chrisvoncsefalvay/vaers-outcomes huggingface dataset:
?On 27AUG21, the first dose of the Moderna COVID Vaccine was administered in the left shoulder of a 45 y/o with a medical history consistent with only Rheumatoid Arthritis (RA) in which she takes weekly methotrexate injections and daily oral hydroxychloroquine.  She had no immediate reaction, waited the 15 minutes in the waiting area, and subsequently returned to work in the clinic.  Shortly after this, she started to feel tightness in her left forearm, which she attributed to her RA.  This eventually progressed to tightness in her left upper arm, left deltoid, and left trapezius muscle with her head deviating to the left side followed by left neck and left upper arm numbness.  She then experienced tightness within her left jaw and returned to the COVID vaccine clinic.  There she received multiple ice packs directly over the injection site on her left deltoid and behind her neck.  After approximately 60-90 minutes her sensation improved and the tightness slowly resolved and her head returned to midline.   She had no other symptoms and her cardiopulmonary exam was within normal limits.  She left the COVID clinic in stable condition and was advised to go to the Emergency Room if there were any changes in her clinical presentation.?
I developed Shingles on my right arm  about 2 weeks after receiving the Moderna Vaccine. I did not know at the time if there was a correlation, but I am a pharmacist and I have heard about several others getting the Shingles after receiving their Moderna Covid vaccine. t. I was treated with Valacyclovir.  The treatment was helpful but the Shingles were very painful. I have spoken to several other pharmacists who have also seen this happen to some of their patients and/or family members.
24 hours later, left arm (from just below shoulder to just above elbow) was red, hot, hard and itchy.  Parent applied cold compress and gave Benadryl. Visit to physician the next day.
This spontaneous report as received from a unspecified reporter refers to a 4 year old female patient. Medical history and concurrent conditions were not reported. On 16-JUN-2014, the patient was vaccinated with MMR II in the right upper thigh, lot # reported as J009885 (dose and strength were not reported). These vaccines were out of range temperature and the vaccines had been administered to patients. Additional information has been requested.
body aches; high fever; fatigue; muscle ache; extremely fatigued; very exhausted; headache; no appetite; while he was driving back home from work, he had to pull over to the side of the road to sleep for about 30 minutes; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (no appetite), SOMNOLENCE (while he was driving back home from work, he had to pull over to the side of the road to sleep for about 30 minutes), PAIN (body aches), PYREXIA (high fever) and FATIGUE (fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced DECREASED APPETITE (no appetite), SOMNOLENCE (while he was driving back home from work, he had to pull over to the side of the road to sleep for about 30 minutes), PYREXIA (high fever), FATIGUE (fatigue), MYALGIA (muscle ache), FATIGUE (extremely fatigued), FATIGUE (very exhausted) and HEADACHE (headache). On an unknown date, the patient experienced PAIN (body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (no appetite), SOMNOLENCE (while he was driving back home from work, he had to pull over to the side of the road to sleep for about 30 minutes), PAIN (body aches), PYREXIA (high fever), FATIGUE (fatigue), MYALGIA (muscle ache), FATIGUE (extremely fatigued), FATIGUE (very exhausted) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) fever-102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
went home & slept about 1, became irritible & began to scream; thus was followed by a time when couldn't get enough air through mouth though could breathe well through nose, lasted 10 mins & repeated 3 times; pt tone dec
received this vaccine, had shingles/ suspected vaccination failure; shingles; painful; feel bad enough to stay in bed and feel yucky; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and feeling bad. On an unknown date, the outcome of the vaccination failure, shingles, pain and feeling bad were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles. It was so painful.  The patient stated he/she had friendly suggestion, definitely felt like received this Shingles vaccine. The patient stated he/she, made feel bad enough to stay in bed for one day and feel Yucky another day. The patient stated he/she really did not ever want shingles again, so might be this would work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Moderna COVID-19 Vaccine EUA Red rash around injection site (oval patch  approximately 3.5x2 inches) very itchy and tender skin.  Appeared on day 7 after vaccination and growing larger the following day/s.  No relief with hydrocortisone cream 1%.
Patient, with no previous heart issues, suffered a massive heart attack on 10/22/2021.
Day after immunization patient states she had hives and burning sensation in face and a rash from the neck to belly. Patient brought prescriptions in from the ER on 12/17/10 patient received a MEDROL Dose pak and OMNICEF.
rt deltoid localized reaction site erythemic @ approx 100mm @ site, tender & warm w/palpation given DPH;
The patient developed severe left shoulder pain.  went to orthopedics, had PT, had cortisone injection.  None of these helped.  She continued with pain and MRI was performed and showed signs concerning for osteomyelitis as well as severe inflammation of tendons, muscles, ligaments.  Biopsy of the bone was negative for infection.  She will be undergoing a total shoulder replacement this month.
ARM PAIN, CHILLS, FATIGUE, LIGHTHEADEDNESS, NAUSEA Narrative:
Employee advises that he was diagnosed with a Pulmonary Embolism the first week of November Narrative:
After I went to bed on Nov 24th, I noticed I was very itchy and my right leg ached. I was vaguely remembered something like that happening about a week after my first or second Moderna shot so I didn't think much of it. However on the 25th the itchiness continued. Eventually it became severe enough that I looked in the a mirror and was shocked at how red my skin was. The rash seemed to move around my body, coming and going. By evening it wasn't just red but raised welts and painful. I could even feel welts in my ear canals. The skin on the back of my head and neck felt weird and stiff.  I went to urgent care the next day. The provider there didn't know what caused it and did not believe it is related to the vaccine, and gave me a steroid shot and prescriptions for oral steroids and antihistamines. By that evening the itchiness has spread to the palms of my hands and bottoms of my feet. However the sensation was less painful and itchy and I was able to sleep.  The next day I didn't feel itchy, however my skin was very prone to getting red where touched. This continued even after I ran out of steroids after 10 days. I saw a dermatologist who was convinced it was from the vaccine, doesn't want me to get any more covid shots, and urged me to see an allergist. I will be seeing an allergist on 12/20/21. In preparation for this I stopped taking the antihistamine on 12/13 and the itching has become quite severe again but the welts are not as bad.
patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) 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 (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022).    Concomitant medications were not reported.  They reported their beyond use date was on 12-Dec-2022 but they discovered it on 17-Dec-2022. This case contains information for the patient 2 out of 10 adult patients. Treatment medications were not reported.
Around three hours after the vaccination, fatigue became very noticeable it was quickly followed by a headache. My tonsils begin swelling and became painful as well and it was easily noticeable when examining my neck, throat and face. An hour or so later experience nausea but not vomiting. There was also some difficulty breathing. I was also unable to swallow normally due to severe pain in my tonsils and head.  I had set out on what was supposed to be a 3 Hour drive back to where I was staying, but was unable to drive for much longer than 40 minutes before I became too debilitated for such a long trip. I ended up sleeping in a parking lot due to being unable to function. My jaw pain and headache joined together and I could  open my jaw any wider than enough to put a straw between my lips;  an hour or so later I could not eat nor drink and begin crying loudly and uncontrollably, which has never been typical of my behavior.  Fortunately I was not traveling alone and do not completely remember all of that two days following the data vaccination, but I cried pretty much straight through the first 48 hours and I just remember being in a lot of pain and could not  control myself emotionally nor  manage the pain. After the first 48 hours, I was severely drained and a little bit dazed. I could not remember a lot at the time that passed after the vaccination. I later found out that I had had a stroke.  The medical facility still wanted to give me the second vaccination one month later.
My Son is 17 years got his 1st moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My Son is 17 years got his 1st moderna dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My Son is 17 years got his 1st moderna dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My Son is 17 years got his 1st moderna dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Reporter did not allow further contact
Brawny edema of face, quite intense. Ruled out superior vena cava syndrome, blood clot and malignancy. Dermatology consult identified no specific etiology. Treated symptomatically with fluid removal. Recently vaccinated with influenza. 60 day follow-up dated 09/27/00 provided no additional data.
Received flu vaccine at 8:00 a.m. At approx. 9:15 a.m. my heart started racing in to 140s, this lasted about an hour. Approx. 10:15 a.m. heart rate came back down to around 100-110 ans started palpitating, this lasted about 3 hours til 1 pm. It felt like my heart was a bowl of jello, it felt like it was jiggling. Through this 3 hours I felt chilled, shaky and tired. My bottom lip lip felt tingly and slightly swollen. I felt slightly wheezy but not enough to use an inhaler. I had no difficulty breathing or swallowing. Also, from 11 a.m. to 12:30 p.m. my bladder filled to the point of being uncomfortable and I urinated a very marked amount 3 times, marked for me because I do not urinate that often and I hadn't drank any more fluids than is ordinary for me.  I did not know until I searched the internet after all this stopped that racing heart is listed under "severe allergic reaction" on the CDC website and that was something I should have gone to the ED for.  On 10/18 the site was very sore, red, warm & started itching.  On 10/19 the site was still sore, pink, warm & itching intensely, also coughing up green gunk (I had no cough or production previous to the vaccine)  On 10/20 there was a little discomfort at the site but still itching but less intensely, no more coughing or production  On 10/21 a little discomfort at the site with slight itching  On 10/22 all symptoms gone
Severe pain in injection arm that makes it hard to lift arm. MD visit with steroid shot and physical therapy for affected arm.
Cough, fever, shortness of breath, dizziness, loss of taste and smell, exhaustion, fatigue
Reporter states a number of c/o regarding intensity of local reacts w/1 lot# during 1 mo JUN93; pt seen @ clinic 4 days following vax w/exacerbated local response; pt recovered;
Improperly stored administered VARIVAX; No additional AE details provided; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # S032356 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 14-OCT-2021) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 9.6° Celsius (C) for 80 minutes respectively.  If a digital data logger was involved was not reported; varicella virus vaccine live (oka/merck) (VARIVAX) did not experience a previous temperature excursion.  No adverse event reported.
pt died 18MAY93 p/2 day hx of vomiting & fever;
Body aches, high fever, chills, diarrhea, headache, dizziness, nausea.
HIVES APPEARING ON UPPER TORSO/HIVES APPEARING ON NECK; FAINTED ON THE FLOOR; EPISODE OF NAUSEA; HEADACHE; FEVER; TIREDNESS; MUSCLE ACHES; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies, migraine (taking medicines as needed), sulfonamide allergy, penicillin allergy, alcohol user (rarely), and non smoker. The patient experienced drug allergy when treated with ciprofloxacin, levofloxacin, and nitrofurantoin for drug used for unknown indication. The patient had allergy to many medications and usually had side effects that happen to a few number of people. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, 1 total, administered on 04-AUG-2021 at 15:20 into left arm for prophylactic vaccination. Concomitant medications included montelukast for allergies.  On 04-AUG-2021 in the evening (8 to 9 hours after vaccination), the patient experienced headache, fever, tiredness, muscle aches and nausea. Within 24 hours of getting the vaccine, the patient had an episode of nausea. On 05-AUG-2021, the patient experienced dizziness and then fainted on the floor. Most of her general side effects went away within 24 to 48 hours. On 09-AUG-2021 (Monday evening), the patient experienced hives appearing on upper torso and neck and the patient thinks that it might be related to the vaccine but not sure if it could be something else. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from episode of nausea, headache, fever, tiredness, and muscle aches on AUG-2021, had not recovered from hives appearing on upper torso/hives appearing on neck, and the outcome of fainted on the floor was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210823298- covid-19 vaccine ad26.cov2.s -Fainted on the floor. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient received vaccination at approximately 10:30am, she said she had a feeling of itching without hives about 2 hours later. She took BENADRYL and itching subsided, she called pharmacy to advise of reaction.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions
Numbness fingers; Tingling sensation; Soreness of the arm after both doses; 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 HYPOAESTHESIA (Numbness fingers), PARAESTHESIA (Tingling sensation) and MYALGIA (Soreness of the arm after both doses) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness fingers), PARAESTHESIA (Tingling sensation) and MYALGIA (Soreness of the arm after both doses). The patient was treated with VITAMIN B12 NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness fingers) and PARAESTHESIA (Tingling sensation) had not resolved and MYALGIA (Soreness of the arm after both doses) outcome was unknown.            Concomitant product use was not provided.   Other treatment information included application of ice the area.   This case was linked to MOD-2021-239025, MOD-2021-239025 (Patient Link).
Patient received Moderna Covid 19 vaccine lot# 031L20A exp date 07/22/2021 0.5ml to left deltoid at 10:15 a.m. 02/12/2021. Patient was asked to wait in parking area for monitoring of adverse reaction. At approximately 10:20 a.m. officer called to nurse that patient was not feeling well. RN and LPN went to assess patient at her vehicle. Patients lips were blue pallor color and she stated that she "just felt weird and a little short of breath". No rash or swelling. Patient reports that she did not feel her throat was swelling. RN applied ambu bag to patient appropriately and LPN assisted patient with air for approximately 2 minutes. EMS contacted. Vitals assessed by RN. BP 90/55, HR 60 and normal, Resp 22. After ambu bag assistance patient reports that she is feeling much better and does not feel short of breath anymore. Lips are pink and patients respirations 18.  EMS arrived and assessed patient at this time. Patient reports feeling fine and no other side effects. Vitals taken again by paramedic. BP 124/86, HR 73 and normal and O2 sat 98%. Patient was asked to wait at site for an additional 30 minutes for monitoring with RN. Patient asked how she was feeling multiple times and she states she was fine now. Patient left site approximately 11 a.m. RN contacted patient at home on the same day at 1446 and patient states she was fine and no other reactions. No medications given at incident. Called patient on 03/01/2021 to check in with her. She states "she is doing fine and has had no other issues."
HPV given 1/27/16. Second dose. Pt seen in office for petechiae on 3/29/16 Blood test results positive for low platelets. Pt referred to Hematology with probable diagnosis of ITP. Diagnoses confirmed 4/4/16. Pt still treated by Hematology for ITP 3/1/17.
NERVE PAIN IN INJECTION LEFT SITE ARM AND MOVING THROUGH NECK AND BACK AREA WITH SEVERE HEADACHES AND PAIN UPON TOUCH WITH WEAKNESS IN EXTREMITIES UPPER BODY.
Reported about 4 hours after injection, experienced weakness, headache, difficulty breathing but not life-threatening, fever, soreness  all over on 11/2 evening. On 11/3, breathing, body temp and body pain improved 11/6/15 - alot better will follow up with MD Mon.
Lips swollen, tongue and airway swollen. Hives. Hospital prescribed steroids and Benadryl.