chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy rash on his torso, arms and legs; bumpy raised rash on his torso, arms and legs; red rash on his torso, arms and legs; fever of 101.2F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on his torso, arms and legs), MASS (bumpy raised rash on his torso, arms and legs), RASH (red rash on his torso, arms and legs) and PYREXIA (fever of 101.2F) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (fever of 101.2F). On 28-Mar-2021, the patient experienced RASH PRURITIC (itchy rash on his torso, arms and legs), MASS (bumpy raised rash on his torso, arms and legs) and RASH (red rash on his torso, arms and legs). At the time of the report, RASH PRURITIC (itchy rash on his torso, arms and legs), MASS (bumpy raised rash on his torso, arms and legs), RASH (red rash on his torso, arms and legs) and PYREXIA (fever of 101.2F) outcome was unknown.            No concomitant information was reported. Treatment details include aspirin,Tylenol ,Benadryl, cortizone cream.
A big round red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (A big round red spot at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (A big round red spot at the injection site). At the time of the report, INJECTION SITE ERYTHEMA (A big round red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-018108 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-018108:
I had gone into my doctor in December because I was sick and ended up testing positive for the flu. Now I had been positive for COVID-19 in August of 2022, but I had received my COVID-19 booster in October. When I was in for being sick with the flu my PCP noticed that my heart rate was elevated. I had come back on January 9th for an appointment that I had, and my heart rate was still up, and this was concerning to her. She did an EKG and she asked me to monitor my heart rate. I have a smart watch and I have been monitoring my heart for about two weeks and sending updates through my chart to her. This has not affected my daily life thus far but is a change. We will keep monitoring this and possibly follow up at a later time.
shot-1/25/21     Reaction  started 2/3/21 Headache, arm swelling , rash spred From Shoulder  to elbow.  Soreness in chest + arm. as of 2/10/21 arm still red and not feeling good.  Tired all the time hard to  breath when in a hurry
She was heating up as soon as they put it in the arm; She did not want to think about anything/she did not want to do anything/wanted to lay in bed/ does not wantded to sit up; Immediately nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (She was heating up as soon as they put it in the arm), FEELING ABNORMAL (She did not want to think about anything/she did not want to do anything/wanted to lay in bed/ does not wantded to sit up) and NAUSEA (Immediately nauseous) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced FEELING HOT (She was heating up as soon as they put it in the arm), FEELING ABNORMAL (She did not want to think about anything/she did not want to do anything/wanted to lay in bed/ does not wantded to sit up) and NAUSEA (Immediately nauseous). At the time of the report, FEELING HOT (She was heating up as soon as they put it in the arm), FEELING ABNORMAL (She did not want to think about anything/she did not want to do anything/wanted to lay in bed/ does not wantded to sit up) and NAUSEA (Immediately nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: increased (High) Body temperature rose..         Concomitant product use was not provided.  The symptoms were worse and lasted longer compared to first shot. The paramedic made the patient to sit half and hour before she drove to home.  Treatment information was not provided.   This case was linked to MOD-2021-342936 (Patient Link).
having pain in his shoulder; This is a spontaneous report received from a contactable consumer (patient himself) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain in his shoulder on an unspecified date, he is asking if he can take the cortisone injection before his 2nd dose this Saturday. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Feeling feverish (but not actually running a fever), sweaty, tired -- started day after shot, and continued through next day.  On day 3 still feeling tired, but not feverish or sweaty.
Severe muscle aches throughout body, severe headache, fever, sweating, severe fatigue.  Duration was about two days.
Headache, Sedation, Myalgia, Arthralgia, Fever, Pain @ injection site Narrative:  Other Relevant History:
Information has been received from a registered nurse concerning a 77 year old retired female with no drug allergies who had an initial outbreak of herpes zoster about 6 months ago who on 10-JUL-2007 was vaccinated with a 0.5mL SC dose of varicella virus vaccine live (Oka/Merck) (lot # 656078/0169U) in the deltoid instead of zoster vaccine live (MSD). There was no illness at the time of vaccination. The wrong vaccination was given because of a "staff error." No adverse event was reported. Unspecified medical attention was sought. No lab diagnostic studies were performed. The patient's recovery status was unknown. Additional information has been requested. Follow-up information received from a registered nurse stated that this was a medication error. She stated that it had nothing to do with the packaging or storage conditions or indications. She stated it was caused by the healthcare professional doing insufficient checks. She reported that the patient did not have any concurrent conditions such as being immunocompromised or receiving chemotherapy or corticosteroids.
No adverse events; second shot was administered too soon. patient received first shot on 1/8 and failed to mention that and got another shot on 1/14
No issues with the first or second vaccine but with booster shot experienced onset of anaphylaxis 10 hours post.  Swelling and difficulty with breathing.  Went to the emergency where i was  administered IV anti-histamine and prednisone
Swelling of throat, tightness of chest, hoarse voice, cough - felt like asthma attack for 4 plus hours.
Initial information received on 21-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 75-year-old patient (gender not reported), who was vaccinated with 0.5 ml two doses of MENACTRA (batch number: U5984AB, expiry date, dose in series and route administration was not reported) in one of each arm on 21-Jun-2018 at 11 AM. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to extra dose administered and inappropriate age at vaccine administration because a 75-year-old patient received MENACTRA dose given twice. Patient was visited to the emergency room. It was unknown if any adverse event occurred or not following the vaccination. Patient was initiated on drug SOLIRIS as corrective treatment. 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. List of documents held by sender: none.
Listless, lack of concentration, feeling cold violent shaking, elevated pulse rate, vivid unusual, weird nonsensical dreams. No fever. Did not feel right the next day.
Right arm had a mild rash at least 5 inches below the injection site. It has lasted about 6 days. The patient stated it was itchy at first, but isn't now. There is just a small patch of redness of the skin.
Open heart surgery/Triple vessel bypass graft; Felt a little iffy after Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CORONARY ARTERY BYPASS (Open heart surgery/Triple vessel bypass graft) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CORONARY ARTERY BYPASS (Open heart surgery/Triple vessel bypass graft) (seriousness criterion medically significant) and IMMUNISATION REACTION (Felt a little iffy after Covid vaccine). At the time of the report, CORONARY ARTERY BYPASS (Open heart surgery/Triple vessel bypass graft) and IMMUNISATION REACTION (Felt a little iffy after Covid vaccine) was resolving.            No concomitant medications were reported. It was unknown if the patient was enrolled in a COVID-19 vaccine Trial. Patient was felt iffy after the COVID vaccine and it was about for a day. No treatment medications were reported.  Company Comment: This spontaneous case concerns an adult male patient with unknown age with no reported medical history who experienced the unexpected serious event (important medical event) of Coronary Artery Bypass. The event Coronary Artery Bypass occurred on unknown date after a dose of mRNA-1273. Outcome of the event was resolving.  Adult male and co suspect adalimumab remains a confounder. Non serious event of Immunisation Reaction was also reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with unknown age with no reported medical history who experienced the unexpected serious event (important medical event) of Coronary Artery Bypass. The event Coronary Artery Bypass occurred on unknown date after a dose of mRNA-1273. Outcome of the event was resolving.  Adult male and co suspect adalimumab remains a confounder. Non serious event of Immunisation Reaction was also reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient c/o very sore left arm. she states that she can't lift it without pain.
Nausea 7:30 pm -> until treated at ER; Diarrhea  7:45 pm -> until treated at ER; Inability to get standing 8:15 pm; near fainting  8:15 pm; breathing difficulty 8:15 pm.
Information has been received from a nurse practitioner concerning a female patient who on 11-MAY-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number 663209/1157X, expiry on 08-MAR-2012). On 12-MAY-2011, while on PNEUMOVAX 23, the patient had a large baseball-sized knot around the injection site. The nurse practitioner advised that this was not an allergic reaction. It was also reported that therapy was discontinued on 12-MAY-2011. The patient's a large baseball-sized knot around the injection site persisted. The patient sought unspecified medical attention. Additional information has been requested.
Over 42 days between 1st (08/26/2021) and 2nd dose (01/17/2022).
Information has been received from a nurse practitioner concerning a 5 year old male who was vaccinated SQ with a 0.5ml dose of varicella virus vaccine live when he was younger. There was no concomitant medication. On 8/16/04, the patient presented to the office with herpes zoster. The patient was given Acyclovir as treatment and sent home. No product quality complaint was involved. The nurse practitioner also reported another patient (WAES0409USA01767) who experienced herpes zoster after vaccination with varicella virus vaccine live. Additional information has been requested.
pt recv vax; pt's mom said a scratch appeared on pt's face a couple of hr p/ vax; few hr later, scratch disappeared;
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Excursion vaccine was administered to patient) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered from vaccines that experienced a T excursion). On 18-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Excursion vaccine was administered to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Excursion vaccine was administered to patient) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Storage condition at the time of the excursion was reported as refrigerator. Maximum temperature reached was reported as 64°F. Excursion duration was reported as approximately 7 hours. Date vial moved from freezer to refrigerator was reported as unknown. They were returned to the refrigerator. No changes on visual inspection noting vaccine state. At the time they were unpunctured. The patient not had any adverse events post injection. No treatment information was reported.
Developed right arm pain, several hours, post vax. Arm (up to neck and down to waist) became very painful and sore. Woke up during the night in a cold sweat. This morning, feels itchy all over and her "skin hurts". States she is having difficulty speaking although she was able to be interviewed for this report. Instructed to take ibuprofen 200 mg q 6 hours X 24 hours and apply ice to right arm and call if not improved.
Woke up at 2:20 am the next morning with uncontrollable shivers. It took 45 minutes to stop shivering but I remained cold in the morning at wake up. I had headache and flu like muscle/joint pain. I was light headed and a bit off balance with no appetite. It is now over 12 hours since onset of events and I still have strong muscle/joint pain but no longer any shivers.
I started feeling sick to my stomach about 3 hours after I got the 2nd vaccine  Pfizer.  In the middle of the night I started vomiting. I ended up throwing up 5 different times (starting around 1 am and ending around 8 am). My stomach hurt for the next 24 hours but I did not vomit after that.
dizzy, red neck and arm. Next day - tired, body aches, headache - lasted 3 days, itchy skin, BP was elevated, chest heavyness, racing heart all symptoms lasted for 2 to 3 weeks. Seventh day full body rash, neck, ears, chest, arms, legs, swollen right ear and psoriasis was flared up badly.
Fever of 101.7 F resolving 01/28/2021 around 3pm.  Muscle aches, malaise. Better on 01/28/21 Nausea and vomiting started on 01/2721, required IV fluids on 01/28/2021 at approximately 4:30am. Feeling better this afternoon 01/28/2021.
loss of words, loss of eye contact, inc toe walking, hand flapping;inappropriate laughing, temper tantrums biting of clothing, repetition of words-no meaning;tx vitamin B-minerals;dx autism M.S.D.D.;
Joints locked; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 08:30 (Lot number: FG3527) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes - Type II" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: If covid prior vaccination Yes. The patient took concomitant medications for Diabetes in two weeks. Past drug history included: Iodine, reaction(s): "Allergy".Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  The following information was reported: JOINT LOCK (disability) with onset 01Nov2021 08:30, outcome "recovered with sequelae", described as "Joints locked". The event "joints locked" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of joint lock included muscle relaxer/pain meds in ER. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care, disability or permanent damage. Clinical course: Joints locked up momentarily with 1st dose for about 2 min. 2nd dose, joint lock far more severe. Required ER visit which turned out to be a strained muscle patient was assumed that it cause by the lock-up. Joint pain and stiffness has lingered to this day.  No follow-up attempts are possible, no information is required.
24 hrs post injection pt experienced redness, swelling, pain and itching greater than 100 mm below injection site. (down to elbow) Pt also experienced full body muscle aches. Treated with MOTRIN and ice. Consulted GSK and advised to continue treatment with ice, MOTRIN and BENADRYL and to monitor for fever and worsening of reaction.
PNEUMOVAX 23 - 9/6/17 - 9/7/17 - 1/2 upper arm red, edema, sl. warm to touch, aches. Given AUGMENTIN, MEDROL DOSEPAK, cool compresses, ADVIL.
Pt received vaccines on 7/3, on R deltoid received pneumococcal vaccine. Presents to clinic today with CC of 'rash' with redness and pain at injection site of R deltoid. Pt was concerned so was seeking advice. Denies fever, chills, SOB, chest pain. Plan: Ice area 20 min on and 20 min off. Take Benadryl PRN. Advised if redness, warmth or pain extends from the marked circumference to RTC ASAP for re-evaluation. Advised pt that is fever, chills, SOB, chest pain or any new symptoms develop to come into clinic ASAP. Pt advised she can walk in at any time. Reported understanding and declined further questions or concerns.
feel ill; fever of 100.3; hot flashe; Very tired and could not stay woke that morning.; I had body aches; chills; fever 100; joint pain (knees/elbows/R-shoulder); R-shoulder pain when reaching & lifting above my head.; Body aches; Itchy; fatigue,; Chills; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy), HOT FLUSH (hot flashe), ILLNESS (feel ill), FATIGUE (fatigue,) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Septra), Allergy to antibiotic (Erythromycin), Drug allergy (Vicodin), Allergy to antibiotic (Clindamycin) and Allergy to antibiotic (Cephalexin). Concomitant products included BIOTIN for Hair disorder NOS and Disease of nail, unspecified, ASCORBIC ACID (VITAMIN C ACID) and VITAMIN D NOS for Immunisation, TURMERIC [CURCUMA LONGA RHIZOME] for Inflammation, FISH OIL and CHONDROITIN, GLUCOSAMINE SULFATE (GLUCOSAMIN + CHONDROITIN) for Joint inflammation.    On 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced PRURITUS (Itchy), FATIGUE (fatigue,) and CHILLS (Chills). On 23-Jun-2021, the patient experienced MYALGIA (Body aches). On 24-Jun-2021, the patient experienced PYREXIA (fever 100), ARTHRALGIA (joint pain (knees/elbows/R-shoulder)) and ARTHRALGIA (R-shoulder pain when reaching & lifting above my head.). On 02-Aug-2021, the patient experienced HOT FLUSH (hot flashe), FATIGUE (Very tired and could not stay woke that morning.), MYALGIA (I had body aches) and CHILLS (chills). On 10-Aug-2021, the patient experienced PYREXIA (fever of 100.3). On an unknown date, the patient experienced ILLNESS (feel ill). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Myalgia, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy), FATIGUE (fatigue,), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (fever 100), ARTHRALGIA (joint pain (knees/elbows/R-shoulder)) and ARTHRALGIA (R-shoulder pain when reaching & lifting above my head.) had resolved and HOT FLUSH (hot flashe), ILLNESS (feel ill), FATIGUE (Very tired and could not stay woke that morning.), MYALGIA (I had body aches), CHILLS (chills) and PYREXIA (fever of 100.3) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Body temperature: 100 (High) 100. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         It was stated that approximately August 4 or 5 patient took a Covid test  The test was negative.    This case was linked to MOD-2021-207616 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Significant FU appended. New events are added which includes i.e., Illness, fatigue, myalgia, hot flush, chills, pyrexia. Lab data updated i.e., Covid-19 test negative.
Pt called saying he had hives on his chest & stomach, but no itching. Asked him to take CLARITIN/ZYRTEC.
Client called into clinic today and reported that she received Tdap and MMR vaccines on August 12, 2014 to her left arm. Starting Sunday August 17 she's been having swelling under her left arm and slight irritation that comes and goes, no fever hsa been reported.