching. Urgent care also informed me that I was supposed to have gotten a paper with information about the shot and possible side effects and how to report it if something goes wrong and the doctors office never gave me this paper. Urgent care then said if it gets worse to go to the emergency room. Saturday July 7, 2018 my rash was much worse so I went into urgent care where I was evaluated and told to keep taking Benadryl and was also prescribed a 5 day course of Prednisone and  famotidine. Sunday July 8, 2018 my rash started to look better but it is still present as of 2:30pm on Monday July 9, 2018
Cough, pale, diaphoretic, non-verbal, dry heaved. Evaluated by EMS, cleared.
They could not think clearly; Brain fog; Feeling very cold; Their arm was really sore; Did not feel themselves; Felt confusion in their brain; Unrelated left hand injury; Muscle aches; Feeling tired; Body pain; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of THINKING ABNORMAL (They could not think clearly), FEELING ABNORMAL (Brain fog), FEELING COLD (Feeling very cold), PAIN IN EXTREMITY (Their arm was really sore) and FEELING ABNORMAL (Did not feel themselves) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included CLONAZEPAM for Anxiety, TRAZODONE for Sleep disorder.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced THINKING ABNORMAL (They could not think clearly), FEELING ABNORMAL (Brain fog), FEELING COLD (Feeling very cold), PAIN IN EXTREMITY (Their arm was really sore), FEELING ABNORMAL (Did not feel themselves), CONFUSIONAL STATE (Felt confusion in their brain), LIMB INJURY (Unrelated left hand injury), MYALGIA (Muscle aches), FATIGUE (Feeling tired), MYALGIA (Body pain) and CHILLS (Chills). At the time of the report, THINKING ABNORMAL (They could not think clearly), FEELING ABNORMAL (Brain fog), FEELING COLD (Feeling very cold), PAIN IN EXTREMITY (Their arm was really sore), FEELING ABNORMAL (Did not feel themselves), CONFUSIONAL STATE (Felt confusion in their brain), LIMB INJURY (Unrelated left hand injury), MYALGIA (Muscle aches), FATIGUE (Feeling tired), MYALGIA (Body pain) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient experienced some side effects that did not hurt but were disturbing because they felt a brain fog, they could not think clear, felt like high on drugs or something, did not feel themselves, felt confusion in their brain, and it was unsettling, they did not like the feeling, their brain was fuzz like a fog, a really odd feeling that lasted for 48hrs and appears 5-6 hours after receiving each dose, both times.   Treatment provided was Heating pad and hot bath.
Today 2/8/21 the Covid bullseye at the injection site appeared. The area is sore, warm to touch, slightly swollen.
Eight days after injection, I got a hard, red, swollen, itchy bump at injection site. It was a 4 inch square that was warm to the touch.
After receiving the second vaccination, a month later I realized I had pain in my left knee. It wasn't that bad at first, but the pain progressed over time until I was unable to bear it. My left knee became inflamed and sore to the touch, which prompted me to see my primary care doctor. I was given a referral for X-rays and sent to an orthopedic specialist. The diagnosis was osteoarthritis, which I never suffered from before. I looked up side effects from the vaccine, and arthritis and leg pain were listed.
Patient was given 1st vaccination shot on 03/05/21 and patient second dose was given on 3/26/21. The 2nd vaccination shot was given 7 days early.
eye is infected; face has been red; eye is swollen shut; face with pimples; face has puffed up,; This case was reported by a consumer and described the occurrence of eye infection in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 18th November 2022, the patient received the 1st dose of Shingrix. On an unknown date, 7 weeks after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced eye infection, red face, eye swelling, pimples and facial puffiness. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the eye infection, red face, eye swelling, pimples and facial puffiness were not recovered/not resolved.   It was unknown if the reporter considered the eye infection, red face, eye swelling, pimples and facial puffiness to be related to Shingrix.     Additional Information: GSK Receipt date: 09-Jan-2023. Reporter's Comment: The patient received Shingrix on left arm. The patient  stated from last few days the patient's face was red with pimples and puffed up and his right eye was infected and swollen shut. Patient also reported that he had his last Covid vaccine (unknown manufacturer) 4 weeks before his 1st Shingrix Vaccine. Patient did not have the Lot for his Shingrix vaccine. He had spoken on the phone to his Dermatologist 18 Jan 2023, and had been prescribed valacyclovir. He was an appointment with his Ophthalmologist this morning, 9th Jan 2023, to look at his eye. The reporter consented to follow up.
A non-serious spontaneous report of '2 children were each inadvertently administrated an expired dose of H1N1 LAIV as the second dose' was received from a registered nurse/health professional concerning a four-year-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in 23-Feb-2010. On an unknown date, the patient received first dose of H1N1 vaccine. On 24-Feb-2010, the patient received second dose of expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
22OCT92 830PM chills, frequent urination, fever, vomiting 2x, myalgias, fatigue, anorexia;
Burning sensation injection site and arm, high blood pressure, asthma, joint pain, muscle pain, costochondritis, insomnia, memory loss, anxiety, angry, irritable, neck rigid, nausea, numbness, tingling fingers, cramps, abdominal pain, difficulty concentrating, conjunctivitis, cough, strength loss, swelling joints, liver functional abnormality, infection, joint stiffness, anxious mood, mucous membrane disorder, libido decreased, liver abnormal, burning sensation abdomen, acid reflux, blood count strange numbers, blood count low, blood count low red, blood count low white, agitation, alopecia, alpha intrusion, amblyopia, blood anemia, anxiety, arthritis, dizzy upon standing, cyst on scalp, blood pressure high, skin turns a funny color at times, sleep problems, not feeling refreshed upon waking up, too much sleeping, stomach problems, stomatitis ulcer, night sweats, inappropriate sweating, inappropriately hot 12/28/06-records requested.  01/30/07-records received and reviewed for provided by VA. HX of epicondylitis, anger, anxiety and insomnia. blepharitis, essential hypertension, ashtma bronchial DX: PTSD, chronic, major depression. Carpal Tunnel